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Found 408 results
510(k) Data Aggregation
(210 days)
BZD
A-Model
The F&P Nova Nasal Mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 ks) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home.
SLA-Model
The F&P Nova Nasal mask is intended to be used by adults aged 22 years and older weighing ≥ 66 lb (30 kg) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The Nova Nasal mask is intended for single-patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
The F&P Nova Nasal Mask is a non-invasive, Positive Airway Pressure (PAP) therapy nasal mask that features an over-the-nose cushion that seals the patient's nose, held in place by adjustable headgear straps. The mask is designed to aid in the delivery of PAP by providing an interface between the flow generator and tubing, and the patient. The F&P Nova Nasal Mask is a prescription-only device, provided in a non-sterile state.
The Nova Nasal Mask range is available in three cushion sizes – Small, Medium, and Large.
The mask has two models: A-Model and Sleeplab (SL) A-Model. Both models are identical except for their Indications for Use, Operating Environment, and Reusability. The A-Model is intended to be single-patient use in the home, while the SL A-Model is intended to be used on multiple patients in a hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
I am sorry, but based on the provided FDA 510(k) Clearance Letter and the accompanying 510(k) Summary, there is no information provided regarding acceptance criteria for an AI/ML powered medical device, nor any study details that would prove such a device meets these criteria.
The document describes the clearance of a physical medical device, the F&P Nova Nasal Mask, which is a non-invasive positive airway pressure (PAP) therapy nasal mask. The performance data section lists standard engineering and biocompatibility tests typically performed on such devices (e.g., cleaning validation, leak, CO2 rebreathing, resistance to flow, vibration and noise, dead space analysis, human factors, mechanical integrity, shelf-life, and various ISO standards related to masks and biological evaluation).
Therefore, I cannot fulfill your request to describe acceptance criteria and a study for an AI-powered device using this document. The information you are asking for (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) are specifically relevant to the validation of AI/ML algorithms in medical devices, which this document does not cover.
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(86 days)
BZD
The myAir app is indicated for patients:
- prescribed with a compatible ResMed Air11 platform device to simulate therapy prior to using their device with their prescribed settings, and to configure their settings to support therapy. It is an optional software accessory to allow patients to acclimate to and operate their therapy device.
- prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process.
The device is intended for home and hospital use for:
- new and existing patients of ResMed Air10 and Air11 PAP therapy devices and
- new users who are prescribed a compatible NightOwl home sleep test (HST).
myAir is a companion mobile medical application ("app") that serves as a patient self-monitoring, therapy usage tracking, and engagement platform for patients prescribed with compatible ResMed PAP therapy devices and the NightOwl home sleep test (HST) sensors. The app allows the patient to connect via Bluetooth to a compatible hardware device for control of their prescribed PAP or HST device and to allow self-tracking of device usage data. myAir can also be used as a communication pathway using the Bluetooth connection with the compatible device in order to send or receive data. Analysis of patient diagnostic data or display of diagnostic results are not in scope of myAir features.
The myAir subject device for this premarket submission adds device software functions related to starting and stopping therapy, and control of comfort settings (collectively referred to as "device control"). The addition of these device software functions within the myAir subject device is a modification to the K241216 myAir predicate device, in addition to sustaining previously cleared medical device functions.
It appears the provided document is an FDA Clearance Letter for the "myAir" device, specifically a 510(k) summary. This type of document primarily focuses on establishing substantial equivalence to a predicate device, rather than detailing the full scope of acceptance criteria and the comprehensive study results typically found in a clinical study report or a more detailed technical submission.
Based on the provided text, the device "myAir" is a companion mobile medical application. The submission is for a modified device, adding "device software functions related to starting and stopping therapy, and control of comfort settings (collectively referred to as 'device control')".
Therefore, the study detailed is primarily non-clinical verification and validation testing of software functions introduced with these modifications. The document states:
"Non-clinical verification and validation testing completed for device software functions under review introduced with the modifications to the myAir app demonstrated that the device met all intended performance requirements. Testing included:
- Software verification and validation, including non-functional requirements and end-to-end functional testing."
Given this, I cannot provide detailed information about acceptance criteria and study results for clinical performance or human-in-the-loop studies (MRMC, effect size, etc.), as such studies are not described in this 510(k) summary for a software modification. The focus is on the software's functional performance and adherence to guidance documents for software and cybersecurity.
