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The Invacare® Platinum® 5NXG Oxygen Concentrator is indicated for patients with respiratory disorders requiring supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare Pediatric Flowmeter accessory. It is not intended to sustain or support life.

The subject Invacare® Platinum® 5NXG Oxygen Concentrator device is used by patients who require supplemental oxygen. The device is not intended to sustain or support life. The oxygen concentration level of the output gas ranges from 87% to 96% at an output flow rate range of 1 to 5 liters per minute (LPM). The oxygen is delivered to the user through the use of a nasal cannula. The concentrator provides supplemental oxygen to patients with respiratory disorders, in the home, long term care facility or other non-acute patient care facilities. It is not intended to sustain or support life. It is to be used indoors and is intended to support the patient's lifestyle within the home or care facility. The device operates at a nominal 120VAC/60 Hertz supply.

The provided document is a 510(k) Pre-Market Notification for the Invacare Platinum 5NXG Oxygen Concentrator. It describes the device, its intended use, and compares it to a predicate device (Invacare Perfecto2™V Oxygen Concentrator K200890) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the format of pass/fail measurements against specific numerical criteria for all aspects. Instead, it describes general performance categories and states that the device "met the performance requirements" or "demonstrates that the subject device meets performance specifications and requirements."

However, we can infer some criteria and reported performance from the "Design Characteristics Comparison" table on page 6 and the "Performance Testing – Bench" section on page 9.

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

The document refers to "design verification testing data" and "bench performance testing." These are laboratory or engineering tests performed on the device itself (or its components) rather than clinical data from a human population. Therefore, the concept of a "sample size" in the clinical sense (e.g., number of patients) is not applicable here. The testing involves physical devices.
The provenance of the data is internal to the manufacturer (Invacare Corporation) as it describes their internal verification testing. The document does not specify the country of origin of the test data (e.g., if the tests were performed in the US, or elsewhere) nor does it explicitly state whether the testing was prospective (done specifically for this submission) or retrospective (using existing data), though the context of "design verification testing" implies it was specifically conducted for the 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)

This product is an oxygen concentrator, a medical device for delivering oxygen. It is not an AI/imaging device requiring expert interpretation for ground truth. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications such as radiologists is not applicable to this submission. The ground truth for performance is established by objective measurements and adherence to recognized consensus standards by qualified testing engineers and laboratories.

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

Not applicable. As noted above, this device does not involve human interpretation requiring adjudication for establishing ground truth. Performance is measured objectively.

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. The device is an oxygen concentrator, not an AI-assisted diagnostic tool. No MRMC study was performed, nor is it relevant to the device.

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

Not applicable. The device is an oxygen concentrator, not an algorithm or software-only device.

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

The "ground truth" for the device's performance is established by objective measurements against defined engineering specifications and recognized consensus standards. This includes:

• Measurements of oxygen concentration, flow rates, electrical characteristics, weight, dimensions, and sound levels.
• Adherence to specific clauses and requirements within international standards like ISO 80601-2-69 (specific for oxygen concentrators), AAMI ES60601-1, IEC 60601-1 (general medical electrical equipment safety), IEC 62304 (software life cycle), ISO 14971 (risk management), and ISO 18562 series (biocompatibility).

8. The sample size for the training set

Not applicable. This is a hardware medical device, not an AI/machine learning model that requires a "training set" of data.

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

Not applicable. There is no training set for this type of medical device.

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The Invacare AVIVA Storm RX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.

The subject device is a rearward drive wheel version substantially equivalent to the previously cleared forward drive wheel Invacare® AVIVA FX Power Wheelchair (K192216) with LiNX Electronics and Ultra Low Maxx Seating System. The subject device version consists of the following changes:

• . Rearward drive wheel placement
• . Modification to suspension system
• . Modification to battery box design and seat interface brackets
• Minor changes to mechanical components such as new rims and colors .
  The Invacare® AVIVA Storm RX Power Wheelchair is a 24V DC system, motor-driven wheelchair, utilizing the predicate device LiNX® control system. The subject device consists of a rigid or "non-folding" type power wheelchair base with rearward drive wheel placement with two (2) casters in the front and two anti-tippers in the rear. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.

