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JALOSKIN is indicated for the management of superficial moderately exuding wounds including pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, skin tears) and first and second degree burns.

JALOSKIN is a semi-permeable, transparent film dressing, composed of HYAFF® 11, a benzyl ester of hyaluronic acid. The hyaluronic acid is derived from bacterial fermentation.

The provided text does not contain detailed acceptance criteria and a study demonstrating the device meets those criteria. Instead, it is a 510(k) summary for the JALOSKIN wound dressing, focusing on its substantial equivalence to predicate devices and biocompatibility data.

Here's a breakdown of what is and is not in the provided document, in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided. The document does not specify quantitative or qualitative acceptance criteria that JALOSKIN needs to meet for performance (e.g., healing rates, time to wound closure, infection rates).
• Reported Device Performance: The document states that the device is "substantially equivalent to the predicate devices with regard to the intended use and/or technological characteristics." This statement implies that its performance is expected to be similar to the predicate devices, but no specific performance metrics for JALOSKIN are reported.

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

• Not provided. There is no mention of a clinical "test set" or a study designed to evaluate JALOSKIN's performance against specific endpoints in a clinical setting. The document focuses on demonstrating substantial equivalence through technological characteristics and biocompatibility.
• Data Provenance: The biocompatibility studies cited (in vitro cytotoxicity, hemolysis, acute toxicity, irritation, sensitization, genotoxicity, implantation) appear to be laboratory-based and animal studies, not human clinical data. No country of origin is specified for these studies, nor whether they are retrospective or prospective.

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

• Not applicable. Since no clinical study or test set with human data is described for JALOSKIN's performance, the concept of "ground truth" derived from expert consensus is not relevant to the information provided. The document relies on laboratory and animal study results for biocompatibility and comparison to predicate devices.

4. Adjudication Method:

• Not applicable. As no clinical study is described that requires expert review or evaluation of outcomes, there is no adjudication method mentioned.

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

• No. The document does not describe a MRMC study, nor does it involve AI or human-in-the-loop performance evaluation. The device is a wound dressing, not a diagnostic or AI-driven system.

6. Standalone (Algorithm Only) Performance Study:

• No. The device is a wound dressing, not an algorithm.

7. Type of Ground Truth Used:

• Not applicable for clinical performance. For the biocompatibility aspects, the "ground truth" is derived from standard laboratory and animal testing protocols (e.g., observing cell viability, hemolysis rates, toxicity symptoms, inflammatory responses).

8. Sample Size for the Training Set:

• Not applicable. As the device is not an AI algorithm, there is no concept of a "training set."

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

• Not applicable.

Summary of what the document does provide regarding evidence:

The FDA 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through new clinical trials with acceptance criteria for the new device's performance.

• Substantial Equivalence: JALOSKIN is claimed to be substantially equivalent to HYALOMATRIX™ KC and HYALOMATRIX PA® based on intended use and technological characteristics (both use HYAFF 11).
• Biocompatibility Data: The document presents details of various biocompatibility tests:
  • In vitro cytotoxicity: HYAFF films are "neither cytogenic."
  • Hemolysis study (in rabbits): HYAFF films are "not hemolytic."
  • Acute oral and dermal toxicity studies (in rats): Lethal dose of HYAFF 11 is >5,000 mg/kg (oral) and >2,000 mg/kg (dermal).
  • Irritation studies (in rabbits): HYAFF 11 powder is "not an ocular or dermal irritant."
  • Sensitization study (in guinea pigs): Provides "evidence for the lack of a sensitizing effect."
  • Genotoxicity: No evidence observed in three in vitro and one in vivo (mice) study.
  • Implantation study (in rats, up to 1 year): No treatment-related toxicity; HYAFF film degraded within 4 months.

In conclusion, this document primarily addresses the regulatory requirement for substantial equivalence and provides biocompatibility data for the material (HYAFF 11) used in the device. It does not contain the kind of performance study, acceptance criteria, or ground truth details you would expect for evaluating a diagnostic algorithm or a device requiring specific clinical efficacy endpoints for approval beyond substantial equivalence.

