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Over-The-Counter Indications Local management of superficial wounds, minor burns, abrasions and lacerations.

RX Use

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds (donor and graft sites, incisions), first and second-degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites, and wound drain sites.

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first- and second-degree mustard-induced vesicant injuries not requiring skin grafting.

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for radiation dermatitis.

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for acute cutaneous radiation injury including moist desquamation without full thickness skin ulceration and/or necrosis.

Silverlon® Wound Contact, Burn Contact Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barner that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Wound Contact, Burn Contact Dressings may help reduce the risk of wound infection and support the body's healing process.

Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlor® Wound Contact, Wound Burn Dressings are a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

The Silverlon® Wound Contact, Burn Contact Dressings (WCD/BCD) are sterile, single use, single layer, non-adherent antimicrobial barrier wound dressings for up to seven day use. The dressings are comprised of Silverlon knitted nylon material plated with 99% elemental silver and 1% silver oxide. When Silverlon® dressings are moistened, the silver ions are activated, which kill wound bacteria held in the dressing which may help to reduce wound infection. The dressings are used as primary dressings that conform to the wound surface. The dressings are available in several configurations (e.g., rectangular, chest/trunk aprons, wraps, and gloves) and sizes.

I am sorry but the provided text is a 510(k) summary for a medical device (wound dressing) and does not contain information about acceptance criteria and study details as typically found for AI/ML-based medical devices. The document explicitly states that the current device is "identical products and thus have identical technological characteristics" to a previously cleared predicate device. Therefore, no new performance studies (such as those involving AI/ML components) were conducted to establish acceptance criteria or prove performance against a ground truth.

The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing and a swine study for a new indication (cutaneous radiation injuries). It does not discuss AI/ML algorithm performance, test sets, ground truth establishment by experts, or MRMC studies.

Therefore, I cannot provide the requested information based on the given text.

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Over-The Counter Indications:

Local management of superficial wounds, minor burns, abrasions and lacerations.

Prescription Indications:

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds (donor and graft sites, incisions), first and second degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites and wound drain sites.

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting.

Silverlon® Wound Contact, Burn Contact Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Wound Contact, Burn Contact Dressings may help reduce the risk of wound infection and support the body's healing process.

Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Wound Burn Dressings are a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

Silverlon Wound Contact, Burn Contact Dressings are sterile, porous, non-adherent, knitted nylon plated with 99% elemental silver oxide. Silver oxide. Silverlon Wound Contact, Burn Contact Dressings delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed.

Silverlon Wound Contact, Burn Contact Dressings are used as the primary wound contact layer and is placed under reticulated foam, gauze, or other wound dressings. Silverlon Wound Contact, Burn Contact Dressings are non-adherent, wound care dressings designed to be used up to seven (7) days.

The provided document is a 510(k) summary for the Silverlon® Wound Contact, Burn Contact Dressings. It describes the device, its indications for use, and a nonclinical (animal) study conducted to support an expanded indication.

Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance

The document describes a non-inferiority study performed on Gottingen minipigs. The acceptance criteria are based on a "non-inferiority margin" for a "histopathology composite score."

Explanation of Performance:
Since a higher histopathology score is implicitly better (as the device score was higher than the standard of care and still met non-inferiority), the device performed as well as or slightly better than the standard of care, falling within the pre-defined non-inferiority margin.

Study Details

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

• Sample Size: 165 Gottingen minipigs.
• Data Provenance: Nonclinical study, animal data (Gottingen minipigs). The study was a GLP (Good Laboratory Practice) nonclinical study.

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):

The document does not specify the number or qualifications of experts used to establish the ground truth (histopathology scores). It only mentions that the primary endpoint was the "histopathology composite score." Typically, a pathologist would be responsible for such assessments, but no details are provided here.

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

The document does not describe any expert adjudication method for the histopathology scores. It only refers to a "histopathology composite score," which implies a single score derived from the histological examination.

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 was a nonclinical (animal) study comparing the wound dressing to standard of care. It was not an MRMC study and did not involve human readers or AI assistance.

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

No. This was a nonclinical study of a physical wound dressing device. It does not involve an algorithm or AI.

