Search Results

The Invacare TPOC Portable Oxygen Concentrator 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 TPOC Portable Oxygen Concentrator can be used in a home, institution, vehicle, and various mobile environments. The Invacare TPOC Portable Oxygen Concentrator does not nor is it intended to sustain or support life.

The Invacare TPOC is to be used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institution, vehicle and various mobile and outdoor environments. The device is not intended to sustain or support life. The device is typically used with a nasal cannula to direct oxygen from the device to the patient.

When set for Continuous Flow Mode, the TPOC can deliver up to 3 LPM continuous flow in 0.5 LPM increments. While in Pulse Delivery Mode, when the demand for oxygen is detected, the oxygen is delivered through pulsed flow with pulse flow settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6% in all modes.

The modified TPOC contains an integrated oxygen sensor to provide added monitoring of the output gas purity, as well as additional patient warnings and alarms based on those levels. The oxygen sensor process uses a heated Zirconia element as the method of measurement. This is the exact same sensor process used in previously cleared oxygen concentrators such as the Invacare Platinum 5 Oxygen Concentrator, K020386.

With the addition of continuous flow, the TPOC is now capable of supporting two features commonly with the addition of ocultified no ne nextrators; usc with a humidification and use in conjunction with PAP, Bi-Level and other such devices as an oxygen bleed-in. The use of this equipment is only during continuous flow mode, as indicated in the User's Manual. odulphileit is only aaning othium battery pack, standard power options include switching power Anong with a rents from AC power outlet (120 VAC/ 60 Hertz nominal) and from accessory DC outlets typically found in a mobile vehicle type environment (12 VDC nominal).

The Invacare TPOC uses a molecular sieve and pressure swing adsorption methodology to produce the The in theater Tr C abber a nair 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 in pulse mode. In continuous flow mode, the operation is the same with the exception that the oxygen is delivered continuously, without the need for breath detection.

The basic technology of the Invacare TPOC is equivalent to its predicate device.

This document describes the Invacare Transportable Oxygen Concentrator (TPOC, Model TPOC100) and its 510(k) summary, which essentially acts as a claim for substantial equivalence to a predicate device, the Invacare Flyer Oxygen Concentrator (K0719028).

There is no detailed study provided within the given text that explicitly describes acceptance criteria and then presents study results to prove those criteria were met for the Invacare TPOC.

The document states: "Performance Testing: The performance testing conducted as a result of the modifications to the Invacare Flyer, as required by the risk analysis, was performed and the results demonstrated that the predetermined acceptance criteria were met." However, it does not provide the specifics of these acceptance criteria or the study details.

Based only on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" are implied by the performance characteristics listed for the device itself and against its predicate. The text explicitly states that "Performance Testing... was performed and the results demonstrated that the predetermined acceptance criteria were met," but it does not list those specific criteria or the detailed results of the tests. The table above largely compares the TPOC's specifications to the predicate and notes its own specifications as the "reported device performance."

Regarding the study proving the device meets the acceptance criteria:

The provided text only makes a general statement about performance testing, rather than describing a specific study with detailed methodology. Therefore, most of the following information is missing from the input text:

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

• Missing. The document does not specify any sample size for a test set or the provenance of data. The "performance testing" mentioned is generic.

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 / Missing. This device is an oxygen concentrator, not an imaging or diagnostic device that would typically rely on expert human interpretation for ground truth establishment. Therefore, there would not be "experts" establishing ground truth in this context, but rather engineering/technical verification against specifications.

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

• Not applicable / Missing. As above, this concept typically applies to studies where human reviewers are assessing data (e.g., medical images) and their agreement is critical for ground truth. It's not relevant to the performance testing of a physical medical device like an oxygen concentrator against its specifications.

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. This is not an AI-assisted diagnostic or interpretive device. An MRMC study would not be applicable to an oxygen concentrator.

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

• Not applicable. This isn't an algorithm; it's a hardware device with embedded software. Its performance would inherently be "standalone" in terms of its mechanical and electronic functions. The "standalone" concept typically applies to pure AI/algorithm performance.