The provided text describes a 510(k) premarket notification for a powered wheelchair, the Invacare AVIVA Storm RX Power Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device (Invacare AVIVA FX Power Wheelchair) through non-clinical testing against various international standards.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with a comprehensive set of international (ISO), American National Standards Institute (ANSI), and European (EN) standards. The reported device performance is that the "subject device components met the performance requirements."

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

The document does not specify a "test set" in terms of a patient cohort or a specific number of devices tested individually. Instead, it refers to "non-clinical test reports" and "design verification test reports" that support the finding of substantial equivalence. The testing is based on compliance with established international standards for wheelchairs. Therefore:

• Sample size: Not explicitly stated as a numerical sample of devices or patients. The assumption is that sufficiently representative samples were used to conduct the required tests under each standard.
• Data provenance: Not explicitly stated, as the focus is on compliance with standards rather than clinical data from a specific geographical region or retrospective/prospective study. The testing is implied to be laboratory-based non-clinical testing.

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

This document does not describe the use of human experts to establish "ground truth" for a performance test set. The evaluation is based on objective, standardized non-clinical engineering and performance tests carried out by the manufacturer to demonstrate compliance with recognized standards.

4. Adjudication Method

There is no mention of an adjudication method as the evaluation relies on compliance with technical standards and objective measurements, not subjective expert reviews.

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 performed for AI or diagnostic devices where human reader performance is a key metric. This submission is for a physical medical device (power wheelchair) where performance is evaluated against engineering standards.

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

This question is not applicable. The device is a power wheelchair, not an algorithm, and its performance is evaluated against engineering and safety standards, not an algorithm's diagnostic output.

7. The Type of Ground Truth Used

The "ground truth" in this context is implicitly defined by the pass/fail criteria of the various international and national standards (ISO, IEC, ANSI) listed in the document. These standards define objective performance thresholds and test methods for aspects like stability, braking, speed, safety, and electromagnetic compatibility.

8. The Sample Size for the Training Set

This question is not applicable. There is no mention of a "training set" as this is a physical medical device, not a machine learning algorithm.

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

This question is not applicable.

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The Invacare® Perfector™V Oxygen Concentrator is indicated for patients with respiratory disorders requiring supplemental oxygen at flow rates of 1 to 5 liters per minute. For flow rates below 1 liter per minute use with Invacare Pediatric Flowmeter accessory. It is not intended to sustain or support life.

The purpose of this this Premarket Notification [510(k)] submission is to obtain commercial clearance for Invacare® Perfecto2™V Oxygen Concentrator. The subject device is used by patients who require supplemental oxygen concentration level of the output gas ranges from 87% to 95.6% at an output flow rate range of 1/2 to 5 liters per minute. The oxygen is delivered to the user through the use of a nasal cannula.

This document is a 510(k) Premarket Notification for the Invacare Perfecto2V Oxygen Concentrator. It asserts substantial equivalence to a predicate device, the Invacare Platinum 5 Oxygen Concentrator (K020386), rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of a new functional claim (e.g., related to AI performance).

Therefore, I cannot extract the information required for the requested table and study details (acceptance criteria, performance, sample sizes, expert involvement, adjudication, MRMC, standalone, ground truth, training set specifics) because the provided text describes a submission for a medical device (oxygen concentrator), not a software/AI device that would involve the assessment of algorithmic performance against a ground truth.

The document primarily focuses on:

• Substantial Equivalence: Demonstrating that the new device has the same intended use, technological characteristics, and performs similarly to a previously cleared predicate device.
• Bench Testing: Performance testing (e.g., oxygen concentration levels, flow rates, electrical safety, biocompatibility) to show the device meets its defined specifications and is equivalent to the predicate.
• Risk Management and Software Verification: Ensuring the device's design and software meet relevant standards.

