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FM-02 Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. FM-02 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

FM-02 Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

FM-02 Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is >70% porous and the pore diameters range from 1 um to 1000 um.

FM-02 Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When FM-02 Bone Graft Substitute is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

The provided document is a 510(k) summary for a medical device (FM-02 Bone Graft Substitute). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study demonstrating performance against specific acceptance criteria for AI or diagnostic imaging.

Therefore, the requested information elements related to AI/algorithm performance (acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document.

However, I can describe the performance data provided in the document which supports the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a bone graft substitute, and its "performance" is assessed against physical and biological standards required for such materials, rather than diagnostic accuracy metrics. The acceptance criteria are essentially meeting the requirements of specific ASTM standards and demonstrating characteristics comparable to the predicate device.

• Wettability
• Fluid retention
• Wash away resistance
• Homogeneity
• Radiopacity
• Bioactivity
• SEM comparisons
  These tests demonstrated that FM-02 is "substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness." |
  | Physical/Chemical Characterization (vs. Predicate Device) | Evaluation of:
• XRD (X-ray diffraction)
• FTIR (Fourier-transform infrared spectroscopy)
• ICP (Inductively coupled plasma atomic emission spectroscopy)
• Porosity
  (These were evaluated for the predicate device, implying FM-02 shared similar characteristics or was evaluated against these established parameters for comparison.) |

Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical performance testing to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance. The study described focuses on characterizing the material and comparing its properties to a legally marketed predicate device and to established material standards.

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

• Sample Size for Test Set: Not applicable in the context of a bone graft substitute material characterization study. The "test set" would refer to samples of the FM-02 material itself, tested in laboratory settings. The number of samples per test (e.g., how many specimens for wettability) is not specified.
• Data Provenance: Not specified in terms of country of origin. This would be laboratory testing conducted by Orthovita, Inc. or a contracted lab. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission.

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. "Ground truth" in this context would refer to the true physical/chemical properties of the material, which are determined by objective laboratory measurements and adherence to scientific standards (e.g., ASTM, ISO). Expert consensus is not relevant for establishing the "truth" of these material properties.

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

Not applicable. This is not a study requiring expert adjudication of results, but rather objective laboratory testing.

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 graft substitute, not an AI or diagnostic imaging device.

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

Not applicable. This device is a bone graft substitute, not an AI or diagnostic imaging device.

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

The "ground truth" for the performance data presented is based on objective laboratory measurements against established standards (ASTM F 1088-04a, ISO 10993-1) and comparison of physical/chemical properties to a predicate device. This involves analytical chemistry techniques (XRD, FTIR, ICP), microscopy (SEM), and various physical property tests (wettability, fluid retention, etc.).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study.

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

Not applicable. This is not an AI/machine learning study.

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