Here's what can be extracted from the provided text according to your request, with a clear indication where information is not available in the document:
Acceptance Criteria and Device Performance for "myAir" (K250624)
The "myAir" device is a mobile application that received FDA 510(k) clearance (K250624) as a modified device, primarily adding "device control functions" (starting/stopping therapy, controlling comfort settings) for compatible ResMed Air11 platform devices. The acceptance criteria and performance detailed below pertain specifically to the non-clinical verification and validation of these new software functions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from document) | Reported Device Performance (As stated/inferred from document) |
|---|---|---|
| Software Functionality | Device control functions (starting/stopping therapy, comfort settings) operate as intended. | "device met all intended performance requirements." "Software verification and validation, including non-functional requirements and end-to-end functional testing." |
| Interoperability | myAir app successfully connects and operates with compatible ResMed Air11 platform devices. | "Device Interoperability and V&V: Identical [to predicate] - ResMed Air11 platform devices and NightOwl HST." "myAir app must be connected to a compatible AS11 or HST device to operate device functions as intended." |
| Compliance with FDA Guidance | Adherence to relevant FDA guidance for medical device software and cybersecurity. | "The following FDA guidance were conformed to: Content of Premarket Submissions for Device Software Functions: June 2023; Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: September 2023." |
| Safety and Effectiveness | The additions to the device do not raise new questions of safety or effectiveness. | "The differences [from predicate] do not raise any new questions of safety or effectiveness; and It is as safe and effective as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "Software verification and validation, including non-functional requirements and end-to-end functional testing." This typically involves a range of test cases, but the specific number is not disclosed in this summary.
- Data Provenance: The document describes "non-clinical verification and validation testing." This implies internal testing conducted by the manufacturer (ResMed Corp, USA). It does not involve patient data or clinical datasets. Therefore, provenance (country, retrospective/prospective) is not applicable in the typical sense of a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable/Not specified. For non-clinical software verification and validation, "ground truth" is typically defined by functional requirements specifications and design documents. The testing validates that the software performs according to these pre-defined specifications. Expert human readers or adjudicators are not typically involved in establishing ground truth for this type of testing.
4. Adjudication Method for the Test Set
- Not Applicable/None stated. As the testing is non-clinical software verification, adjudication methods like 2+1 or 3+1 (common in image interpretation studies) are not relevant here. The success or failure of a test case is determined by whether the software performs as specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not conducted as part of this submission, based on the provided document. The submission pertains to software functionality and its substantial equivalence, not to comparative effectiveness for human readers.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study or human reader performance evaluation was described. The "myAir" app is an accessory for device control and patient engagement, not an AI diagnostic tool assisting human readers.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, implicitly. The "non-clinical verification and validation testing" is a form of standalone testing for the software's functional performance. The software is tested to operate its intended device control functions (starting/stopping therapy, comfort settings) without direct human intervention in the execution of those specific software commands once initiated. However, this is not "standalone performance" in the sense of a diagnostic algorithm's accuracy, sensitivity, or specificity. It's about the software performing its programmed tasks correctly.
7. The Type of Ground Truth Used
- Functional Requirements and Design Specifications. For this type of software verification, the "ground truth" is established by the detailed specifications of how the software functions are designed to operate. Test cases are then executed to confirm that the actual software behavior matches these expected behaviors. No clinical ground truth (e.g., pathology, outcomes data, expert consensus on patient conditions) is mentioned as being used for the specific software modifications under review.
8. The Sample Size for the Training Set
- Not Applicable/Not disclosed. Since this is software functional verification and validation for a non-AI/ML application (it controls a medical device and provides user interface), there is no "training set" in the sense of data used to train a machine learning model. The software's logic is developed through traditional programming methods, not data training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8. No training set for an AI/ML model is indicated, so no ground truth establishment process for a training set is relevant or described.
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(238 days)
BZD
The 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 and multi-patient multi-use in the hospital environment.
The Mask is to be used by adults weighing ≥ 30 kg whom positive airway pressure (CPAP or bi-level system) has been prescribed.
WiZARD 520 Full Face Mask's cushion and frame provide a secure interface between the mask and the patient's face and the flexible cushion improves seal. A series of vents on the elbow, serve as an exhalation vent to purge the exhaled carbon dioxide from the mask. The mask is designed to maintain a continuous airflow to minimize the amount of CO2 rebreathed by the patient. The mask features a wider visibility design that ensures a clear line of sight. It also includes a fabric frame equipped with 3D-shaped headgear for enhanced comfort and stability.
WiZARD 520 Full Face Mask is intended for connection to a positive air pressure source such as CPAP or bi-level for the treatment of Obstructive Sleep Apnea. WiZARD 520 Full Face Mask can be linked to the CPAP or bi-level system's standard 22 mm breathing tube using a swivel hose, flexible tube, and tubing connector. Various sizes (small, medium, and large) are offered to ensure adequate fit over the extended patient population.
