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510(k) Data Aggregation
(60 days)
Respironics Inc.
Medium and Large Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>30 kg) who are appropriate candidates for noninvasive ventilation.
Small Size: The AF531 Oro-Nasal SE Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>20 kg) who are appropriate candidates for noninvasive ventilation.
The AF531 Oro-Nasal SE Face Mask is designed for single-patient use in the hospital or institutional environment. AF531 Oro-Nasal SE Face Mask covers the nose and mouth while avoiding the eye region. The mask is available in three (3) sizes: Small, Medium, and Large.
The headgear options for the AF531 Oro-Nasal Masks include the four-point headgear and a CapStrap headgear.
The AF531 Oro-Nasal SE Face Mask requires use of a separate exhalation device. The mask utilizes a click-style elbow that secures to the mask hub yet can be removed by pressing the release tabs.
The document describes a medical device, the AF531 Oro-Nasal SE Face Mask, and its substantial equivalence to predicate devices, rather than a study on an AI/ML powered device. Therefore, it does not contain the information required to answer your query regarding acceptance criteria and performance studies for an AI/ML device.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample sizes used for a test set (in the context of AI/ML).
- Data provenance (country of origin, retrospective/prospective) for AI/ML data.
- Number of experts or their qualifications for establishing ground truth for AI/ML.
- Adjudication method for AI/ML ground truth.
- Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
- Sample size for a training set in an AI/ML context.
- How ground truth for a training set was established for an AI/ML model.
The document is a 510(k) summary for a physical medical device (a face mask for ventilation) and focuses on demonstrating substantial equivalence based on intended use, design, materials, and performance specifications relevant to a physical component. The "Non-Clinical Data Submitted" section lists engineering and biological performance tests (e.g., total mask leak, pressure drop, sound testing, biocompatibility), not AI/ML model performance metrics.
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(84 days)
Respironics Inc.
This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients >7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.
The Therapy Mask 3100 NC/SP consists of a minimal contact nasal mask cushion/SP: silicone pillows cushion), a two-point headgear, and a mask frame with exhalation port. The mask frame contains enclosed magnets and connects to the nasal mask cushion (NC/SP) magnetically for easy and secure assembly/disassembly by the user. The nasal mask cushion enclosed magnets and the mask frame enclosed magnets are of opposite polarity to prevent incorrect assembly of the mask. The Therapy Mask 3100 NC/SP has a pig tail tube in front mask.
The nasal cushion seals around the bottom of the patient's nose. Nasal cushion (NC) has five sizes: extra small (XS), small (S), medium (M), medium wide (MW), and large (L). The silicone pillows cushion tips seal at the entrance to the nares and the pillows cushion base sits under the silicone pillows cushion (SP) has five sizes: extra small (XS), small (S), medium (M), medium wide (MW), large (L). The headgear has one size and includes adjustment sliders to allow for a large or small fitting on the patient's head. The mask frame is one size and connects to the mask frame connects to the mask cushion magnetically for easy and secure assembly/disassembly by the user.
The Therapy Mask 3100 NC/SP has a 10 mm pig tail tube in front mask. The 10 mm pig tail tubing contains built-in exhalation at the top of the tube where the pig tail tubing connects to the pig tail tubing will also include an ISO 5356-1 compliant, 22 mm male conical swivel connector. The male connector will connector will connect directly to ISO 5356-1 compliant, 22 mm female connector used on therapy device tubing. The male conical swivel connector is detachable from the pig tail tubing, via a quick disconnect feature. When the male concector is detached, the pig tail tubing connects to 12 mm therapy device tubing directly.
The Therapy Mask 3100 NC/SP is designed to be easily disassembled for cleaning or replacement purposes. The components may be cleaned by the patient in the home (single patient - multiple use) or cleaned and disinfected by the professional in the hospital/institutional environment (multiple patient – multiple use).
The provided document describes a 510(k) premarket notification for a medical device (Therapy Mask 3100 NC/SP) and establishes its substantial equivalence to a predicate device. It does not present a study with acceptance criteria and device performance results in the context of an AI/ML medical device where performance metrics (e.g., sensitivity, specificity, AUC) are typically evaluated.
Instead, this document focuses on demonstrating that modifications made to an existing device (K231313) do not impact its safety and effectiveness compared to a previously cleared device (K210386). The "acceptance criteria" here implicitly refer to the continued adherence to established performance specifications and safety standards for CPAP/bi-level therapy masks.
Therefore, I cannot extract information related to:
- A table of acceptance criteria vs. specific device performance metrics (like sensitivity, specificity, etc.) for AI/ML models.
- Sample sizes used for a test set (in the context of AI/ML evaluation).
- Number of experts for ground truth establishment.
- Adjudication methods.
- MRMC studies or effect sizes of human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth (pathology, outcomes data).
- Training set sample size or how its ground truth was established.
The document explicitly states:
"No non-clinical and/or clinical tests summaries are submitted with this CBE submission. These labeling changes do not affect the product performance related to design outputs or specifications; therefore, additional design validation of product performance requirements was not required to implement this change."
This means that the submission is primarily for labeling changes (updated contraindications and warnings regarding magnets) and a re-naming of a component, not for a new device requiring extensive performance testing against acceptance criteria in the way an AI/ML diagnostic or prognostic device would.
However, I can extract the following relevant information based on the premise of the K231313 application, which focuses on device similarity and updated labeling:
1. A table of acceptance criteria and the reported device performance:
As explained above, this document does not present performance data in the typical sense of an AI/ML device. The "acceptance criteria" are implied by the performance of the predicate device and the claim that the current device maintains those performance characteristics. The table below outlines the comparison of key specifications between the predicate and subject devices, which serves as the basis for the "acceptance" of substantial equivalence. The "performance" is implicitly stated as "Same" across these critical parameters, indicating that the subject device performs equivalently to the predicate.
