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The ciSNaP® Closed Incision System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudate from surgical incisions that continue to drain following sutured or stapled closure.

The ciSNaP® Closed Incision System ("ciSNaP System") is a new addition to Spiracur Inc.'s ("Spiracur") family of negative pressure wound management devices. The ciSNaP System is a portable, non-powered, disposable Negative Pressure Wound Therapy ("NPWT") system that is intended for wound management through the removal of small amounts of exudate from surgically closed incisions. The ciSNaP System utilizes the concept of forced expansion of volume to produce negative pressure at the closed incision. The ciSNaP System can be applied in the sterile field. The ciSNaP System has no electrically powered parts and is disposable after use. Additionally, it is capable of delivering negative pressure wound therapy at a near-constant pressure level over several days without any required adjustments by the patient or clinician. The dressing component of the ciSNaP System incorporates an antimicrobial interface.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the ciSNaP® Closed Incision System.

Here's the breakdown of the information requested:

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

4.3 for MRSA
4.5 for VRE
4.4 for Escherichia coli
4.1 for Pseudomonas aeruginosa
4.3 for Klebsiella pneumoniae
4.3 for Candida albicans
3.2 for Aspergillus brasiliensis |
| Antimicrobial Log Reduction (Day 3) | >4.4 for Staphylococcus aureus
4.3 for MRSA
4.6 for VRE
4.4 for Escherichia coli
4.1 for Pseudomonas aeruginosa
4.2 for Klebsiella pneumoniae
4.2 for Candida albicans
3.2 for Aspergillus brasiliensis |
| Antimicrobial Log Reduction (Day 7) | >4.1 for Staphylococcus aureus
4.2 for MRSA
4.6 for VRE
4.3 for Escherichia coli
4.4 for Pseudomonas aeruginosa
4.4 for Klebsiella pneumoniae
4.1 for Candida albicans
3.6 for Aspergillus brasiliensis |
| Equivalence to predicate devices (intended use and technology) | Nonclinical performance test results demonstrate the ciSNaP System performs equivalently to predicate devices and is as safe and effective. |
| No new issues of safety or effectiveness | Differences in technological characteristics do not raise any new issues of safety and effectiveness. |

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

The provided text does not specify sample sizes for human subjects or clinical data in the "test set" as the studies described are nonclinical, bench testing. The antimicrobial log reduction tests were conducted on "samples of the silverplated skin interface layer" and "silverplated samples" (of the ciSNaP® Controlled Tension Relief Layer). The exact number of samples tested for each organism or time point is not provided.

The provenance (country of origin, retrospective/prospective) is not applicable or provided as these are in vitro laboratory tests.

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)

This information is not applicable to the provided document. The studies described are nonclinical, bench tests, and in vitro antimicrobial log reduction tests. These types of tests do not typically involve human experts establishing ground truth in the way a clinical study or imaging study would. The 'ground truth' for these tests would be the measured physical, chemical, or biological properties and performance against established standards (e.g., ISO 10993-1 for biocompatibility, or microbial counts for antimicrobial efficacy).

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

This information is not applicable to the provided document. As mentioned above, the studies are nonclinical bench tests and in vitro antimicrobial tests, which do not typically involve adjudication methods for human interpretation.

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 MRMC comparative effectiveness study was done. The document solely describes nonclinical bench testing and in vitro antimicrobial tests. There is no mention of human readers, AI assistance, or clinical comparative effectiveness studies.

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

This is not applicable. The device is a physical medical device (negative pressure wound therapy system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The in vitro antimicrobial tests represent the standalone performance of the silver-plated material's antimicrobial properties.

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

The ground truth for the nonclinical tests was based on:

• Design specifications and verification testing: For appropriate design characteristics.
• ISO 10993-1 standards: For biocompatibility.
• Product specifications: For packaging and shelf life.
• Measured silver ion availability: For ion release rate.
• Microbial counts of control samples: For antimicrobial log reduction tests (comparing silver-plated samples to unplated controls).

8. The sample size for the training set

This information is not applicable. The document describes nonclinical testing and does not mention any machine learning or AI models with training sets.

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

This information is not applicable, as there is no mention of a training set for machine learning or AI models.

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Silver Glucan Wound Dressing is an effective barrier to bacterial and candida penetration. The dressing may be use for partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Silver Glucan dressings may be used over partial thickness wounds, debrided wounds, and as a temporary covering for full thickness and grafted wounds.

