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

AOC Bone Wax is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by additional handling and manipulation, if so desired. AOC Bone 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 barrier along the 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.

I am sorry, but the provided text describes a 510(k) submission for a bone wax product and does not contain information about acceptance criteria, device performance, clinical studies, or AI/software analysis. Therefore, I cannot generate the requested table and study details.

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

AOC Bone Wax is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by additional handling and manipulation, if so desired. AOC Bone 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 barrier along the 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.

This 510(k) submission for AOC Bone Wax does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone performance (algorithm only) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

Key points from the document relevant to its purpose:

• Device Name: AOC Bone Wax, Ostene™, Osteotene™, Ceretene™
• Intended Use/Indications for Use: Control of bleeding from bone surfaces.
• Substantial Equivalence: The submission asserts that the modified AOC Bone Wax has the "same intended use fundamental scientific technology as the legally marketed AOC Bone Wax (K041363)." This is the core of a 510(k) submission – to show the new device is as safe and effective as an existing one, not necessarily to prove new performance metrics against predefined acceptance criteria through clinical trials.
• Predicate Device: Ceremed, Inc. AOC Bone Wax K041363.

This type of submission often relies on a comparison of technical characteristics, material properties, and intended use to an already approved device, rather than new extensive performance studies.

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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.

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