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

The primary endpoint (ground truth) was a histopathology composite score of dermal wounds. This suggests a pathology-based assessment.

8. The sample size for the training set:

Not applicable. This was a nonclinical study of a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there was no training set.

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Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings.

The Over-The-Counter Indications:

Local management of superficial wounds, minor burns, abrasions and lacerations.

Prescription Indications:

Under the supervision of a healthcare professional Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlor® Island Wound Dressing and Silverlon® Wound Pad Dressing may help reduce the risk of wound infection and support the body's healing process.

Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings may be used for the management of painful wounds, Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

Silverlon Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost order): The Silverlon Wound Pad Dressing is comprised of Layers 1 - 4, they are not supplied with Layer 5 (adhesive tape layer).

• . Layer 1 is a non-adherent wound contact layer that consists of a single layer of knitted continuous nylon fiber coated with metallic silver at the rate of 5.05 mg/cm (50.5 g/m²); the silver surface coating is approximately 0.8 - 1.0 µm thick and contains approximately 1% silver oxide).
• . Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below;
• Layer 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound . exudate;
• . Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below; and,
• Layer 5 is a non-woven, medical grade polyester fabric coated on the skin-contacting . side with a self-curing acrylic, pressure-sensitive, medical grade adhesive covered with a silicone-coated (one side) paper liner. The Silverlon Wound Pad dressings do not have a tape layer.

All materials are biocompatible per irritation, sensitization and cytotoxicity testing results.

Layer 1 delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provide an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and the dressing intimately conforms to the wound surface.

This document is a 510(k) premarket notification for the Silverlon Island Wound Dressing and Silverlon Wound Pad Dressing. It does not describe a study involving an AI device or elaborate on acceptance criteria and device performance in the way requested. Instead, it demonstrates substantial equivalence to a previously cleared device. Therefore, I cannot provide the detailed information requested in the prompt.

However, based on the provided text, I can infer some aspects related to the "acceptance criteria" through the lens of device clearance and testing for a medical device that is not AI-driven:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of performance metrics in the context of an AI study. Instead, it refers to the results of standard non-clinical tests to demonstrate safety and effectiveness for a wound dressing.

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

This information is not applicable in the context of the provided document, as it describes a clearance for a physical medical device (wound dressing), not an AI algorithm. The testing mentioned (e.g., in vitro stability, biocompatibility, MR compatibility) uses samples of the device itself or biological proxies, not a "test set" of data for an algorithm. There is no data provenance in the sense of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable. Ground truth for an AI algorithm is established by expert review of data. For this physical device, "ground truth" refers to established scientific and regulatory standards (e.g., ISO 10993, ASTM standards) that determine the device's properties. Experts involved would be those performing or overseeing these standardized tests, or regulatory reviewers evaluating the results, but not in the context of establishing "ground truth" for an algorithmic output.

4. Adjudication Method:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers when establishing ground truth for AI model training or evaluation. This document describes a physical medical device's clearance process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. An MRMC study compares human reader performance, often with and without AI assistance. This document describes a wound dressing, not an AI system.

6. Standalone Performance:

This information is not applicable. Standalone performance refers to the algorithm's performance without human intervention. The device here is a physical product.

7. Type of Ground Truth Used:

For the tests conducted, the "ground truth" refers to established scientific and regulatory standards and experimental outcomes. For example:

• Biocompatibility: Results of standardized in vitro and in vivo tests per ISO 10993.
• Antimicrobial Effectiveness: Results from standardized assays like Kirby-Bauer and ASTM E2315.
• MR Compatibility: Results from standardized tests like ASTM F2052, F2213, F2182, F2119, interpreted against pre-defined safety thresholds.
• Substantial Equivalence: Comparison against the characteristics and intended use of a legally marketed predicate device as assessed by regulatory bodies.

8. Sample Size for the Training Set:

This information is not applicable. There is no AI algorithm being trained.

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

This information is not applicable, as there is no training set for an AI algorithm.