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

• Inferred: The "ground truth" for oxygen concentrators meeting performance criteria is based on direct physical measurements against engineering specifications and validated test methods (e.g., oxygen concentration using a sensor, flow rate measurement, weight measurement, battery life tests, safety tests). The document mentions an integrated oxygen sensor and "predetermined acceptance criteria" from risk analysis, which implies such direct measurements.

8. The sample size for the training set

• Not applicable/Missing. This device does not use a "training set" in the context of machine learning or AI. Performance testing involves demonstrating the device meets its specifications, not training an algorithm.

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

• Not applicable/Missing. No training set is involved for this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device

The intended use of the Invacare Topaz Bariatic Manual Wheelchair is to provide mobility to persons that may be restricted to a sitting position.

The Invacare Model 9000 Bariatric Manual Wheelchair (Topaz) is a manually operated, user propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons limited to a sitting position. The wheelchair consists primarily of a steel frame, large rear wheels with hand rims for propelling the wheelchair, and smaller front pivoting casters for steering and turning. It is a folding, or non-rigid type of wheelchair that is designed for use by patients weighing up to 1000 lbs.

The frame is constructed of round, steel tubing that is welded. The tubing is 1" outside diameter (O.D.) with a wall thickness of 1/8". The seat width ranges from a minimum of 28" wide to a maximum of 30" wide and seat to floor height ranges from 17½" to 19½". The modification to this device consists of a frame with a reinforced design to withstand the higher weight capacity of 1000 lbs. In particular, two extra gussets have been added to the frontal tube and thicker gussets have been added to the rear upright and head tube. Also, the armrests have been reinforced and a stronger tire is used on the front caster.

The Invacare Model 9000 Bariatric Manual Wheelchair (Topaz) underwent performance testing to demonstrate that modifications made to the device met predetermined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "Performance Testing conducted as a result of the modifications," implying that at least one modified wheelchair was tested to confirm the increased weight capacity and structural integrity.
• Data Provenance: The testing was conducted by Invacare Corporation and the results were submitted to the FDA as part of a 510(k) premarket notification. The text does not specify a country of origin for the data beyond Invacare's location in Elyria, Ohio, USA. The testing was likely prospective, performed specifically for the 510(k) submission to validate the design changes.

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

This type of information is generally not applicable to the performance testing of a mechanical device like a wheelchair. Ground truth for a device like this is established through engineering specifications, industry standards (like ISO 7176), and physical testing, rather than expert consensus on interpretive data.

4. Adjudication Method for the Test Set:

Not applicable. Device performance is determined by objective measurements against established engineering and safety standards, not by an adjudication process as might be used for subjective medical image interpretation.

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 relevant for diagnostic devices where human readers interpret data (e.g., radiologists reading medical images) and evaluate the impact of AI assistance on their performance. For a mechanical device like a wheelchair, the performance is assessed through its physical attributes and mechanical testing.

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

Yes, the performance testing described for the wheelchair can be considered "standalone" in the sense that the device's mechanical integrity and functionality were evaluated in isolation against engineering standards, without a human "in the loop" for interpretive tasks. The wheelchair itself is not an algorithm, so this question may be interpreted differently in this context. The core testing was on the device's physical capabilities.

7. The Type of Ground Truth Used:

The ground truth used for the performance testing was based on:

• Engineering Specifications: The design parameters for the reinforced frame, armrests, and caster tires, specifically to achieve a 1000 lbs weight capacity.
• Industry Standards: The performance testing was conducted "in accordance with ISO 7176, parts 1 and 8." These international standards specify requirements and test methods for manual wheelchairs, establishing the benchmarks for safe and effective performance.

8. The Sample Size for the Training Set:

Not applicable. For a mechanical device like a wheelchair, there is no "training set" in the context of an AI/machine learning algorithm. The design and validation of the modified wheelchair are based on engineering principles and physical testing, not data-driven machine learning models.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for the device's design and performance validation is established by adherence to existing engineering principles and relevant ISO standards for manual wheelchairs.

