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510(k) Data Aggregation
(60 days)
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)
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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(332 days)
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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(442 days)
The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric 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, home, and non-emergency transport settings for example wheelchair or personal vehicle. It may be used for both invasive and non-invasive ventilation.
The Trilogy Evo ventilator is a microprocessor controlled blower based 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, home, and non-emergency transport settings for example wheelchair or personal vehicle. 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, A/C-VC), Spontaneous modes (CPAP, PSV), Mixed modes (S/T, SIMV-PC, SIMV-VC), AVAPS-AE modes (AVAPS-AE with PC Breath enabled, with auto backup; AVAPS-AE with PC Breath enabled, without auto backup; AVAPS-AE with PC Breath disabled, with auto backup; AVAPS-AE with PC Breath disabled, without auto backup). In addition to the therapy modes, the Trilogy Evo provides the following major functions: Therapy Features, Power Manaqement, 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, Remote alarm and nurse call capability, 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 provided text describes the 510(k) premarket notification for the Trilogy Evo Ventilator, demonstrating its substantial equivalence to previously marketed predicate devices. However, the document does not contain information about studies involving AI or machine learning algorithms, human readers, or the establishment of ground truth by expert consensus that would typically be associated with AI/ML device performance evaluation as per your prompt.
Therefore, I cannot extract the specific details requested regarding acceptance criteria, study methodologies for AI performance, sample sizes, expert involvement, or MRMC studies, as these aspects are not present in the provided text, which focuses on the regulatory submission for a traditional mechanical ventilator.
The performance data section details non-clinical tests such as:
- Software verification and validation
- Biocompatibility testing
- General safety, electrical safety, and electromagnetic compatibility (EMC)
- Human factors testing
It explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the Trilogy Evo ventilator. Product functionality has been adequately assessed by non-clinical tests."
This indicates that the performance evaluation for this device did not involve clinical studies with human subjects or methods, like MRMC studies, often used to assess devices that employ AI/ML impacting diagnostic or clinical decision-making.
If you have a document about an AI/ML-based medical device, please provide that, and I would be happy to help describe its acceptance criteria and supporting studies as per your detailed request.
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(442 days)
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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(259 days)
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. 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 solution that will provide entities involved in a patient's therapy lifecycle with the ability to manage patients and referrals, control access to patient information and theract with billing information, enhance patient compliance management workflow, manage the resupply of medical equipment, and gain efficiencies in the overall Patient Therapy Workflow. Care Orchestrator will support patient data management for sleep therapy devices (BZD, MNS, MNT) and respiratory devices (CBK, NOU, CAW). Care Orchestrator will support prescription updates for sleep therapy devices. There are no input flows to the respiratory device interfaces (Bluetooth and SD Card). Device prescription and settings are read-only for these respiratory device types.
The provided text does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics typically associated with medical device studies (e.g., sensitivity, specificity, accuracy against a referent standard).
Instead, the document is a 510(k) Premarket Notification for a device called "Care Orchestrator," which is a data management system for therapy devices. The key focus of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (also named Care Orchestrator, K152356).
Here's a breakdown of what the document does state, and why it doesn't fit the requested criteria:
- Device Type: Care Orchestrator is a software-based data management system for tracking and managing patient data from therapy devices (e.g., sleep therapy, respiratory devices). It's not a diagnostic device or one that performs a specific measurement or medical interpretation that would require traditional performance metrics like sensitivity or specificity.
- Purpose: Its primary functions are remote patient data collection and viewing, managing patient and referral information, controlling access to patient data, handling billing information, managing medical equipment resupply, and allowing clinicians to adjust prescription/performance settings for compatible non-life support therapy devices.
- "Study" type: The relevant section is "VII. Performance Data: Software Verification and Validation Testing." This section describes non-clinical tests focused on verifying the software's functionality and ensuring it meets product requirements. It explicitly states, "Clinical tests were not required to demonstrate the safety and effectiveness of Care Orchestrator. Product functionality has been adequately assessed by non-clinical tests."
Therefore, I cannot provide the requested table or detailed information because the provided text does not include:
- A table of acceptance criteria and reported device performance for specific medical metrics. The "performance data" refers to software verification and validation against product requirements, not medical diagnostic or treatment efficacy metrics.
- Sample size for a test set in a medical performance study.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size.