The provided text is an FDA 510(k) clearance letter for the WiZARD 520 Full Face Mask. This document describes the substantial equivalence of the new device to a predicate device, focusing on its physical and functional characteristics. It does not describe a study proving the device meets acceptance criteria related to an AI/Machine Learning model, nor does it provide information relevant to a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or the establishment of ground truth by expert consensus.
The clearance is for a physical medical device (a CPAP mask), not a software or AI-driven diagnostic tool. Therefore, the concepts of "acceptance criteria for an AI model," "sample size for test/training sets," "number of experts for ground truth," "adjudication method," "MRMC study," or "standalone algorithm performance" are not applicable to this document.
The document discusses performance tests that are standard for a physical medical device, such as CO2 rebreathing, pressure-flow characteristics, resistance to flow, anti-asphyxia valve operating pressures, and sound levels. These are engineering and physiological performance metrics, not metrics for an AI's diagnostic accuracy or expert agreement.
Therefore, I cannot fulfill your request using the provided input, as the input material does not contain the type of information you've asked for. It's crucial to understand that a 510(k) for a physical medical device like a CPAP mask does not involve AI development or validation processes.
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(265 days)
BZD
AirFit F20 Mask System:
The AirFit F20 mask has two product variants:
- AirFit F20 mask is intended for single-patent reuse in the home environment.
- AirFit F20 SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.
AirFit F20 NM Mask System:
The AirFit F20 Non Magnetic mask has two product variants:
- The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment.
- The AirFit F20 Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.
The AirFit F20 and AirFit F20 NM Mask Systems are both full-face masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices. CPAP & Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth.
The AirFit F20 mask system has two product variants:
- AirFit F20 Mask: This is the home use variant that is intended for single patient re-use.
- AirFit F20 SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.
AirFit F20 (K170924) had a "For Her" variant which was cleared with aesthetic colour pops, the AirFit F20 Mask and AirFit F20 SLM also have the same "For Her" variant.
The AirFit F20 NM mask system has two product variants:
- AirFit F20 NM Mask: This is the home use variant that is intended for single patient re-use.
- AirFit F20 NM SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.
The AirFit F20 and AirFit F20 NM Mask Systems share a common design architecture as the predicate AirFit F20 (K170924), except that the AirFit F20 NM Mask System has non-magnetic clips.
The AirFit F20 and AirFit F20 NM mask systems are made up of the following four main component assemblies: cushion, elbow, frame, and headgear. The cushion and headgear are available in various sizes to allow for adequate mask fit over the intended patient population.
The AirFit F20 and AirFit F20 NM mask systems are prescription devices supplied non-sterile.
The provided FDA 510(k) clearance letter and associated summary pertain to the AirFit F20 Mask Systems, which are non-continuous ventilators (CPAP/Bi-Level masks). This type of device does not typically involve complex diagnostic algorithms or AI components that would necessitate the study structure outlined in your request (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance for AI).
Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (AirFit F20, K170924) through non-clinical performance and safety testing, adherence to recognized standards, and biocompatibility evaluations.
Therefore, many of the specific questions you've asked cannot be directly answered from this document as they are not relevant to the type of device and clearance process involved.
Here's an attempt to extract the relevant information and address your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a format typically used for diagnostic algorithm validation. Instead, it compares specific design parameters and performance characteristics of the new devices (AirFit F20 Mask System and AirFit F20 NM Mask System) against the predicate device (AirFit F20, K170924). The "Comments" column often indicates that the performance is "Equivalent" or "Identical," implying that the new devices meet or perform similarly to the established safety and performance profile of the predicate, which serves as the de facto acceptance benchmark.
