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For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.

For Prescription Use: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP. The devices are offered in 100mL, 250mL, and 500mL bottles, and 120mL cups.

The provided document describes a 510(k) premarket notification for the "Anexa Wound Flush, Sterile Water and Sterile Normal Saline" device. This is a medical device clearance, not an AI/ML device approval, therefore, many of the requested criteria related to AI/ML device evaluation are not applicable.

Based on the information provided in the document:

1. Table of acceptance criteria and the reported device performance:

The document concludes that "Sterile Water and Sterile Normal Saline perform at least as well as the predicates' devices" and are "substantially equivalent" based on these comparisons and tests.

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

This document does not specify a "test set" in the context of an AI/ML algorithm. The tests conducted (biocompatibility, sterility, etc.) are standard material and device performance tests, not AI model evaluations. Therefore, information about sample size, country of origin, or retrospective/prospective nature of data for an AI/ML test set is not provided.

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. This device is not an AI/ML algorithm that requires expert-established ground truth for a test set.

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

Not applicable. This device is not an AI/ML algorithm that requires an adjudication method for a test set.

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 wound flush solution, not an AI system.

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

Not applicable. This device is a wound flush solution, not an AI algorithm.

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

Not applicable. The "ground truth" for this device would be its chemical composition, sterility, and biocompatibility, which are verified through laboratory testing against established physical, chemical, and biological standards (e.g., USP , ISO 10993 standards). This is not equivalent to ground truth in the context of AI/ML.

8. The sample size for the training set:

Not applicable. This device is a wound flush solution, 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 is no training set for an AI/ML algorithm, no ground truth needs to be established for it.

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For moistening of absorbent wound dressings and irrigation to remove loose debris and dirt from the wound.

The Wound Flush, Sterile Water & Sterile Normal Saline device can be used 1) for moistening a dry sterile dressing for wound cleansing and 2) irrigation to remove loose debris and dirt from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of loose foreign material such as dirt and debris. The product has a shelf life of 2-years.

The solution is available as sterile saline for irrigation and is gamma sterilized. The subject device is offered in various bottle sizes of 100ml, 250ml, and 500ml and cup sizes of 120ml.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Anexa Wound Flush, Sterile Water & Sterile Normal Saline device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of "acceptance criteria" in the traditional sense of performance metrics for a medical device (e.g., sensitivity, specificity, accuracy). Instead, it describes a substantial equivalence (SE) determination based on a comparison to a predicate device and a series of non-clinical tests. The "performance" is demonstrated by passing these tests and showing similarity to the predicate.

• Same Regulatory Product Code (FRO)
• Same Classification (Pre-amendment)
• Similar Indications for Use
• Similar Principle of Operation (mechanical action removing foreign objects)
• Same Chemical Composition (0.9% Sterile Saline or Sterile Water; no additives)
• Uses same materials and container designs
• Same method of sterilization (gamma) |
  | Biocompatibility Testing | Anexa conducted and passed the following biocompatibility tests:
• Cytotoxicity
• Dermal Sensitization
• Intracutaneous test (direct injection)
• Acute Systemic Toxicity
• Bacterial Endotoxin Test |
  | Compliance with Recognized Standards (Non-Clinical Testing) | Anexa conducted and passed tests according to the following standards:
• ASTM F1980-07 (Reapproved 2011)
• AAMI/ANSI/ISO 11607-1:2006/(R)2010
• AAMI/ANSI/ISO 11607-2:2006/(R)2010
• AAMI / ANSI / ISO 11137-1:2006/(R)2010
• AAMI / ANSI / ISO 11137-2:2013
• AAMI / ANSI / ISO 11737-1:2006 (R)2011
• AAMI / ANSI / ISO 11737-2:2009/(R)2014
• AAMI/ANSI/ISO 10993-1:2009/(R) 2013
• AAMI / ANSI/ISO 10993-5:2009/(R) 2014
• ISO 10993-10 Third Edition 2010-08-01
• AAMI/ANSI/ISO 10993-11:2006/(R)2010
• AAMI TIR 22:2007
• AAMI TIR 33:2005
• AAMI/ANSI/ISO TIR 13004:2013 |
  | Device Stability / Shelf-life | Product has a shelf life of 2-years. This implies successful testing to demonstrate this. |

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

The document describes non-clinical testing and a comparison to a predicate device, not a "test set" in the context of clinical performance evaluation (e.g., for an AI algorithm). The sample sizes for the specific non-clinical tests (biocompatibility, shelf-life, etc.) are not provided in this summary. The data provenance is also not explicitly stated beyond being part of Anexa Biomedical, Inc.'s internal testing records.

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

This information is not applicable as the document describes non-clinical testing for a wound flush solution, not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #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

This information is not applicable. The device is a wound flush solution, not an AI-powered diagnostic tool. An MRMC study is explicitly designed for evaluating the impact of AI on human reader performance.

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

This information is not applicable. The device is a wound flush solution, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests (biocompatibility, sterility, shelf-life), the "ground truth" would be established by:

• Reference Standards/Controls: For biocompatibility, comparisons are made to established safe materials and adverse reactions are assessed.
• Scientific Methods and Measurements: For sterility, microbiological testing to confirm absence of microorganisms. For shelf-life, stability studies measuring chemical and physical properties over time.
• Compliance with Recognized Standards: Meeting the pass/fail criteria outlined in the referenced ASTM, AAMI/ANSI/ISO standards.

For the substantial equivalence claim, the "ground truth" is the legally marketed predicate device and its established safety and effectiveness profile.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI algorithm requiring a training set.

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

This information is not applicable for the same reasons as #8.

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