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OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, illium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.

OSSAPLAST ORTHO (1000 – 2000 µm) is a synthetic, implantable, resorbable, radiopaque β-tricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of pure-phase β-ΤСР [Саз(РОд)չ] and is osteoconductive, with high interconnecting porosity. OSSAPLAST ORTHO (1000 – 2000 µm) is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.

The provided text is a 510(k) summary for the OSSAPLAST™ ORTHO bone void filler. It describes the device and claims substantial equivalence to predicate devices. However, this document does not contain a study explicitly designed to prove device performance against acceptance criteria in the manner requested.

Specifically, the document states: "Performance testing was conducted in conformance with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA (FDA/ODE, 6/2/2003). All data demonstrated that OSSAPLAST ORTHO (1000 – 2000 µm) is suitable for use as a bone void filler."

This statement indicates that performance testing was performed, and the results were found acceptable, but it does not provide the details of the acceptance criteria, the specific study design, the reported performance data, or the specific information requested in your numbered points. The 510(k) process relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical trial with explicit acceptance criteria for a novel device.

Therefore, many of your requested points cannot be answered from the provided text.

Here's an attempt to answer what can be inferred or directly stated from the document, with extensive notes about missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., "resorption should be X% at Y months") or specific numerical results for these criteria. The approval is based on "suitability" and "substantial equivalence."

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance: Not specified. It likely involved preclinical testing (e.g., in vitro, animal studies) as part of the "Performance testing" and "biocompatibility" assessments, but no details are given. The context of a 510(k) for a device like this usually indicates laboratory and possibly animal testing rather than large human clinical trials, unless specifically stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This type of information is not relevant to the "performance testing" described in this 510(k) summary, which focuses on material properties and biological response (biocompatibility, resorption), not interpretation of medical images or diagnoses.

4. Adjudication method for the test set

• Not applicable as this is not a diagnostic device or a study involving human reader interpretation.

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 not a diagnostic AI device.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

• For material properties: ASTM F1088-04 standard specifications for medical grade ß-TCP as a "ground truth" for material composition and characteristics.
• For biocompatibility: Standardized biocompatibility testing parameters (e.g., ISO 10993 series) would serve as the "ground truth" to determine if the device elicits an acceptable biological response. The document states "biocompatibility" was assessed.
• For osteoconductivity/resorption: Likely histological analysis in animal models or in vitro studies. The document states it is "osteoconductive" and "gradually resorbed and replaced with bone."

8. The sample size for the training set

• Not applicable in the context of device performance testing for a bone void filler as described in this 510(k) summary. "Training set" is a concept typically associated with machine learning or AI models, which this device is not.

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

• Not applicable for the same reasons as point 8.

In summary: The provided document is a 510(k) summary for a medical device (bone void filler) and primarily demonstrates substantial equivalence to predicate devices and adherence to relevant standards and guidance documents. It does not outline a specific study with detailed acceptance criteria and performance metrics in the way one might expect for a novel diagnostic device or AI application. The "performance data" mentioned generally refers to compliance with established material and biological safety standards rather than a formal clinical trial with quantitative endpoints.

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OSSAPLAST ORTHO is intended for use in filling bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone or a degenerative process. OSSAPLAST ORTHO is gradually resorbed and replaced with bone during the healing process.

OSSAPLAST ORTHO is a synthetic, implantable, resorbable, radiopaque ß-tricalcium phosphate (β-ΤCP) ceramic in granulate form (particle size of 500 - 1000 µm). It consists of pure-phase ß-TCP [Ca3(PO4)2] and is osteoconductive, with high interconnecting porosity. OSSAPLAST ORTHO is supplied sterile in sealed glass vials in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.

This document describes a 510(k) premarket notification for the "OSSAPLAST™ ORTHO" bone void filler. The information provided heavily emphasizes substantial equivalence to a predicate device and adherence to regulatory standards, rather than a clinical study with detailed performance metrics and acceptance criteria as would be expected for an AI/ML powered device.

Therefore, it is important to note that the following response is based on the information provided in the document, which does not detail a study designed to meet specific acceptance criteria in the context of device performance as one might expect for a diagnostic or therapeutic AI product. The document primarily focuses on demonstrating that the device meets safety and efficacy expectations as a resorbable calcium salt bone void filler by showing its technological characteristics are equivalent to a predicate device and that it conforms to relevant ASTM standards and FDA guidance.

Here's the breakdown of what can be extracted from the document, acknowledging the limitations for an AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a medical device (bone void filler) and not an AI/ML product, many of the subsequent questions are not directly applicable. However, I will answer them based on the spirit of the questions where possible, or explicitly state when the information is not provided or applicable.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in terms of distinct "test set" or a number of patients/cases. The "performance data" section refers to conducting "performance testing" in conformance with FDA guidance, covering parameters like material characteristics, biocompatibility, and physical properties. This likely involved chemical analyses, in-vitro testing, and possibly animal studies, but the number of samples/tests is not detailed.
• Data Provenance: Not explicitly stated. For material testing, it would be laboratory data. For any biological assessments, it would be from controlled lab environments or animal models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable in the context of an AI/ML diagnostic device. The "ground truth" here relates to the inherent properties of the material and its biological interaction. These are established through scientific consensus, validated testing methods, and regulatory standards rather than expert consensus on diagnostic images. The "experts" would be the scientists and engineers conducting the tests and the regulatory body (FDA) reviewing the scientific evidence.

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

• Not applicable. This concept typically applies to discrepancies in expert readings of medical images or other diagnostic data. The "acceptance" of the device is based on meeting pre-defined material specifications and performance characteristics, as reviewed by the FDA.

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

• No. This is a bone void filler, not a diagnostic AI device. MRMC studies are not relevant for this type of product.

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

• No. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this device is based on:
  • Material Science Specifications: Chemical composition (pure-phase ß-TCP), particle size, porosity, radiopacity confirmed through analytical chemistry and physical characterization tests.
  • Biocompatibility Standards: Established through in-vitro and potentially in-vivo (animal) studies against recognized international standards.
  • Performance Benchmarks: Demonstrated through adherence to ASTM F1088-04 and consistency with the known performance characteristics of the predicate device.
  • Regulatory Guidance: Conformance with the FDA's "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device."

8. The sample size for the training set

• Not applicable. This product does not involve a training set for an AI/ML algorithm. The "development" and "formulation" of the material would be based on scientific literature, material science principles, and previous research on ß-TCP bone void fillers.

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

• Not applicable. As a non-AI/ML device, there is no "training set." The understanding of the material's properties (its "ground truth") is derived from fundamental scientific knowledge, established material characterization techniques, and biological studies, which inform the design and manufacturing of the device to meet its intended purpose.

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