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The Invacare Flyer (Model XPO100) is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.

The Invacare Flyer is used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institutional environment or in a vehicle or other mobile environment. The device is not intended to sustain or support life. The device is used with a nasal cannula to direct oxygen from the device to the patient.

The Invacare Flyer provides oxygen in pulsed demand flow dosages at settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6%.

Standard power options include an AC to DC switching power supply operating from AC power outlet (120 VAC/ 60 Hertz nominal), a DC to DC switching power supply operating from accessory outlets typically found in a mobile vehicle type environment (12 VDC nominal) and an external rechargeable battery.

The Invacare Flyer uses a molecular sieve and pressure swing adsorption methodology to produce the oxygen gas output. Ambient air enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath.

The basic technology of the Invacare Flyer is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the noted predicate device.

The provided document is a 510(k) summary for the Invacare Flyer, Model XPO100, an oxygen concentrator. It establishes substantial equivalence to a predicate device, the Inogen One Oxygen Concentrator (K032818). This type of regulatory submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical studies with acceptance criteria in the way one might for a novel AI/ML device.

Therefore, the following information about acceptance criteria and studies (especially those relating to AI/ML device performance) is not applicable in this context. The "study" here is generally a comparison to a predicate and adherence to recognized standards.

Here's an analysis based on the provided text, addressing the points where information is available or noting its N/A status:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are not reported as specific performance metrics with thresholds in the way a diagnostic AI might have. Instead, substantial equivalence is demonstrated through comparative features and adherence to recognized standards. The "reported device performance" is implicitly shown by meeting these standards and having comparable features to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable. The submission does not detail a "test set" or specific patient data in the context of diagnostic performance. Performance testing refers to engineering and electrical safety standards testing, not clinical studies with patient data.

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 is not applicable. There is no "ground truth" establishment in the context of diagnostic accuracy for this device, nor a test set requiring expert adjudication.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. No test set or adjudication method is described.

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

This is not applicable. This is an oxygen concentrator, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is an oxygen concentrator, not an algorithm-only device. Its operation is standalone in the sense that it produces oxygen, but it doesn't perform diagnostic or interpretive functions that would be evaluated in this manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable. "Ground truth" in the context of medical device performance studies (particularly for AI/ML) is not a concept applied to oxygen concentrators. The device's "truth" is its ability to produce oxygen within specified parameters and operate safely according to engineering standards.

8. The sample size for the training set

This is not applicable. There is no "training set" for an oxygen concentrator. The device's design is based on established engineering principles and technology, not machine learning or data training.

9. How the ground truth for the training set was established

This is not applicable. As there is no training set, there is no ground truth for it.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" in this 510(k) submission is primarily a comparative analysis against a legally marketed predicate device (Inogen One Oxygen Concentrator; K032818) and adherence to recognized performance and safety standards.

• Evidence Type: Bench testing, adherence to national and international standards for medical electrical equipment (e.g., ASTM, ISO, UL, IEC standards for electromagnetic compatibility, safety, and oxygen concentrator-specific requirements), and a comparison of technical specifications.
• Key Finding: The Invacare Flyer performs as intended and is substantially equivalent to the predicate device, with differences in physical dimensions and weight determined not to affect safety or effectiveness.
• No specific sample sizes (e.g., patients, images) are mentioned as this is not a clinical performance study in the typical sense for AI/ML.
• Data Provenance (for comparative data): The performance data is derived from direct testing of the Invacare Flyer against engineering standards and comparison of its specifications to the publicly available specifications of the predicate device.
• Experts/Ground Truth/Adjudication: Not applicable in the context of diagnostic performance. The "experts" are likely the engineers and regulatory professionals who conducted the tests and compared the specifications. The "ground truth" is adherence to the scientific and engineering principles embodied in the referenced standards.

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The Invacare Twilight Full Face Mask is intended to be used with positive airway pressure (PAP) devices, such as CPAP and Bi-Level, which provide 4-20 cmH2O for the treatment of adult obstructive sleep apnea. There is a port on the mask to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.