Here's a summary derived from the comparison table (Pages 9-12 of the provided document):
| Design parameter or feature | Predicate device: AirFit F20, K170924 (Performance/Criteria based on predicate) | Modified device: AirFit F20 Mask System (Reported Performance) | Modified device: AirFit F20 NM Mask System (Reported Performance) | Acceptance Criteria (Implied) |
|---|---|---|---|---|
| Indications for Use | Specified for CPAP/bi-level, >66lb (30kg), single-patient home, multi-patient hospital use. | Equivalent to predicate, with variants for home/sleep lab use. | Equivalent to predicate, with variants for home/sleep lab use. | Equivalent to predicate |
| Intended Use | Interface for CPAP/bi-level devices. | Identical | Identical | Identical to predicate |
| FDA Product Code | BZD | BZD | BZD | Identical to predicate |
| Patient population | Weighing more than 66 lb (30 kg) | Patients weighing more than 66lb (30kg) | Patients weighing more than 66lb (30kg) | Identical to predicate |
| Environment of Use | Home or health institution | Home or health institution | Home or health institution | Identical to predicate |
| Reprocessing claims | Single patient re-use or multi-patient re-use. | Identical | Identical | Identical to predicate |
| Sterility state as provided | Non-sterile | Non-sterile | Non-sterile | Identical to predicate |
| Validated reprocessing methods | High-Level Thermal disinfection, Sterilization | High-Level Thermal disinfection, Sterilization | High-Level Thermal disinfection, Sterilization | Identical to predicate |
| Vent type | Multi-hole vent | Multi-hole vent and diffuser vent | Multi-hole vent and diffuser vent | Equivalent to predicate's safety/efficacy profile |
| PAP tubing connection point | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | ISO 5356-1 (22mm) | Identical to predicate |
| Construction material | Polymeric, Textile, magnets | Polymeric, Textile, magnets | Polymeric, Textile | Equivalent to predicate's safety/efficacy profile (NM variant removes magnets) |
| Operating pressure range (cmH2O) | 3 - 40 | 3 – 40 | 3 – 40 | Identical to predicate |
| Sizes | Cushion (3), Headgear (3), Frame (1) | Identical | Identical | Identical to predicate |
| Mask exhaust flow (Nominal) ISO 17510:2015 Annex B | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 20.1, 55.5, 82.4 | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 19, 54, 82 | Pressure (cm H2O): 3, 20, 40 -> Flow (L/min) 'Full Face' curve: 19, 54, 82 | Equivalent to predicate (minor differences within acceptable range for substantial equivalence) |
| CO2 rebreathing performance (normal condition) ISO 17510:2015 Annex F | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: 14.8%, 7.5%, 6.8% SLM: 11.7%, 7.3%, 2.9% | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: ≤ 11.4%, ≤ 11.4%, - SLM: 11.7%, 7.3%, 2.9% | Pressure (cm H2O): 3, 5, 10 -> Relative CO2 increase Non-SLM: ≤ 11.4%, ≤ 11.4%, - SLM: 11.7%, 7.3%, 2.9% | Equivalent ( Relative CO2 increase Non-SLM: 32.3%, 39.5% SLM: 40.5%, 52.7% |
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(112 days)
BZD
Respiration Data Management Software is installed in a computer to perform patient management by treatment data viewing, treatment data reporting and remotely adjusting the prescribed compatible BMC CPAP and BPAP devices' settings. It is intended for healthcare professionals in healthcare facilities use only.
The Respiration Data Management Software is a softwareonly device, which allows physicians and other clinical staff to transmit, analyze and review respiration data from the compatible CPAP and BPAP devices (non-life support systems), thus to assist the users in patient management and follow-up work. This also includes remote modification of the treatment parameters of the compatible devices. It can also store patient data, upload data to the cloud platform, generate and print reports.
The provided text is a 510(k) Summary for the "Respiration Data Management Software." It highlights the device's indications for use and its substantial equivalence to a predicate device, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The document focuses on:
- Software Verification and Validation: Stating that it was conducted according to FDA guidance.
- Cybersecurity: Stating that it was considered and evaluated according to FDA guidance.
- Comparison to Predicate Device: Detailing similarities and differences in functionality, compatible devices, and communication mediums, and asserting that differences do not raise new questions of safety or effectiveness.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed performance study.
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(84 days)
BZD
The Nasal Pillow Mask is intended for patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in home, hospital, or institutional environments. This device is intended to be use under the direction of a physician.
The Nasal Pillow Mask is patient interface device intended for use with CPAP/VPAP therapy systems. The device provides non-invasive means of delivering positive airway pressure to the user by creating a sealed interface using nasal pillows that fit directly into the patients' nostrils. The Nasal Pillow Mask is made of silicone material and comes in 3 different sizes (S, M & L). The nasal mask comes with standard hose fitting intended to be used with standard CPAP/VPAP system. It is intended to be use on patients (> 30 kg) who have been prescribed CPAP/VPAP therapy at home, hospital, or institutional environments. The complete mask set incudes headgear, frame, tube, and nasal pillows (S, M, & L sizes).
This document is a 510(k) summary for a Nasal Pillow Mask, indicating that the device is substantially equivalent to a previously cleared predicate device. As such, it highlights the lack of a new study to demonstrate acceptance criteria because the device is deemed identical to its predicate in all relevant aspects.
