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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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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, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.

The Wound Flush, Sterile Water & Sterile Normal Saline device is a wound and device cleansing solution that is intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile saline for irrigation and meets all of the associated requirements defined in the USP . The subject device is offered in various bottle and cup sizes with and without a spray applicator

This 510(k) summary describes a wound and device cleansing solution, but it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document details:

• Device name: Wound Flush, Sterile Water & Sterile Normal Saline
• Manufacturer: Nurse Assist Incorporated
• Intended Use/Indications for Use: For moistening dressings and cleaning various wound types (minor cuts, burns, abrasions) for both OTC and prescription use, and for device irrigation.
• Technological Characteristics: The mechanical action of fluid aids in the removal of foreign objects.
• Predicate devices: Several legally marketed sterile water/saline and wound care products are listed.
• Regulatory classification: Unclassified, pre-amendment device (Product code FRO).
• FDA determination: Substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving the device meets those criteria, as it is not present in the provided text.

Ask a specific question about this device