Silver Glucan dressing consists of a nylon mesh coated with silver and oat glucan. The glucan facilitates the placement of the mesh and the silver protects the wound site from bacterial and yeast contamination.

The sterile, single use dressing will be sold in a variety of sizes ranging from 4" x 4" to 16" x 16" and rolls of 4" x 48".

This premarket notification (K050086) for Brennen Medical, Inc.'s Silver Glucan Wound Dressing does not contain detailed acceptance criteria or a dedicated study report proving the device meets specific performance metrics in the way modern medical device submissions typically do for AI/ML devices.

Instead, this 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, and intended use, and presents a list of general performance tests conducted. The "acceptance criteria" here are implied by the successful completion of these tests and the determination of substantial equivalence (rather than specific quantitative thresholds).

Therefore, I will extract the information available and note where specific details are not provided in this document format.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative thresholds for "acceptance criteria" (e.g., minimum tensile strength in Newtons, specific cytotoxicity scores, exact zone of inhibition measurements) are not detailed in this summary. The summary broadly states that the device "is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices."

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

This 510(k) summary does not describe specific "test sets" in the context of an algorithm or AI model evaluation. The "studies" mentioned (Biocompatability, Animal Wound Healing, Silver Dissolution, Tensile Strength, Barrier Efficacy, Zone of Inhibition, Stability) are laboratory or animal-based performance tests, not clinical evaluations with human patient data or AI algorithm testing with a specific test set.

• Sample Size for Test Set: Not applicable/not specified for a "test set" in the context of an AI/ML device. The underlying details of the sample sizes for each specific performance study (e.g., number of animals in the wound healing study, number of samples for tensile strength) are not provided in this summary.
• Data Provenance: Not applicable/not specified for an AI/ML device test set. The provenance of the data for the performance studies (e.g., which lab conducted the tests, what species for animal studies) is not detailed.

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

This information is not applicable. This 510(k) pertains to a wound dressing, not an AI/ML diagnostic or prognostic device that would require expert-established ground truth on a test set. The listed studies are laboratory and preclinical performance tests.

4. Adjudication Method for the Test Set

This information is not applicable. There is no AI/ML test set requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not an imaging or diagnostic AI/ML system that would typically undergo such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study (in the context of an algorithm) was not done. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance studies refers to the direct measurement or observation of the physical, chemical, or biological properties and effects of the wound dressing.

• Biocompatibility: In-vitro (cytotoxicity, sensitization assays) and in-vivo (irritation, sensitization on animals/humans) test results.
• Wound Healing: Clinical and histological assessment of wound closure, tissue regeneration, inflammation in an animal model.
• Silver Dissolution: Analytical chemistry measurements of silver release.
• Tensile Strength: Physical testing measurements of material strength.
• Barrier Efficacy: Microbiological challenge tests demonstrating reduction of bacterial/fungal penetration.
• Zone of Inhibition: Microbiological growth assays on agar plates.
• Stability Testing: Comparison of pre- and post-aging performance characteristics.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that is "trained."

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

Not applicable. This device is not an AI/ML algorithm that is "trained."

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Intended Use: Cryosurgical unit used for ablative type surgical technique
Indications for use: Multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.

The CryoPen system provides a means of freezing tissue without the use of cryogenic liquids or gases. The system consists of three hand-held freezing modules, a refrigeration unit, and disposable tips. When used properly, the system will deliver effective temperature for tissue ablation. The refrigeration component is the largest unit, and is used to lower the temperature of the CryoPen units to temperature of -100 C. It operates on 115 VAC obtained from conventional convenience outlets. The supporting housed in the refrigerator cabinet include a DC power source to indicate the temperature of the CryoPen units during cool down, and all other necessary control and electrical safety features. There are currently three different sizes of the hand-held modules: a 0.4 inch diameter unit, a 0.25 inch diameter unit, and a 0.19 inch diameter unit.

The provided text is a 510(k) summary for the CryoPen device. However, it does not contain information regarding acceptance criteria, device performance studies, or details of ground truth establishment.

The document primarily focuses on:

• General Information: Submitter, contact details, date prepared, registration number.
• Device Description: Name, trade name, common name, classification, product code, description of the CryoPen system components (hand-held modules, refrigeration unit, disposable tips).
• Intended Use Statement: Cryosurgical unit for ablative surgical techniques on multiple organ systems for various diseases (viral, benign, pre-malignant, malignant tissue).
• Components: List of parts and part numbers.
• Substantial Equivalence: Comparison to a predicate device (Wallach LL100) and rationale for substantial equivalence (both use cryogenic temperatures for tissue destruction, with a note on different contact materials).
• FDA Letter: A letter from the FDA confirming the substantial equivalence determination for K012214, allowing the device to be marketed.