Here's the breakdown of why the requested information cannot be fully provided based solely on the input, and what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "The subject device is identical to predicate device except for manufacturer name, brand name, and resulting labeling updates. The indications for use, design, principles of operation, and materials are all identical to the predicate device already cleared by FDA. Therefore, no new non-clinical testing is required."
This means that for the current 510(k) submission (K243225), no new acceptance criteria or reported device performance data was generated or provided for the subject device. The acceptance criteria and performance data would have been established and demonstrated for the predicate device (K120920) in its original submission.
The table in the document provides specifications for Deadspace Volume, Resistance, Therapy pressure, Noise level, Environmental Conditions, Weight, and Size Flow, which are common technical specifications for such devices. These are not explicitly stated as "acceptance criteria" but rather as "Specifications" that are "Same" as the predicate.
| Specification Item | Subject Device Performance (Reported as "Same" as Predicate) |
|---|---|
| Deadspace Volume | S size: 90.8 |
| M size: 94.3 | |
| L size: 95 | |
| Resistance 50 L/m | (Value not numerically given, stated as "Same") |
| Resistance 100 L/m | S size: 6.87 |
| M size: 5.93 | |
| L size: 5.3 | |
| Therapy pressure | 5~20cmH2O (Reported as 10cmH2O) |
| Noise level | S size: 35.0~36.0 |
| M size: 34.2~35.6 | |
| L size: 35.4~36.8 | |
| Environmental Conditions | Storage and Transportation: 15°C ~ 25°C, up to 95% non-condensing |
| Storage relative humidity: |
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(116 days)
BZD
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.
Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment.
Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital institutional environment.
Innova is intended for Single patient, multi-use in the home or hospital/institutional environment.
Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.
The Sleepnet Mojo Vented Full Face Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are used with positive pressure devices, such as CPAP and Bi-level.
The modifications to the cleared Mojo Full Face mask (K120463) are:
- Addition of contraindication and updated warning related to presence of magnets
- Change to the headgear material
- Addition of an XL size
The modifications to the cleared Veraseal Full Face mask (K120463) are:
- Modified design, now called the Veraseal 2 Full Face Vented Mask
- . Addition of an XL size
Other modifications include:
- Addition of the Innova Full Face Vented Mask version
- Addition of the Ascend Full Face Vented Mask version
This document does not describe an AI/ML device or a comparative effectiveness study. It is a 510(k) summary for several full face vented masks (Mojo, Veraseal 2, Innova, Ascend) and compares them to a predicate device (Mojo Full Face Mask and Veraseal Full Face Mask, K120463).
The summary focuses on demonstrating substantial equivalence to a previously cleared device through comparisons of indications for use, patient population, environment of use, and technological characteristics. This typically involves performance testing, biocompatibility, transportation, shelf-life, and reprocessing.
Therefore, many of the requested elements for an AI/ML device evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the provided "Table of Comparison to Predicate" and "Non-Clinical Testing Summary" as they relate to these medical masks.
1. Table of Acceptance Criteria and the Reported Device Performance (as applicable to a physical medical device, not AI/ML):
| Acceptance Criteria (Typically based on ISO 17510 and predicate device performance) | Reported Device Performance (Subject Device: Mojo, Veraseal 2, Innova, Ascend Full Face Vented Mask) | Predicate Device Performance (K120463: Mojo, Veraseal Full Face Mask) | Explanation of Differences (and compliance) |
|---|---|---|---|
| Exhaust Flow Characteristics: (Comparison to predicate device) | Mojo: 3cmH2O: 17.88 lpm, 10cmH2O: 32.57 lpm, 20cmH2O: 48.90 lpm | ||
| Veraseal 2: 3cmH2O: 22.08 lpm, 10cmH2O: 38.50 lpm, 20cmH2O: 54.30 lpm | |||
| Innova: 3cmH2O: 22.08 lpm, 10cmH2O: 38.50 lpm, 20cmH2O: 54.30 lpm | |||
| Ascend: 3cmH2O: 26.80 lpm, 10cmH2O: 41.50 lpm, 20cmH2O: 58.00 lpm | Mojo: 3cmH2O: 21.20 lpm, 10cmH2O: 37.20 lpm, 20cmH2O: 53.10 lpm | ||
| Veraseal: 3cmH2O: 21.10 lpm, 10cmH2O: 36.40 lpm, 20cmH2O: 53.00 lpm | Similar. The exhaust flow characteristics of the subject devices are similar to the predicate. | ||
| Anti-Asphyxia Valve (AAV) Opening/Closing Pressure: ( |
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(87 days)
BZD
The Easy Care Tx 2 software is intended to be used with ResMed compatible therapy devices in a clinical environment. EasyCare Tx 2 provides therapy device setting changes and displays real-time data and treatment settings from compatible ResMed therapy devices when used together with the TxLink 2 module.