The Twilight full Face Mask consists of a mask that fits over the nose and mouth of a patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose and mouth. The cushion mounts to a rigid clear plastic frame. The frame has built in exhalation ports, a full swivel for locating the pressure device hose, a tubing swivel to allow for twisting of the hose, and a built in anti-asphyxia valve to allow the inner volume of the mask to be open to the outer atmosphere when there is no pressure being supplied by the flow generator device. Mounted to the frame is an adjustable forehead support for resting against the patient's forehead. The headgear has quick release clips and loop adjustment on the straps.

The provided document describes a 510(k) Pre-market Notification for the Invacare Twilight Full Face Mask, which aims to demonstrate substantial equivalence to legally marketed predicate devices rather than necessarily proving the device meets specific acceptance criteria in a quantitative performance study. The document focuses on comparing the proposed device's specifications and intended use to those of existing devices.

Therefore, the requested information elements related to detailed study methodologies (sample size, ground truth, expert adjudication, MRMC studies, training sets) are largely not applicable in the context of this 510(k) submission, as it relies on a comparison of device characteristics and adherence to general performance standards rather than a clinical efficacy trial.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" here are implicitly defined by the specifications of the predicate devices. The "Reported Device Performance" is the Invacare Twilight Full Face Mask's own specifications. Substantial equivalence is demonstrated by showing that these specifications are comparable.

The study proving the device meets these "acceptance criteria" is the 510(k) submission itself, which argues for substantial equivalence. The document states: "The performance data found in this submission shows that the Invacare Full Face Mask performs as intended and in a manner that is substantially equivalent to the predicate devices." This substantial equivalence argument is supported by the detailed comparison table and performance testing against recognized standards.

Specifically, the device performance was evaluated against the following standards:

• ISO 17510-2:2003: Sleep apnoea breathing therapy - Part 2: Masks and application accessories
• ISO 5356-1:2004: Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
• ISO 13485:2003: Medical devices - Quality management systems -- Requirements for regulatory purposes
• ISO 14971:2000 (Amendment 2003): Medical devices -- Application of risk management to Medical Devices
• EN 980:2003: Graphical symbols for use in the labeling of medical devices
• EN 1041:1998: Information supplied by the manufacturer with medical devices

These standards represent the "acceptance criteria" for the performance and safety aspects of the mask, and conformance to them is asserted by the manufacturer.

Information Not Applicable or Not Provided in the Document:

Due to the nature of a 510(k) submission predominantly focused on substantial equivalence to predicate devices and adherence to recognized standards, the following detailed study methodologies are not described or are not relevant to this type of regulatory filing.

2. Sample size used for the test set and the data provenance: Not applicable. Performance testing typically involves engineering tests on prototypes/production samples, not a clinical "test set" in the sense of patient data for a diagnostic algorithm. No country of origin for such data is specified beyond the device being from Invacare Corporation in Elyria, Ohio, USA. The testing is laboratory-based, not retrospective/prospective patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to engineering specifications and performance benchmarks from international standards, not expert clinical assessment of a diagnostic outcome.
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 a medical device (face mask), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (face mask), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance is adherence to the specified technical parameters (e.g., exhaust flow, pressure drop, internal volume) and compliance with relevant international standards (ISO, EN). This is established through engineering testing and quality management systems.
8. The sample size for the training set: Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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To assist persons who have difficulty rising from a seated position to a standing position.

The EasyStand Evolv is a modular standing frame for indoor use that allows users with various degrees of physical disability to be supported in a standing, weight-bearing position. The device is modular and is configured around a centralized seat. It incorporates pivot points that allow a user to rise from a fully seated to a fully standing position. Pivot action is such that shear the user, seat and seat back is minimized. Device is modular in that multiple uses of the device can be accommodated depending on the overall configuration of the device. Current modules allow for passive standing (Basic), workstation use at an elevated or seated position (Shadow Support Tray) and standing with leg exercise (Glider). Elevation action is provided by one of two means. The standard device utilizes a user controlled hydraulic pump. The optional electrical version uses a low voltage motor-driven linear actuator that is powered by two 12-Volt batteries and actuated by a hand held control pendant. On the electrical version, the patient or a care provider activates the hand held control pendant to change the position of the seat. The electric version also provides an emergency release. Recharge of batteries is accomplished by connection of an external battery charger to the control pendant. The EasyStand Evolv is designed for indoor use and will accommodate individuals ranging in height from 5' to 6'2" (152cm - 188 cm) and up to 280lbs (127kg)

