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Cem-Ostetic™ is an osteoconductive bone substitute formulated as cancellous, cortical or cortico-cancellous granules, blocks as well as injectable putty that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.

The granules or blocks may be pressed into the void or into the surgical site by hand. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. Cem-Ostetic™ provides a void filler that can augment hardware to support bone fragments during the surgical procedure and acts as a temporary support medium. This void filler is not yet intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic™ is biocompatible and resorbs in the body as bone ingrowth occurs.

Cem-Ostetic™ consists of a pre-shaped ready-for-use formulation of cancellous, cortical or cortico-cancellous blocks or granules. The granules or blocks are supplied sterile for single patient use only.

This document is a 510(k) summary for the Cem-Ostetic™ Bone Void Filler. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study related to specific acceptance criteria for performance. Therefore, most of the requested information regarding acceptance criteria and performance study details cannot be extracted from this document.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific quantitative performance metrics for the Cem-Ostetic™ granules and blocks. Its primary claim is substantial equivalence to an existing device (Cem-Ostetic™ putty).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical performance study with a test set of data.

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. The document does not describe a clinical performance study requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The document does not describe a clinical performance study with a test set.

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 is a medical device for bone void filling, not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm.

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

Not applicable. The device's "safety and effectiveness" are supported by "substantial equivalence information, materials data, and test results" but no specific ground truth type for a performance study is mentioned. The focus is on material properties and comparison to a predicate device.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a "training set."

Summary of what is provided in the document related to "acceptance criteria" and "study":

The document states that the safety and effectiveness of Cem-Ostetic™ granules and blocks are supported by:

• Substantial equivalence information: Primarily demonstrating that the new granules and blocks are fundamentally similar to the already marketed Cem-Ostetic™ putty.
• Materials data: This would typically involve laboratory testing of the physical and chemical properties of the material to ensure it meets specifications. Specific acceptance criteria for these material properties are not detailed in this summary, but would have been part of the full 510(k) submission.
• Test results: Similar to materials data, these would be lab-based tests demonstrating biocompatibility, radio-opacity, and potentially mechanical properties relevant to its intended temporary support. Again, specific acceptance criteria and results are not provided in this summary.

The "study" referenced is the process of demonstrating substantial equivalence to a predicate device (Cem-Ostetic™ putty), rather than a clinical performance study with specific patient outcomes or diagnostic accuracy metrics. The key aspects of this "study" are:

• Identical Indications-for-Use: Both the new device and the predicate are intended to fill voids and gaps not intrinsic to bone stability in extremities, spine, pelvis, or cranium.
• Identical Contraindications, Warnings, Precautions, and Potential Adverse Events: This suggests a shared safety profile.
• Very Similar Technical Characteristics: This implies that the material composition, physical form (even if different shapes like granules vs. putty), and other properties are comparable and do not raise new safety or effectiveness concerns.

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