| Feature / Function | Predicate Device: Magneto Nasal Mask (K210386) | Subject Device: Therapy Mask 3100 NC/SP (K231313) | Reported Device Performance (Similarity/Difference) |
|---|---|---|---|
| Product Code | BZD | BZD | Same |
| Intended Use | This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients >7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed. | This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients >7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed. | Same |
| Indications for use | This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients >7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed. | This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients >7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed. | Same |
| Contraindications | Use of this mask is contraindicated in patients with the following metallic implants: brain shunts, aneurysm clips, splinters in the eyes, and certain neurostimulators used in and around the head and neck. | Use of the mask is contraindicated for patients and their household members, caregivers, and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to: Pacemakers, Implantable cardioverter defibrillators (ICD), Neurostimulators, Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head), Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt), Aneurysm clips, Embolic coils, Intracranial aneurysm intravascular flow disruption devices, Metallic cranial plates, screws, burr hole covers, and bone substitute devices, Metallic splinters in the eye, Ocular implants (e.g., glaucoma implants, retinal implants), Certain contact lenses with metal, Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants), Magnetic denture attachments, Metallic gastrointestinal clips, Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary), Implantable ports and pumps (e.g., insulin pumps), Hypoglossal nerve stimulators, Devices labeled as MR (Magnetic Resonance) unsafe, Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field. | The updated contraindications provide a more detailed list. |
| Additional Labeling Update | Current warning: Magnets are used in the mask. The magnetic field strength is 400 mT. Ensure the mask is kept at least 2 inches (5 cm) away from any active medical implant or medical device that can be impacted by the magnetic field (e.g., pacemaker, defibrillators, neurostimulators, cochlear implants, hearing aids) to avoid possible effects from localized magnetic fields. | Updated Warning: Magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the contraindication, ensure the mask is kept at least 6 inches (approx. 15.24 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks. | The updated warning extended the mask use distance and includes possible impacted populations. |
| Patient Population | Patients >7 years (>40 lbs) | Patients >7 years (>40 lbs) | Same |
| Functional Indication | Interface for application of CPAP or bi-level therapy to patients | Interface for application of CPAP or bi-level therapy to patients | Same |
| Environment of Use | Home or hospital/institutional environment | Home or hospital/institutional environment | Same |
| Patient Usage Type | Single patient use or multi-patient use | Single patient use or multi-patient use | Same |
| Anatomical Sites | Nose | Nose | Same |
| Provided Sterile or Non-Sterile | Non-sterile | Non-sterile | Same |
| Pressure Range Specification | 4 cm H2O to 30 cm H2O | 4 cm H2O to 30 cm H2O | Same |
| Deadspace Volume | Nasal Cradle Cushion: XS - 13.6 ml, S - 17.9 ml, M - 18.5 ml, MW - 16.9 ml, L - 23.7 ml. | ||
| Nasal Pillows Cushion: XS - 11.4 ml, S - 11.6 ml, M - 12.0 ml, MW - 13.0 ml, L - 12.4 ml. | Under the nose nasal cushion size: XS - 13.6 ml, S - 17.9 ml, M - 18.5 ml, MW - 16.9 ml, L - 23.7 ml. | ||
| Silicone Pillows Cushion: XS - 11.4 ml, S - 11.6 ml, M - 12.0 ml, MW - 13.0 ml, L - 12.4 ml. | Same (Nasal Pillows Cushion renamed to Silicone Pillows Cushion; no change in design, materials, or use). | ||
| Pressure Drop | (Detailed values provided for both cushion types and sizes at 50 SLPM and 100 SLPM) | (Detailed values provided for both cushion types and sizes at 50 SLPM and 100 SLPM, matching predicate) | Same (Nasal Pillows Cushion renamed to Silicone Pillows Cushion; no change in design, materials, or use). |
| Sound Power and Pressure Level | A-weighted Sound Power Level - 28 dBA; A-weighted Sound Pressure Level @1m: - 20 dBA | A-weighted Sound Power Level - 28 dBA; A-weighted Sound Pressure Level @1m: - 20 dBA | Same |
| Total Mask Leak | 9.2 SLPM @ 4 cm H2O, 10.8 SLPM @ 5 cm H2O, 17.2 SLPM @ 10 cm H2O, 26.7 SLPM @ 20 cm H2O, 34.6 SLPM @ 30 cm H2O | 9.2 SLPM @ 4 cm H2O, 10.8 SLPM @ 5 cm H2O, 17.2 SLPM @ 10 cm H2O, 26.7 SLPM @ 20 cm H2O, 34.6 SLPM @ 30 cm H2O | Same |
| Mask Weight | XS Pillow Mask 37.3 g, S Pillow Mask 37.4 g, M Pillow Mask 37.6 g, MW Pillow Mask 37.7 g, L Pillow Mask 37.8 g. | ||
| XS Cradle Mask 39.3 g, S Cradle Mask 40.8 g, M Cradle Mask 41.6 g, MW Cradle Mask 40.9 g, L Cradle Mask 43.1 g. | XS Pillow Mask 37.3 g, S Pillow Mask 37.4 g, M Pillow Mask 37.6 g, MW Pillow Mask 37.7 g, L Pillow Mask 37.8 g. | ||
| XS Cradle Mask 39.3 g, S Cradle Mask 40.8 g, M Cradle Mask 41.6 g, MW Cradle Mask 40.9 g, L Cradle Mask 43.1 g. | Same | ||
| Exhalation/Exhaust | Built-in exhalation through the mask tubing | Built-in exhalation through the mask tubing | Same |
| Storage Conditions | Temperature: -4° to 140° F (-20° to +60°C); Relative Humidity: 15% to 95% | Temperature: -4° to 140° F (-20° to +60°C); Relative Humidity: 15% to 95% | Same |
The study that proves the device meets the acceptance criteria:
The "study" in this context is the comparison between the subject device (K231313) and its predicate (K210386), as presented in the 510(k) summary. The applicant's assertion is that because the "performance and technological characteristics" of the subject device are substantially equivalent to the predicate, and the modifications (primarily labeling changes and a component re-naming) do not raise new questions of safety and effectiveness, no new non-clinical or clinical tests were required to demonstrate adherence to performance criteria.
This is a claim of substantial equivalence for a minor modification/re-submission, not a de novo performance study for a new device, especially not an AI/ML powered device.
Therefore, for your remaining points, the answer is that the document explicitly states "No non-clinical and/or clinical tests summaries are submitted with this CBE submission." This means the typical elements of an AI/ML device study are not applicable or provided here:
- 2. Sample sized used for the test set and the data provenance: Not applicable; no new test set was used to re-evaluate performance due to the nature of the submission (labeling changes, re-submission for an existing device).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
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(155 days)
Respironics, Inc.
The Dream Wear Silicone Pillows Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
The DreamWear Silicone Pillows Mask consists of a nasal pillows cushion, a silicone mask frame, an elbow with swivel and exhalation ports, headgear with arm extenders, and optional fabric sleeves. The nasal pillows cushion tips seal at the entrance to the nillows cushion base sits under the nares, and comes in four sizes (small, medium, medium wide, large).
Exhalation ports are incorporated into the mask. The built-in exhalation ports are molded into the front of the cushion as well as the top of the elbow. The mask exhalation ports for the DreamWear Silicone Pillows Mask were incorporated in both components, rather than only one of these components, to optimize diffusion, noise, comfort of breathing and CO2 inside the mask. The exhalation openings are used to flush exhaled CO2 out of the circuit. The fabric headgear is attached through the slots on the left and right headgear arms, which in turn are inserted into the slots on the sides of the frame to support the mask fit. The headgear can be adjusted with the hook and loop tabs. The elbow is inserted to the top of the frame. The fabric headgear goes over the mask frame and around the patient's head. The headgear comes in one size and includes adjustment sliders to allow for a large or small fitting on the patient's head. Fabric sleeves (optional) are also provided to provide additional comfort if desired.