The provided text describes a 510(k) summary for the EasyStand Evolv, an electric positioning chair. It details the device's functionality, intended use, and its substantial equivalence to predicate devices, in addition to performance standards it was tested against. However, the document does not contain information about a study proving the device meets specific acceptance criteria in the way typically associated with AI/ML medical devices (e.g., performance metrics based on sensitivity, specificity, accuracy, or comparative effectiveness studies with human readers).

Instead, the "acceptance criteria" here refer to compliance with established safety and electrical standards for medical devices and demonstrating substantial equivalence to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent or not applicable in this context:

Acceptance Criteria and Device Performance (Based on Regulatory Compliance)

Study Details (Information Not Provided for AI/ML-style studies)

The provided text describes a regulatory submission for a physical medical device (an electric positioning chair), not an AI/ML algorithm or software as a medical device. Therefore, many of the requested details about statistical studies (sample size for test/training, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable or not present in this type of document.

1. Sample size used for the test set and the data provenance: This information is not provided. The "testing" referred to is against safety and electrical standards, not performance against a diagnostic or predictive ground truth using a clinical test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of "ground truth" establishment in a clinical evaluation sense for this device.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 affecting human reader performance.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device with direct user interaction.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic/predictive performance. The "ground truth" for this device would be its ability to physically perform its described functions safely and effectively (e.g., lift a person of a certain weight, meet electrical safety standards), which is assessed through engineering and compliance testing rather than clinical data comparison to a true diagnosis.
7. The sample size for the training set: Not applicable. There is no "training set" for this type of physical device.
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary focuses on demonstrating the EasyStand Evolv's safety and effectiveness through compliance with recognized standards and substantial equivalence to existing predicate devices. It is not an AI/ML device, and thus, typical performance study metrics and methodologies for AI are not found in this document.

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The Invacare Model Twilight II Nasal Mask is intended to be used with positive airway pressure devices such as CPAP, for the treatment of adult obstructive sleep apnea. There is a port on the mask swivel to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.

The Invacare Twilight II Nasal Mask is a prescription device intended for use with positive airway pressure devices. It is intended to provide single or multiple patient use/reuse for the delivery of respiratory therapy to adult patients (>30 Kg) with obstructive sleep apnea in a sleep lab or home care setting. It is designed for use with positive airway pressure devices having pressure ranges from 3-20 cmH2O. The Invacare Twilight II Nasal mask consists of a mask that fits over the nose of the patient and headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A small, standard and a large cushion are designed for use with the same mask. This also allows for replacement of a worn or damaged cushion without the need to replace the entire mask. The cushion mounts into a rigid polycarbonate shell by means of a flanged area that fits snugly between the wall of the mask shell and an inner retaining ring that is permanently mounted into the shell. The mask includes an opening that accepts a standard, flexible, 22mm (outside diameter) breathing tube. The breathing tube is connected to the output of the positive airway pressure device and to the input of the Invacare Twilight II Nasal Mask. The mask is then placed over the user's nose. The flexible tube provides a transition between the more rigid output tube of the delivery device and the mask, thus allowing fr3eedom of movement while maintaining patient circuit integrity. The Invacare Twilight II Nasal Mask can be reused on multiple patients by disinfecting the mask according to provided instructions. Following cleaning with Enzol® enzymatic cleaning detergent, the mask is disinfected u sing a Cidex OPA solution or STERRAD Disinfection System. Testing has shown the mask can be disinfected 30 times without loss of effectiveness.

Analysis of Invacare Twilight II Nasal Mask 510(k) Summary

This document describes the acceptance criteria and the study that proves the Invacare Twilight II Nasal Mask meets the acceptance criteria, based on the provided 510(k) summary.