There is no mention of an AI component, image analysis, human reader studies, or any of the elements typically associated with the kind of "acceptance criteria" and "study" described in your prompt, which are relevant to diagnostic or AI-driven medical devices.

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them in the context of AI or sophisticated diagnostic performance.

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The Invacare® AVIVA FX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.

The subject device is a front wheel drive version of the existing previously cleared Invacare TDX SP2 (Center Wheel Drive) Power Wheelchair (K170507) with LiNX Electronics and Ultra Low Maxx Seating System. The subject version of the Invacare TDX SP2 Power Wheelchair consists of the following changes: Alternative Front Wheel Drive Base, Seating Brackets to connect the Ultra Low Maxx Seating System to the base, Wiring Harness to connect the LiNX controller, the AVIVA FX base and the Ultra Low Maxx Seating System. The Invacare® AVIVA FX Power Wheelchair is a 24V DC battery-powered, motor-driven wheelchair, utilizing the predicate device LiNX® Control System and Ultra Low Maxx Seating System. The subject device consists of a rigid or "non-folding" type power wheelchair base with front wheel drive with 2 casters in the rear and two anti-tippers in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.

This document describes the Invacare® AVIVA FX Power Wheelchair (Model: IFX-20MP), a front-wheel-drive version of the previously cleared Invacare TDX SP2 Power Wheelchair, with LiNX Electronics and Ultra Low Maxx Seating System.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily relies on demonstrating substantial equivalence to a predicate device (Invacare TDX SP2 Power Wheelchair, K170507) and adherence to recognized international and national standards for safety and performance. The acceptance criteria are implicitly derived from these standards and the characteristics of the predicate device.

2. Sample size used for the test set and the data provenance:

The document describes non-clinical laboratory testing. For such tests, the "test set" typically refers to the devices or components manufactured and tested according to the specified standards. The document doesn't explicitly state the exact number of units tested for each standard, but it implies that tests were conducted on the subject device (Invacare® AVIVA FX Power Wheelchair).

• Sample Size: Not explicitly stated as a number of devices, but testing was performed on the "subject Invacare® AVIVA FX Power Wheelchair" (singular/representative unit for engineering testing).
• Data Provenance: Non-clinical laboratory data generated to specifically evaluate the subject device against recognized standards. It is prospective testing designed to confirm compliance. The country of origin of the data is not specified but would typically be from accredited testing laboratories, likely within the manufacturer's region or designated by them.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is a powered wheelchair and its evaluation primarily relies on engineering and performance standards, not on interpretation of images or clinical diagnoses by human experts to establish "ground truth" in the medical imaging sense. Therefore, the concept of "experts establishing ground truth" as typically seen in AI/diagnostic device submissions using a test set of patient data, is not directly applicable here.

Instead, the "ground truth" for the performance criteria is derived from:

• The requirements set forth in the international and national standards (e.g., ISO, IEC, CAL, ANSI).
• The published specifications and validated performance of the predicate device.

The "experts" involved would be:

• Engineers and quality assurance personnel from Invacare Corporation responsible for design, manufacturing, and internal testing.
• Personnel at accredited testing laboratories who perform the tests according to the standards and provide certified results. These individuals would have expertise in mechanical engineering, electronics, software validation, biocompatibility, etc., relevant to the specific test being conducted. Their qualifications are inherent in their accreditation to perform such tests.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus "ground truth." This is not relevant for the non-clinical performance and engineering tests described for this powered wheelchair.

For the non-clinical tests, the "adjudication" is essentially:

• Direct measurement and observation: The device either meets the quantitative specification (e.g., a stability angle, a speed, a dimension) or it does not.
• Compliance to a specified test protocol: The testing laboratory follows a defined protocol from the standard, and the results are reported as compliant or non-compliant. Deviations and failures would be investigated and resolved by the manufacturer to achieve compliance.