The mask design is intended to remove movement restrictions during sleep with the air inlet on the top of the head and air movement through both sides of the frame and cushion for therapy delivery to the patient's nose. The tubing frame is intentionally designed such that one side can collapse when the patient is lying on their side, while therapy is delivered to the cushion through the open side of the frame. The frame is available in three sizes (small, medium, and large) The mask was tested and verified to ensure performance is maintained according to its specifications.
The mask elbow can rotate freely through 360 degrees and has a 22mm quick disconnect swivel that is used to connect the conventional air delivery hose between the mask and pressure source. The 22mm quick disconnect swivel can also rotate freely through 360 degrees and be easily removed from the elbow.
The mask is designed in such a way that they can be easily disassembled for cleaning or replacement purposes. The mask components may be cleaned by the patient in the home (single patient use) or disinfected by the professional in the hospital/institutional environment (multi-patient use).
The key benefits of this device to the patient are:
- Ease of use ●
- . Comfort
- Fewer movement restrictions ●
- Easy disassemblv .
The provided text describes the regulatory clearance for a medical device, the DreamWear Silicone Pillows Mask, and compares it to a predicate device, the TI Nasal Mask. However, it does not describe an AI model or a study proving that an AI-driven device meets acceptance criteria.
The document details the device's design, intended use, and various performance characteristics through non-clinical laboratory testing, not a clinical study involving human readers or AI.
Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI device based on this input. The document explicitly states:
- Clinical Tests: "Clinical tests were not required to demonstrate the safety and effectiveness of the DreamWear Silicone Pillows Mask. All risks have been sufficiently mitigated and product functionality has been adequately assessed by non-clinical tests." (page 13)
This product is a physical medical device (a CPAP mask), not an AI-powered diagnostic tool. The performance metrics discussed (e.g., pressure drop, sound levels, CO2 rebreathing, leaks) are physical or mechanical properties of the mask itself, verified through laboratory tests (non-clinical tests), not cognitive performance metrics of an AI.
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(153 days)
Respironics, Inc.
This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients > 7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.
The Magneto Nasal Mask includes two cushion type options: a nasal, cradle cushion and nasal, pillows cushion. The nasal cradle cushion seals around the bottom of the patient's nose, and comes in five sizes (extra small, medium wide, large). The nasal pillows cushion tips seal at the entrance to the nares. The pillows cushion base sits under the nares, and comes in five sizes (extra small, small, medium wide, large). Both of the cushion design options contain enclosed magnets.
The mask frame also contains enclosed magnets, and connects to the mask cushion magnetically for easy and secure assembly by the user. The mask frame comes in one size and connects to the tubing with a snap fit, which allows the frame attached to the tubing.
The fabric headqear goes over the top of the mask frame and around the patient's head. The headgear comes in one size and includes adjustment sliders to allow for a large or small fitting on the patient's head.
The mask includes 10 mm tubing. The 10 mm tubing contains built-in exhalation at the top of the tube where the tubing connects to the mask frame. The tubing also includes an ISO 5356-1 compliant, 22 mm male conical swivel. The tubing swivel connects directly to ISO 5356-1 compliant, 22 mm female connections used on therapy device tubing. The tubing swivel detaches from the mask tubing, via a quick disconnect feature. The tubing connects to 12 mm connections when the tubing swivel is detached.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Magneto Nasal Mask." It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence.
This document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format typically required for performance studies of AI/ML-driven medical devices. The Magneto Nasal Mask is a physical medical device (a mask for CPAP/bi-level therapy), not an AI/ML software device.
Therefore, many of the requested categories in the prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary for a physical medical device.
However, I can extract the closest analogous information regarding performance testing and acceptance criteria for this physical device.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this physical device are primarily based on demonstrating equivalence to the predicate device and meeting relevant international standards for safety and performance. The "reported device performance" refers to the measurements taken for the Magneto Nasal Mask compared to the predicate.
Note: The acceptance criteria are largely implied by compliance with standards (e.g., ISO 17510 for masks, ISO 10993 for biocompatibility) and demonstrating that differences from the predicate do not raise new questions of safety and effectiveness. Specific numerical "acceptance criteria" are not explicitly stated as pass/fail thresholds in this summary for most metrics, but rather performance values are presented for comparison.
| Metric (Acceptance Criteria Implicitly derived from standards and predicate comparison) | Reported Device Performance (Magneto Nasal Mask) | Predicate Device Performance (Simple T Youth Nasal Mask, K140268) |
|---|---|---|
| Deadspace Volume | Nasal Cradle Cushion: |
- Extra small: 13.6 ml
- Small: 17.9 ml
- Medium: 18.5 ml
- Medium wide: 16.9 ml
- Large: 23.7 ml
Nasal Pillows Cushion: - Extra small: 11.4 ml
- Small: 11.6 ml
- Medium: 12.0 ml
- Medium wide: 13.0 ml
- Large: 12.4 ml | - Small size: 37.4 ml
- Medium size: 48.7 ml
- Large size: 72.8 ml |
| Pressure Drop | Nasal Cradle Cushion: - XS: 1.7 cm H₂O @ 50 SLPM, 6.3 cm H₂O @ 100 SLPM
- S: 1.5 cm H₂O @ 50 SLPM, 6.5 cm H₂O @ 100 SLPM
- M: 1.4 cm H₂O @ 50 SLPM, 6.1 cm H₂O @ 100 SLPM
- MW: 1.6 cm H₂O @ 50 SLPM, 6.1 cm H₂O @ 100 SLPM
- L: 1.5 cm H₂O @ 50 SLPM, 5.3 cm H₂O @ 100 SLPM
Nasal Pillows Cushion: - XS: 1.9 cm H₂O @ 50 SLPM, 7.5 cm H₂O @ 100 SLPM
- S: 2.0 cm H₂O @ 50 SLPM, 7.2 cm H₂O @ 100 SLPM
- M: 1.5 cm H₂O @ 50 SLPM, 6.1 cm H₂O @ 100 SLPM
- MW: 1.6 cm H₂O @ 50 SLPM, 6.3 cm H₂O @ 100 SLPM
- L: 1.8 cm H₂O @ 50 SLPM, 6.8 cm H₂O @ 100 SLPM | - 0.8 cm H₂O @ 50 SLPM
- 3.1 cm H₂O @ 100 SLPM |
| A-weighted Sound Power Level | 28 dBA | 26.5 dBA |
| A-weighted Sound Pressure Level | 20 dBA | 18.5 dBA |
| Total Mask Leak | - 9.2 SLPM @ 4 cm H₂O - 10.8 SLPM @ 5 cm H₂O
- 17.2 SLPM @ 10 cm H₂O
- 26.7 SLPM @ 20 cm H₂O
- 34.6 SLPM @ 30 cm H₂O | - 19.8 SLPM @ 5 cm H₂O
- 29.5 SLPM @ 10 cm H₂O
- 43.6 SLPM @ 20 cm H₂O |
| Biocompatibility | Compliant with ISO 10993 series and ISO 18562 series. (No specific numerical performance reported, only compliance) | (Implied compliance, not explicitly detailed in the predicate comparison for this summary) |