Key Finding: The 510(k) summary primarily addresses the disinfection process allowing for multiple patient reuse as the main difference from predicate devices. The performance data focuses on demonstrating substantial equivalence, particularly regarding the disinfection process, rather than establishing direct clinical efficacy of the mask itself through a comparative effectiveness study.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary does not explicitly list numerical acceptance criteria for a "device performance" in terms of clinical outcomes or specific engineering metrics (e.g., seal pressure, leak rate, comfort scores) directly comparable in a table with reported performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices and meeting disinfection standards.

Therefore, the table below reflects what can be inferred from the document regarding "acceptance" and "performance."

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify a "test set" in the context of clinical performance data in human subjects for the Twilight II Nasal Mask. The primary performance data relates to disinfection efficacy and durability.

• Test Set for Disinfection: The summary states, "Testing has shown the mask can be disinfected 30 times without loss of effectiveness." This implies a sample size of at least one mask, or a representative number, was subjected to 30 disinfection cycles. The exact number of masks tested is not provided.
• Data Provenance: The nature of disinfection testing would be laboratory-based (in vitro) and likely conducted by the manufacturer or an independent testing lab. The country of origin for the data is not specified but is presumably within the regulatory framework of the US submission (Invacare Corporation is based in Ohio). This type of testing is generally prospective as it evaluates a specific protocol applied to the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the context of this 510(k) summary. The "ground truth" for disinfection efficacy is established through standardized laboratory testing (AAMI TIR12 requirements), not expert consensus on human performance or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. The disinfection testing would involve objective measurements (e.g., microbial counts, material degradation assessment) rather than subjective expert adjudication.

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 device is a medical accessory, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a passive accessory and does not involve an algorithm.

7. The Type of Ground Truth Used

• For Disinfection Efficacy: The ground truth is laboratory-defined standards for high-level disinfection (AAMI TIR12) and the absence of material degradation or loss of effectiveness after repeated cycles. This is based on objective scientific measurements in a controlled environment.
• For Substantial Equivalence: The ground truth is the performance and safety profiles of the identified predicate devices (Invacare Twilight Nasal Mask K022642 and ResMed Mirage Activa Nasal Mask K030798), which were previously cleared by the FDA. The performance data demonstrates the Twilight II Nasal Mask "performs in a manner that is substantially equivalent to the predicate devices."

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of this device. The device itself is not an algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

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The intended function of the tilt/recline seating system is for repositioning and/or weight shift for pressure relief for individuals who cannot do this independently due to injury or disability. The elevate function is intended primarily to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility. The Invacare 3G Tarsys is rated for a combined user and accessory weight of 300 pounds. The tilt only and recline only versions are rated for a combined user and accessory weight of up to 400 pounds. The seating system is intended to be used with power wheelchair bases for which it is found to be compatible.

The Invacare 3G Tarsys is a battery powered, motorized seating system designed for use with power wheelchairs. The seating system is rated for 300 pounds. Tilt only and recline only versions are rated for 400 pounds. An electrically operated linear actuator drives the tilt and recline functions with weight balance maintained through the stability of the base. The recline function incorporates a mechanical sliding back mechanism to reduce back shear as well as optional power elevating leg rests. The elevate function is driven by an electrically operated linear ball screw actuator mounted in a vertical fashion and allows the seat to be elevated to a maximum of 7" ± .25". The tilting, reclining and elevating systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline/elevate system, a combination of tilt/recline, tilt/elevate or as separate tilt only, elevate only systems depending on the user's needs. The joystick in conjunction with the Tilt Recline Elevate Control Mechanism (TRECM) and the Invacare MK V EX controller activates the power positioning modules.

This response is based on the provided text, which is a 510(k) summary for the Invacare 3G Tarsys seating system. The document focuses on regulatory approval based on substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria. As such, much of the requested information, particularly regarding specific performance metrics, sample sizes, expert ground truth, and comparative effectiveness studies, is not present in the provided text.