Ask a specific question about this device

The intended use of the Invacare Pro Nebulizer and the Invacare Compact Nebulizer is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication.

The Invacare Pro Nebulizer and Compact Nebulizer are indicated for use with any commercially available nebulizer and mouthpiece.

The Invacare Pro Nebulizer and Compact Nebulizer are intended for home health care use.

The intended use of the Invacare Portable Desktop Nebulizer is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication.

The Invacare Portable Desktop Nebulizer is used exclusively with its own nebulizer and mouthpiece.

The Invacare Portable Desktop Nebulizer is intended for home health care use.

Invacare Pro Nebulizer: The Invacare Pro Nebulizer is a lightweight, self-contained basic aerosol compressor system intended to provide compressed air to a nebulizer mouthpiece. It is designed to operate with any commercially available, small volume disposable nebulizer mouthpiece. The Invacare Pro Nebulizer supplies pressurized air to the nebulizer mouthpiece. A small piston air compressor provides the compressed air necessary to drive the nebulizer. The Invacare Pro Nebulizer has a maximum output pressure of 39 psi. The maximum flow rate is 8.5 LPM and the operating flow rate is 4.8 LPM @ 16 psi. Air is drawn into the compressor through a filter and exits the unit through a barbed tubing connection. The compressor is kept cool by drawing air across the motor coil using an integral fan. A permanently attached mains power cord supplies AC power for the unit and power is controlled by the use of an ON/OFF switch. The motor incorporates a current/temperature overload protector, which opens the electrical circuit in the event of high current draw or high temperature in the motor winding. The casing for the unit is constructed of ABS flame retardant material.

Invacare Compact Nebulizer: The Invacare Compact is a smaller version of the Invacare Pro. It is a lightweight, self-contained basic aerosol compressor system intended to provide compressed air to a nebulizer's mouthpiece. It is designed to operate with any commercially available, small volume disposable nebulizer mouthpiece. The Invacare Compact Nebulizer supplies pressurized air to the nebulizer mouthpiece. A small piston air compressor provides the compressed air necessary to drive the nebulizer. It has a maximum output pressure of 33 psi. The maximum flow rate is 8 LPM and the operating flow rate is 4.0 LPM (@ 16 PSI. Air is drawn into the compressor through a filter and exits the unit through a barbed tubing connection. The compressor is kept cool by drawing air across the motor coil using an integral fan. A permanently attached mains power cord supplies AC power for the unit and power is controlled by the use of an ON/OFF switch. The motor incorporates a current/temperature overload protector, which opens the electrical circuit in the event of high current draw or high temperature in the motor winding. The casing for the unit is constructed of ABS flame retardant material.

Invacare Portable Desktop Nebulizer: The Invacare Portable Desktop Nebulizer system consists of a nebulizer and a DC powered piston-type compressor that generates compressed air. Small, lightweight and designed for convenience, the Invacare Portable Nebulizer device offers the user a choice of running off of AC power via a universal adapter or DC power via a 12 volt auto adapter or an optional rechargeable battery pack. The compressor unit consists of a motor driven piston compressor, printed circuit board and a switch. The circuit board does not incorporate a microprocessor, but serves as a means to prevent double feed of power. This is a safety feature that allows power draw from either the battery or the input adapter, but not both. There is a thermistor incorporated into the circuit board that provides protection by opening the electrical circuit in the event of high motor temperature. The circuit board is not part of the charging circuit for the battery pack. The unit has a maximum pressure of 36 psi and an operating pressure of 10 psi. The maximum flow rate is 5.2 LPM and the operating flow rate is 2.5 LPM @ 10 psi. The nebulizer mouthpiece employs a venturi effect to convert the medication into a fine aerosol mist. It is used with an extension tube. The nebulizer mouthpiece has a particle size range of ~ 5 microns and a capacity of 7 ml (cc). Providing a connection between the compressor outlet and the nebulizer mouthpiece bottom, the extension tube allows the compressor on a sturdy surface and to simply hold onto the nebulizer mouthpiece. The nebulizer mouthpiece is designed for single patient use, is reusable and intended to be used exclusively with the Invacare Portable Desktop Nebulizer. Use of the nebulizer mouthpiece, compressor or tubing with other compressors, nebulizer mouthpieces or tubing may produce incorrect flow resulting in improper treatment.

