To assist in the management of venous stasis ulcers by applying pressure.

The device includes a Leg Compressor and a Pre-Filled Air Bladder (PFAB).

The PFAB does not apply pressure, but when it is used in conjunction with a compression bandage, it will exert local pressure (because of the air pocket). Compression bandages exert pressure, therefore the pre-filled air bladder will redistribute the pressure that the bandage would already by supplying.

Overall the device is meant to redistribute and apply pressure to the venous ulcer. It has been found over the years that compression bandages or stockings healed more venous leg ulcers than no compression.

If the venous ulcer is kept covered and clean with applied pressure the healing process is more effective. The concept behind this device is to keep the wound covered and apply pressure on the wound.

PFAB (Pre-Filled Air Bladder)

The PFAB is an oval shaped polyurethane pre-filled air bladder with four flanges. The tips of the flanges have medical adhesive, which adheres to the skin. The bottom of the PFAB has medical grade hydrophilic foam, which will cover the ulcer and is used to absorb the exudates.

The PFAB will be offered in three sizes (Small, Medium, and Large).

Leg Compressor

The leg compressor is used to hold the PBAB in place and apply additional pressure. The leg compressor contains an air chamber that is made of 2 layers of urethane film. The outer black fabric is Nylon. The leg compressor also has a self adjusting manometer attached to the outside to measure the pressure within the air bladder, which will be situated along the Great Saphenous Vein.

The manometer is used for reference only and is not meant to be used for accurate measurements of pressure.

The Leg Compressor includes a safety release valve to deflate the compressor. In addition, the manometer is color coded. As a precaution the user should not inflate the compressor in the red zone.

The pressure at the beginning of the red zone is approximately 30 mm Hg, which is similar to the pressure from a typical Umma Boot or compression bandage.

The provided document K070457 describes the submission of a 510(k) for the "Leg Compressor & PFAB" device. However, it explicitly states that performance data consists solely of biocompatibility testing. The submission concludes that the device is "as safe and effective as the predicate device" based on minor changes and material identity to a predicate.

Therefore, the document does not contain any information regarding a study demonstrating the device's clinical performance, acceptance criteria, sample sizes, ground truth establishment, or expert involvement. The device was classified as "Unclassified" and later as "Elastic Bandage" (Product Code FRO N.HW / MHW), which typically implies a lower regulatory burden and often does not require extensive clinical performance studies for 510(k) clearance if substantial equivalence to existing devices can be proven through other means (e.g., material equivalence, intended use equivalence).

Here's a breakdown of why many of your requested items cannot be fulfilled from this document:

1. Table of acceptance criteria and reported device performance: Not available. The document does not define specific performance metrics or acceptance criteria for clinical effectiveness.
2. Sample size for test set and data provenance: No clinical test set or study is mentioned beyond biocompatibility.
3. Number of experts and qualifications for ground truth: Not applicable, as no clinical ground truth was established for performance.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not done.
6. Standalone performance study: No standalone clinical performance study is described. The "Performance Data" section only mentions biocompatibility.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device, and no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Summary from the provided document:

The only "performance data" mentioned is:
"The materials that make contact with the patient are biocompatible and are identical to the materials used in one of the predicate devices."

And the conclusion:
"We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device."

This indicates that the clearance was based on demonstrating substantial equivalence through material safety and comparison to existing predicate devices, rather than a new clinical performance study.

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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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ComfortCare Compression Support with Magnets is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actors associated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable anatomical areas and for recovery from minor physical injuries.

ComfortCare Absortek fabric construction provides for absorption and venting of perspiration thereby minimizing potential for skin irritation.

ComfortCare Magnetic Insoles provide foot comfort while layered absorptive fabric vents moisture and minimizes damp layer conducive to bacterial and fungal growth.

(a) Elasticized material to support and compress a part of the body. (b) Insole provides magnetic Magnets encased in breathable fabric reader comers (a) (ents moisture to keep feet dry.

This document describes a Special 510(k) Pre-Market Notification for modifications to an existing device, not a new device requiring a comprehensive performance study with acceptance criteria. Therefore, much of the requested information regarding performance metrics, sample sizes, and expert adjudication for a study proving acceptance criteria will not be present.

Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, despite the addition of magnets.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is largely not applicable in the traditional sense for this type of 510(k) submission. The "acceptance criteria" here relate to the regulatory standards for substantial equivalence, rather than specific performance metrics of the device itself that would require a study to "prove".

The fundamental "acceptance criteria" for this Special 510(k) were to demonstrate that the modifications (adding magnets) did not alter the fundamental technology, safety, or intended use of the predicate devices. The "reported device performance" is the claim of substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

• Not applicable. This submission does not describe a clinical performance study with a test set. The evidence provided is primarily based on regulatory comparison and literature review regarding magnet safety.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable. No test set or expert ground truth was established for the device's efficacy in this submission. The FDA's review process inherently involves regulatory experts (e.g., those in the Division of Dental, Infection Control and General Hospital Devices) evaluating the substantial equivalence claim.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication was performed.

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 not an AI-enabled device or a diagnostic device where MRMC studies would typically be conducted.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the established regulatory framework for similar existing devices (predicate devices) and scientific consensus/literature regarding the safety of static magnets.
  • For the compression component: Established regulatory classifications (Section 880.5075) for elastic bandages and common use/characteristics of legally marketed products (e.g., Ace, Decam).
  • For the insole component: Established regulatory classifications (Section 880.6280) for medical insoles and common use/characteristics of legally marketed products.
  • For the magnet component: World Health Organization reports and "numerous studies" supporting the safety limits of 20,000 Gauss, and the historical use of magnets.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that would have a "training set." The product's development would likely incorporate design verification and validation testing, but these are not described as "training" in the context of this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As above, there is no "training set" for this type of device.

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SKAR-KARE™-SHEET is intended for use in the topical management of hypertrophic and keloid scars. Do not use on open wounds.

SKAR-KARE™-SHEET is a soft, durable and washable elastic device for topical patient use over intact skin. It is not sterile. It is composed of a standard silicone sheeting (inert) in a flexible-link, ionic, micro-patterned appearance.

The provided text is a 510(k) Premarket Notification for the SKAR-KARE™-SHEET. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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