EasyCare Tx 2 is a personal computer application designed to allow clinicians to monitor real-time data from the ResMed compatible therapy device and adjust the therapy device settings from the control room of the sleep lab.
The device in question is the EasyCare Tx 2, a therapy titration software developed by ResMed Corp. The provided document is a 510(k) Premarket Notification summary to the FDA. The submission seeks to prove substantial equivalence to a predicate device, the EasyCare Tx System (K113780).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in a quantitative sense as might be seen for diagnostic device performance (e.g., sensitivity, specificity). Instead, it focuses on comparing the technological characteristics and intended use of the EasyCare Tx 2 with its predicate device to demonstrate substantial equivalence. The "performance" here relates to functional capabilities and parameter ranges rather than diagnostic accuracy.
| Feature/Parameter | Predicate Device (EasyCare Tx - K113780) | Subject Device (EasyCare Tx 2) | Comparison/Performance Notes |
|---|---|---|---|
| Intended Use | To be used with ResMed compatible therapy devices via Tx Link; provides real-time data and treatment settings display, and can also provide therapy device setting changes remotely; intended for clinical environment. | To be used with ResMed compatible therapy devices in a clinical environment; provides therapy device setting changes and displays real-time data and treatment settings from compatible ResMed therapy devices when used together with TxLink 2 module. | Similar. |
| Technological Characteristics | |||
| Prescription Use | Yes | Yes | Same. |
| Intended Environment of Use | Hospital or Sleep Lab | Hospital or Sleep Lab | Same. |
| Display Type | PC | PC | Same. |
| Hardware Requirements | Standard PC platform with microprocessor and ancillary controllers | Standard PC platform with microprocessor and ancillary controllers | Same. |
| Operating System | Microsoft Windows | Microsoft Windows | Same. |
| Accessories | CD for downloading to PC, Tx Link | CD for downloading to PC, Tx Link 2 | Similar (Tx Link vs. Tx Link 2). |
| Compatible Therapy Devices | BZD, MNS, MNT | BZD | Similar. EasyCare Tx 2 does not support product codes MNS and MNT. |
| Therapy Device Adjustments (Settings) | |||
| Adjust Device Therapy Mode | Yes | Yes | Same. |
| Adjust Device Therapy Settings | Yes | Yes | Same. |
| Available Therapy Modes | CPAP, AutoSet, AutoSet for Her, S, ST, TVAuto, ASV, ASVAuto, PAC, iVAPS | CPAP, AutoSet, AutoSet for Her, S, ST, TVAuto, ASV, ASVAuto, PAC | The PAC and iVAPS modes are no longer used and supported as they are for devices under MNS and MNT product codes, and not in scope for EasyCare Tx 2 with BZD devices. |
| Humidifier Control | Humidifier on/off | Humidifier on/off, level control, auto | Similar. Auto mode added for the attached therapy device optimizes humidifier temperature. EasyCare Tx 2 controls humidifier settings. |
| Tubing Control | Tube Temperature on/off, auto | Tube Temperature on/off, auto | Same. Therapy device optimizes tube temperature. |
| Ramp | 0 to 45 min | 5 to 45 min, off, auto | Similar. Off mode added for usability. Auto mode stops ramp when sleep detected. |
| Output Parameters | |||
| Pressure | -3 to 35 cm H2O | 0 to 30 cm H2O | Similar. Therapy for EasyCare Tx 2 only supports OSA devices requiring lower pressure, removing the -3 cm H2O which was for a niche case in older devices. The therapy range has not changed for the relevant BZD devices. |
| Flow | -120 to 120 L/min | -240 to 240 L/min | Similar. Increased range due to larger data model and scalable architecture. Risks are considered by the parent therapy device. |
| Leak | -30 to 120 L/min | 0 to 2 L/s | Similar. Leak parameters are sent from the attached therapy device in L/s. EasyCare Tx 2 allows toggling between L/s and L/min. |
| Respiratory Rate | 6 to 35 BPM | 0 to 90 BPM | Similar. Higher range supports pediatric patients using AirSense 11. |
| Tidal Volume | 0.01 to 3 L | 0 to 4 L | Similar. |
| Target Ventilation | 0 to 30 L/min | 0 to 30 L/min | Same. |
| Minute Ventilation | 0 to 30 L/min | 0 to 30 L/min | Same. |
| Ti (Inspiration Time) | 0 to 9 seconds | 0.3 to 4 seconds | Similar. |
| Pulse Rate | 18 to 300 BPM | 0 to 300 BPM | Similar. Expansion of range due to new sensor supporting increased data monitoring. |
| SpO₂ | 40 to 100% | 0 to 100% | Similar. Expansion of range due to new sensor supporting increased data monitoring. |
The acceptance criteria here are implicitly met by demonstrating that the EasyCare Tx 2 has similar intended use and technological characteristics to the predicate device, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" are the parameter ranges and functional capabilities described for EasyCare Tx 2.
