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The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals.

The TiLite Aero X is a folding manual wheelchair. The frame components of the TiLite Aero X are tubular aluminum alloy. The folding mechanism components of the TiLite Aero X are extruded aluminum alloy.

The provided text describes a 510(k) premarket notification for a medical device, the TiLite Aero X folding manual wheelchair. It does not contain information about acceptance criteria or a study proving its performance in the context of AI/ML or diagnostic accuracy. Instead, it focuses on the device's classification, predicate device, and compliance with existing standards for manual wheelchairs.

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment in the context of an AI/ML device.

The only relevant information regarding "testing results" is:

1. Table of Acceptance Criteria and Reported Device Performance:

The following information cannot be extracted from the provided text as it pertains to AI/ML device evaluation, which is not applicable to this document:

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done and its effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The intended use of this device (manual, rigid wheelchair) is the same as the predicate device, the TiSport Cross-Sport (manual, rigid wheelchair) manufactured by TiSport, LLC. The intended use for the manual, rigid wheelchair is to provide mobility to physically persons. The manual wheelchair is intended for ongoing daily use.

This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions:

• Amputee;

• Arthritis;

• Arthrogriposis;

• Cerebral Palsy;

• Geriatric conditions;

• Head injury or trauma;

• Hemiplegic;

• Multiple Sclerosis;

• Muscular Dystrophy;

• Paraplegic;

• Polio;

• Quadraplegic;

• Spina Bifida;

• Stoke/CVA;

• Tetraplegic; and

• Other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis

The TiLite Evo wheelchair is a rigid manual titanium wheelchair.

The TiLite Evo manual, rigid wheelchair met its acceptance criteria by complying with several international standards for wheelchairs.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:
The document does not specify the sample sizes used for the testing or the data provenance (e.g., country of origin, retrospective/prospective). The testing refers to compliance with ISO standards, which typically involve standardized laboratory testing rather than clinical data from human subjects.

3. Number and Qualifications of Experts:
Not applicable. The study involved engineering and performance testing against international standards, not expert review of medical images or diagnostic outputs.

4. Adjudication Method:
Not applicable. The study involved compliance testing against predefined international standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a manual wheelchair, and the testing focused on its physical properties and compliance with safety and performance standards, not diagnostic efficacy or human reader performance.

6. Standalone Performance (Algorithm only):
Not applicable. This device is a physical product, not a software algorithm.

7. Type of Ground Truth:
The "ground truth" in this context is the set of objective performance and safety requirements specified by the ISO 7176 series of standards for wheelchairs. Compliance is determined through laboratory testing and engineering assessments.

8. Sample Size for Training Set:
Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the context of its regulatory submission.

9. How Ground Truth for Training Set was Established:
Not applicable. There is no training set for this type of device. The ISO standards represent established international consensus on test methods and performance criteria for wheelchairs.

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The intended use of this device (growable, manual, rigid wheelchair) is the same as the predicate device, the Zippie® (growable, manual, rigid wheelchair) manufactured by Sunrise Medical Inc. The intended use for the growable, manual, rigid wheelchair is to provide mobility to physically impaired children. The manual wheelchair is intended for ongoing daily use and is designed so that the wheelchair can be adjusted as the user grows.

This device is indicated for individuals with the specific medical conditions listed, but the indications are not necessarily limited to such conditions:

• Amputee;

• Arthritis:

• Arthrogriposis;

• Cerebral Palsy;

• geriatric conditions;

• head injury or trauma;

• hemiplegic;

• Multiple Sclerosis;

• Muscular Dystrophy;

• paraplegic;

• Polio:

• quadraplegic;

• Spina Bifida;

• Stoke/CVA;

• tetraplegic; and

• other immobilizing or debilitating conditions, including spinal cord injuries and other lower and upper extremity paralysis

The TiLite YG and YGS model wheelchairs are rigid manual titanium wheelchairs.

The provided text describes the TiLite YG and YGS growable, manual, rigid wheelchairs. It details their intended use, target population, and comparison to a predicate device. The information supplied focuses on the physical and functional characteristics of the wheelchair and its equivalence to a predicate device based on meeting specific standards.

However, the input document does not contain information about a study involving software or AI performance, acceptance criteria in terms of metrics like sensitivity, specificity, or AUC, or details about ground truth establishment, expert adjudication, or reader studies in the context of AI/software.

Given the nature of the device (a mechanical wheelchair) and the provided 510(k) summary, the "acceptance criteria" and "study" refer to engineering and safety standards, not an AI or software performance study as implied by the user's request.