Therefore, I cannot provide the requested information such as acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment, as these essential data points are missing from the provided text.

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Silverlon™ Island Wound Dressings are multi-layer, sterile, non-adherent, absorbent, composite, antimicrobial barrier wound dressings indicated for local management of superficial wounds, minor burns, and abrasions and lacerations. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. Silverlon™ Island Wound Dressings may also be used under the care of a health care professional for wounds such as vascular access or peripheral IV sites, orthopaedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Topical application of Silverlon™ Island Wound Dressings protects the wound area and the open weave of the silver-nylon fabric wound contact layer permits passage of wound fluid through the product to be absorbed by an overlying absorbent material. The silver provides effective protection of the dressing against microbial contamination.

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

The Prescription Professional indications:
Wounds such as vascular access or peripheral IV sites, orthopaedic 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 are multi-layer, sterile, non-adherent, absorbent composite dressings with an attached adhesive tape or pad. The dressings are composed of five distinct lavers:

• Layer 1 is a non-adherent wound contact layer that consists of 1 or 4 layers of knitted continuous nylon fiber substrate with a metallic silver surface (Silverlon™). The layers of Silverlon™ are sewn together with silver nylon thread that is plated in an identical fashion to the silver nylon utilized to make the Silverlon™ knitted fabric. The silver coating is a uniform 1-micron thick layer that completely covers the nylon.
• Layer 2 is Delnet P530N
• Layer 3 is a needle punched non-woven 8-ounce rayon web that absorbs drainage from the wound site.
• Layer 4 is polyurethane film that keeps external contaminants out and maintains a moist wound healing environment. (Note: Layers 2, 3, and 4 are manufactured as a laminate by AET).
• Layer 5 is a non-woven polvester fabric coated with a skin contact pressure sensitive acrylic adhesive backed with a one sided poly coated lay flat release liner. The pressure sensitive acrylic adhesive is H-566 a hypoallergenic adhesive that meets USP Class 6 standard and satisfies tripartite guidelines for skin contact devices. The Silverlon Island Pad does not have the tape layer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silverlon™ Island Wound Dressing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence to predicate devices and inherent material properties rather than defining explicit numerical performance acceptance criteria. The "reported device performance" is inferred from statements confirming the device meets certain qualities or passes specific tests.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "standard in vitro and in vivo biocompatibility tests" but does not provide details on the number of samples or subjects used in these tests.
• Data Provenance: The biocompatibility tests were conducted by North American Science Associates, Inc. (NAmSA), Northwood, Ohio. It is not explicitly stated whether the tests were retrospective or prospective, but "standard" tests are generally prospective. The country of origin for the data is the USA.

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

• This information is not provided. The document describes standard biocompatibility and material performance tests, which typically rely on established protocols and measurement techniques rather than expert consensus on a "ground truth" in the way a clinical study would for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable as the tests described are laboratory-based performance and biocompatibility assessments, not clinical evaluations requiring adjudication of expert opinions.

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, an MRMC comparative effectiveness study was not done. This is a medical device (wound dressing), not an AI-powered diagnostic or assistive technology for human readers. Therefore, the concept of "human readers improve with AI" is not relevant to this submission.

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

• Yes, in essence, standalone performance was assessed. The "device performance" described (biocompatibility, protection against microbial contamination, absorbency, etc.) are inherent properties of the product itself, evaluated independently of human-in-the-loop interaction in a clinical setting. The tests evaluate the material's characteristics and its ability to function as intended.

7. The Type of Ground Truth Used

The ground truth used for the performance assessment described primarily involved:

• Established Test Standards: For biocompatibility, the ground truth was meeting the requirements of Part-10993 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices).
• Physical and Chemical Properties Validation: For aspects like absorbency, non-adherence, and the presence of antimicrobial silver, the ground truth would be direct measurements and material analysis confirming these properties.

8. The Sample Size for the Training Set

• Not applicable. This device is a wound dressing, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The product's design and materials are based on scientific principles and manufacturing processes, not a data-driven training approach.

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

• Not applicable. As stated above, there is no "training set" in the context of this device. The "ground truth" for the device's design and expected performance comes from established scientific understanding of material properties, wound healing, and antimicrobial action, as well as the performance of predicate devices.

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