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The Petit Silma Elastic Bandage with Germanium/Titanium Oxide is designed to provide relief of minor physicial discomforts that have their origin in stress and strain of repetitive actions associated with athletic, workplace and at-home activities. The device provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries.

The Petit Silma Elastic Bandage is a simple device to provide relief of minor physical discomforts arising from stress or strain of repetitive actions including athletic, workplace and at-home activities. It consists of an elastic compression bandage, containing the element Germanium in a circular pellet. The product is worn on the injured portion of the body (elbow, knee, wrist) as appropriate. Alternatively, a second version of the the product would contain a Titanium Oxide pellet, instead of Germanium.

The provided document is a 510(k) summary for the "Petit Silma Elastic Bandage With Germanium/Titanium Oxide". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through new clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not typically included or required in a 510(k) summary for a Class I device like an elastic bandage.

Here's the breakdown of what can be extracted and what cannot:

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

Not applicable. The 510(k) summary does not define specific performance acceptance criteria for the "Petit Silma Elastic Bandage" itself, as it relies on demonstrating substantial equivalence to a predicate device. Performance is generally assumed to be similar to the predicate.

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. A dedicated test set for evaluating specific performance metrics of the device is not described in this 510(k) summary. The submission relies on a comparison to a predicate device, not new performance data from a specific test set.

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. No test set requiring expert ground truth establishment is described.

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

Not applicable. No test set involving adjudication is described.

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 a simple elastic bandage, not an AI-powered diagnostic device. An MRMC study is not relevant and was not performed.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. No new data requiring ground truth establishment is presented. The basis for approval is substantial equivalence to a predicate device, which implies that the predicate device's established safety and effectiveness serve as the "ground truth" for the new device's intended use.

8. The sample size for the training set

Not applicable. There is no mention of machine learning or an algorithm requiring a training set in this 510(k) summary.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of available information from the K040936 document:

The 510(k) summary for the "Petit Silma Elastic Bandage With Germanium/Titanium Oxide" focuses on demonstrating substantial equivalence to a predicate device: "Comfort Care™ Compression Support With Magnets, 510(k) # K013239".

The study that "proves" the device meets acceptance criteria, in the context of a 510(k) for this type of device, is essentially the comparison to the predicate device. The fundamental "acceptance criteria" here is that the device is as safe and effective as a legally marketed device.

Device Description and Intended Use:

• Trade Name: Petit Silma Elastic Bandage With Germanium/Titanium Oxide
• Common Name: Elastic Bandage or Compression Bandage
• Classification Name: Elastic Bandage (21 C.F.R. § 880.5075), Product Code: FQM
• Device Description: An elastic compression bandage containing either a Germanium or Titanium Oxide pellet. It is worn on injured body parts (elbow, knee, wrist) to provide relief of minor physical discomforts.
• Intended Use/Indications for Use: To provide relief of minor physical discomforts arising from stress and strain of repetitive actions (athletic, workplace, at-home). It provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries.
• Predicate Device: Comfort Care™ Compression Support With Magnets, 510(k) # K013239, manufactured by Med Gen, Inc.

The conclusion of the 510(k) summary is based on the belief that the "Petit Silma Elastic Bandage is substantially equivalent to its claimed predicates under conditions of intended use." This statement is the core of how the device "meets acceptance criteria" in this regulatory context. No new clinical studies demonstrating specific performance metrics were required or conducted.

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For relief of minor physical discomforts incurred by acute trauma, repetitive stress and overuse injuries associated with first degree sprains of overstretched ligaments and first degree strain injuries to tendons. The device compresses, supports and protects vulnerable body parts from post-injury impact incurred by repetitive stress and overexertion self-limiting physical injuries.

(a) Elasticized fitment to support and compress an injured part of the body. (b) Anatomically contoured for adjustable fit and firmness for personal comfort and control of slippage and bunching of fabric. (c) Absortek fiber absorbs perspiration and transfers heat and moisture away from skin (d) Fabric treated with agent to resist growth of odor-causing bacteria and mildew (e) Non-intrusive magnetic panel encased in fabric.