Here's an analysis of what can be extracted and what is missing:

Invacare 3G Tarsys Seating System: Acceptance Criteria and Study Details

The provided 510(k) summary describes the Invacare 3G Tarsys seating system, a battery-powered, motorized seating system for power wheelchairs, and seeks to establish its substantial equivalence to legally marketed predicate devices. The document does not contain a detailed study proving the device meets specific quantitative acceptance criteria in the format typically seen for algorithm performance. Instead, it relies on demonstrating that the device's design, intended use, and performance characteristics are similar to existing approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of quantitative acceptance criteria with corresponding performance data in the typical sense of a clinical study or algorithm validation. The "performance" discussed is primarily related to safety, operational features, and design equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of an algorithm or device performance study involving human subjects or collected data specific to the 3G Tarsys. The testing mentioned appears to be internal engineering verification and validation.

• Sample Size for Test Set: Not applicable/Not mentioned for performance claims. The "testing" referred to appears to be internal engineering verification on the device itself.
• Data Provenance: Not applicable. No external data or clinical data is cited for performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not present. The 510(k) summary does not describe a study that used expert consensus to establish ground truth for performance metrics.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is described as there is no mention of a clinical or performance "test set" requiring expert review for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or is mentioned. The submission focuses on device design and functional equivalence to predicate devices, not on comparing reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical power wheelchair seating system, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the claims appears to be derived from:

• Engineering specifications and measurements: E.g., 7" ± .25" elevation.
• Internal safety testing: E.g., drive lock-out functionality, stability testing.
• Compliance with recognized standards: E.g., CAL 117 flammability, ANSI/RESNA Section 7.
• Substantial equivalence to predicate devices: The primary basis for regulatory clearance, implying that if predicate devices are safe and effective, a substantially equivalent new device will also be.

8. Sample Size for the Training Set

Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set exists for this type of device submission.

In summary: The provided text is a regulatory submission (510(k) summary) focused on demonstrating "substantial equivalence" of a physical medical device (a power wheelchair seating system) to pre-existing, legally marketed predicate devices. It outlines the device's features, intended use, and general safety considerations, along with basic performance specifications (like weight capacity and elevation range) determined through internal testing and adherence to relevant industry standards. It does not contain information about clinical studies with specific acceptance criteria, sample sizes, expert ground truth, or AI-related performance metrics, as these are typically not required for this type of 510(k) submission for a mechanical device.

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The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA).

The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort.

The Invacare Polaris EX Heated Humidifier is an accessory for the Invacare Polaris EX CPAP, a prescription device for use in the home, that is used by an adult (>30 kg) who has been diagnosed with Obstructive Sleep Apnea (OSA).

The intended function and use of the heated humidifier is to provide moisture to the patient circuit in order to improve patient comfort. The addition of heated humidification relieves the drying and irritating effects on the patient airways, which may result from the use of a CPAP system.

The provided text is a 510(k) summary for the Invacare Polaris EX Heated Humidifier. It details the device's intended use, description, and regulatory information, but it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification to the FDA, focused on establishing substantial equivalence to a predicate device. It does not include performance data or studies against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the input text.

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The intended function and use of the Invacare Polaris EX CPAP is to provide positive airway pressure therapy to adult patients (>30kg.) for the treatment of Obstructive Sleep Apnea (OSA).

All units consist of a flow generator (blower), patient circuit, exhalation port, humidifier (if desired), microprocessor based control system, pressure sensor and operate on 120 volts AC, 60Hz

This document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. It is a 510(k) summary for the Invacare Polaris EX CPAP, primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance. It lacks detailed performance data, study design, or ground truthing methods.

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The intended use of the Adventure scooters is to provide mobility to persons limited to a seated position.