Therefore, I can only provide information based on the document's content, which describes compliance with ISO standards for the physical product.

Here’s the information based on the provided text, interpreted for a mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the device "Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7, and 8." This acts as both the acceptance criteria and the reported performance.

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

The document does not specify a "test set" in the context of data or images. For a mechanical device, testing usually involves prototypes or production units. The document does not provide details on the sample size of wheelchairs tested or data provenance (country of origin, retrospective/prospective).

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

This information is not applicable to the provided document, which describes a physical medical device (a wheelchair) and its compliance with engineering standards. The phrase "ground truth" typically refers to verified diagnoses or labels in AI/software performance studies. The testing mentioned (ISO 7176) involves standardized mechanical and safety tests.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies or expert labeling for AI ground truth, not for the testing of a mechanical wheelchair against ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which doesn't fit the context of this wheelchair submission.

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

This information is not applicable. The device is a physical, mechanical wheelchair, not an algorithm.

7. The type of Ground Truth Used

This information is not applicable. The "ground truth" for the wheelchair is its physical properties and performance against established engineering and safety standards (ISO 7176), not expert consensus, pathology, or outcomes data in a diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable to the provided document. There is no mention of a "training set" as this is for a physical device, not an AI model.

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

This information is not applicable.

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The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.

The specific medical conditions for which the device is indicated are listed as, but not limited to:

Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis

The TiPower RimPower and PowerDrive X and SX are folding power/manual titanium wheelchairs.

The provided text describes the 510(k) summary for the TiPower RimPower and PowerDrive X & SX folding power/manual wheelchairs. This document focuses on demonstrating substantial equivalence to a predicate device (Commuter, K934232) and ensuring compliance with relevant standards, rather than detailing a clinical study with a device performance vs. acceptance criteria table, sample sizes, expert ground truth, or MRMC studies for AI devices.

Therefore, many of the requested elements for an AI device study are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (wheelchair) and its compliance with established performance standards.

Here's a breakdown of what can be extracted based on the provided text:

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

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 testing involved compliance with engineering standards, not clinical data sets with "test sets" in the context of AI or imaging devices.

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 applicable to this type of device and testing. Ground truth in this context refers to compliance with established engineering and safety standards, not expert medical diagnoses.

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

This information is not applicable to this type of device and testing. Adjudication methods are typically used in clinical trials or AI model evaluation.

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 applicable as this is not an AI device or a diagnostic device involving human readers.

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

This information is not applicable as this is not an algorithm or AI device.

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

The "ground truth" for this device's performance is adherence to recognized international and national standards for wheelchairs (ISO 7176, ANSI/RESNA WC, EN 12184). These standards define objective performance and safety requirements.

8. The sample size for the training set

This information is not applicable as this is not an AI device with a "training set."

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

This information is not applicable as this is not an AI device with a "training set."

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The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.

The specific medical conditions for which the device is indicated are listed as, but not limited to:

Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis

The TiPower TR Rim Power and TiPower TRA RimPower are rigid power/manual titanium wheelchairs.

The provided document describes a 510(k) summary for the TiPower TR RimPower and TiPower TRA RimPower wheelchairs, which are power/manual wheelchairs. It details the device, its intended use, and comparison to a predicate device. The document also includes an FDA clearance letter.

However, the provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The "Testing Results" section only states: "Meets the requirements of the ISO 7176 Parts 1, 3, 5, 7,and 8 Standards (other parts not applicable) and ANSI/RESNA WC/Vol. 2-1998 Section 21 and EN 12184:1999." This indicates that the device underwent testing according to these recognized standards, and the results met their requirements, but it does not provide the specific numerical acceptance criteria or the detailed performance data.

Therefore, I cannot fulfill your request for an acceptance criteria table or information about the study's methodology as the necessary details are not present in the provided document.

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The intended use of this device (folding manual wheelchair) is the same as the predicate device, Sunrise's Quickie 2HP folding wheelchair (K890050). It is intended to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use.

The specific medical conditions for which the device is indicated are listed as, but not limited to:

Spinal chord injury
Stoke/CVA
Post Polio Syndrome
Spina Bifada
Amputee
Multiple Scierosis
Arthrogriposis
Muscular Dystrophy
Lower and upper extremity paralysis

The TiSport X and XC manual titanium wheelchairs are folding everyday chairs.

The TiSport X and TiSport XC manual titanium wheelchairs are folding everyday chairs.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample size for the test set used to demonstrate compliance with the ISO 7176 standards.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, it is an engineering test of the physical product, likely conducted in a controlled laboratory environment.