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 states: "Non-clinical verification and validation testing completed for EasyCare Tx 2 demonstrated that the device met all intended performance requirements. Testing included: Software verification and validation."
It also mentions: "The verification testing performed with EasyCare Tx 2 was software verification and validation against the non-functional requirements and end-to-end functional testing."
This indicates that the "test set" consisted of various software testing scenarios (unit, integration, system, performance, usability tests) to verify functionality and non-functional requirements. However, no specific sample size (e.g., number of data points, cases, or patients) for a test set is provided, nor is the data provenance (country of origin, retrospective/prospective) for any specific clinical data mentioned. The testing described is primarily software-centric, not based on a dataset of patient outcomes.
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 is software verification and validation, which typically involves engineering and quality assurance professionals, not clinical experts establishing ground truth in the context of medical image analysis or similar diagnostic tasks.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of the software verification and validation, adjudication methods typical for clinical or image-based studies are not relevant here.
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. This device is a software application for clinicians to monitor and adjust therapy device settings, not a diagnostic AI intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a human-in-the-loop software. Its purpose is to allow clinicians to monitor and adjust therapy settings. The "performance" is the software correctly displaying data and applying setting changes, not standalone diagnostic accuracy. The testing performed was "software verification and validation against the non-functional requirements and end-to-end functional testing," indicating validation of its functional integrity, not standalone diagnostic capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the software verification and validation, the "ground truth" would be the defined software requirements and expected behavior based on engineering specifications and design documents. For example, if a setting is changed from X to Y, the ground truth is that the software should correctly register and apply that change to the therapy device and display it accurately. It's not a clinical ground truth like pathology or outcome data.
8. The sample size for the training set
This information is not applicable/not provided. The EasyCare Tx 2 is described as therapy titration software, not an AI/ML model that would require a "training set" in the context of learning from data to make predictions or classifications. The software's functionality is based on programming and engineering, not machine learning.
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no mention of a machine learning training set.
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(148 days)
BZD
The myAir app is indicated for patients:
• prescribed with a compatible ResMed Air11 platform device to simulate therapy prior to using their device with their prescribed settings. It is an optional software accessory to allow patients to acclimate to their therapy device.
• prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process.
The device is intended for home and hospital use for:
• new and existing patients of ResMed Air11 PAP therapy devices and
• new users who are prescribed a compatible NightOwl home sleep test (HST).
myAir is a companion mobile medical application ("app") for self-monitoring use of the compatible devices that serve as a patient Home Sleep Test (HST), pre-therapy, and engagement platform for positive airway pressure (PAP) therapy. The app allows the patient to connect via Bluetooth to a compatible hardware device for temporary control of their prescribed HST or PAP device and to allow self-tracking of device usage data. myAir can also be used as a communication pathway using the Bluetooth connection with the compatible device in order to send or receive data. Analysis of patient diagnostic data or display of diagnostic results are not in scope of myAir features.
The subject device modifies the predicate device by adding interoperability with the NightOwl HST (Stella functions) in addition to sustaining previously cleared medical device function of connecting to the Air 1 platform.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. The document is primarily a 510(k) summary for the myAir app, outlining its substantial equivalence to a predicate device and a reference device. It mentions "non-clinical verification and validation testing" but does not elaborate on the specific tests, acceptance criteria, or results.
Therefore, I cannot provide the requested table or detailed information regarding the study.
However, I can extract the available relevant information:
Acceptance Criteria and Device Performance:
The document states: "Non-clinical verification and validation testing completed for NightOwl HST interoperable (Stella) functions introduced with the modifications to the myAir app demonstrated that the device met all intended performance requirements."
This is a general statement that the device met its intended performance requirements, but no specific acceptance criteria (e.g., accuracy metrics, thresholds for errors) or reported device performance data (e.g., a measured accuracy of X%) are provided in the text.
Regarding the study (based on limited information):
- Sample size used for the test set and data provenance: Not specified. The document only mentions "non-clinical verification and validation testing," implying a test set was used, but details on its size or provenance (country of origin, retrospective/prospective) are absent.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not specified. The information provided is about software testing, not clinical performance evaluation that would typically involve expert ground truth.
