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HVO surgical drapes are made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. They are designed to be repackaged and/or sterilized before use. This single use product is a disposable non-sterile drape designed to be re-packaged and/or sterilized prior to use. This product may be sterilized using Ethylene Oxide (EO) following the Validation and Routine Control under ANSI/AMMI/ISO 11135. For more information about sterilization of this product, contact HVO, Inc.

The proposed HVO, Inc. Various Disposable Non-Sterile Surgical Drapes function in the same manner as predicate devices in that they are intended to be used as protective patient coverings, such as used to isolate a site of surgical incision from microbial and other contamination. Device Design/ Materials Used/ Physical Properties: The HVO, Inc. Various Disposable Non-Sterile Surgical Drapes are made of materials commonly used for their purpose. The primary material components are SMS, Micro-embossed LDPE, Clear LDPE, Nonwoven (wetlaid cellulose), Airtex, Sontara, Krayton, Medical Grade Single and Double Coated Tapes, Bridging, Polyfoam, Velcro, Polyester Mesh, Hot Melt, Cold Glue and Coated Medical Grade Liners. Primarily all of our drapes are offered in the color blue, which is the common color for medical device materials, but some materials are offered in white or with white backing. These materials include Nonwovens, SMS, Airtex, Sontara, Polyfoam, Back Table Covers, Bridging, and LDPE's. All other materials are clear plastics or adhesives, which are not colored, but natural.

The provided text describes a 510(k) submission for "Haywood Vocational Opportunities, Inc. Various Disposable Non-Sterile Surgical Drapes." This document primarily focuses on establishing substantial equivalence to existing predicate devices based on material composition, intended use, and general characteristics rather than presenting a performance study with specific acceptance criteria and detailed statistical analysis for a novel device.

Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment from a study is not present in the provided text.

Here's an analysis of the available information:

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

The document doesn't provide specific numerical acceptance criteria or performance metrics in the format of a table you'd typically see for an AI algorithm or a device requiring specific functional performance targets. Instead, the "performance" is implicitly demonstrated through a comparison of characteristics to predicate devices.

Study that proves the device meets the acceptance criteria:

The "study" presented is a comparison to legally marketed predicate devices. The sponsor argues that their devices are substantially equivalent to these predicates due to similar design, materials, and intended use. The FDA concurred with this assessment, indicating that the device meets the regulatory requirements for market entry based on this comparison. The FDA's 510(k) clearance letter (K050508) serves as the "proof" that the device met the criteria for substantial equivalence.

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

• Sample Size for Test Set: Not applicable. This submission is for surgical drapes and relies on a comparison to existing devices, not a performance study with a test set of data. There are no "data" in the sense of patient cases or images.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: 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:

• MRMC Study: No, this is not an AI-assisted device.
• Effect Size: Not applicable.

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

• Standalone Performance: No, this is not an algorithm-based device.

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

• Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness profile of the legally marketed predicate devices. The HVO drapes are deemed "substantially equivalent" if they share similar technological characteristics and intended use with these predicates, implying they would also share similar safety and effectiveness.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.

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

• Ground Truth for Training Set: Not applicable.

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The Aquilla Modular Wheelchair is intended to provide mobility for occupants who are unable to walk or have difficulty in walking without assistance.

The Aquilla Modular Wheelchair is manually operated, and can be configured for propulsion by an attendant or an occupant. The range of sizes and build configurations are suitable for male or female sizes from junior to adult. The Aquilla Modular Wheelchair consists of typical components found on most manual wheelchairs. The chairs feature a backrest, folding seat frame, footrest, rear wheels and front castors. Accessories include occupant-positioning belts, and optional features which allow a chair to be changed simply to meet the changing environmental and health requirements of the occupant. Aquilla is suitable for use both indoors and outdoors on surfaces that are intended typically for public access. This type of wheelchair is not suitable for soft and undulating terrain or for climbing obstacles. Aquilla can be easily folded for compact storage, and armrests and footrests can be removed to reduce the weight for lifting. Aquilla is labeled to indicate important aspects of use, including warnings and cautions.

The provided text describes the 510(k) premarket notification for the Aquilla Modular Wheelchair, which is a mechanical wheelchair. The information focuses on its substantial equivalence to a predicate device and its compliance with relevant ISO 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

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 does not specify the sample size used for the tests. It only states that the "Aquilla wheelchair has been tested to and met the following ISO requirements." The provenance of the data is not explicitly stated beyond the fact that the manufacturer, Remploy Mobility, is located in the United Kingdom. It is implied to be prospective testing carried out for regulatory 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 is not applicable as the device is a mechanical wheelchair and its performance is evaluated against ISO standards through physical testing, not against expert interpretation of medical images or data. No experts for ground truth establishment were mentioned or would be relevant in this context.

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

This is not applicable. The device undergoes objective physical tests according to ISO standards, which do not involve subjective adjudication methods like those used in clinical or imaging studies.

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. The device is a mechanical wheelchair, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study is not relevant.

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. Performance is assessed through physical tests.

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

The "ground truth" in this context is defined by the objective pass/fail criteria established within each of the specified ISO 7176 standards. This involves physical measurements, strength tests, stability tests, and other performance metrics, not expert consensus or medical outcomes.

8. The sample size for the training set

This is not applicable. The Aquilla Modular Wheelchair is a physical device, and its development and testing do not involve a "training set" in the context of machine learning or AI models. Its performance is validated against established engineering and safety standards.

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

This is not applicable for the reasons stated above.

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