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 comparative effectiveness study is not mentioned and would not be applicable to a powered wheelchair. Such studies are typically conducted for diagnostic devices (e.g., AI in medical imaging) to assess how AI assistance impacts human reader performance. This submission focuses on the mechanical and electrical safety and performance of the wheelchair as a standalone mobility device.

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

The concept of "standalone performance" for an "algorithm only" device is not directly applicable here in the same way it would be for an AI diagnostic algorithm. While the wheelchair does incorporate the LiNX Control System (which has software and control algorithms), its performance is evaluated as an integrated system (device + software) through the various ISO, IEC, CAL, and ANSI standards. The software verification testing (IEC 62304:2006) ensures the software itself functions correctly and safely within the device's overall design. The overall device's performance is tested, essentially, "without human-in-the-loop" in the sense that the tests are designed to objectively measure the device's inherent capabilities against a standard, rather than evaluating a human operator's improved performance with the device.

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

The "ground truth" for the evaluation of this powered wheelchair is primarily:

• Industry and regulatory performance standards: International (ISO, IEC) and national (CAL, ANSI) standards define acceptable performance limits, test methods, and safety requirements.
• Predicate device characteristics: The specifications and previously cleared performance of the Invacare TDX SP2 Power Wheelchair (K170507) serve as a benchmark for substantial equivalence.
• Engineering specifications and design verification: Internal technical requirements define the expected operating parameters and safety features.

8. The sample size for the training set:

Not applicable. This submission is for a physical medical device (powered wheelchair), not an AI algorithm that requires a training set of data.

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

Not applicable. As there is no "training set," there is no "ground truth for the training set."

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Invacare® Platinum® Mobile Oxygen Concentrator: The Invacare® Platinum® Mobile Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders. The device can be used in a home, institution, vehicle, or other environments outside the home. The device is not intended to be life supporting or life sustaining.

Invacare Mobile Medical Application Accessory PICCOLO O2: The Invacare Mobile Medical Application Accessory PICCOLO O2 is intended to allow patients via their Android™ or iOS™ mobile phone or tablet to display device settings, control flow setting, and to collect device performance and usage information for maintenance/servicing purposes.

The purpose of this this Premarket Notification [510(k)] submission is to obtain commercial clearance for Invacare Mobile Medical Application Accessory Piccolo O2 which is compatible with the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator, cleared under K160630 on September 27, 2016. Invacare Mobile Medical Application Accessory PICCOLO O2 is a Mobile App is intended to provide useful device performance information to the previously cleared Invacare® Platinum® Mobile Oxygen Concentrator end users such as dosage level setting and fault codes as well as allow the user to control the selected dosage level.

• . Invacare® Platinum® Mobile Oxygen Concentrator with Connectivity
• . Invacare Mobile Medical Application Accessory for Piccolo O2 use on iOS and Android devices
• POC1 USB Bluetooth Dongle .

The provided text describes a 510(k) submission for the Invacare Platinum Mobile Oxygen Concentrator with Connectivity and its associated mobile application. However, the document does not contain the information required to answer your specific questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML-driven medical device.

This document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are similar to devices already legally marketed. It highlights design verification testing, risk management, software verification, electrical safety, wireless coexistence, cybersecurity, and biocompatibility testing. It explicitly states that clinical testing was not required for this submission.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test set sample size, expert involvement, or AI/MRMC studies because the provided text does not contain this information. The device in question is a portable oxygen concentrator with a mobile app for displaying settings and controlling flow, not an AI/ML diagnostic or therapeutic device which would typically require the kind of performance studies you are asking about.

I can only confirm that based on the provided text:

• Clinical testing was not required for this submission. This implies there was no study proving the device meets acceptance criteria related to clinical performance on a test set of patient data, as would be expected for an AI/ML device.
• The "study" that proves the device meets acceptance criteria in this context appears to be the design verification testing, software verification testing, electrical safety/EMC testing, wireless coexistence, and cybersecurity documentation. These tests demonstrate the device functions as intended and safely, but not in the way an AI/ML algorithm's diagnostic or therapeutic performance would be evaluated.
• The ground truth for these engineering performance tests would be established by direct measurements against known standards and specifications, not by expert consensus or pathology on patient data.

