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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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