- Adjudication method: Not applicable/specified. This type of method is typically used in clinical studies with human assessors, which is not described here.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The document focuses on software interoperability and functional testing, not comparative clinical effectiveness with human readers.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study: The "non-clinical verification and validation testing" likely includes standalone software testing, but specific details or results are not provided. The myAir app acts as a user interface and data transfer mechanism, not an algorithm for diagnostic analysis or interpretation.
- Type of ground truth used: Not specified. For software functional testing, ground truth would typically be defined by expected system behavior and output under various conditions.
- Sample size for the training set: Not applicable and not specified. The myAir app described here is a companion mobile medical application for control and data transfer, not one that employs machine learning models requiring a training set for diagnostic purposes.
- How the ground truth for the training set was established: Not applicable and not specified.
Summary of what is available from the text:
The document concerns the ResMed myAir app (K241216). It states that non-clinical verification and validation testing was performed for the NightOwl HST interoperable (Stella) functions. This testing "demonstrated that the device met all intended performance requirements." The testing followed FDA guidance documents: "Content of Premarket Submissions for Device Software Functions: June 2023" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: September 2023."
The core of the submission is to establish Substantial Equivalence because:
- The subject device (myAir) and predicate device (Galapagos, K200565) have the same intended use.
- They have similar technological characteristics and operating principles.
- The subject device adds interoperability with the NightOwl HST (Stella functions) to its existing cleared function of connecting to the Air11 platform.
- The differences do not raise any new questions of safety or effectiveness.
- It is as safe and effective as the predicate devices.
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(270 days)
BZD
AirFit F30i Mask System
The AirFit F30i mask has two product variants:
· AirFit F30i mask is intended for single-patent reuse in the home environment.
• AirFit F30i SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.
AirFit F30i NM Mask System
The AirFit F30i Non Magnetic mask has two product variants:
· The AirFit F30i Non Magnetic variant is intended for single-patient reuse in the home environment.
· The AirFit F30i Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multipatient reprocessing and must be reprocessed if reused between patients.
Arcadia Mask System
The Arcadia has two product variants:
· Arcadia mask is intended for single-patient reuse in the home environment.
· Arcadia SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
These masks are intended for patients weighing more than 66 lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.
The AirFit F30i, AirFit F30i NM and Arcadia mask systems are full-face conduit masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or non-life supporting ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth.
The AirFit F30i, AirFit F30i NM and Arcadia mask systems each have two product variants:
- . AirFit F30i Mask/ AirFit F30i NM Mask/ Arcadia Mask: This is the home use variant that is intended for single patient re-use.
- . AirFit F30i SLM/ AirFit F30i NM SLM/ Arcadia SLM (sleep lab mask): This is intended for multipatient re-use and must be reprocessed if reused between patients using the disinfection guide
The AirFit F30i, AirFit F30i NM and Arcadia mask systems are made up of the following four main component assemblies: Cushion, conduit frame, elbow and headgear. The cushion and conduit frame are available in various sizes to allow for adequate mask fit over the intended patient population.
The AirFit F30i, AirFit F30i NM and Arcadia mask systems are prescription devices supplied non-sterile.
The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria in the format requested. The document is a 510(k) summary and FDA clearance letter, which outlines the device's substantial equivalence to a predicate device based on various performance and safety tests. However, it does not provide the specific "acceptance criteria" (e.g., minimum sensitivity, specificity, or accuracy thresholds) or the detailed methodology and results of a single study with the requested metrics.
Instead, the document lists several non-clinical data submitted, which include performance and safety tests in accordance with ISO standards and other bench tests. The conclusion states that "Non-clinical verification and validation assessment/testing demonstrated that AirFit F30i NM and Arcadia mask systems met all intended performance requirements." and "Verification confirmed that the new device met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate AirFit F30i mask system (K183512)."
Therefore, I can extract the types of tests performed and the comparison to the predicate device, but I cannot fill in the table or answer all sub-questions as the specific numerical acceptance criteria and a single "study" proving it with the requested detail are not present.
Here's what can be extracted based on the provided text, with an explanation for missing information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally qualitative (e.g., "met all intended performance requirements") and tied to ISO standards or established performance of the predicate device. Specific numerical thresholds for acceptance are not explicitly listed in the 510(k) summary, except for some comparative parameters.
| Acceptance Criteria (General) | Reported Device Performance (as compared to predicate) |
|---|---|
| CO2 rebreathing ( |
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