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The Safety Poncho is used for restraint. The Shoulder Strap Poncho provides restraint and posture support.

Safety Poncho: A poncho-style, upper body device made from either woven polyester or polyester mesh. A waist strap secures the device to the wheelchair kickspurs. The strap is 1 1/8-inch-wide polyester webbing. The edges of the garment are finished with a bias cut binding, the color of which corresponds to a size chart included on the package insert. The device is intended for wheelchair use only. Shoulder Strap Poncho: The Shoulder Strap Poncho has the same configuration as the above with the addition of a strap sewn on the shoulder area. This strap ties to the wheelchair pushhandles to provide posture support. Strap is 1 1/8-inch-wide polyester webbing.

This document describes a 510(k) submission for the "Safety Poncho" and "Shoulder Strap Poncho" by Skil-Care Corporation. It's important to note that this submission is from 1996, and modern medical device submissions, especially for AI/ML-driven devices, look vastly different and require significantly more rigorous data and study details.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the way one would expect for an AI/ML device. This is because the devices described are physical restraints, not AI-powered diagnostics or therapeutics.

Therefore, I cannot populate the requested table or answer most of your detailed questions, as they pertain to the evaluation of AI/ML device performance.

However, I can extract the relevant information from the document as it pertains to the nature of the submission:

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

• No acceptance criteria or reported device performance metrics are provided in the document. The submission is not for a device requiring performance evaluation against quantitative metrics like sensitivity, specificity, or F1 score.

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

• Not applicable. There is no "test set" in the context of evaluating a physical restraint device's performance. The submission refers to 18 years of commercial distribution of the predicate 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)

• Not applicable. There is no "ground truth" establishment in the context of this submission.

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

• No. This is a physical device, not an AI or diagnostic tool, so an MRMC study is irrelevant.

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.

Summary of the K96346 submission relevant to its context:

The core of this 510(k) submission (K96346) is a substantial equivalence claim for two physical restraint devices: the "Safety Poncho" and the "Shoulder Strap Poncho."

• Device Description:
  • Safety Poncho: A poncho-style upper body device made of woven polyester or polyester mesh with a waist strap to secure it to wheelchair kickspurs.
  • Shoulder Strap Poncho: Same as the Safety Poncho but with an additional strap on the shoulder area to tie to wheelchair pushhandles for posture support.
• Indications for Use:
  • Safety Poncho: Used for restraint.
  • Shoulder Strap Poncho: Provides restraint and posture support.
• Predicate Device: The predicate devices are the "Safety Poncho" and "Slider Poncho" already marketed by Skil-Care Corporation.
• Basis for Equivalence: The submission states that the devices used for comparative purposes (the predicate devices) are currently marketed and have been for approximately 18 years. The only difference mentioned is a change in labeling to incorporate suggestions from an FDA draft guidance document for protective restraints.
• Regulatory Context: The document highlights that such restraints are subject to HCFA (Health Care Financing Administration, now CMS) regulations and accreditation standards, which govern their appropriate use and personnel training. This implies that the safety and effectiveness are managed through existing clinical practice guidelines and regulatory oversight for restraint use, rather than through a device-specific performance study presented in this 510(k).

In essence, this is a notification for minor labeling changes to existing, legally marketed devices, rather than a submission for a new device requiring extensive performance data validation in the modern sense, especially as it relates to AI/ML.

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