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The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or posttraumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use.

Exactech Alteon Bone Screws 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. Exactech Alteon Bone Screws 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.

The Exactech Alteon Bone Screws are also indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The tibial tray implant and its porous structure is manufactured from Ti-6Al-4V titanium alloy using electron beam melting (EBM) technology. This product line represents a scope extension of the Truliant knee implant system. The previously cleared Alteon Bone Screws are now cleared for use with the TRULIANT Porous Tibial Trays.

This document does not describe a study involving an algorithm or AI. It is a 510(k) summary for a medical device (TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws), which means it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data from non-clinical (mechanical) testing.

Therefore, many of the requested categories, such as "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission.

Here's an analysis based on the information provided, focusing on the mechanical performance data:

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

Note: The document states that "The results of this non-clinical testing show that the strength of the TRULIANT Porous Tibial Tray is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The specific numerical acceptance criteria (e.g., minimum load or cycles) and quantitative results for the mechanical tests are not provided in this 510(k) summary, but are implicitly met as per the FDA's clearance.

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 given text. For mechanical testing, sample sizes are typically determined by the relevant ASTM standards, but the exact numbers are not mentioned here. The data provenance is also not specified, as this is non-clinical lab testing rather than patient data.

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 is not applicable as the document describes mechanical and pyrogenicity testing, not studies requiring expert review for ground truth in the context of medical image analysis or clinical outcomes.

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

This is not applicable for the type of testing described. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for standardized mechanical tests.

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 is not applicable. This document describes the clearance of a physical medical device (tibial tray and bone screws) through non-clinical testing, not an AI-powered diagnostic or assistive tool.

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

This is not applicable. This document does not pertain to an algorithm.

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

For the mechanical tests, the "ground truth" would be the physical properties and performance of the device under controlled laboratory conditions as measured against established ASTM standards. For pyrogenicity, it's the measured endotoxin level. This is not "expert consensus", "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no "training set" and thus no ground truth to establish for it in this context.

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The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for anatomic total shoulder arthroplasty are as follows:

• Osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• Congenital abnormalities in the skeletally mature
• Primary and secondary necrosis of the humeral head.
• Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
• Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
• To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.

The Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

The Equinoxe Stemless Shoulder is intended to be used with Exactech glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The Equinoxe Stemless Shoulder includes humeral components and humeral heads. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V, and have porous regions. The Equinoxe Stemless Humeral Heads are manufactured from Cobalt Chrome. The Equinoxe Stemless Humeral Components are available in two types, Caged and Non-Caged, with each type available in three sizes, with lengths between 17mm and 24mm. The Equinoxe Stemless Humeral Heads are available in 12 sizes, with diameters between 38mm and 53mm and two height options (Extra Short, Short).

This FDA 510(k) premarket notification for the Exactech® Equinoxe® Stemless Shoulder device does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria, AI/ML study design, ground truth, and sample sizes for training/testing sets are not applicable in this context.

This submission is for a medical implant (a shoulder prosthesis) and focuses on demonstrating substantial equivalence to previously approved predicate devices through non-clinical (mechanical) testing, material comparisons, and similar indications for use.

Instead of AI/ML performance metrics, the document presents mechanical performance criteria.

Here's a breakdown of the relevant information provided:

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

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

• Not applicable for AI/ML device. The "test set" here refers to mechanical test samples, not clinical data for an algorithm. The document does not specify the number of mechanical samples used for each test. Data provenance is not relevant as it's mechanical testing of a physical device.

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 AI/ML device. Ground truth, in the context of AI/ML, refers to labels or diagnoses. For a physical implant, ground truth would be established through engineering specifications and standards.

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

• Not applicable for AI/ML device. Adjudication methods are used to resolve disagreements in expert labeling for AI/ML ground truth.

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 an AI/ML device, so no MRMC studies or human reader improvement with AI assistance were performed.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable for AI/ML device. For this physical device, "ground truth" equates to the established engineering specifications, performance standards (e.g., ISO, ASTM for fatigue, pull-out strength), and material properties that the device must meet to function safely and effectively.

8. The sample size for the training set:

• Not applicable for AI/ML device. There is no training set for a physical implant.

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

• Not applicable for AI/ML device. There is no ground truth or training set in the AI/ML sense for this device.

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