| Cleaning & Disinfection Validation | Validated (Cleaning residuals, disinfection residuals confirmed). (No specific numerical performance reported, only validation status) | (Methods outlined for predicate, no direct comparison of validation results) |
| Magnetic Strength | Tested (No specific numerical performance reported, only tested status) | (Not mentioned for predicate, but implies acceptable levels to prevent interference while providing secure connection) |
| CO2 Rebreathing | Tested (No specific numerical performance reported, only tested status) | (Not mentioned for predicate, implies meeting safety standards for CO2 washout) |
| Resistance (Pre & Post Cleaning/Disinfection) | Tested (derived from pressure drop, implies within acceptable limits after reprocessing) | (Covered by pressure drop for predicate, implies acceptable limits after reprocessing) |
| Conical Connectors | Complies with ISO 5356-1:2015 (No specific numerical performance reported, only compliance) | (Implied compliance for predicate, not explicitly detailed) |
Study Proving Device Meets Acceptance Criteria:
A series of non-clinical tests were performed to verify the safety and effectiveness of the device and demonstrate substantial equivalence to the predicate device. These tests assessed various physical and performance characteristics of the mask.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated in terms of number of masks or specific test replicates for each performance metric, but the tests were conducted on the "Magneto Nasal Mask."
- Data Provenance: The tests were performed by the manufacturer, Respironics, Inc., to verify the device modifications. This is retrospective testing done on manufactured devices. The country of origin of the data is implicitly the USA, where Respironics is based and where the FDA submission occurred.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical medical device, not an AI/ML software. "Ground truth" in the AI/ML sense (e.g., expert annotation of images) is not used. Performance is assessed through objective physical and functional measurements against standards and predicate device data.
4. Adjudication method for the test set
Not applicable. This is a physical medical device, not an AI/ML software. Performance is measured objectively according to specified test protocols for physical devices.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI/ML software. No human readers or AI assistance are involved in interpreting its output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI/ML software.
7. The type of ground truth used
The "ground truth" for this medical device is established by:
- International standards (e.g., ISO 17510 for mask performance, ISO 10993 for biocompatibility).
- Performance data of the legally marketed predicate device (Simple T Youth Nasal Mask, K140268).
- Engineering specifications and safety requirements for medical devices.
- The tests themselves produce objective physical measurements.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML software. It does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML software.
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(90 days)
Respironics, Inc.
Sleepware G3 is a software application used for analysis (automatic and manual scoring), display, retrieval, summarization, report generation, and networking of data received from monitoring devices used to categorize sleep related events that help aid in the diagnosis of sleep-related disorders. It is indicated for use with adults (18 and older) and infant patients (one year old or less) in a clinical environment by or on the order of a physician.
The optional Somnolyzer scoring algorithms are for use with adults (18 and older) to generate an output that is ready for review and interpretation by a physician. Cardio-Respiratory Sleep Staging (CReSS) is an additionality of Somnolyzer which uses standard Home Sleep Apnea Test HSAT signals (in the absence of EEG signals) to infer sleep stage.
Sleepware G3 software is a polysomnography scoring application, used by trained clinical professionals, for managing data from sleep diagnostic devices using a personal computer. Sleepware G3 is able to configure sleep diagnostic device parameters, transfer data stored in sleep diagnostic device memory to the personal host computer, process and auto-score data to display graphical and statistical analyses, provide aid to clinical professionals for evaluating the physiological data waveforms relevant to sleep monitoring, and create unique patient reports.
Sleepware G3 includes an optional Somnolyzer plug-in. The auto-scoring algorithms of the Somnolyzer Inside software can be used in addition to, or in the place of, the auto-scoring algorithms that are included in Sleepware G3.
Sleepware G3, remains unchanged in function and fundamental scientific technology from Sleepware G3 which was cleared under K142988.
Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Somnolyzer scoring algorithms are based on demonstrating non-inferiority to manual expert scoring. The reported device performance indicates that all primary and secondary endpoints were met.
| Acceptance Criterion (Non-Inferiority to Manual Expert Scoring) | Reported Device Performance |
|---|---|
| Full PSG Acquisition: | |
| Sleep stages according to AASM criteria | Non-inferior (all primary and secondary endpoints met) |
| Arousals during sleep according to AASM criteria | Non-inferior (all primary and secondary endpoints met) |
| Apneas and hypopneas during sleep according to AASM criteria | Non-inferior (all primary and secondary endpoints met) |
| Periodic limb movements during sleep according to AASM criteria | Non-inferior (all primary and secondary endpoints met) |
| HST Acquisition: | |
| Apneas and hypopneas according to AASM criteria | Non-inferior (all primary and secondary endpoints met) |
| Cardio-Respiratory Sleep Staging (CReSS): | |
| REI based on cardio-respiratory feature-based sleep time is superior to REI based on monitoring time (for HST acquisition) | Evidence provided that REI calculated using CReSS is a more accurate estimate of AHI than REI calculated using total recording time. Accuracy further improved with additional signals: mean difference between REI and AHI reduced from -6.6 events/hour (95% CI -7.51 to -5.71) to -1.76 events/hour (95% CI -2.27 to -1.24). |
Detailed Study Information:
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: A total of 1,204 polysomnography (PSG) and home sleep apnea test (HSAT) files were used in the five clinical studies.
- Data Provenance: The document does not explicitly state the country of origin. The studies are described as using a "large, diverse sample... collected via a number of different platforms," suggesting diverse sources but not specifying geographical location. The studies were likely retrospective, as they involved validating algorithms against existing manual scoring, but this is not explicitly stated.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated how many individual experts were used across all studies. However, the non-inferiority margin for comparisons was "set at the lower-margin of the agreement observed across expert technologists." This implies multiple experts were involved in defining the range of agreement for ground truth.
- Qualifications of Experts: The experts are referred to as Registered Polysomnographic Technologists (RPSGT). This indicates their professional qualification in sleep study scoring.
