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The Bio2 Fusion Implant System is indicated for fracture fixation, osteotomies, and inter-digital fusion of the fingers, toes and small bones in the presence of appropriate immobilization.

When used in the foot (including hammertoe, claw toe, and mallet toe) patients should use protected weight bearing or heel bearing until fusion or healing has occurred.

The Bio2 Technologies Fusion Implant is a cylindrical shaped implant designed for fracture fixation repair, osteotomy and to fit into the proximal and distal sides of the proximal interphalangeal joints of the foot or hand. The implants are made of bioactive glass material that has been demonstrated to be biocompatible and osteoconductive. The implants are available in multiple diameters, lengths and in a straight and angled configuration. The implants are provided sterile and are intended for single use.

The provided text describes the Bio2 Fusion Implant System, a medical device intended for fracture fixation, osteotomies, and inter-digital fusion of fingers, toes, and small bones. The document is a 510(k) premarket notification from the FDA, aiming to demonstrate substantial equivalence to previously marketed predicate devices.

However, the document does not contain the kind of detailed information requested about the acceptance criteria and the study that proves the device meets those criteria, specifically for an AI/CADe device. The Bio2 Fusion Implant System is a physical implant, not a software or AI-based diagnostic tool.

Therefore, for this specific input, the following requested information cannot be provided as it is not present in the document:

1. A table of acceptance criteria and the reported device performance: Not applicable as this is a physical implant, and the performance testing described is mechanical, not related to AI metrics.
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 for an AI test set. The document mentions "performance testing" of the implant but doesn't detail sample sizes or data provenance in the context of AI evaluation.
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 for a physical implant; ground truth establishment as it pertains to AI/diagnostic accuracy is not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI device. The ground truth for biocompatibility and mechanical properties would be in vitro/in vivo assays and mechanical testing results.
8. The sample size for the training set: Not applicable, as there is no AI algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

Information that is available in the document regarding traditional device testing:

Performance Data Mentioned:
The document states: "Performance testing supports the substantial equivalence of the subject device to the predicate device."

• Biocompatibility: Established according to blue book memorandum #G95-1 entitled "Use of International Standard ISO-10993. Biological Evaluation of Medical Devices Part-1: Evaluation and Testing."
• In vitro bioactivity testing: (ISO 23317:2012) showed the material forms a surface apatite layer when submerged in simulated body fluid.
• Mechanical Testing: "Static and fatigue bending tests and in vitro stability tests were conducted on the subject and predicate devices to demonstrate substantial equivalence."

Type of Ground Truth Used (for a physical device):
For biocompatibility, the ground truth would be established through standard biological evaluation methods and outcomes per ISO-10993. For bioactivity, the formation of a surface apatite layer in simulated body fluid per ISO 23317:2012 is the ground truth. For mechanical performance, established engineering standards for static, fatigue, and stability tests serve as the ground truth.

Sample Sizes for these physical tests are not specified in this summary document.
Data Provenance (for physical device testing): Not specified beyond the tests being conducted on "the subject and predicate devices."

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