This document is a 510(k) premarket notification for three nebulizer devices (Invacare Pro, Invacare Compact, and Invacare Portable Desktop Nebulizer). It describes the devices, their intended use, and claims substantial equivalence to predicate devices. The document does not describe a study to prove acceptance criteria for a general AI/device system, but rather performance testing for mechanical nebulizer devices. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Study for Nebulizers:

The document describes performance testing for the Invacare nebulizers to demonstrate their functionality according to specifications and safety standards. However, it does not explicitly define "acceptance criteria" in a tabular format as one might for a classification task or an AI device, as the document is for a mechanical medical device seeking 510(k) clearance based on substantial equivalence. Instead, it refers to performance specifications and standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of "acceptance criteria" versus "reported performance" in the context of an AI device. However, it states the following regarding the nebulizer's performance:

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

• Sample Size (Test Set):
  • For Compact and Pro Nebulizers: Three separate samples of each device.
  • For Portable Desktop Nebulizer: Three separate samples of the device.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is typically not relevant for mechanical device performance testing of this nature. The testing appears to be conducted in-house by the manufacturer to demonstrate compliance.

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

• Not applicable. This document describes performance testing of mechanical nebulizer devices, not a study involving human interpretation of data where "ground truth" would be established by experts (e.g., radiologists for medical images). The "ground truth" for these tests are objective measurements against engineering specifications and international standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Not applicable. See point 3. This is not a study requiring adjudication of expert opinions.

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 document is for mechanical nebulizer devices, not an AI diagnostic or assistance system.

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

• Not applicable. See point 5.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth: For this type of device, the "ground truth" is adherence to established engineering specifications and international performance standards (e.g., specific particle size distribution, flow rates, pressure outputs, nebulization rates, and electrical safety standards). Performance was measured objectively.

8. The Sample Size for the Training Set:

• Not applicable. This document describes performance testing for mechanical devices, not training an AI model.

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

• Not applicable. See point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The intended function and use of the Invacare Model Platinum Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.

The Invacare Model Platinum 5 Oxygen Concentrator is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. Its intended function and use is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve, It is not intended to sustain or support life.

Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used, if desired.

The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch.

The provided text describes a 510(k) submission for the Invacare Model Platinum 5 Oxygen Concentrator. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.

The document primarily focuses on establishing substantial equivalence to a predicate device (Sunrise Medical Model DeVilbiss 5 Liter Oxygen Concentrator K990711) and confirming that the device was tested to relevant performance requirements.

Here's an attempt to answer your questions based on the available information, highlighting what is not present:

1. A table of acceptance criteria and the reported device performance

Missing Details: The specific numerical or qualitative thresholds for "electrical, mechanical, and environmental performance" are not detailed in this document. For example, specific oxygen concentration purity, flow rates, noise levels, or operating temperatures are not provided as acceptance criteria.

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

• Sample Size: Not specified. The document only states "The Invacare Model Platinum Oxygen Concentrator was tested..." without detailing the number of units tested.
• Data Provenance: Not specified, but given Invacare Corporation is based in Elyria, Ohio, USA, it's highly probable the testing was conducted in the USA.
• Retrospective or Prospective: Not specified. It's likely prospective testing conducted specifically for this submission.

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. This type of medical device (oxygen concentrator) does not typically involve expert interpretation for establishing "ground truth" in the way an imaging or diagnostic AI device would. Performance is assessed through objective measurements (e.g., oxygen concentration, flow rate, safety tests) against engineering and regulatory standards.

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

Not applicable. See point 3.