The Invacare Adventure Series of Scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to persons limited to a seated position. The scooters are basic conventional rear wheel drive, rigid frame vehicles that are battery powered. Various options and accessories are available depending upon user needs and preferences. They consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They also include a tiller handle for steering and a throttle control to engage and disengage the scooter motion in both the forward and reverse directions. The scooters can also be disassembled for ease of transport, are powered by two (2) 12 volt DC batteries, and utilize an on-board charger. The scooters have a status indicator located on the face of the control panel that provides diagnostic information. The status LED will flash a certain number of times, separated by a pause when a fault is detected in the controller or in the wiring. This feature is for diagnostic information only and does not control the operation of the scooter. The Adventure SX-3 is a compact version of the scooter with a 250 lb. weight capacity while the Adventure LX-3 scooter is a mid-size version of the scooter with a 350 lb. weight capacity.

This document describes a 510(k) premarket notification for the Invacare Adventure Motorized Scooters. This type of submission relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials or extensive performance studies for regulatory approval. As such, the structure of the data provided is different from what would be expected for a novel AI/medical imaging device.

Here's an analysis based on the provided text, addressing your questions where applicable, and noting when the information is not present due to the nature of a 510(k) submission for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (motorized scooter), performance is typically assessed against established industry standards for safety and functionality, rather than specific diagnostic accuracy metrics.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable in the context of this 510(k) submission for a motorized scooter. There isn't a "test set" of patient data in the way one would analyze for an AI diagnostic device. The performance data refers to the scooter itself meeting engineering and safety standards, likely through bench testing, materials testing, and mechanical evaluations of the physical product.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable. Ground truth, in the sense of expert consensus on diagnostic findings, is not relevant for the regulatory approval of a motorized scooter. The "truth" here is whether the physical product adheres to engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts when establishing ground truth for diagnostic studies. This is not performed for mechanical device evaluation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improving with AI vs. Without AI Assistance

This information is not applicable. This submission is for a physical medical device (motorized scooter), not an AI diagnostic tool. Therefore, no MRMC study or analysis of human reader improvement with AI assistance was conducted or would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is adherence to established, published engineering and safety standards:

• ANSI/RESNA WC/14 (1991) for wheelchairs.
• ISO 7176: 1993 (E) for power and control systems of electric wheelchairs.
• California 116 and 117 specifications for upholstery fire retardancy.

The device itself (scooter) is the object of evaluation against these standards, through physical testing, material analysis, and design verification.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of a physical medical device submission like this one. Training sets are used for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is a series of engineering evaluations, material tests, and design reviews that demonstrate the Invacare Adventure Scooters (and their components) meet the requirements of specific, recognized industry standards: ANSI/RESNA WC/14 (1991), ISO 7176: 1993 (E), and California 116 and 117. The primary method of demonstrating regulatory compliance under a 510(k) is to show substantial equivalence to existing legally marketed predicate devices (Invacare Lynx SX-3, Lynx LX-3, and Lynx LX-3P06 scooters, K010135). The submission states that "minor differences in performance specifications... do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness," which is the core argument for substantial equivalence. The FDA, by granting clearance, concurred with this assessment.

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The Invacare Model Twilight Nasal CPAP Mask is intended to be used with positive airway pressure devices such as CPAP, to provide 3-20 cmH2O for the treatment of adult obstructive sleep apnea. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single patient use.

The Twilight nasal mask is a prescription device intended for use with Continuous Positive Airway Pressure (CPAP), and Bi-Level devices. It is intended to provide a single patient use interface for the delivery of CPAP or Bi-Level therapy to adult patients (>30Kg). It is designed for use with CPAP and Bi-Level delivery systems having pressure ranges from 3-20 cmH2O.

The Twilight nasal mask consists of a mask that fits over the nose of the patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose. A standard and a large cushion are designed for use with the same mask. This also allows for replacement of a worn or damaged cushion without the need to replace the entire mask. The cushion mounts into a rigid polycarbonate shell by means of a flanged area that fits snugly between the wall of the mask shell and an inner retaining ring that is permanently mounted into the shell.

The mask includes an opening that accepts a standard, flexible, 22cm OD breathing tube. The breathing tube is connected to the output of the CPAP/Bi-Level delivery device, and to the input of the Invacare Twilight Nasal Mask. The mask is then placed over the users' nose and mouth. The flexible tube provides a transition between the more rigid output tube of the delivery device, and the mask, thus allowing freedom of movement while maintaining patient circuit integrity.

