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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

AcuMatch® P-Series and AcuMatch® L-Series press-fit femoral stems are intended for press-fit fixation.

AcuMatch® A-Series press-fit acetabular cups are intended for press-fit fixation.

Press-fit acetabular shells and press-fit femoral stems without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.

Cobalt chromium femoral heads are intended for use in cemented and press-fit applications.

The Exactech 12/14 Total Hip System includes AcuMatch 12/14 Press-Fit Femoral Stems, AcuMatch 12/14 CoCr Femoral Heads, and AcuMatch A-Series Acetabular Component (36mm I.D.). The femoral stem tapers were modified to a "12/14 Euro-style" design. A 36 mm line of femoral heads and mating acetabular liners was added.

12/14 CoCr Femoral Heads are composed of cobalt chromium alloy conforming to ASTM F1537. The femoral stem taper connection was modified to a 12/14 Euro-style taper design.

AcuMatch 12/14 Press-Fit femoral stems are composed of titanium alloy (ASTM F1472), have a trapezoidal cross-sectional geometry and distal taper. The P-Series model is available with a porous bead or plasma-spray surface enhancement. The L-Series model has a corundum finish. Options include collared and non-collared versions and hydroxapatite (HA) coating. The components are intended for press-fit applications. Modifications were made to the femoral neck length, femoral neck geometry, insertion hole feature, and laser-etching. A "High Offset" version was added to the P-Series Plasma product line.

The 36 mm AcuMatch A-Series Acetabular Liners are a line extension designed to mate with A-Series Acetabular "shell" components (A-Series Porous Acetabular Shells and A-Series Corundum Acetabular Shell). Each liner has a size designation (H, J, or K) that matches it to the correct mating shell component. The new 36 mm A-Series Acetabular liners are designed to articulate with the Exactech 12/14 36mm cobalt chromium femoral heads.

All Exactech implant components are provided as sterile, single use only to a sterility assurance level (SAL) of 10^-6.

The provided text is a 510(k) summary for the Exactech® 12/14 Total Hip System. It describes modifications to existing Exactech devices and claims substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or a study that directly proves the device meets specific performance criteria in terms of clinical outcomes or diagnostic accuracy.

The summary focuses on:

• Device Modifications: Changes to femoral stem tapers, addition of a 36mm femoral head and mating acetabular liners, reduced femoral neck length, shifted femoral neck geometry, modified insertion hole feature, and added laser-etching.
• Materials: Specific materials used (cobalt chromium alloy, titanium alloy).
• Indications for Use: The conditions for which the hip system is intended.
• Conclusion: A general statement about "testing and engineering evaluations" conducted to verify adequate performance for anticipated in vivo use, concluding substantial equivalence.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's an attempt to answer the questions based on the available information and, where information is missing, to explicitly state its absence:

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

The document states: "Testing and engineering evaluations were conducted to verify that the performance of the new Exactech 12/14 Total Hip System components would be adequate for anticipated in vivo use." It also mentions "successful results" from these evaluations. However, no specific acceptance criteria or quantitative performance metrics (e.g., in terms of range of motion, wear rates, fracture resistance thresholds, or clinical success rates) are reported in this 510(k) summary.

The evaluation appears to be based on an assessment of substantial equivalence to predicate devices, rather than meeting novel performance criteria.

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

This information is not provided in the document. The document refers to "testing and engineering evaluations," which typically involve bench testing (e.g., mechanical strength, fatigue, wear) rather than human clinical trials for a 510(k) submission for an orthopedic implant unless there are significant new safety questions. If clinical data were used, the sample size and provenance are absent.

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)

This information is not applicable and not provided. For orthopedic implants submitted via 510(k) and relying on substantial equivalence, the "ground truth" is typically defined by established material standards (e.g., ASTM F1537 for cobalt chromium, ASTM F1472 for titanium alloy) and predicate device performance, not expert clinical consensus on a test set in the same way it would be for a diagnostic AI device.

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

This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes where there might be disagreement, which is not described as part of this submission. The "evaluation" mentioned is likely internal engineering or bench 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

This information is not applicable and not provided. An MRMC study is not relevant for an orthopedic implant device submission. This type of study is for evaluating diagnostic accuracy or reader performance with an AI tool.

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

This information is not applicable and not provided. This device is an orthopedic implant, not an algorithm or AI system.

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

As discussed in point 3, the concept of "ground truth" as typically applied to diagnostic studies (expert consensus, pathology, outcomes data) is not directly applicable here. For an orthopedic implant, the "ground truth" for evaluating substantial equivalence would relate to:

• Material properties: Conformance to ASTM standards (e.g., F1537, F1472).
• Mechanical performance: Bench testing demonstrating comparable strength, fatigue resistance, and wear characteristics to predicate devices and acceptable levels for in vivo use.
• Biocompatibility: Assumed through use of well-established, previously cleared materials.

The document implicitly relies on these engineering and material-based "truths" to support its claims of safety and effectiveness.

8. The sample size for the training set

This information is not applicable and not provided. This device is an orthopedic implant, not a machine learning model. There is no concept of a "training set" in this context.

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

This information is not applicable and not provided. (See point 8).

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