If you have a document describing an AI/ML device, please provide that, and I would be able to answer your questions more comprehensively.

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The indication for use of the Invacare® TDX® SP2-HD with Captain's Seat is to provide mobility and positioning to persons limited to a sitting position.

The subject device is an update to the existing previously cleared Invacare® TDX® SP2 Power Wheelchair (K170507) with LiNX Electronics and Ultra Low Maxx Seating System. The updated subject version of the Invacare® TDX® SP2 Power Wheelchair has the following changes:

• Increase in the weight capacity of the previously cleared device from 300 lb to 450 lb.
  Invacare® TDX® SP2 Power Wheelchair is a battery-powered, motor-driven powered wheelchair, controlled by the LiNX® control system with enhanced suspension and additional back, arm and leg rest types. The subject device is a rigid or "non-folding" type power wheelchair base with center-wheel drive capability, two casters in the rear and two casters in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors. No new accessories were added to the new device.

The provided text describes a 510(k) premarket notification for a powered wheelchair, the Invacare® TDX® SP2-HD with Captain's Seat. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Invacare® TDX® SP2 Power Wheelchair, K170507), primarily by performing non-clinical testing to meet recognized consensus standards.

Here's an analysis of the requested information based on the provided text:

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

The document states that "The acceptance criteria for the full verification of the design and acceptance criteria for each section of the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) testing standard was met." However, it does not provide a specific table detailing the acceptance criteria for each test and the corresponding reported performance of the device.

It lists the following design characteristics and notes some differences compared to the predicate device, which could be interpreted as performance metrics:

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

The document mentions "Design verification and validation testing was performed on the subject device," but it does not specify the sample size used for the test set. It describes non-clinical testing, implying a prospective testing approach on physical units of the device. There is no information provided about the country of origin of the 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 product is a powered wheelchair and the testing described is non-clinical, focusing on engineering and performance standards (RESNA). Therefore, the concept of "ground truth established by experts" in the context of medical image analysis or diagnostics does not apply to this type of device and study. The "ground truth" here is the defined performance parameters and limits specified by the RESNA standards.

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

Not applicable. As described in point 3, this is non-clinical performance testing against established engineering standards, so there is no expert adjudication process for ground truth.

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 powered wheelchair; it is not an AI-assisted diagnostic tool or system that would involve human readers or a MRMC study.

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

Not applicable. This device is a physical product (a powered wheelchair), not an algorithm or AI system. The "standalone" performance here relates to the wheelchair's physical performance characteristics according to engineering standards.

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

The "ground truth" in this context is the performance requirements and limits specified by recognized consensus standards, specifically ANSI/RESNA WC-1 and WC-2 series. The device's performance was compared against these established engineering standards.

8. The sample size for the training set

Not applicable. This device is a physical powered wheelchair, not a machine learning or AI model that requires a training set.

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

Not applicable. As described in point 8, there is no training set for a physical device like a powered wheelchair.

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The Invacare® Solara® 3G Manual Wheelchair and Invacare® Solara® 3G Spree Manual Wheelchair are intended to provide mobility to adults limited to a sitting position.

The Invacare® Solara® 3G Manual Wheelchair is an attendant operated and self-propelled, mechanical wheelchair for adults. The indication for use of the Invacare® Solara® 3G Manual Wheelchair is to provide mobility to adults limited to a sitting position. The indication for use of the Invacare® Solara® 3G Spree Manual Wheelchair is to provide mobility to person limited to a sitting position. These devices are rigid, "non-folding" type wheelchairs that incorporate a solid seating surface (seat pan).

The Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs were evaluated for substantial equivalence to their predicate devices through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" against which performance is measured for each test, but rather states that design verification testing demonstrated the device met the requirements and was substantially equivalent. The performance data focuses on demonstrating equivalence to the predicate devices through adherence to ANSI/RESNA WC-1:2009 standards and other relevant tests.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the exact number of devices or components tested. It generally refers to "the subject device" or "the subject Invacare® Solara® 3G Manual Wheelchair with weight capacities of 300 and 400 lbs. and Invacare® Solara® 3G Spree Manual Wheelchair with capacity of 200 lbs."
• Data Provenance: The tests are non-clinical laboratory tests, likely conducted at an Invacare facility or a contracted testing lab. The location/country of origin for the testing is not specified, but the manufacturer is listed as INVAMEX S.DE R.L. DE C.V. in Reynosa Tamaulipas, Mexico. The nature of the tests (e.g., static stability, impact tests) indicates they are typically prospective, conducted specifically for the submission.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not applicable. This is a medical device for mobility (manual wheelchair) and the testing is based on engineering and safety standards (e.g., ANSI/RESNA, ISO), not expert interpretation of medical images or conditions. The "ground truth" for these tests is the performance against specified physical and mechanical standards.

4. Adjudication method for the test set:

Not applicable. As this involves objective non-clinical performance testing against established standards, an adjudication method for expert consensus is not relevant. The pass/fail criteria are defined by the standards themselves.

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

Not applicable. This device is a manual wheelchair, not an AI-powered diagnostic or assistive tool for human interpretation.

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:

The "ground truth" for the non-clinical testing of the manual wheelchairs is the adherence to the objective performance specifications and safety requirements outlined in recognized national and international standards, such as ANSI/RESNA WC-1:2009, CAL 117:2013, ISO 8191, and ISO 10993. This is best described as objective engineering and safety standards conformance.

8. The sample size for the training set:

Not applicable. There is no AI model or algorithm being trained for this device. The "training set" concept does not apply to non-clinical performance testing of a physical medical device.

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

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

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The indication for use of the Invacare® TDX® SP2 Power Wheelchair is to provide mobility and positioning to persons limited to a sitting position.

The subject device is an update to the existing previously cleared Invacare® TDX® SP2 Power Wheelchair (K141783) with the MK6i™ control system and Formula™ CG Seating System. The updated subject version of the Invacare® TDX® SP2 Power Wheelchair has the following changes:

• . The LiNX® control system, which incorporates updated software, wireless technology and a touch user interface,
• The Ultra-Low Maxx™ Seating System, and ●
• Minor changes to mechanical components such as rim inserts and new colours. .

The TDX® SP2 Power Wheelchair is a battery-powered, motor-driven powered wheelchair, controlled by the LiNX® control system with enhanced suspension and additional back, arm and leg rest types. The subject device is a rigid or "non-folding" type power wheelchair base with centre-wheel drive capability, two casters in the rear and two casters in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.

This document describes acceptance criteria and testing for the Invacare® TDX® SP2 Power Wheelchair.

1. Table of Acceptance Criteria and Reported Device Performance:

The document highlights conformity to various ISO, IEC, ANSI, CAL, and EN standards for different aspects of the wheelchair's hardware, software, and materials. Due to the nature of the device (a configurable power wheelchair) and the submission type (510(k) for substantial equivalence), the acceptance criteria are primarily described as meeting the requirements and passing the tests of these recognized standards. The reported device performance is generally stated as meeting these requirements and demonstrating substantial equivalence.

Here's a summary derived from the document, focusing on categories rather than specific numerical values where not explicitly provided for the subject device in comparison tables:

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

The document states: "Because the subject Invacare® TDX® SP2 Power Wheelchair is highly configurable Power Wheelchair (PWC), intended to serve a diverse population with unique individual needs, a wide variety of options and accessories have been designed. However, due to the highly customizable nature of the subject device, testing to every possible combination would not be practical. However, every design feature of the subject device was verified. This was accomplished by identifying the specific wheelchair configurations that represent the full range of product permutations."