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

This type of testing (ISO 7176 standards for wheelchairs) typically involves engineering and quality assurance professionals, not medical "experts" in the context of clinical ground truth. The "ground truth" here is compliance with established international engineering standards. The document does not specify the number or qualifications of the individuals who performed or validated these tests, but it would involve personnel trained in mechanical testing and quality control.

4. Adjudication Method for the Test Set:

Adjudication methods like 2+1 or 3+1 consensus are not applicable to the type of engineering compliance testing described. The results are objective measurements against predefined thresholds within the ISO standards. The evaluation would be based on whether the test results fall within the acceptable parameters defined by each part of the ISO 7176 standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No MRMC comparative effectiveness study was done. This device is a manual wheelchair, and the testing focuses on its mechanical performance and safety standards, not on AI assistance to human readers or clinicians.

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

This is not applicable. The device is a physical product (manual wheelchair), not an algorithm or AI system. The testing is for the standalone performance of the physical device.

7. The Type of Ground Truth Used:

The ground truth used is compliance with international engineering standards (ISO 7176 Parts 1, 3, 5, 7, and 8). This is a form of objective, empirical measurement against predefined criteria.

8. The Sample Size for the Training Set:

This is not applicable. There is no AI or machine learning component to this device, so there is no "training set." The testing performed is physical product testing.

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

This is not applicable as there is no training set.

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The intended use of this device (manual wheelchair) is to provide mobility to physically impaired individuals. The manual wheelchair is intended for on-going "everyday" use and/or recreational sports applications. The specific medical conditions for which the device is indicated are listed as, but not limited to: Spinal chord injury Post polio Spina Bifada Amputee

The Cross-Sport manual titanium wheelchair is a custom, rigid, everyday/sport chair manufactured to the specifications of the intended user.

Here's an analysis of the provided text regarding the TiSport Cross Sport wheelchair's acceptance criteria and studies:

Summary of Acceptance Criteria and Device Performance:

The document states that the TiSport Cross Sport meets the requirements of ISO Standards. However, it does not explicitly list specific, quantitative acceptance criteria that the device had to achieve (e.g., maximum deflection under load, minimum fatigue life cycles). Instead, the acceptance is based on compliance with general "ISO Standards."

The reported device performance, in the absence of specific numerical criteria, is primarily descriptive:

• Materials: Manufactured from titanium.
• Design: Custom, rigid, everyday/sport chair.
• Strength-to-Weight Ratio: Proven superior strength-to-weight ratio compared to chromoly (used in the predicate device).
• Customization: Offers a higher degree of customization for proper "fitting" to the operator.
• Safety: The superior material and customization are presented as benefits from a safety perspective.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Breakdown of Study Information:

Based on the provided 510(k) summary, the "study" conducted for this device is focused on conformance to ISO standards and a comparison to a predicate device for substantial equivalence, rather than a clinical trial or performance study against specific, measurable performance criteria.

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

   • Sample Size: Not specified. The document states "Testing Results: Meets the requirements of the ISO Standards." This typically implies that the device (or representative samples) underwent a series of engineering/mechanical tests. There is no mention of a human test set in the context of clinical performance.
   • Data Provenance: Not explicitly stated, but assumed to be from engineering and manufacturing tests conducted by TiSport or an accredited testing facility, likely within the US given the submission to the FDA. The tests are focused on mechanical properties and standards, not human data.
   • Retrospective or Prospective: Not applicable, as this refers to engineering testing, not a clinical study.

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

   • Not applicable. Ground truth, in this context, would be established by the ISO standards themselves and the objective measurements demonstrating compliance (e.g., load capacities, fatigue cycles, material properties). The experts involved would be engineers/testers verifying adherence to test protocols and interpreting results, not clinical experts establishing a ground truth for diagnostic accuracy.

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

   • Not applicable. Adjudication methods like 2+1 are used in studies involving human interpretation or clinical outcomes where there might be disagreement among reviewers. This submission describes engineering and standards compliance testing.

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

   • Not applicable. This is a medical device (wheelchair), not an AI diagnostic or assistance system. MRMC studies are not relevant here.

5. 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.

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

   • The "ground truth" for this submission is compliance with established ISO (International Organization for Standardization) standards for mechanical wheelchairs and demonstrated equivalence in design and intended use to a legally marketed predicate device (Shadow Rigid, K925451). This involves engineering specifications, material properties, and a comparison of features.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

   • Not applicable, as there is no training set.

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