Search Results

The Hippocampe Marathon and Trail is indicated to provide mobility to persons restricted to a seated position on various terrains, including footpaths and trails.

The Hippocampe Marathon and Trail is an occupant or care provider propelled manual operated wheelchair. The Hippocampe Marathon and Trail is designed for everyday use as well as recreational activity such as running and trail running, in the following environments:

• Indoors and outdoors;
• Over smooth, rough, and uneven ground;
• Over soft and hard surfaces;
• Over small obstacles, like door jams; and
• Up, down and across slopes.

The Hippocampe Marathon and Trail is a three-wheel triangular wheelchair comprised of bent aluminum tubing frame that are bent, joined, fastened, and/or coupled with connectors to form a frame. The frame consists primarily of a lower frame, adjustable height seat back frame, adjustable headrest, push bar and push bar frame, tubing clamp connectors, footrest, arm rests, rear axle assembly, and front fork and axle assembly. Once assembled, the wheelchair frame is fixed. The recline of the seat back frame can be adjusted with depth adjustment screws at the base of the seat back frame. The upholstery is attached to the frame using nylon straps and buckles and is fire resistant. A rigid plastic open basket-like structure located in the middle of the lower frame and behind the front fork assembled provides the occupant a footrest and has a removable layer of foam. On the push bar are control levers for disc brakes of the rear wheels which are operated by the occupant's care provider. The disc brakes also act as parking brakes and are activated by the care provider. The Hippocampe Marathon and Trail can be easily assembled and disassembled for stowage or storage by detaching the lower frame of the armrest and folding the seat back frame forwards. The wheelchair is available in three sizes: medium, large and extra-large. The maximum weight capacity of Hippocampe Marathon and Trail is 220 lbs.

This document is a 510(k) clearance letter for the Hippocampe Marathon and Trail wheelchair, which is a physical device, not an AI/software device. Therefore, the questions regarding acceptance criteria and study data for AI/software performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment, etc.) are not applicable to this submission.

The clearance is based on demonstrating substantial equivalence to a predicate device (Hippocampe Wheelchair K051709) through non-clinical validation testing of physical properties and performance (e.g., static stability, braking effectiveness, static/impact/fatigue strengths, resistance to ignition).

Here's how to address the request based on the provided document, acknowledging its nature as a physical device clearance:

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

   Since this is a physical device subject to ISO standards for wheelchairs, the "acceptance criteria" are the specific pass/fail requirements defined within each of the listed ISO standards, and the "reported device performance" is that the device passed these tests. The document doesn't provide specific numerical results or detailed pass/fail thresholds within the clearance letter itself; it states that the tests were "performed" and "demonstrates that the Hippocampe Marathon and Trail is substantially equivalent in safety, effectiveness, and performance to the predicate device."

   Acceptance Criterion (ISO Standard)	Reported Device Performance
   ISO 7176-1: Static Stability	Device passed
   ISO 7176-3: Effectiveness of Brakes	Device passed
   ISO 7176-5: Dimensions, Mass, Maneuvering Space	Device passed
   ISO 7176-7: Seating & Wheel Dimensions	Device passed
   ISO 7176-8: Static, Impact, Fatigue Strengths	Device passed
   ISO 7176-11: Test Dummies	Not applicable (test method)
   ISO 7176-13: Coefficient of Friction of Test Surfaces	Not applicable (test method)
   ISO 7176-15: Information Disclosure, Documentation, Labeling	Device passed
   NF ISO 7176-16: Resistance to Ignition of Postural Support Devices	Device passed
   NF ISO 7176-22: Set-up Procedures	Not applicable (test method)

   (Note: ISO 7176-11, -13, and -22 are standards for test methodologies or components, not direct performance criteria of the end device in the same way as the others.)

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

   • Sample Size: Not explicitly stated for each test, but typically, testing against ISO standards for medical devices involves a representative sample of manufactured units. It's usually a small number (e.g., 1-3 units) per specific test as per the standard's requirements, due to the destructive nature of some tests.
   • Data Provenance: The testing was "non-clinical validation testing". The applicant is "Vipamat Sarl" from "Ploemeur 56270 France." The testing was likely conducted in a lab, potentially by the manufacturer or a third-party testing facility, in a prospective manner to demonstrate compliance.

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

   • Not Applicable. For a physical device like a wheelchair, "ground truth" isn't established by human experts in the same way it is for medical image interpretation or diagnostic AI. The "ground truth" is typically defined by the objective, quantifiable parameters of the ISO standards themselves (e.g., brake force, stability limits, material strength). Compliance is determined by whether the device's performance meets these predefined engineering and safety specifications, measured by calibrated equipment.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used in subjective expert review scenarios, common in AI/radiology studies. For physical device performance testing against objective standards, the outcome is typically a direct measurement and comparison against a numerical threshold, or a pass/fail determination based on observable performance (e.g., no breakage under load).

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. MRMC studies are specific to evaluating the clinical performance of AI algorithms, often in medical imaging, and their impact on human reader performance. This device is a physical wheelchair, not an AI diagnostic tool.

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

   • Not Applicable. This question relates to AI algorithm performance. The device is a manual wheelchair, so there is no "algorithm only" performance to evaluate.

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

   • Objective Engineering Standards / Bench Testing Results. The "ground truth" here is the objective, measurable performance of the wheelchair against the defined physical and mechanical limits specified in the ISO standards (e.g., forces applied, distances traveled, angles achieved, material integrity). This is determined by controlled bench testing with appropriate load application and measurement equipment.

8. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of a physical device like this. Training sets are relevant for machine learning algorithms.

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

   • Not Applicable. As there is no training set, there's no ground truth to establish for one.

In summary, the provided document is a 510(k) clearance for a physical medical device (a wheelchair), not a software or AI device. Therefore, many of the questions asked, which are highly relevant to AI/software validation studies, do not apply. The device's "acceptance criteria" and "proof" come from demonstrating compliance with established international physical performance and safety standards for wheelchairs (ISO 7176 series).

Ask a specific question about this device

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.

Ask a specific question about this device

The Renegade Wheelchair is a versatile, mechanical wheelchair intended for indoor and outdoor use.

The Renegade is designed to offer the user the option of conventional hand-to-wheel propulsion, or the use of pushbar levers which provide thrust by way of a gear and chain system. Each wheel has multiple gears and independent brakes, providing versatility and control. The wheelchair is fitted with accessory holders to provide a means to carry sports and recreational equipment.

The provided text is a 510(k) summary for the Alpha One Renegade Wheelchair. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document is a traditional 510(k) submission for a mechanical wheelchair, not a medical imaging or AI-enabled device.

Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, expert involvement, and AI performance metrics is not applicable to this type of submission. Traditional 510(k)s for mechanical devices primarily focus on demonstrating substantial equivalence to legally marketed predicate devices in terms of material composition, technical characteristics, and intended use, often relying on engineering specifications, performance testing (e.g., durability, stability), and comparisons of features, rather than clinical study data with statistical measures like sensitivity, specificity, or reader performance.

Here's an attempt to address the applicable points based only on the provided text, while noting the limitations:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the way one would expect for an AI/imaging device. The overall "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to predicate devices.

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 summary. For a mechanical wheelchair, clinical "test sets" in the context of diagnostic performance are not typically used. Testing would likely involve engineering and performance benchmarks, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable for a traditional mechanical wheelchair 510(k). "Ground truth" in this context would relate to engineering specifications and performance standards, not diagnostic interpretations by medical experts.

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

This information is not provided and is not applicable for a traditional mechanical wheelchair 510(k).

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

An MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a mechanical wheelchair.

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

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

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

The concept of "ground truth" as typically understood in AI/imaging studies (e.g., pathology, clinical outcomes) is not applicable here. For a mechanical device, performance is evaluated against engineering standards and safety requirements. The "truth" is whether the device meets its design specifications and performs safely and effectively according to its intended use and comparison to the predicate.

8. The sample size for the training set

This information is not provided and is not applicable. There is no AI training set for a mechanical device.

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

This information is not provided and is not applicable. There is no AI training set for a mechanical device.

In summary: The provided document is a 510(k) summary for a mechanical wheelchair. It demonstrates substantial equivalence to predicate devices based on design and intended use. The questions posed are primarily relevant to AI/imaging devices, and therefore, most of the requested information cannot be extracted from this particular submission.

Ask a specific question about this device

The Hippocampe Wheelchair is a versatile, mechanical wheelchair intended for use on various terrains including sand, grass, gravel, snow, foot/hiking paths, and in water.

The Hippocampe Wheelchair is an all terrain wheelchair suitable for use on various terrains and in water. It can be used on surfaces such as the beach, seaside, snow, mountain pathways, forest, hiking paths, gardens and grass. The Hippocampe Wheelchair is a versatile durable wheelchair that is comprised of the following components.

• Wheel chair t
• Pushbar .
• Trunk harness (optional) .
• Armrest (optional) .
• Headrest (optional) .
• . Skiing kit (optional)
• . Traction kit
• Transport bag (optional) .
  The Hippocampe is available in small, medium, large and extra large configurations which all vary in length but have the same seat wydth, total width and seat height dimensions. Two versions of the Hippocampe, standard and pool, are available. The standard Hippocampe is intended for use in natural water (beaches, ponds, lakes). The pool Hippocampe is only intended for pool use by children and thin adults and is only available in a small size.

The provided text is a 510(k) summary for the Vipamat Technologie Hippocampe Wheelchair. It describes the device, its intended use, technological characteristics, and performance testing. However, it does not contain detailed information about specific acceptance criteria or a comprehensive study that proves the device meets those criteria in the way a medical AI/ML device submission would.

Instead, the document states: "Testing has been performed to evaluate the overall stability, dimensions and mechanics of the Hippocampe Wheelchair. The testing showed that the Hippocampe is safe and effective for its intended use."

This indicates that general safety and effectiveness testing was conducted, but specific metrics, thresholds, or detailed study designs are not provided. The information typically requested for AI/ML device performance studies (like sample sizes for test/training sets, expert adjudication methods, MRMC studies, etc.) is not applicable to this type of mechanical device submission from 2005.

Therefore, I cannot fulfill the request with the provided information in the format requested for an AI/ML device.

However, I can extract the general "performance testing" information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not specified. The document only mentions "testing has been performed."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical device, not one requiring expert human interpretation for "ground truth."
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.
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. The "ground truth" for a mechanical device would be compliance with engineering standards and functional specifications through direct measurement and observation.
8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The Vipamat Technologie Hippocampe Wheelchair underwent "performance testing" to evaluate its overall stability, dimensions, and mechanics. The outcome of this testing was a determination that the device is "safe and effective for its intended use." The 510(k) summary does not elaborate on the specific acceptance criteria, testing methodologies, sample sizes, or detailed results of these tests, which is typical for mechanical device submissions around 2005. It focuses on demonstrating substantial equivalence to predicate devices based on design and intended use, supported by general safety and effectiveness testing.

Ask a specific question about this device