- Standalone algorithm performance (as it's a data management system, not an AI for diagnosis/treatment).
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for a training set.
- How ground truth for a training set was established.
Summary of available information related to "performance":
The document focuses on demonstrating that the software functions as intended and is equivalent to the predicate device.
- Non-Clinical Tests: Software verification and validation testing was conducted.
- Focus: Complete system testing to verify data transfer from therapy devices to Care Orchestrator (wireless and SD card), display of patient and device information, display of therapy data (including compliance and therapy reports), and the ability for a user to create/edit patient prescriptions for applicable therapy devices.
- Outcome: "The testing of Care Orchestrator verified that all product requirements have been met with passing test results." And "The verification and validation testing demonstrated the overall substantial equivalence of the Care Orchestrator system."
- Clinical Tests: "Clinical tests were not required to demonstrate the safety and effectiveness of Care Orchestrator."
In essence, the "study" described is a software verification and validation process to ensure the data management system functions correctly and securely, rather than a clinical study evaluating diagnostic accuracy or therapeutic outcomes.
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(141 days)
Sapphire 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. Sapphire 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. Sapphire allows read-only access to patients. Sapphire is intended to be used in hospital, institutional, provider, and home care settings.
Sapphire is a web application that is used to manage patients utilizing compatible sleep and respiratory devices, view therapy data, generate reports and update device settings for applicable therapy devices. Sapphire is intended to be used by healthcare representatives (e.g., Physicians, Clinicians, Durable Medical Equipment providers) in hospital, institutional, provider and home settings. Device data is transferred either wirelessly or from an SD card to a centralized database. A user can view this data through a web based application on their computer.
The provided document, a 510(k) summary for the Sapphire device, offers limited details regarding specific acceptance criteria and detailed study results. Based on the available information, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance metrics. Instead, it broadly states that "The testing of Sapphire verified that all product requirements have been met with passing test results." The description of "product requirements" is general and includes:
- Displaying patient and device information.
- Displaying therapy data, including compliance and therapy reports.
- Allowing a user to create and/or edit a patient's prescription for applicable therapy devices.
- Verification of cybersecurity requirements (encryption of data at rest and in transit).
The "reported device performance" is a high-level statement that these requirements were met. No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) are provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set or the data provenance. It mentions "complete system testing to verify data transfer from therapy devices to Sapphire, through both wireless data transfer." This implies patient data was used, but the quantity, origin, or retrospective/prospective nature of that data is not specified.
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)
This information is not provided. The testing described appears to be software verification and validation, not a study involving expert-adjudicated ground truth data for diagnostic performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No adjudication method is mentioned, as the nature of the testing described does not involve expert adjudication of diagnostic outcomes.
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 MRMC comparative effectiveness study was done. The Sapphire device is a data management system, not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data from that perspective.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The testing performed was standalone in the sense that it verified the software's ability to correctly process and display data, and manage settings, without explicitly assessing human interaction improvements. However, it's a data management system, so its "standalone performance" refers to its functional correctness in handling data and settings as intended, not diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not detail how "ground truth" was established for the data processed by Sapphire. Given the functionality (data transfer, display, report generation, setting adjustment), the "ground truth" would likely refer to the accuracy of the transferred data matching the source device data and the correct application of prescribed settings. This would be established through comparison with the original therapy device data and verification of setting changes.
8. The sample size for the training set
The document does not mention a training set, as Sapphire is a data management system and not explicitly described as having a machine learning component that would require a distinct training set (in the typical AI/ML sense).
9. How the ground truth for the training set was established
Not applicable, as a training set is not mentioned.
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(316 days)
The Revolution Full Face Mask is intended to provide an interface for continuous possitive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.
The Respironics Revolution Full Face Mask consists of a frame (faceplate) with a silicone cushion and an elbow with an integral entrainment valve. The faceplate holds multiple sizes in order to exchange mask cushion sizes on one (frame) faceplate. The Revolution Full Face Mask cushion has eight exhalation vents, with four vents located on either side of the mask cushion. As a result, a separate exhalation device is not required for use of this mask. The mask has an integrated entrainment valve elbow with a two-piece polycarbonate valve body with a silicone flapper and exhalation vents located on the valve body. This feature was modified from Revolution Full Face (K082866) from a "stream-line" design however this elbow design was cleared under K073600. The design of the Revolution Full Face Mask headgear has two slide-through top strap adjustments, side and back straps, a Lower Headgear Band and a Chin Support Band. The mask is available in four sizes – small, medium, and large.