• Sample Size: The exact numerical sample size for "test sets" (e.g., number of individual wheelchairs or components tested) is not explicitly provided. Instead, it indicates that "specific wheelchair configurations that represent the full range of product permutations" were identified and tested for each design feature. This implies a comprehensive, representative testing approach rather than a fixed "sample size" in the sense of clinical trials.
• Data Provenance: The testing was "Non-clinical Test" and "Software Verification Testing" performed on the "subject Invacare® TDX® SP2 Power Wheelchair." This indicates that the data was generated through laboratory testing by the manufacturer (Invacare Corporation) as part of their design verification process. There is no mention of country of origin for the data or whether it was retrospective or prospective in the clinical sense, as it was non-clinical laboratory testing.

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

This information is not applicable to this submission. The device is a physical product (power wheelchair) and the testing performed is non-clinical laboratory testing against established engineering and safety standards (ISO, IEC, etc.). The "ground truth" is defined by the technical specifications and performance limits set by these international standards, not by expert consensus on clinical diagnoses or interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable. As the testing is non-clinical laboratory testing against defined standards, there is no ambiguity or subjective interpretation requiring adjudication by multiple parties or a specific method like 2+1 or 3+1. The tests yield objective results (e.g., pass/fail for a specified load, speed, or range).

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 performed for diagnostic devices where human interpretation (e.g., radiologists reading images) is involved, and the AI's assistance to human readers is being evaluated. This submission is for a physical medical device (power wheelchair) and involves non-clinical performance and safety testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

While not an "algorithm only" in the sense of an AI diagnostic tool, the non-clinical tests performed on the physical wheelchair and its software are effectively "standalone" tests in that they evaluate the device's performance against defined criteria without active human intervention in the loop of the specific test itself (beyond setting up and observing the test). For example, stability tests, braking tests, and energy consumption tests are direct measurements of the device's inherent capabilities. The "Software Verification Testing" also falls into this category, assessing the software's functionality independently.

7. The Type of Ground Truth Used:

The ground truth used for these tests is objective performance specifications and safety requirements defined by internationally recognized standards (e.g., ISO 7176 series for wheelchairs, IEC 62304 for software, ISO 10993 for biocompatibility, flammability standards). The device's performance characteristics are measured and compared against the limits and criteria set forth in these standards.

8. The Sample Size for the Training Set:

This information is not applicable. This is a 510(k) submission for a physical medical device based on engineering and safety testing, not a machine learning or AI-driven diagnostic device that would typically involve a "training set" of data.

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

This information is not applicable for the same reason as point 8.

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The Invacare® Tracer Manual Wheelchair, Invacare® Tracer® SX5 Manual Wheelchair, Invacare Tracer SX5 Recliner Manual Wheelchair, and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair are intended to provide mobility to persons limited to a sitting position.

The Invacare® Tracer® SX5 Manual Wheelchair is intended to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.

The Invacare® Tracer® SX5 Recliner Manual Wheelchair is a Tracer SX5 model with the addition of a recline feature. This recliner model incorporates a mechanism that allows the backrest to recline in angles from 90° to 180°. Both models of the chair have a weight capacity of 250 to 300 lbs. depending on the seat width. Both models also come with an anti-tipper device to ensure the chair remains stable while in use.

The Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair has the same intended use as the Invacare® Tracer® SX5 Manual Wheelchair. However, the Tracer IV does not come with a recliner model and has a higher weight capacity of 350 lbs. depending on the configuration. Both models of Tracer IV chairs come with a push-to-lock or pull-to-lock feature to engage and disengage the wheel locks. Both models also come with anti-tippers that allow clearance of 1.5 to 2 inches.

The provided text describes the 510(k) premarket notification for three manual wheelchair models by Invacare Corporation: Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer SX5 Recline Manual Wheelchair, and Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair. The document focuses on demonstrating substantial equivalence to predicate and reference devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of an AI/algorithm-based medical device.

