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OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Ostene®CT 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 warming and by additional handling and manipulation, if so desired.

Ostene®CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. * Ostene® CT contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.

As a bone hemostasis agent, Ostene®CT stops 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. Ostene CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

Ostene®CT is provided sterile by irradiation and must not be resterilized. * A substitution has been made in a neutral excipient copolymer.

This submission describes a medical device, Ostene®CT, which is a bone hemostasis implant material. The document provided is primarily a 510(k) summary for a Special 510(k) submission, indicating a modification to an already legally marketed device. Therefore, the focus is on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report typical for novel devices.

Given the nature of a Special 510(k) and the provided text, there is no specific performance study with defined acceptance criteria in the way one might expect for a new, high-risk device requiring detailed clinical trial data. The device is for bone hemostasis and is classified as "Unclassified," which typically means less stringent performance study requirements for demonstrating substantial equivalence, especially when it's a modification of a predicate.

The primary "study" is the demonstration that a "substitution has been made in a neutral excipient copolymer" and that the modified Ostene®CT "has the same intended use and fundamental scientific technology as the legally marketed Ostene®CT Soluble Bone Hemostasis Implant."

Here's an attempt to answer your questions based on the provided text, noting where specific information is absent due to the type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) for a modified device, the "acceptance criteria" are generally that the modified device remains substantially equivalent to the predicate device and that the change (a neutral excipient copolymer substitution) does not adversely affect safety or effectiveness. Specific numerical performance targets are not provided in the document for the new Ostene®CT against the predicate.

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

• Sample Size: Not specified. Clinical trial data with defined sample sizes and test sets are not presented in this 510(k) summary. The submission focuses on the modification of an excipient in an already cleared device.
• Data Provenance: Not applicable in the context of a performance study; the submission details the device composition and its mechanism of action, emphasizing its similarity to the predicate.

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

• Not applicable. There is no mention of a clinical "test set" requiring ground truth established by experts in this 510(k) summary.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not applicable. This device is a bone hemostasis implant material, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

• Not applicable. This device is a physical implant material, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable in the context of a typical performance study for diagnostic AI or imaging devices. For a medical device like this, "ground truth" often relates to established scientific principles of material compatibility and physiological function, as well as pre-clinical testing (e.g., biocompatibility, hemostatic efficacy in animal models), which are standard for medical device development but not detailed in this 510(k) summary. The primary "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set."

Summary based on the document:

This 510(k) submission for Ostene®CT is for a modified version of an already cleared device. The "study" proving it meets acceptance criteria is primarily the demonstration of substantial equivalence to the predicate device (Ceremed, Inc. Ostene® Soluble Bone Hemostasis Implant Material, K082491), especially considering a "substitution has been made in a neutral excipient copolymer." The acceptance criteria are implicitly met if the FDA determines that the modified device has the same intended use, fundamental scientific technology, and does not raise new questions of safety or effectiveness compared to the predicate. Details on specific performance metrics, sample sizes, or expert adjudication for clinical performance studies are not provided in this regulatory summary.

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OSTENE® is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Ostene 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 warming and by additional handling and manipulation, if so desired.

Ostene is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. Ostene contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.

As a bone hemostasis agent, Ostene stops 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. Ostene, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

Ostene is provided sterile by irradiation and must not be resterilized.

This document is a 510(k) submission for the Ceremed, Inc. AOC Bone Wax (marketed as Ostene®). It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets acceptance criteria.

The 510(k) summary (page 9-1 and 9-2) explicitly states: "The modified Ostene® Bone Hemostasis Material has the same intended use fundamental scientific technology as the legally marketed Ostene® Bone Hemostasis Material." This indicates that the submission relies on the substantial equivalence principle, asserting that the new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical or performance data for acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions as the provided text does not describe a study.

Here's what can be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance:
Not provided in the document. The submission claims substantial equivalence and does not detail specific performance acceptance criteria or report results from a study designed to meet such criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No new study data is presented.

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. No new study data is presented.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No new study data is presented.

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 bone hemostasis material, not an AI or imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a bone hemostasis material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No new study data is presented.

8. The sample size for the training set:
Not applicable. No new study data is presented.

9. How the ground truth for the training set was established:
Not applicable. No new study data is presented.

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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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