This document describes a 510(k) premarket notification for a medical device called the "Revolution Full Face Mask" by Respironics, Inc. This is a submission to demonstrate substantial equivalence to previously cleared predicate devices, rather than a novel device requiring extensive clinical trials to prove efficacy against specific acceptance criteria for an AI or medical device's diagnostic performance.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device's performance metrics (like sensitivity, specificity, etc.) is not directly applicable to this document. This document focuses on demonstrating that the modified Revolution Full Face Mask is as safe and effective as its predicate devices through non-clinical testing and comparison of technological characteristics.
However, I can extract information related to the device's performance testing and the standards it aims to meet, which can be interpreted as the "acceptance criteria" for demonstrating substantial equivalence for this type of medical device.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (based on non-clinical tests and standards) | Reported Device Performance (Implied by conclusion of substantial equivalence) |
|---|---|
| Performance Testing: | |
| Intentional Leak | Met (no new questions of safety/effectiveness raised) |
| Total Mask Leak | Met (no new questions of safety/effectiveness raised) |
| Deadspace Volume | Met (no new questions of safety/effectiveness raised) |
| Pressure Drop | Met (no new questions of safety/effectiveness raised) |
| Anti-Asphyxia Feature Open to Atmosphere Pressure | Met (no new questions of safety/effectiveness raised) |
| Anti-Asphyxia Feature Closed to Atmosphere Pressure | Met (no new questions of safety/effectiveness raised) |
| CO2 Rebreathing | Met (no new questions of safety/effectiveness raised) |
| Cleaning and Disinfection Efficacy | Met (no new questions of safety/effectiveness raised) |
| Storage | Met (no new questions of safety/effectiveness raised) |
| Standards Compliance: | |
| ISO 17510-2 Sleep Apnoea Devices Part 2: Masks | Met |
| ISO 10993-1 Biological evaluation of medical devices | Met |
| ISO 14971 Medical devices – Risk management | Met |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "Non-Clinical Tests" (Page 6).
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. This refers to the number of physical masks or components tested in the non-clinical performance evaluations. Given it's a device modification and non-clinical, typical engineering test sample sizes would be used, but the exact numbers are not provided in this summary.
- Data Provenance: The tests were performed by Respironics, Inc. The nature of these tests (e.g., bench testing, material analysis) means the "provenance" isn't country-specific in the way clinical trial data might be. These are likely internal lab tests. They are retrospective in the sense that the testing was performed on the device modification before submission, to compare against a baseline or standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to a non-clinical device performance test of this nature. "Ground truth" is established by engineering specifications, validated test methods, and compliance with recognized standards (ISO standards mentioned). No human experts are used to establish "ground truth" for physical device performance in the way they would be for image interpretation by an AI.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or evaluators in studies where subjectivity plays a role (e.g., interpreting medical images). The non-clinical tests described here are objective engineering measurements.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This device is a physical mask for respiratory therapy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not an AI algorithm.
7. The type of ground truth used:
- For the non-clinical tests, the "ground truth" is defined by:
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI algorithm developing a model.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or corresponding "ground truth" for a training set.
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(169 days)
The Kangaroo Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. This mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital/institutional environment. This mask is to be used on patients greater than 66 Ibs /30 kg.
The Kangaroo Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. It provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned by the patient in the home (single patient use) or cleaned by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).
The Kangaroo Nasal Mask consists of a frame with a gel cushion is designed in such a way that it minimizes leaks and is comfortable for the patient. An elbow is connected to the cushion and includes integrated exhalation features. The elbow can rotate freely through 360 degrees and is connected to 15 mm tubing that includes an integrated 22 mm swivel connector. The mask is designed in such a way that it can be easily disassembled for cleaning or to replace several of the mask components.
The 22 mm swivel connector on the 15 mm tubing is used to connect the mask to a conventional 22 mm air delivery hose that is in turn connected to the positive airway pressure source. The swivel connector can rotate freely through 360 degrees.
The provided text describes a 510(k) submission for the "Kangaroo Nasal Mask." This submission does not include an AI-powered device or a study involving AI integration. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to demonstrate safety and effectiveness, and substantial equivalence to predicate devices, as typically required for medical devices.