Therefore, most of the requested information regarding acceptance criteria, study design for AI devices, sample sizes, expert involvement, ground truth establishment, MRMC studies, and standalone performance is not applicable to this document. This is because the submission is for a mechanical medical device (manual wheelchairs), not a software or AI-driven device.

However, I can extract the relevant information from the document that pertains to the types of "performance testing" conducted to demonstrate substantial equivalence for these mechanical devices.

Here's a breakdown based on the document's content:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it states that "Verification Testing demonstrated that the subject Invacare® Tracer® SX5 Manual and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual are substantially equivalent to the marketed predicate and reference devices." This implies that the devices met the performance standards outlined in the referenced ANSI/RESNA and ISO standards. The performance reporting is implicit; the tests were successfully passed, indicating conformance with the standards.

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: The document does not specify the number of individual wheelchairs tested. It refers to "the subject Invacare® Tracer Manual Wheelchairs" and "the subject Invacare® Tracer® SX5 Manual and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual," suggesting representative samples were tested as per the standards. Specific quantities are not provided.
• Data Provenance: The testing was "Non-clinical laboratory testing" conducted on the subject devices. Location of testing and whether it was retrospective or prospective is not explicitly stated, but for a mechanical device undergoing performance testing, it would inherently be prospective testing of new models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The "ground truth" for mechanical performance tests like these is established by adherence to recognized international and national standards (e.g., ANSI/RESNA, ISO) and the physical properties and performance characteristics of the devices themselves, measured by accredited laboratories and engineers. It does not involve expert consensus in the way an AI diagnostic tool's ground truth would.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments (e.g., medical image interpretation). Mechanical performance testing relies on objective measurements against established engineering standards.

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. MRMC studies are specific to AI-assisted diagnostic or interpretative tasks involving human readers. This submission is for mechanical manual wheelchairs.

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

This is not applicable. This refers to an AI algorithm's performance independent of human input. The device is a mechanical wheelchair.

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

The "ground truth" for these mechanical devices is established through adherence to recognized national and international performance standards (ANSI/RESNA, ISO, CAL117) via physical and material testing. For biocompatibility, the ground truth is established by the results of cytotoxicity and skin irritation tests conforming to ISO standards.

8. The sample size for the training set:

This is not applicable. "Training set" refers to data used to train machine learning models. This is a mechanical device.

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

This is not applicable.

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The device is indicated to provide mobility to persons limited to a sitting position.

The Küschall K-Series Attract Manual Wheelchair is a manual or attendant operated wheelchair that is designed to provide mobility to persons limited to a sitting position with a weight capacity of 265 lbs. The subject device is a lightweight rigid "non-folding" design. Several adjustments such as: center of gravity, seat to floor height, backrest angle, and knee to heel length can be made to the subject device to meet the individual user needs. The chair can be either equipped with a 75° or 90° frame angle. Multiple wheel locks are available, as well as other safety accessories such as anti-tippers. There is no prior submission for the subject device.

The provided document is a 510(k) premarket notification for a manual wheelchair. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving a device meets them for an AI/CAD system.

Here's why and what information is missing:

• Device Type: The device is a "Küschall K-Series Attract Manual Wheelchair," which is a physical medical device, not a software or AI/CAD system.
• Study Type Implied by Questions: The questions (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance) are specific to the evaluation of AI, machine learning, or computer-aided detection/diagnosis systems, which involve algorithms making interpretations or classifications.
• Nature of "Performance Data" in Document: The "Performance Data" section describes non-clinical performance testing against established standards for physical wheelchairs (e.g., static stability, brake effectiveness, dimensions, strength, flammability, biocompatibility). It does not involve diagnostic accuracy metrics like sensitivity, specificity, AUC, or F1-score which would be relevant for AI systems.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on demonstrating substantial equivalence based on physical characteristics and adherence to safety standards for a mechanical device.

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