The provided text describes a 510(k) submission for the Invacare Model Twilight Nasal Mask. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics described in typical AI/ML medical device studies.

Therefore, much of the requested information (acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, ground truth methodology, MRMC studies, standalone performance) is not applicable or not provided in the context of this 510(k) summary.

Here's a breakdown of what can be extracted and what is not available:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence through comparison of technological characteristics and performance data to predicate devices.
• Reported Device Performance: The document states:

  "A number tests were conducted on the Invacare Model Twilight Nasal Mask. In all cases the mask performed as designed and intended."
  This is a general statement and does not provide specific performance metrics (e.g., leak rate, comfort scores, efficacy in treating OSA) that would typically be found in a clinical study report. It implies that the engineering and design validation tests were successful.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. The document mentions "a number tests" but does not specify the type of tests (e.g., patient trials, bench testing), the number of subjects/samples, or the nature of the data (prospective, retrospective, country of origin).

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)

• Not Applicable / Not Available. This device is a physical medical device (nasal mask) for CPAP therapy, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth for its performance evaluation in the way imaging algorithms do. Performance testing likely involved engineering validation and possibly limited human factors testing, but not "ground truth" establishment by experts in the sense of image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Available. As above, this concept (adjudication of expert readings) does not apply to the type of performance evaluation described for a CPAP nasal mask in a 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC study is relevant for AI-assisted diagnostic or interpretive tasks. This device is a CPAP nasal mask and does not involve "human readers" or "AI assistance" in that context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. See points 3 and 4. The performance of a nasal mask is evaluated based on its physical properties, comfort, seal, and ability to deliver prescribed pressure, as demonstrated through engineering tests and potentially user feedback, rather than against a medical "ground truth" for diagnosis.

8. The sample size for the training set

• Not Applicable / Not Available. This device is not an AI/ML model; therefore, there is no "training set" in the computational sense.

9. How the ground truth for the training set was established

• Not Applicable. This device is not an AI/ML model.

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The intended use of the Invacare Model Storm TDX Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.

The Invacare Storm TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or "non- folding" type power wheelchair, with mid wheel drive capability.

The Invacare Model Storm TDX Power Wheelchair underwent testing to demonstrate its performance and safety, specifically focusing on its electromagnetic compatibility (EMC).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size (number of units tested) for the performance evaluation. It refers to "the Invacare Storm TDX Power Wheelchair" in the singular, which could imply testing of one unit, or it could be a general reference to the model. The data provenance is implied to be directly from the manufacturer's testing (Invacare Corporation). The study appears to be prospective as it was conducted specifically for the submission. The country of origin of the data is not explicitly stated, but given Invacare Corporation is based in Elyria, Ohio, USA, it is likely the testing was conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. This type of device performance testing (electromagnetic compatibility) does not typically involve expert consensus to establish "ground truth" in the same way a diagnostic medical device would. The ground truth here is defined by the technical specifications and requirements outlined in the ISO EMC Draft Standard 7176-14.

4. Adjudication Method for the Test Set:

Not applicable. Performance against a technical standard (ISO EMC Draft Standard 7176-14) does not involve an adjudication method in the context of human expert review. The pass/fail criteria are defined by the standard itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices where human interpretation is involved. The performance data presented relates to the technical specifications and safety (EMC) of the device.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

Yes, a standalone study was performed. The testing described in the "PERFORMANCE DATA" section evaluates the Invacare Storm TDX Power Wheelchair in isolation against the ISO EMC Draft Standard 7176-14. It is an evaluation of the device itself, without human intervention or interpretation as part of the performance metric.

7. The Type of Ground Truth Used:

The ground truth used was the technical specifications and requirements outlined in the ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995). This standard sets the acceptable levels of electromagnetic emissions and immunity for powered wheelchairs.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML-driven device, therefore, there is no "training set." The testing performed is to demonstrate compliance with an engineering standard.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

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