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PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery:
As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and
To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.
PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.

This document describes the PosiSep® EAR Fragmentable Ear Dressing, a medical device, and its acceptance criteria as demonstrated through a substantial equivalence submission to the FDA. The information provided focuses on comparing the device to a predicate device (NasoPore® Ear) and reference devices (PosiSep/PosiSep X) rather than detailing a specific clinical study with granular data on acceptance criteria and performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical targets and corresponding reported device performance. Instead, substantial equivalence is claimed based on comparable characteristics to predicate devices. The key "acceptance criteria" are implied through the comparison parameters.

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

The document primarily relies on non-clinical performance data, specifically biocompatibility testing and performance bench testing. It does not mention a "test set" in the context of clinical data or patient samples for evaluating device performance against the specified indications. The evaluation appears to be based on:

• Biocompatibility testing: Performed internally, demonstrating compliance with ISO 10993 and FDA guidelines.
• Performance bench testing: Performed internally to demonstrate physical and functional requirements were met.
• Comparison to predicate devices: The primary data provenance is the established safety and effectiveness of the legally marketed predicate devices (NasoPore® Ear, PosiSep/PosiSep X).

The document does not specify a sample size for these non-clinical tests. As it's a 510(k) submission, the focus is on demonstrating "substantial equivalence" rather than conducting a de novo clinical trial with a large patient sample.

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

This information is not provided because the submission primarily relies on non-clinical data and comparisons to predicate devices for demonstrating substantial equivalence, not on a clinical test set with human expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with 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. The device described is a physical ear dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

Not applicable, as the device is a physical medical dressing, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by standardized biological tests (e.g., cytotoxicity, irritation, sensitization) following ISO 10993 guidelines, where "ground truth" means the objective results of these tests (e.g., non-cytotoxic). For performance, the "ground truth" relates to the physical and functional properties of the device meeting predetermined engineering specifications during bench testing.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm requiring a training set.

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

Not applicable, as the device is not an AI/ML algorithm.

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SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.

SynePure is a biocompatible, cleansing solution that is intended for rinsing and cleansing dermal wounds through irrigation. The solution is preserved and provided in flexible low density polyethylene (LDPE) bottles with a nozzle spray top to allow for easy delivery of a stream of liquid to remove dirt, debris and contamination from a wound. A screw cap is used to secure the device when not in use. The cap/bottle assembly is sealed with a strip to indicate tampering.

The wound cleanser is supplied as 125mL single-use or 250mL multiple-use bottle. The mechanical action of fluid moving across the wound provides for the mechanism of action to aid in the removal of foreign objects, such as dirt and debris, from the wound.

This document is a 510(k) premarket notification for a medical device (SynePure Wound Cleanser). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and results typical for a completely novel device or an AI/software as a medical device (SaMD).

Therefore, much of the requested information regarding acceptance criteria, study design for ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details for AI/SaMD is not applicable to this document. This document describes a relatively simple wound cleanser, not an AI-powered diagnostic or predictive tool.

Here's a breakdown of the available information based on your request:

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

Based on the document, two performance data points are mentioned, which could be interpreted as meeting certain criteria. However, explicit numerical acceptance criteria are not stated.

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

• Sample Size for Performance Data (Spray Duration, Solution Delivered): Not specified.
• Sample Size for Biocompatibility Testing: Not specified for individual tests. For acute systemic toxicity, it mentions "all animals," implying a group of animals, but the exact number is not given.
• Data Provenance: Not specified. The testing was done by Synedgen, Inc.

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

• Not Applicable. This device is a physical wound cleanser, not an AI or diagnostic tool that relies on expert interpretation for ground truth. Biocompatibility testing follows established protocols and laboratory readouts rather than expert consensus on interpretations of images or data.

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

• Not Applicable. See point 3.

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 device.

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

• Not Applicable. This is not an AI device.

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

• For the physical performance tests (spray duration, solution delivery), the ground truth is likely direct measurement and observation against a defined threshold.
• For biocompatibility, the ground truth is established through standardized laboratory assays (e.g., cell cultures for cytotoxicity, animal models for sensitization and systemic toxicity) which yield objective results based on predefined biological endpoints.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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