-
Adjudication method for the test set:
- The document implies a form of consensus or agreement among experts was utilized to set the non-inferiority margin, but it does not explicitly describe a specific adjudication method like 2+1 or 3+1 for individual cases within the test set. The focus is on comparing the algorithm's performance against the established range of agreement among experts.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not the primary focus described. The study design primarily involved a standalone evaluation of the AI algorithm (Somnolyzer) against human expert scoring, demonstrating its non-inferiority.
- The document states that Somnolyzer's output is "ready for review and interpretation by a physician," implying it assists human readers by providing a pre-scored output. However, it does not quantify the improvement in human reader performance with AI assistance versus without AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone evaluation was performed. The clinical studies "validated the Somnolyzer and CReSS algorithms against manual scoring." The non-inferiority claims ("Somnolyzer scoring... is non-inferior to manual expert scoring") directly refer to the algorithm's performance without human intervention in the scoring process.
-
The type of ground truth used:
- The ground truth was expert consensus scoring. The document states that the algorithms were validated "against manual scoring" by "expert technologists" (RPSGTs). The non-inferiority margin was based on "the agreement observed across expert technologists."
-
The sample size for the training set:
- The document does not provide information on the training set sample size. The provided text focuses solely on the clinical performance testing for validation.
-
How the ground truth for the training set was established:
- As the training set information is not provided, the method for establishing its ground truth is also not described in the document.
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(116 days)
Respironics, Inc.
Care Orchestrator is intended to support clinicians by tracking data on patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. Care Orchestrator provides remote patient data collection & viewing and is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in conjunction with compatible non-life support therapy devices to adjust prescription and/ or performance settings. In addition, Care Orchestrator can be used for analysis (automatic and manual scoring), display, retrieval, summarization, and report generation of data received from compatible monitoring devices used to categorize sleep-related events that help aid in the diagnosis of sleep-related disorders. The Home Sleep Testing function of Care Orchestrator is indicated for Adult use only. Care Orchestrator allows read-only access to patients. Care Orchestrator is intended to be used in hospital, institutional, provider, and home care settings.
Care Orchestrator is a cloud-based software platform that allows entities including physicians, other professional home and clinical staff, and durable medical equipment providers in a patient's therapy lifecycle the ability to manage patients and referrals, control access to patient information and therapy data, enhance patient compliance management workflow, and gain efficiencies in the overall patient therapy workflow. Care Orchestrator also provides a method for sleep data acquired from a supported home sleep test (HST) devices to be imported, scored and reviewed by a qualified user. The HST function of Care Orchestrator is for adult use only.
The intent of the Care Orchestrator sleep diagnostic functionality is to provide a capability that allows users to analyze, score, review and generate clinical reports for HST acquisitions (i.e. sleep studies) from within a web browser. Users can upload acquisitions to Care Orchestrator and perform these actions all from within the browserbased Care Orchestrator Client application.
Care Orchestrator software has undergone no significant changes since in K181053. The addition of the Home Sleep Testing features, subject of this submission, add a sub-set of Home Sleep Testing functionality.
The provided document is a 510(k) summary for the "Care Orchestrator with Home Sleep Testing" device. It outlines the device's indications for use, its comparison to a predicate device, and a brief statement about performance data. However, it does not contain a detailed study proving the device meets specific acceptance criteria, nor does it provide a table of acceptance criteria with reported device performance.
The document states:
- "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- "Software verification and validation included software code reviews, automated testing, bench verification testing and labeling review."
This indicates that general software V&V activities were performed, but the specific details requested in your prompt (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, etc.) are not included in this summary.
Therefore, many of your questions cannot be answered from the provided text.
Here's a breakdown of what can be inferred or directly stated, and what information is missing:
1. A table of acceptance criteria and the reported device performance
- Missing from the document. The document states that software verification and validation testing was done, but it does not provide a table of specific acceptance criteria or quantitative performance metrics for those criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing from the document. The summary mentions "bench verification testing" but does not detail the sample size of the test set, the nature of the data (e.g., patient data, synthetic data), its origin, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Missing from the document. The document does not specify if experts were used to establish ground truth for a test set, nor their number or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing from the document. There is no information provided regarding any adjudication methods for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Missing from the document. The document does not mention any MRMC comparative effectiveness studies. The device's function involves automatic and manual scoring to aid in the diagnosis of sleep-related disorders, but how it impacts human reader performance through such studies is not discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Partially addressed. The device performs "analysis (automatic and manual scoring)". The "automatic scoring" component implies standalone algorithmic functionality. However, the document does not provide specific performance metrics for this standalone component.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Missing from the document. The type of ground truth used for any validation of the automatic scoring algorithm is not specified.
8. The sample size for the training set
- Missing from the document. This document focuses on the regulatory submission and does not disclose details about the training set size for any machine learning components.
9. How the ground truth for the training set was established
- Missing from the document. Similar to the test set, the method for establishing ground truth for any potential training set is not provided.
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(134 days)
Respironics, Inc.
The DreamStation 2 CPAP/DreamStation 2 Auto CPAP system delivers positive airway for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30 kg (66 lbs). It is for use in the home or hospital/institutional environment.
The DreamStation 2 System uses a microprocessor-controlled blower to treat patients with Obstructive Sleep Apnea (OSA). There are 2 models: DreamStation 2 and DreamStation 2 Advanced. Both aforementioned models will be available in two therapy modes: CPAP only and Auto CPAP. With CPAP therapy, the device provides a continuous positive airway pressure throughout the entire therapy session. With Auto CPAP therapy, the device provides a positive airway pressure that automatically adjusts to the patient's needs as various breathing events are detected, such as apneas and hypopneas. In addition to the therapy modes, the DreamStation 2 System provides several optional features to aid with patient comfort. These patient comfort features include: Ramp Plus, adjustable pressure relief (FLEX), EZ-Start, Opti-Start, and humidification (adaptive and adaptive with heated tube). Note: some of the features are only available in the DreamStation 2 Advanced model. The DreamStation 2 device also features integrated Bluetooth and cellular technology for the transfer of patient management data between the therapy device and Respironics proprietary compliance software, Care Orchestrator.
This document describes the 510(k) premarket notification for the DreamStation 2 System, a noncontinuous ventilator (CPAP system) for treating Obstructive Sleep Apnea. It does not contain information about a study proving the device meets acceptance criteria from clinical trials involving human subjects, nor does it provide a table of acceptance criteria and reported device performance from such a study.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing, software testing, biocompatibility testing, general safety and electrical compatibility testing, and human factors/usability testing.
Therefore, I cannot fulfill the request for information regarding clinical acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, or training set specifics, as this information is not present in the provided text.
