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The Oscera7™ Synthetic Absorbable Bone Wax is indicated in the control of bleeding from cut or damaged bones by acting as a pressure tamponade, or mechanical barrier .

The Oscera7™ Synthetic Absorbable Bone Wax is a kneadable, biocompatible, synthetic absorbable material indicated for control of bleeding from bone surfaces. Hemostasis is accomplished by the physical mechanism of tamponade as it is pressed into the pores of the cut or damaged bone surface.

Post-application, the component materials, which include a fatty acid salt, isopropyl hexadecanoate, an alkylene oxide copolymer and ß-tricalcium phosphate, are dispersed and absorbed within the body.

The provided text describes a 510(k) submission for the Oscera7TM Synthetic Absorbable Bone Wax. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and studies in the format requested for AI/software devices.

Therefore, many of the requested fields cannot be directly extracted or are not applicable to this type of medical device submission. However, I can infer some information based on the context of a 510(k) and the provided text.

Here's a breakdown of the available and inferred information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Inference:

• Acceptance Criteria: These are inferred from the "Intended Use," "Device Description," and "Design Verification" sections. For a 510(k), compliance with these functional requirements and demonstrating substantial equivalence to legally marketed predicate devices are the primary "acceptance criteria."
• Reported Device Performance: The document states that "Verification testing of Oscera7™ included both bench and animal testing. The testing demonstrated the hemostatic capability, bioresorbability, and biocompatibility, thereby establishing compliance to the functional requirements of the device." It also concludes that "the cumulative test results demonstrated the functionality, safety and effectiveness of Oscera7™, as well as its substantial equivalence to the predicate devices."

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

This information is not provided in the document. The text only mentions "bench and animal testing" but does not specify sample sizes or data provenance (e.g., country, retrospective/prospective). This level of detail is typically not included in a 510(k) summary.

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

This information is not provided and is not applicable to a non-AI/software medical device like bone wax. "Ground truth" in this context would likely refer to direct measurements or observations from animal models or bench tests, not expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation, especially for diagnostic or screening devices.

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 is not applicable as the Oscera7TM Synthetic Absorbable Bone Wax is a physical medical device, not an AI or software device.

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

This is not applicable as the Oscera7TM Synthetic Absorbable Bone Wax is a physical medical device, not an AI or software device.

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

Based on the type of device and testing mentioned ("bench and animal testing"), the "ground truth" would likely be established through:

• Direct measurement/observation in bench tests: For properties like mechanical integrity, absorption rates, or material composition.
• Histopathology or physiological measurements in animal models: To assess hemostasis, bioresorption, and biocompatibility (e.g., inflammation, tissue integration, presence/absence of material).
• Clinical observation in animal models: For immediate hemostatic effect.

The document does not explicitly state the specific ground truth methods but implies these through the types of tests mentioned.

8. The Sample Size for the Training Set

This information is not provided and is not applicable to this type of device. "Training set" is a term used in machine learning; this device undergoes traditional design verification and validation testing.

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

This information is not provided and is not applicable to this type of device for the same reasons as #8.

Ask a specific question about this device

AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.

Desertifican of this an odorless, opaque wax-like material designed to be utilized directly AOC Done Wage. It is best used immediately following removal from the package, and our of the packager over cased in stickiness by additional handling and manipulation, if so can be of ence wax is provided sterile by irradiation and must not be resterilized.

Used for over 100 years, bone waxes stop bone bleeding by the creation of a physical Osed for over he edges of bones that have been damaged by trauma or cut during a surgical procedure. The wax, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

The provided text is a 510(k) summary for the Ceremed, Inc. AOC Bone Wax. This document focuses on establishing substantial equivalence to predicate devices, primarily through comparison of intended use, materials, and mechanical properties. It does not contain information about acceptance criteria, clinical studies, or performance metrics in a way that would allow for the detailed answers requested in the prompt.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because the provided text does not contain this information. The submission is a 510(k) for a device that stops bone bleeding by physical occlusion, making it a "physical barrier" device, and therefore the regulatory requirements are different from those for AI/ML-driven diagnostic or prognostic devices that would have the types of performance metrics and studies you're asking about.

Here's what I can infer from the document regarding its regulatory pathway:

• Type of Device: Bone Wax, used for hemostasis (stopping bleeding) from bone surfaces.
• Regulatory Pathway: 510(k) Premarket Notification. This pathway demonstrates substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials for efficacy (unless new safety or effectiveness questions are raised).
• Basis for Equivalence: The submission argues for substantial equivalence based on:
  • Same intended use and indications for use as predicate devices.
  • Biocompatibility in accordance with ISO-10993.
  • Substantially equivalent mechanical properties to predicate devices, with "any minor differences raise no new issues of safety and efficacy."
  • The predicate devices were preamendement (Ethicon Bone Wax) or previously cleared 510(k)s (Lukens Bone Wax K791495, Auto Suture Bone Wax K971680).

Why the requested information is not present:

The information requested, such as "table of acceptance criteria and reported device performance," "sample sizes for test set," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "type of ground truth," and "training set details," are typically associated with AI/ML-based diagnostic or prognostic devices that rely on algorithms to interpret data (e.g., images, lab results) and provide a clinical output.

A bone wax, as described, is a physical device with a mechanical function (plugging vascular openings). Its regulatory clearance focuses on material safety, biocompatibility, and physical/mechanical properties that are comparable to existing, safe, and effective devices, not on the performance of a diagnostic algorithm.

Ask a specific question about this device