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Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and the Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are intended to provide moist wound environment and are used for the management of chronic, acute, surgical, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic}, partial-thickness burns, flaps and grafts; when used in conjunction with an NPWT pump that is intended to be used for negative pressure wound therapy (NPWT), the NPWT system is indicated for patients who benefit from wound management therapy via the application of negative pressure wound of fluids and excess exudates, infectious material, and tissue debris which may promote wound healing. It provides a non-adherent, conformable, antimicrobial barrier and may help reduce infection when placed under reticulated foam, gauze, or other wound fillers. Silverlon® Fenestrated Wound Contact Dressings may be cut or overlapped to fit any wound size.

Silverlon® Fenestrated Wound Contact Dressings-Models Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are sterile, porous, non-adherent, knitted with 99% elemental silver and 1% silver oxide. The dressings may promote wound healing via assisting the removal of fluids, including body fluids, wound exudates and infectious materials. The Silverlon® Fenestrated Wound Contact Dressing delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed.

The Silverlon® Fenestrated Wound Contact Dressings are used as the primary wound contact layer for NPWT dressing sets and is placed under reticulated foam, gauze, or other wound fillers. Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing are non-adherent, wound care dressings designed to be used in negative pressure wound therapy dressing sets up to seven (7) days.

Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing is a non- adherent, wound care dressings designed to be used in negative pressure wound therapy dressing sets up to three (3) days.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as requested:

Device Name: Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing

1. Table of Acceptance Criteria and Reported Device Performance

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

The text describes in-vitro and bench testing. These are not clinical studies involving human or animal subjects, so the concept of "sample size for the test set" in the context of human data or "data provenance" (country of origin, retrospective/prospective) is not directly applicable here. The testing was conducted on samples of the device and simulated wound exudate.

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

Not applicable. The reported studies are in-vitro and bench testing, which do not involve expert interpretation or ground truth establishment based on clinical observations. The ground truth for these tests would be the chemical and biological reactions observed and measured.

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

Not applicable. This concept pertains to clinical studies where multiple experts evaluate cases; the provided studies are scientific laboratory and bench tests.

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. The device is a wound dressing, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a physical wound dressing, not an algorithm or AI system.

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

For the in-vitro and bench testing:

• Biocompatibility: Ground truth established through standardized biological evaluations (ISO 10993 series) measuring cellular responses, reactivity, etc.
• Antimicrobial Effectiveness: Ground truth established through standardized microbiological testing methods (e.g., Kirby-Bauer, ASTM E2315) measuring bacterial growth inhibition or kill rates.
• Fluid Removal: Ground truth established through quantitative measurements of fluid passage in a simulated environment using established engineering principles.

8. The sample size for the training set

Not applicable. The device is a physical product, not a machine learning model, so there is no training set.

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

Not applicable, as there is no training set for this type of device.

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Silverlon® Island Wound Dressings is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing.

The Over-The-Counter Indications:

Local management of superficial wounds, minor burns, abrasions and lacerations.

Under the supervision of a healthcare professional Silverlon Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

Silverlon® Island Wound Dressing is indicated for the management of infected wounds', as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Island Wound Dressing may help reduce the risk of wound infection and support the body's healing process.

Silverlon® Island Wound Dressing may be used for the management of painful wounds' Silverlor® Island Wound Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound.

1Clarified/New Indication, not previously included in this format under K984208.

Silverlon® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order):

· Layer 1 is a non-adherent wound contact layer that consists of a single layer of knitted continuous nylon fiber coated with metallic silver at the rate of 5.05 mg/cm (50.5 g/m²); the silver surface coating is approximately 0.8 - 1.0 um thick and contains approximately 1% silver oxide).

• · Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below;
• · Laver 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound exudate;

· Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below; and,

· layer 5 is a non-woven, medical grade polyester fabric coated on the skin-contacting side with a self-curing acrylic, pressure-sensitive, medical grade adhesive covered with a silicone-coated (one side) paper liner.

Laver 1 delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and the dressing intimately conforms to the wound surface.

The provided text is a 510(k) summary for the Silverlon® Island Wound Dressing, a medical device. This document focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria in the manner typically seen for algorithmic devices. Therefore, much of the requested information regarding AI/algorithm performance studies is not directly applicable or available in this specific document.

