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Fine Osteotomy™ is a system intended for open- and closed-wedge osteotomies, treatment of bone and joint deformities, fixation of fractures and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.

Fine Osteotomy™ disposable instrumentation is intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding of surgical instruments in non-acute, non-joint replacing osteotomies around the knee.

Fine Osteotomy™ is a patient-specific device.

Fine Osteotomy™ is a system for planning osteotomies of the distal femur and proximal tibia, and for stabilizing the bone with bone screws and a patient-specific bone plate that fits the patient's anatomy " consists of patient-specific surgical planning and instrument guides designed from images of the patient-specific bone plate designed from the patient's images, compression and/or locking bone screws, and class 1 reusable manual instruments. The bone plate is a patient-specific, single-use implant; the surgical planning and instrument guides are patient-specific, single-use, and discarded after surgery. Fine Osteotomy™ is offered in three configurations: 1) as a system of patient specific implants and single use instruments for performing osteotomies and implanting hardware to stabilize the resection, 2) as patient specific single use instruments alone for performing osteotomies, and 3) as a patient specific bone plate and screws for stabilizing a bone resection or fracture.

When used as a system, Fine Osteotomy™ enables the surgeon to perform and stabilize the bone around the knee that matches the pre-surgical plan using the patient-specific cutting quides and bone planning quides and resection instruments are used alone, Fine Osteotomy™ enables the surgeon to perform an osteotomy around the knee the presurgical plan using the patient-specific cutting guident's CT images. When the bone plate and screws are used alone, Fine Osteotomy™ enables the surgeon to stabilize fractured or resected bone per the pre-surgical plan using the patient's CT images in design of the Bodycad plate and use of the bone models intra operatively to quide placement of the implants and alignment of bone. The Fine Osteotomy System is provided clean, not sterile to the user.

Materials: Wrought Titanium-6Alum ELI Alloy (Ti6A4V ELJ; ASTM F136-13) for the bone plates and screws, additively manufactured Nylon-12 for patient specific, single use resection guides and models.

This FDA 510(k) summary for the Fine Osteotomy™ system (K240066) explicitly states that the technological characteristics and indications for use of the subject device are identical to its primary predicate device (K231314), with the exception of updates and additions to single-use instrumentation and shelf-life.

Therefore, the document does not contain the detailed information necessary to answer some of the questions regarding acceptance criteria and performance studies, specifically:

• A table of acceptance criteria and the reported device performance: This is not provided because substantial equivalence is claimed based on identity to a cleared predicate, not on new performance data demonstrating meeting specific criteria.
• Sample sized used for the test set and the data provenance: No new test set data is reported.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set is described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Based on the provided text, here is what can be extracted regarding the "study" that proves the device meets acceptance criteria:

The "study" or rather the justification for meeting acceptance criteria is a demonstration of substantial equivalence to a previously cleared predicate device.

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

The document does not provide a table of acceptance criteria and reported device performance in the context of a new clinical or non-clinical performance study. Instead, the device's acceptance is based on its substantial equivalence to a predicate device already on the market.

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

No new test set was used or described for this 510(k). The regulatory submission relies on the substantial equivalence to the predicate device K231314.

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

Not applicable, as no new test set requiring expert ground truth establishment for performance evaluation is described.

4. Adjudication method for the test set

Not applicable, as no new test set is described.

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 MRMC comparative effectiveness study is mentioned.

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

No standalone algorithm performance study is mentioned.

7. The type of ground truth used

Not applicable, as no new performance study is described. The acceptance is based on substantial equivalence.

8. The sample size for the training set

Not applicable, as no new algorithm development requiring a training set is described. The device is a patient-specific surgical guide system, not an AI/ML algorithm that identifies or diagnoses.

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

Not applicable.

Summary of "Study" to Prove Acceptance:

The provided document indicates that the Fine Osteotomy™ system (K240066) achieves acceptance (i.e., substantial equivalence to a predicate device) through the following:

• Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b)):
  • Verification and validation (V&V) activities included:
    • Mechanical Engineering Analysis of updated and new single-use instruments demonstrating no new worst-case scenarios.
    • Modification of Shelf-Life Referential for Fine Osteotomy Systems.

This implies that the key "study" involved analyzing the updated and new single-use instruments (from an engineering perspective) and reassessing the shelf-life, to confirm that these changes do not alter the fundamental safety and effectiveness demonstrated by the predicate device. The performance data for the core technology is implicitly referenced as that of the predicate device (K231314).

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