The provided text is a 510(k) summary for a medical device called "Back in Action" Compression & Support with Anti-Bacterial Agent and Magnet. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Explanation Based on Document Content:

The 510(k) summary explicitly states its reliance on demonstrating substantial equivalence to a predicate device (ComfortCare Compression and Support with Anti-Bacterial and Magnet, K013244). It emphasizes that:

• "The properties of 'Back in Action' devices demonstrate the same technological characteristics in design as an elastic bandage, woven fabric, fiber, finish, composition, anti-microbial agent, application, compression/support function, layered absorption/venting mechanisms, magnets and Indications for Use - as granted to ComfortCare products under K 013244..."
• "There are no material modifications that affect or change the fundamental technology and science for a similar legally marketed device."

This means that the device's acceptability is based on its similarity to an already cleared device, not on specific performance metrics established through new clinical trials with acceptance criteria. No new performance study or clinical data is detailed in the provided text.

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ComfortCare Compression Support with Magnets & Anti-Bacterial Agent is designed to provide relief of minor physical discomforts that have their origin in strenuous or intense physical activities associated with athletic, workplace and at-home activities. Device provides support for relief of minor physical discomforts and at-home activities. Device provides support for relief of discomfort in self-limiting physical injuries.

ComfortCare Absortek fabric construction provides for absorption and venting of perspiration in compressed areas, minimizing potential for skin irritation.

ComfortCare Magnetic Insoles with Anti-Bacterial Agent provide foot comfort while layered absorptive fabric vents moisture from soles of feet, thereby minimizing damp environment conducive to breeding bacterial and fungal growth.

(a) Elasticized material to support and compress a part of the body. Magnets encased in breathable fabric reader comfort. (b) Insole provides magnetic coverage of full foot insole and layered fabric absorbs and vents moisture to keep feet dry. (c) resists the growth of odor-causing bacteria and mildew

The provided document is a 510(k) summary for a medical device modification, specifically for "ComfortCare Compression Support with Magnets & Anti-Bacterial Agent" and "ComfortCare Magnetic Insoles with Anti-Bacterial Agent." The document does not contain acceptance criteria or a study that establishes device performance against such, in the way one would expect for a performance study.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their modified device is as safe and effective as existing legally marketed devices, rather than presenting novel performance data.

Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design, ground truth establishment, sample sizes for test and training sets, MRMC studies) are not applicable or cannot be extracted from this particular type of regulatory submission. The document explicitly states: "In the absence of a classification ruling, Med Gen Inc. has referenced similar compression support products and insoles as comparative bases for substantial equivalence." and "ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices."

However, I can extract the information that is present and explain why other information is absent based on the nature of a 510(k) substantial equivalence submission.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the typical sense for a performance study. The "acceptance criteria" for a 510(k) submission of this type are based on demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially the manufacturer's assertion that the modifications (addition of magnets and anti-bacterial agents) do not alter the fundamental intended use, safety, or effectiveness compared to the predicate devices.

The document states:

• "Similarities exist in 9 of 12 basic technical characteristics between ComfortCare and legally marketed products."
• "The intended use, technical and safety attributes with or without magnets are essentially the same as ComfortCare products."
• "ComfortCare's enhancements do not alter the intended use of 'compression support and insole products'..."
• "ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices."

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

Not applicable. This document does not describe a performance study with a test set. The submission relies on a comparison of characteristics to existing legally marketed devices.

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

Not applicable. No "ground truth" establishment by experts for a test set is described.

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

Not applicable. No test set or expert adjudication is described.

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 device is a physical medical device (compression support and insoles), not an AI/software device. Therefore, no MRMC study involving human readers or AI assistance would be relevant or performed.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The ground truth for this type of submission is the established safety and effectiveness of the predicate devices to which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning or AI device that would require training data.

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

Not applicable. This document does not describe a machine learning or AI device.

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