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HYALOMATRIX® is indicated for the management of wounds including: partial and full-thickness wounds; second-degree burns; pressure ulcers; venous ulcers; diabetic ulcers; chronic vascular ulcers; tunneled/undetermined wounds; surgical wounds (donor sites/grafts, post-Moh's surgery , post-laser surgery, podiatric, wound dehiscence); trauma wounds (abrasions, lacerations, skin tears); and draining wounds. The device is intended for one-time use.

HYALOMATRIX is a bilayered, sterile, flexible, and conformable wound dressing that acts as an advanced wound care device. It is comprised of a nonwoven pad entirely composed of HYAFF 11, a benzyl ester of hyaluronic acid, and a semipermeable silicone membrane, which controls water vapor loss, provides a flexible covering for the wound surface, and adds increased tear strength to the device. The HYAFF 11 wound contact layer biodegradable matrix acts as a scaffold for cellular invasion and capillary growth.

The provided text describes a 510(k) submission for the HYALOMATRIX® wound dressing. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria or a "performance study" in the traditional sense (e.g., a clinical trial with predefined endpoints and statistical analysis) are described in the provided text. The submission primarily relies on biocompatibility testing and the assertion that "Clinical experience HYALOMATRIX as a wound dressing supports the safety and effectiveness of the device."

The closest approximations to "reported performance" are the general statements related to biocompatibility:

Important Note: The "Cytotoxicity" for the Silastic® component is listed as having "cytotoxic effects." This is a critical finding, and it's unusual for a component description to include such a negative result without further context or mitigation strategies. However, the subsequent findings for "Loctite cured film" and the overall conclusion suggest that this might have been related to raw material testing or specific extraction methods, and the final device's performance was considered acceptable for its intended use. Without more detail, it's hard to interpret fully.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. The submission does not describe a specific "test set" in the context of a clinical performance study with a predefined sample size of wounds or patients. The biocompatibility tests used animal models (e.g., guinea pigs for sensitization), in vitro cell cultures, and chemical analyses, but specific sample sizes for these individual tests are not detailed in the summary.
• Data Provenance: The biocompatibility data is likely from laboratory studies (in vitro and in vivo animal models). There is no mention of country of origin for this data or whether it was retrospective or prospective. The statement "Clinical experience HYALOMATRIX as a wound dressing supports the safety and effectiveness of the device" vaguely implies real-world usage but provides no specifics on the data source, size, or methodology.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as there was no comparative clinical performance study described that would require expert adjudication of results (e.g., wound healing assessment by multiple clinicians). Biocompatibility tests rely on established scientific methods and laboratory protocols rather than expert consensus on a 'ground truth'.

4. Adjudication Method for the Test Set

Not applicable. Since no specific test set or clinical performance study requiring human assessment is mentioned, there is no adjudication method described.

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

No. There is no mention of an MRMC study or any comparative effectiveness study involving human readers with or without AI assistance. This device is a wound dressing, not an imaging or diagnostic AI-powered device.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical wound dressing and does not involve an algorithm or AI. Therefore, a standalone algorithm performance study is not relevant or described.

7. Type of Ground Truth Used

The "ground truth" in this context is derived from:

• Biocompatibility test results: These are objective measurements and observations from standardized in vitro and in vivo (animal) tests (e.g., cell viability, hemolytic index, irritation scores, histological findings).
• Clinical experience: While not explicitly detailed, the reference to "clinical experience" implies that observing actual patient outcomes with the device in practice forms a qualitative basis for safety and effectiveness, but it is not quantified as a "ground truth" through a rigorous study.

8. Sample Size for the Training Set

Not applicable. As this is a medical device (wound dressing) and not an AI/algorithm-based diagnostic or imaging tool, there is no "training set" in the context of machine learning.

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

Not applicable. Since there is no training set mentioned, the establishment of its ground truth is also not applicable.

In summary: The provided 510(k) summary for HYALOMATRIX® focuses on demonstrating substantial equivalence primarily through detailed biocompatibility testing of its components and a general statement about clinical experience supporting its safety and effectiveness. It does not contain information about prospective clinical trials with defined acceptance criteria, sample sizes for test or training sets, expert adjudication, or AI performance studies.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device