The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the DreamStation 2 System. Safety and efficacy of the DreamStation 2 System has been established via nonclinical tests."
The only "acceptance criteria" presented are related to technical specifications (e.g., pressure accuracy) and compliance with various international standards, which is then demonstrated through the completion of non-clinical testing.
Here's a breakdown of what is available in the document regarding performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison of technical characteristics between the DreamStation 2 System and its predicate devices in Table 5-1 (pages 5-6) and Table 5-2 (page 8). While it doesn't explicitly state "acceptance criteria" for clinical outcomes, it does list performance specifications for pressure accuracy and notes whether the subject device's performance is "Same" or "Similar" to the predicates.
| Feature/Function | Predicate 1 (K131982) Performance | Predicate 2 (K130077) Performance | Subject Device DreamStation 2 CPAP/Auto CPAP Performance | Acceptance Criteria (Implied by Substantial Equivalence to Predicates) |
|---|---|---|---|---|
| Pressure Accuracy (Static) | ||||
| 15mm/22mm Tubing | ± 0.5 cm H2O | N/A | ± 0.5 cm H2O | Match Predicate 1: ± 0.5 cm H2O |
| 12mm Tubing | N/A | ± 1.0 cm H2O | ± 1.0 cm H2O | Match Predicate 2: ± 1.0 cm H2O |
| Pressure Accuracy (Dynamic) | ||||
| 15mm/22mm Tubing | ± 1.0 cm H2O (of established static pressure values) | N/A | ± 1.0 cm H2O | Match Predicate 1: ± 1.0 cm H2O |
| 12mm Tubing | N/A | Device: ± 2.0 cm H2O, Device w/ Humidifier (15mm/22mm Tubing): ± 2.0 cm H2O / ± 2.5 cm H2O | ± 2.0 cm H2O | Match Predicate 2: ± 2.0 cm H2O |
Note: The "Acceptance Criteria" column is inferred from the document's claim of "Same" or "Similar" performance to the predicates, which is the basis for substantial equivalence. The document does not specify exact acceptance criteria values for new features, but rather demonstrates that the new device meets or exceeds the performance of existing legally marketed predicate devices for similar functionality.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The document explicitly states that clinical tests were not required. The testing performed was non-clinical. Therefore, no "test set" of patient data or data provenance information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As no clinical "test set" was used, there was no need for experts to establish ground truth in a clinical context. Product requirement and specification experts within the company would have been involved in defining the non-clinical testing parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This refers to clinical data adjudication, which was not performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. No MRMC study involving human readers or AI assistance was performed or described. This device is a CPAP system, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This refers to AI algorithm performance. The DreamStation 2 System is a hardware device for delivering airway pressure, not primarily an AI algorithm. Its software is for controlling the device and managing patient data, not for making diagnostic or treatment recommendations independently in an "algorithm only" sense beyond its intended function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable (for clinical ground truth). For the non-clinical and software testing, the "ground truth" would be the device's technical specifications, design requirements, and adherence to recognized international standards (e.g., ISO, IEC).
8. The sample size for the training set:
- Not Applicable. No clinical training set was used or described.
9. How the ground truth for the training set was established:
- Not Applicable. No clinical training set was used or described.
Summary of the Study that Proves the Device Meets the (Non-Clinical) Acceptance Criteria:
The DreamStation 2 System demonstrated that it meets acceptance criteria through a series of non-clinical performance tests which include:
- Performance Testing: To address device requirements, risk mitigations, show substantial equivalence, and assure safety and efficacy. (Details not provided in terms of specific tests, but performance characteristics like pressure accuracy are compared to predicates).
- Software Testing: Developed according to IEC 62304:2015 ("Medical Device Software - Software Life Cycle Processes"). Software verification and validation were performed based on product requirements, following FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was deemed to have a "Moderate" level of concern.
- Biocompatibility Testing: Conducted in accordance with FDA Guidance and international standards ISO 10993-1:2018 and ISO 18562-1:2017, proving the device to be biocompatible.
- General Safety, Electrical Safety, and Electromagnetic Compatibility (EMC) Testing: The system complies with AAMI/ANSI/ES 60601-1:2005/A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-1-11:2015, ISO 80601-2-61: 2011, ISO 80601-2-70: 2015, and ISO 80601-2-74: 2017.
- Human Factors/Usability Testing: Aligned with IEC 62366-1: 2015 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." A human factors validation study indicated safe and effective operation by intended users with acceptable residual risk.
The conclusion drawn from these non-clinical tests is that the DreamStation 2 System is substantially equivalent to its predicate devices, and that modifications do not raise new questions of safety and effectiveness. Clinical tests were not deemed necessary.
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(332 days)
Respironics Inc.
Care Orchestrator Essence is intended for use by healthcare professionals (e.g., Physicians, Durable Medical Equipment providers) to gather, store, manage, and view compliance data for patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. The software also includes the ability to create new or updated prescriptions and/or performance settings, store them, and transmit them to compatible Respironics' non-life supporting therapy devices and Respironics Trilogy ventilator. Data and prescription settings are transferred between Care Orchestrator Essence and compatible devices via removable media. Care Orchestrator Essence is intended to be used in hospital, institutional, provider, and home care settings by healthcare representatives.
The software does not perform automatic scoring or diagnosis. The data it provides are only one of several elements to consider when making decisions about patient therapy.
Care Orchestrator Essence software is a desktop solution that allows healthcare representatives (e.g., physicians, clinicians, durable medical equipment providers) involved in a patient's therapy lifecycle the ability to manage patients and referrals; control access to patient information; view and interact with therapy and prescription data from Respironics devices; enhance the patient compliance management workflow; and gain efficiencies in the overall patient therapy workflow.
Care Orchestrator Essence supports patient data management and prescription updates for sleep therapy devices (BZD, MNS, MNT) and Trilogy respiratory devices (CBK, NOU) through an SD card.
I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) premarket notification for a medical device called "Care Orchestrator Essence," which is a software for managing patient compliance data and therapy settings for compatible Respironics devices.
While it mentions software verification and validation testing and non-clinical tests were conducted, it does not provide details on:
- A table of acceptance criteria and reported device performance. It broadly states that "all product requirements have been met with acceptable test results," but no specific criteria or performance metrics are listed.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study. The device does not perform automatic scoring or diagnosis, so this type of study would not be applicable.
- Standalone (algorithm-only) performance. The device is intended to be used by healthcare professionals.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document emphasizes that clinical tests were not required and that the effectiveness was demonstrated through non-clinical testing and comparison to predicate devices. It focuses on the functional similarities and differences between the new device and previously cleared predicate devices rather than providing detailed performance metrics from a study that fits the criteria of your request (e.g., studies involving ROC curves, sensitivity, specificity, etc., which are common for diagnostic or AI-driven systems).
