(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.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).