Here's a breakdown of the requested information based on the provided text, focusing on the device's substantial equivalence through non-clinical testing, as no AI component, MRMC study, or standalone algorithm performance is mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Performance & Functionality | Device performance and functionality remain unaffected after cleaning and disinfection processes. | "Extensive performance testing was performed pre and post cleaning and disinfection treatments to demonstrate performance and functionality was unaffected as a result of these changes." |
| Disinfection Efficacy | Disinfection efficacy meets established standards. | "Disinfection efficacy testing was performed in accordance with AAMI TIR No.12-2010, AAMI TIR No. 30-2011 and ASTM E1837-96 (2007) and the 'Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants' – FDA CDRH, January 3, 2000." |
| Biocompatibility | All patient-contacting and gas path materials are biocompatible. | "All patient contacting or gas path materials used in the mask have been previously cleared by the FDA or biocompatibility tested in accordance with the guidance provided by ISO 10993-1." |
| Safety and Effectiveness | Device raises no new issues of safety or effectiveness compared to predicate devices. | "Results from this testing demonstrate that the Kangaroo Nasal Mask meets its performance specifications, raises no new issues of safety or effectiveness, and is substantially equivalent to the identified device predicates." |
| Substantial Equivalence | Device is substantially equivalent to predicate devices based on intended use, operating principle, scientific concepts, technology, materials, design, and physical properties. | The device was found substantially equivalent to Respironics GoLife Nasal Mask (K110008) and Respironics TrueBlue Nasal Mask (K110405) despite minor differences in cushion design (gel inclusion), frame, elbow, headgear, materials, and disinfection methods. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "extensive performance testing" and the execution of various standards, but does not provide specific sample sizes (e.g., number of masks tested per condition).
- Data Provenance: Not applicable in the traditional sense of patient data. The provenance relates to laboratory testing of the physical device and its materials, conducted by the manufacturer, Respironics, Inc. (USA). This testing is retrospective in the sense that it evaluates the manufactured product against predefined specifications and regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the "ground truth" for the non-clinical performance and safety testing is based on established engineering specifications, industry standards (e.g., AAMI TIR, ASTM, ISO 10993-1), and regulatory guidance from the FDA. The "experts" involved would be the testing engineers and scientists at Respironics, and potentially third-party labs if specialized testing was outsourced, whose qualifications would involve expertise in materials science, mechanical engineering, microbiology, and regulatory compliance, but they are not adjudicating clinical cases for ground truth.
4. Adjudication Method for the Test Set
- Not applicable in the context of clinical adjudication. The "adjudication" for this type of submission involves comparing test results against predefined thresholds and criteria outlined in the referenced standards and internal performance specifications. It's a binary outcome (pass/fail) based on objective measurements, not a consensus among clinical experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document explicitly states: "Use of nasal masks with CPAP or bi-level therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Kangaroo Nasal Mask, as was the case with the predicate devices." This indicates that no clinical studies, including MRMC comparative effectiveness studies, were conducted or deemed necessary for this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This product is a physical medical device (a nasal mask) and does not involve any algorithms or AI for performance. Therefore, no standalone algorithm performance testing was conducted.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on engineering specifications, industry standards, and regulatory guidelines. For example:
- Performance & Functionality: Meeting pre-defined operational parameters (e.g., airflow, pressure integrity, fitting) after various treatments.
- Disinfection Efficacy: Achieving specified log reductions of microorganisms as per AAMI/ASTM standards.
- Biocompatibility: Conforming to ISO 10993-1 requirements for biological safety.
- Substantial Equivalence: Alignment with predicate devices in key technological characteristics and safety/effectiveness profiles.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as above.
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(72 days)
The Simple T Nasal Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospitallinstitutional environment. The mask is to be used by patients greater than 66lbs/30kg.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Simple T Nasal Mask." It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The letter primarily:
- Confirms that the FDA has reviewed the premarket notification (K120145) for the Simple T Nasal Mask.
- States that the device is substantially equivalent to legally marketed predicate devices.
- Outlines general regulatory requirements for marketing the device.
- Provides contact information for further regulatory guidance.
- Includes an "Indications for Use" statement for the device.
Therefore, I cannot provide the requested information from this document.
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