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(296 days)
Respironics, Inc.
The SomnaPatch™ is a single use physiologic recorder intended to collect and record data for use by clinical software used in polysomnography and sleep disorder studies by providing the information required for calculation of the apnea-hypopnea index. It is intended for adult use and can be used in a hospital, clinic, or patient home.
The SomnaPatch Home Sleep Test is a single-use disposable physiologic recorder used as an aid in the diagnosis of sleep related breathing disorders. The SomnaPatch device is affixed to the face of the user and is designed to continuously be worn overnight, up to approximately 10-hours. Once activated, the device records and stores patient data for the wear period. After the wear period, the device is returned to the healthcare professional, where the data is downloaded and processed by the SomnaPatch Data Processing Software. The processed data can be viewed by a healthcare professional and analyzed either manually or by third-party sleep data viewing and scoring software. The SomnaPatch device is not involved in the data management performed by the host or third-party data viewing or scoring software.
The forehead patch contains three sensors (Pressure Sensor, Accelerometer, and Optical SpO2), wherein their outputs' are recorded to a secure MicroSD card. The SomnaPatch Data Processing Software installed on a PC downloads the recorded data from the secure MicroSD card to derive 4 channels (nasal pressure, oxygen saturation (SpO2), pulse rate, and head position) of data in EDF format.
Here's an analysis of the provided text to extract information about the SomnaPatch device's acceptance criteria and the study proving it, structured as requested:
Acceptance Criteria and Device Performance for SomnaPatch
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Alice PDx) rather than explicitly stating pre-defined acceptance criteria with precise numerical targets for clinical accuracy. However, based on the clinical study summarized and the comparison section, we can infer the performance considered acceptable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Clinical Study and Comparison) | Reported Device Performance (SomnaPatch) |
|---|---|
| AHI Accuracy (vs. Gold Standard PSG) | Mean difference in AHI: -0.7 events per hour (95% confidence interval -2.4 to 1.1 events/hour). |
| The device "accurately estimates the AHI for values >=15 events/hour as compared with in-lab polysomnography (PSG)." | |
| SpO2 Signal Accuracy | Performs within the standard accuracy range of ±4% for non-invasive pulse oximetry, "the same as compared to Alice PDx." |
| Sensor Performance (Optical SpO2, Accelerometer, Pressure) | Optical SpO2: Comparable performance to Nonin pulse oximeters (mentioned as predicate device's compatible oximeters) and agreed with expected pulse rate. |
| Accelerometer: Performed comparably to the Alice PDx accelerometer, recording all motion as intended. | |
| Pressure Sensor: Detected hypopneas and apneas generated by ASL scripts comparably to Alice PDx pressure-based flow. | |
| Biocompatibility | No potential for cytotoxicity, sensitization, or negligible irritation results. Acute systemic toxicity showed no evidence of mortality or toxicity. (Considered biocompatible per ISO 10993). |
| Safety (General, Electrical, EMC) | Complies with IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, IEC 60601-1-11:2015, and ISO 80601-2-61: 2011. All product requirements met with passing test results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study for AHI accuracy): 178 participants
- Data Provenance (Clinical Study for AHI accuracy): Multi-center, open-label study (country of origin not explicitly stated, but submission is to US FDA, implying relevance to US market). The study involved a "within-subject comparison" against overnight polysomnography (PSG) in a laboratory setting. This indicates a prospective study design for data collection against the gold standard.
- Sample Size (Clinical Testing for SpO2 signal): Not explicitly stated, but refers to "arterial blood samples drawn under hypoxic conditions over the SaO2 range of 70-100%."
- Data Provenance (Clinical Testing for SpO2 signal): Partnered with University of California San Francisco (UCSF) Hypoxia Research Laboratory. This is likely a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number or specific qualifications of experts used to establish the ground truth for scoring the AHI from the gold standard PSG, beyond referring to "in-lab polysomnography (PSG)" being the gold standard. For the SpO2 testing, the ground truth was "arterial blood samples," which is an objective physiological measure, not dependent on expert interpretation.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method for the test set regarding AHI scoring or any other clinical readouts. It mentions "in-lab polysomnography (PSG)" as the gold standard, implying that the AHI from PSG was considered definitive.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or described. The clinical study focused on the device's standalone accuracy in estimating AHI compared to PSG, not on assisting human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted. The clinical study described for AHI accuracy directly assessed the SomnaPatch device's ability to estimate AHI compared to the gold standard PSG. The SpO2 accuracy validation was also a standalone assessment against arterial blood samples. The device processes data via software to derive channels and calculate AHI, which is then viewed and analyzed by a healthcare professional. The core evaluation is the device's accuracy in producing this data, which is a standalone performance metric.
7. The Type of Ground Truth Used
- For AHI Accuracy: Overnight polysomnography (PSG) in a laboratory setting (clinical gold standard).
- For SpO2 Accuracy: Arterial blood samples (objective physiological measurement).
- For Sensor Performance (Pressure): Hypopneas and apneas generated using ASL scripts, then viewed in Sleepware G3. This appears to be a simulated, controlled environment ground truth rather than real patient data for this specific sensor comparison.
8. The Sample Size for the Training Set
The document does not specify a sample size for a training set. The device appears to be a physiological recorder that provides raw/processed data channels (like nasal pressure, SpO2) and then relies on clinical software or healthcare professionals to calculate AHI. There's no indication that the device itself uses a trainable algorithm in the sense of deep learning or machine learning that would require a distinct training set for its core function of recording and deriving these physiological channels.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of a trainable algorithm (see point 8), this information is not applicable and therefore not provided in the document. The device's function is data collection and processing based on sensor readings.
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(442 days)
Respironics Inc.
The Trilogy Evo Universal ventilator provides continuous or intermittent pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediativ through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair. It may be used for both invasive ventilation.
The Trilogy Evo Universal ventilator is a microprocessor controlled blower based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. The ventilator is intended to provide continuous or intermittent ventilatory support. The ventilator is suitable for use in institutional/hospital settings and non-emergency transport settings for example wheelchair. It is applicable for adults and pediatric patients weighing at least 2.5 kg who require the following types of ventilatory support:
Control Modes
- A/C-PC: Assist control .
- . A/C-VC: Assist control
Spontaneous modes
- CPAP: Continuous positive airway pressure .
- PSV: Pressure support ventilation .
Mixed modes
- S/T: Spontaneous/timed ventilation .
