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The Oceanic is a manual attendant-operated wheelchair intended to provide mobility to people with reduced-mobility problems.

The Oceanic Wheelchair is a wheelchair suitable for use on different terrains and also in water. It can be used on surfaces like sand, snow, gravel, grass and in water. The user must be accompanied at all times, since it can not be driven by the person sat on it. This is a very long life product with the following components: Wheelchair, Foldable armrests, Foldable footrest, Starring/traction bar. The Oceanic is available in large (Oceanic) and small (Oceanic Baby) configurations which vary in length and also in the width and height of the Seat. The Oceanic Baby and Oceanic intended use is the same, but the Oceanic Baby has a maximum weight load of 50kg while the maximum weight load for the Oceanic is 100kg. All parts on our wheelchair are fabricated from aluminium and selected materials suitable for use in an aquatic environment. The chair can be submersed in water without any harmful effects. Users manual provides information on warnings, cautions, maintenance and operation instructions.

The provided text describes a 510(k) premarket notification for a medical device, the Novaf Oceanic Wheelchair. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive clinical studies to prove effectiveness with specific acceptance criteria in the same way a new drug or high-risk medical device might. The "performance testing" mentioned is primarily for safety and mechanical aspects to support this substantial equivalence.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance with metrics like sensitivity/specificity, and training set details) are not applicable to this type of regulatory submission and are not present in the provided document.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document states "Testing has been performed to evaluate the overall stability, dimensions and mechanics of the Oceanic. The testing showed that the Oceanic is safe and effective for its intended use." However, it does not provide a detailed table of specific acceptance criteria (e.g., maximum deflection under load, specific stability angles, etc.) or quantitative results against those criteria. It only offers a high-level statement of successful testing.

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

• Sample Size for Test Set: Not specified. The document only mentions "Testing has been performed" without detailing the number of wheelchairs or components tested.
• Data Provenance: Not specified, but implied to be from internal testing conducted by the manufacturer, Novaf Andalucia 2007, S.L., likely in Spain (country of origin for the sponsor). The testing is retrospective in the context of the 510(k) submission, meaning it was performed before filing the notification.

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

• Not Applicable. This type of device (manual wheelchair) does not typically involve expert review for "ground truth" establishment in the sense of diagnostic accuracy or interpretation. The performance testing would be against engineering standards and specifications.

4. Adjudication method for the test set

• Not Applicable. As there's no expert interpretation or "ground truth" adjudication in the diagnostic sense, no adjudication method would be used. The testing would involve objective measurements and comparisons to predetermined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This device is a manual wheelchair, and its safety and effectiveness are determined by mechanical and functional performance, not diagnostic interpretation.

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

• Not Applicable. This is a mechanical device, not an algorithm or AI system. Therefore, standalone performance in this context is irrelevant. The "standalone" performance refers to the device itself (the wheelchair) performing its function as intended.

7. The type of ground truth used

• The "ground truth" for this device would be established by engineering specifications, regulatory standards (e.g., ISO standards for wheelchairs if referenced, though not explicitly stated here), and internal design requirements. For example, the "ground truth" for stability would be a specific angle or load threshold it must withstand. For weight capacity, it would be a specific weight it must support without failure. The document implies these standards were met, but doesn't list the exact standards or specifications.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI/ML algorithm. There is no concept of a "training set" for this product.

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

• Not Applicable. As there is no training set.

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The Mechanical Wheelchair is intended to provide mobility to persons restricted to a sitting position.

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This document is an FDA 510(k) clearance letter for a Mechanical Wheelchair. It does not contain information about acceptance criteria or a study proving device performance in the context of AI or machine learning. The letter confirms substantial equivalence to a predicate device, which is a regulatory pathway for Class I and II medical devices that typically relies on the device meeting established performance standards rather than requiring extensive clinical trials or AI-specific performance metrics.

Therefore, I cannot provide the requested information from the provided text, as it describes a traditional mechanical medical device and not an AI-enabled one.

Here's why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not available. This is a clearance letter, not a performance report for an AI device.
2. Sample size used for the test set and the data provenance: Not applicable. There's no AI test set mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no AI ground truth establishment described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for a mechanical wheelchair, not an AI-assisted device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses regulatory clearance for a physical product (a mechanical wheelchair) and does not involve AI/ML performance evaluation.

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DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.

DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor. It consists of a rigid, mechanical and foldable steel frame and nylon upholstery back and seat. It has two 24" rear wheels and two 8" front casters for turning and maneuverability.

The provided text describes a 510(k) premarket notification for a manual wheelchair and does not contain information about a study or acceptance criteria for an AI-powered device. Therefore, I cannot fulfill the request using the provided input.

The document is a standard 510(k) summary for a medical device (a manual wheelchair, Model DS 202-S) establishing substantial equivalence to a predicate device. It details:

• Device Name: DS 202-S manual wheelchair
• Intended Use: To provide mobility to physically challenged persons limited to a sitting position on flat and firm terrain, outdoor or indoor.
• Classification: Class I, Mechanical wheelchair
• Predicate Device: HUADONG HD11 manual wheelchair (K082274)
• Non-Clinical Testing: The device meets applicable performance requirements specified in ANSI/RESNA WC Vol. 1 Sec. 1, Sec. 5, Sec. 8, Sec. 15, Sec. 15, Sec. 16 and California Bureau of Home Furnishings 117. These standards are for mechanical wheelchair performance and safety.

The request, however, asks for information typically associated with the validation of AI-powered medical devices, including acceptance criteria tables, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and details of comparative effectiveness studies (MRMC) or standalone performance studies. None of this information is present in the provided text as the device in question is a manual wheelchair, not an AI device.

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Our new Wheelchair, Zephyr is not envisioned nor will it be marketed to a first time user but rather directed to a handicapped user who has become relatively proficient in the use of a wheelchair. And who is seeking a lighter and more maneuverable wheelchair for use in sports and athletic enhancement.

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This document is a FDA 510(k) clearance letter for a mechanical wheelchair named "Zephyr" and does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given text.

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