Here's an analysis based on the provided text:

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

The document does not specify quantitative acceptance criteria with reported device performance in the typical sense of a clinical trial for diagnostic or prognostic devices. Instead, the "acceptance criteria" for K122817 are implicitly defined by demonstrating substantial equivalence to predicate devices and meeting established safety and effectiveness standards for wound dressings.

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

The document does not describe a "test set" in the context of an AI/algorithm evaluation. The studies mentioned are primarily pre-clinical (in vitro/in vivo biocompatibility) and in vitro (antimicrobial effectiveness).

• Biocompatibility Studies: Specific sample sizes for cytotoxicity, sensitization, and intracutaneous reactivity tests are not provided, but these are standard tests performed according to ISO 10993. The provenance would be the testing laboratories that conducted these standard tests.
• Antimicrobial Effectiveness: No specific sample size is given for the "accelerated stability testing for antimicrobial effectiveness" or "Kirby-Bauer Standard Antimicrobial Susceptibility Test." These are laboratory-based in vitro studies. The "Microbiological Consultants - ASTM E2315 Time Kill Assay for Antimicrobial Agents Report" would also be an in vitro lab study.

These are not clinical studies with human participants that would typically have a "test set" for performance evaluation in the way requested for AI.

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

This information is not applicable as there is no mention of a "test set" requiring expert ground truth in the context of an AI/algorithm evaluation in the provided summary. The studies are laboratory-based for material properties and antimicrobial activity.

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

This information is not applicable as there is no mention of a "test set" requiring adjudication or expert review in the provided summary.

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 such study was done. This document is for a traditional wound dressing, not an AI-powered device, and therefore MRMC studies or AI assistance are not relevant.

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

No such study was done. The device is a physical wound dressing and does not involve an algorithm.

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

For the studies mentioned:

• Biocompatibility: Ground truth is established by standard ISO 10993 criteria for material safety.
• Antimicrobial Effectiveness: Ground truth is based on established microbiological testing methods (e.g., Kirby-Bauer, ASTM E2315) and scientific principles of bacterial inhibition/kill.

8. The sample size for the training set

This is not applicable. The device is a physical wound dressing, not an AI/algorithmic device that requires a training set.

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

This is not applicable for the reasons stated above.

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Silverlon™ CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and fullthickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree burns. Silverlon™ CA Advanced Antimicrobial Dressing is indicated for external use only.

Silverlon™ CA Advanced Antimicrobial Alginate Dressing, is a sterile, non-woven pad composed of a calcium (and sodium) alginate and a silver nylon contact layer. The dressing is available in various sizes ( 2" x 2", 4.2", 4.25" x 4.25", 4" x 8", 8" x 12", and a %" x 12" rope) and packaged in Tyvek pouches. The release of silver ions provides an antimicrobial barrier, which protects the dressing from microbial colonization. The dressing absorbs exudates, maintains a moist wound environment and allows for intact removal.

The provided text describes a 510(k) summary for the Silverlon™ CA Calcium Alginate Dressing. However, it does not contain the acceptance criteria or the study details that you've requested.

The document focuses on:

• Device Identification: Name, submitter, contact information.
• Predicate Device: Claims equivalence to prior Silverlon products and other marketed alginate dressings.
• Device Description: Sterile, non-woven calcium alginate pad with a silver nylon contact layer for antimicrobial barrier and exudate absorption.
• Intended Use/Indications: For moderate to heavy exudating partial and full-thickness wounds (pressure ulcers, venous ulcers, diabetic ulcers, donor/graft sites, traumatic/surgical wounds, 1st and 2nd-degree burns). External use only.
• Technological Characteristics Comparison: States silver content and alginate amount per square inch are identical to the predicate device.
• Performance Data: Mentions non-clinical studies showing good balance of tolerability and safety. These studies are:
  • Systemic Injection Test in Mice
  • Cytotoxicity - Agar Diffusion
  • Primary Dermal Irritation in Rabbits
• FDA Clearance Letter: Confirms substantial equivalence determination based on the 510(k) submission.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because it is not present in the given text.

The document only details non-clinical safety and tolerability tests (Systemic Injection, Cytotoxicity, Dermal Irritation) which are part of demonstrating safety, but not specific performance acceptance criteria for its indicated uses (e.g., wound healing rates, infection reduction rates) or clinical study results to prove those.

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