- . SIMV-PC: Synchronized intermittent mandatory ventilation (pressure control)
- SIMV-VC: Synchronized intermittent mandatory ventilation (volume control)
In addition to the therapy modes, the Trilogy Evo Universal provides the following major functions:
- Therapy Features including Backup Ventilation, Inspiratory Time Min/Max and Sigh ●
- Power Management of various power sources (AC, internal and detachable Li-lon batteries and ● external Pb-Acid battery)
- Physiological alarms
- . Graphical User Interface using a touch screen display, status LEDs and dedicated keys for user input
- . Bluetooth and USB Communications
- Compatibility with various patient interfaces and multiple circuit types
- Connectivity with hospital monitors ●
- . Capability to connect, display and alarm SpO2, FiO2 and ETCO2 monitors
- . Ventilation with supplemental low flow oxygen or oxygen blender
The associated accessories include:
- Bacteria Filter ●
- Circuits, including Passive, Active and Dual Limb
- FiO2 Sensor ●
- . Active Exhalation Valves
- . Leak Device
- . Heat and Moisture Exchangers (HME's)
- Oximeter and Sensors
- Capnography Sensors and cable ●
- Flow Sensors
- Detachable Battery and Battery Cables ●
- Roll Stand
- Mounting Bracket .
Here's a breakdown of the acceptance criteria and study information for the Trilogy Evo Universal Ventilator, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Trilogy Evo Universal) |
|---|---|---|
| Intended Use | Continuous or intermittent ventilatory support for individuals requiring mechanical ventilation, with or without air/oxygen blending. Intended for pediatric through adult patients weighing at least 5kg (11lbs). Oximetry Interface kit measures functional oxygen saturation and pulse rate. Used in home, hospitals, institutions, and portable applications (wheelchairs, gurneys). Invasive and noninvasive ventilation. Not a transport ventilator. | Continuous or intermittent positive pressure ventilation for individuals requiring mechanical ventilation. Intended for pediatric through adult patients weighing at least 2.5 kg. Measures, displays, records, and alarms SpO2, FiO2, CO2, and Pulse Rate data when integrated with appropriate accessories. Suitable for institutional/hospital settings and non-emergency transport settings (e.g., wheelchair). Used for both invasive and non-invasive ventilation. |
| Patient Population | Pediatrics and Adults | Pediatrics and Adults |
| Principle Of Operation | Microprocessor controlled, Electronically powered, Software driven | Microprocessor controlled, Electronically powered, Software driven |
| Performance | Met ISO 80601-2-12 requirements on essential performance of ventilators. | Met ISO 80601-2-12 requirements on essential performance of ventilators. |
| Waveform Comparison | Comparable waveform results | Comparable waveform results |
| Design | LCD screen, hard keys, and LED indicators. | Graphic user interface with LCD with touch screen. |
| Delivery method to patient | Continuous or intermittent positive pressure ventilation | Continuous or intermittent positive pressure ventilation |
| Energy Used for device | AC and DC (Battery) Power | AC and DC (Battery) Power |
| Therapy Types | Invasive and Non-Invasive Mechanical ventilation | Invasive and Non-Invasive Mechanical ventilation |
| Software | Not explicitly stated as a separate criterion, but implied under "Principle of Operation" and the software's "major" level of concern. | Software verification and validation testing performed based on product requirements, meeting FDA guidance for "major" level of concern software. All product requirements met with passing test results. |
| Biocompatibility | Not explicitly stated, but implied as a general safety requirement | Biocompatibility evaluation conducted in accordance with FDA Guidance and ISO 10993-1. Testing (cytotoxicity, sensitization, irritation, genotoxicity, implantation, extractables, condensate) found materials biocompatible. Gas pathway materials evaluated via Gas emission VOC, Inorganic gases (CO, CO2, Ozone) and PM2.5 testing. |
| General & Electrical Safety, EMC | Not explicitly stated, but implied to meet relevant standards. | Complies with AAMI/ANSI/ES 60601-1:2005/A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-1-8:2012, ISO 80601-2-12:2011, ISO 80601-2-55:2011, ISO 80601-2-61: 2011, ISO 5356-1:2015, ISO 5367:2014. |
| Human Factors | Not explicitly stated, but implied as a general safety requirement. | Human Factors/Usability Engineering process followed IEC 62366-1 and FDA guidance. Human factors validation study indicates appropriate user operation and acceptable residual risk. |
Study That Proves the Device Meets Acceptance Criteria:
The document states that the "Trilogy Evo Universal device is as safe and as effective as the predicate device, Trilogy Series Ventilator with Oximetry (K111610) and is deemed substantially equivalent to the predicate device, Trilogy Series Ventilator with Oximetry (K111610)." This substantial equivalence is primarily established through non-clinical tests and a comparison of technological characteristics with the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a numerical sample size for the test set used in the non-clinical tests.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the data was retrospective or prospective. The tests were performed on the device itself as part of the verification and validation process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number of experts used or their qualifications for establishing ground truth in the non-clinical tests. The tests rely on compliance with established standards and internal validation processes rather than expert interpretation of data like in a diagnostic study.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method for the test set in the context of expert consensus, as the testing involves engineering and performance validation against predefined standards and requirements rather than subjective expert evaluation of study data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the Trilogy Evo Universal ventilator. Product functionality has been adequately assessed by non-clinical tests." Therefore, there is no mention of human readers improving with or without AI assistance, as AI assistance in the diagnostic sense is not the primary function of this ventilator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not directly applicable in the traditional sense of a diagnostic AI algorithm. The device itself is a standalone medical device that performs ventilation. The "software verification and validation testing" assessed the algorithm (software) without human intervention during the automated tests. The "Human Factors" study assessed the human-in-the-loop performance from the perspective of safe and effective user interaction with the device, rather than an AI diagnostic aid.
7. The type of ground truth used:
- The ground truth for the non-clinical tests was primarily established by engineering specifications, regulatory standards (e.g., ISO, IEC), and predefined product requirements. For example:
- Performance: Compliance with ISO 80601-2-12 and "All product requirements have been met with passing test results."
- Software: Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Biocompatibility: Compliance with ISO 10993-1.
- Safety/EMC: Compliance with AAMI/ANSI/ES 60601-1 and various IEC/ISO standards.
- Human Factors: Compliance with IEC 62366-1 and FDA guidance, with validation showing appropriate user operation and acceptable residual risk.
8. The sample size for the training set:
- The document does not specify a sample size for a training set. This is because the device is a ventilator, not a machine learning model that requires a "training set" in the common sense of AI/ML software for diagnosis or prediction. The software development process likely involved various internal testing and refinement, but not a distinct "training set" like one would find in, for example, an image recognition algorithm.
9. How the ground truth for the training set was established:
- As a "training set" as commonly understood in AI/ML is not applicable here, the question of how its ground truth was established is not relevant to this document. The "ground truth" for the device's functionality was based on the performance standards and design specifications it was built to meet.
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