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MERIL - BONEWAX™ is intended to be used in the control of bleeding from bone surfaces during surgical operations.

MERIL - BONE WAX™ is ivory white, intended to aid mechanically in the control of bleeding of bone injuries, whether attributable to trauma or surgical intervention. It is composed of refined beeswax with Iso propyl myristate added as softening agent, and is supplied sterile in thin sheets. It is opaque and has a waxy odor. It is available as 2 or 2.5gm bone wax per pack. MERIL - BONE WAX™ achieves local hemostasis of bone by acting as a mechanical (tamponade) barrier. It does not act biochemically and is nonabsorbable.

This document, K200452, pertains to the FDA 510(k) premarket notification for MERIL-BONEWAX™. As a 510(k) submission, it aims to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data that would be typical for a new device requiring a PMA.

Therefore, the information regarding acceptance criteria and a study proving the device meets these criteria is limited to performance tests designed to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of precise quantitative acceptance criteria with corresponding performance values for parameters like sensitivity, specificity, or quantifiable clinical outcomes. Instead, the acceptance criteria are generally qualitative or based on demonstrating equivalence to predicate devices and adherence to established standards.

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

The document does not specify exact sample sizes for the "kneadability and spreadability tests." For the "animal performance test," it mentions a "porcine model" but does not provide the number of animals used.

• Test Set Sample Sizes: Not explicitly stated for non-animal tests. For the animal performance test, it indicates a "porcine model" without specifying the number of animals.
• Data Provenance: Not explicitly stated whether the data is retrospective or prospective, or the country of origin. Given the submitter's address in Gujarat, India, and the use of ISO/ASTM standards, it's plausible the testing was conducted in India or by a contract research organization adhering to these international standards.

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

This information is not provided in the document. The type of device (bone wax for hemostasis) and the nature of the preclinical tests (bench, animal model) for a 510(k) submission typically do not involve establishing ground truth through expert consensus on diagnostic images or clinical outcomes in the same way as, for example, an AI diagnostic device for radiology. The "ground truth" here is objective performance in mechanical tests, hemostatic efficacy in an animal model, and compliance with recognized standards.

4. Adjudication Method for the Test Set

Not applicable. The tests described (kneadability, spreadability, animal hemostasis, biocompatibility, sterilization, endotoxin, packaging) are objective measurements and do not typically involve human adjudication in the way clinical diagnostic studies might.

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

No. An MRMC comparative effectiveness study is not mentioned. Such a study would be relevant for devices that involve human interpretation of medical data (e.g., radiologists reading images) and the impact of AI assistance. This device is a bone wax, which is a surgical aid, not a diagnostic or AI-driven interpretive tool.

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

Yes, in essence, the preclinical tests described are "standalone" performance evaluations of the device itself (the bone wax) without human intervention in its function (beyond application in the animal model). The device is not an algorithm, so the term "algorithm only" does not apply. The performance tests evaluate the physical properties and biological interactions of the bone wax directly.

7. The Type of Ground Truth Used

The "ground truth" for the various tests mentioned typically refers to:

• Objective measurements and observable outcomes: For kneadability, spreadability, hemostasis in the animal model (e.g., cessation of bleeding, time to hemostasis).
• Established biological and chemical standards: For biocompatibility (ISO 10993-1), sterilization (ISO 11137), and bacterial endotoxin (ANSI/AAMI ST72:2019).
• Engineering and packaging standards: For packaging and shelf life validation (ISO 11607, ICH Q1A (R2), ASTM D 999, ASTM D 5276).

There is no mention of pathology, expert consensus on diagnostic interpretations, or long-term clinical outcomes/data as "ground truth" in this submission.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (bone wax), not an AI algorithm that requires a training set.

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

Not applicable, as this device is not an AI algorithm and does not have a training set.

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