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 an oxygen concentrator, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This document describes a physical medical device, not a software algorithm. The "performance" refers to the device's physical operation.

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

The "ground truth" for this type of device would be objective measurements against established technical standards and specifications (e.g., oxygen purity measured by sensors, flow rate measured by flowmeters, safety compliance with electrical safety standards, environmental testing for durability).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

Not applicable. See point 8.

Ask a specific question about this device

The intended function and use is to provide mobility to persons limited to a sitting position that have the capability of operating a powered wheelchair.

The purpose of this pre-market notification is to request marketing clearance from FDA to change the controller of certain power wheelchairs models, manufactured by Invacare Corporation, which have already been granted marketing clearance by FDA under separate submissions.

The controller change applies to the Invacare Pronto Powered Wheelchair Series (K012927, 9/19/2001), and the Nutron Powered Wheelchair Series (K900565, 2/15/1990). Each of these devices are battery powered, motorized mobility vehicles. Their intended function and use, which has not changed, is to provide mobility and transportation to physically challenged persons that may be restricted to a seated position.

The controller for the Nutron and Pronto Series of Wheelchairs is being modified from the Invacare MKIV-RII controller to the Invacare MKV-NX controller. The Invacare MKV-NX controller, which is the subject of this premarket notification, is an electronic, microcomputer based. motion control device designed for use with Invacare powered wheelchairs. The intended function of the controller is to activate and control powered wheelchair motions. Additionally, it provides a method of adjusting, selecting and programming certain powered wheelchair performance characteristics to better suit the specific control needs of the user.

Two versions of the controller will be available. These are the MKV-NX and the MKY-NX LP. The MKV NX version has full programming capability, while the MKV-NX LP version has limited programming capability. Programming capability for the LP version is limited to forward speed, turning speed, and reverse speed only. Otherwise the controllers are identical.

The Invacare MKV-NX and MKV-NX LP controllers are programmed using the Invacare MIV remote programmer, previously cleared with the Model MCC-MKIV Micro Computer Control (K940972, 6/2/1994). The controller software and electronics will not allow wheelchair operation during programming.

The provided text describes a 510(k) premarket notification for a modification to power wheelchairs, specifically a change in the controller. The document primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance data for the modified device.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, and comparative effectiveness studies are not present in the provided text.

Here's a breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document states:
"The Invacare Elevating Seat meets the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993(E), 'ISO Standard, Wheelchairs -Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs.'"

This indicates the types of standards against which performance was assessed. However, specific numerical acceptance criteria (e.g., maximum speed, minimum turning radius, battery life) and the actual reported performance values are not provided in this summary.

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 provided in the document. The document refers to "the Invacare Elevating Seat" meeting standards, but doesn't specify if this refers to the new controller or a separate component, nor does it detail a specific test set, its size, or provenance.

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 and is not relevant to this type of device submission, which references engineering standards rather than diagnostic accuracy.

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

This information is not provided.

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 information is not provided and is not applicable to a power wheelchair controller. This type of study is relevant for diagnostic AI devices, not mobility devices.

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

The device is a physical controller for a power wheelchair. The "performance data" refers to its ability to meet engineering safety and functional standards. The concept of "standalone" performance in the context of an algorithm's diagnostic accuracy is not applicable to this device. The controller functions as an integral part of the human-in-the-loop system (the user operating the wheelchair).

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

For this type of engineering device, "ground truth" would be established by objective measurements against the specified performance parameters in the ANSI/RESNA and ISO standards (e.g., speed measurements, control response times, stability tests). The specific method for establishing these ground truths (e.g., specific test equipment, calibrated sensors) is not detailed in this summary.

8. The sample size for the training set
9. How the ground truth for the training set was established

These questions are typically relevant for machine learning algorithms. While the controller is "electronic, microcomputer based," the document does not describe it as an AI/ML device that requires a "training set" in the conventional sense. Therefore, this information is not provided and likely not applicable to this type of device submission.

Ask a specific question about this device