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The Vantage® Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage® Total Ankle System is indicated for cemented use only.

The Vantage® Total Ankle System is a system of orthopedic implants intended for total ankle replacement. The system includes Tibial Plates, Tibial Inserts, Talar Components, and Locking Clips. This submission proposes three new components as line extensions of the Vantage Total Ankle System, which are modifications of their respective predicate components:

• 3D Tibial Plates
• 3D+ Tibial Plates ●
• 3D/3D+ Locking Clips ●

The proposed devices have the same indications for use and similar design characteristics as their predicate devices (cleared under K152217). The proposed tibial plates differ from the predicate in that they are additively manufactured, have minor geometrical modifications, and are offered in additional sizes. The proposed locking clips differ from the predicate in that they are offered in additional sizes.

The provided text describes the 510(k) summary for the Exactech® Vantage® Total Ankle System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, many of the requested details, such as those pertaining to a multi-reader multi-case (MRMC) study, human reader improvement with AI assistance, standalone algorithm performance, or the sample size and ground truth establishment for training and test sets of an AI/ML device, are not applicable to this 510(k) submission.

This submission is for a traditional medical device (total ankle system implants and components), not an AI/ML-driven diagnostic or prognostic device that would typically involve the types of studies described in the prompt. The "acceptance criteria" here refer to the demonstration of substantial equivalence through non-clinical performance testing of mechanical properties and material characteristics, rather than diagnostic accuracy metrics.

Here's a breakdown of the available information based on your request, highlighting what is present and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a traditional medical device like this are primarily based on established ASTM standards and demonstrating mechanical equivalence to a predicate device. The performance is shown through passing these tests, rather than providing specific numerical thresholds for diagnostic accuracy.

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

• Not Applicable: This is not a study involving a "test set" of clinical data or images for an AI/ML algorithm. The "testing" refers to mechanical and material performance testing of the device components themselves.

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

• Not Applicable: "Ground truth" in this context refers to the defined mechanical and material properties as per ASTM standards, not expert medical opinion on clinical cases.

4. Adjudication method for the test set

• Not Applicable: No adjudication method for a test set of clinical data is described. The "adjudication" would be related to the interpretation and validation of engineering test results, which is part of standard test protocols.

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: This is a mechanical implant device, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.

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

• No: This is a mechanical implant device, not a standalone AI algorithm.

7. The type of ground truth used

• For mechanical and material testing, the "ground truth" is based on established engineering principles and recognized consensus standards (e.g., ASTM F2665, ASTM F1044, ASTM F1147, ASTM F1978, ASTM F1160, ASTM F1854). These standards define the parameters and methodologies for evaluating the device's performance characteristics.

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device that requires a training set of data.

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

• Not Applicable: As above, this is not an AI/ML device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study described is a series of non-clinical engineering and material characterization tests designed to demonstrate the substantial equivalence of the Exactech® Vantage® Total Ankle System to a legally marketed predicate device (K152217).

• Objective: To show that the proposed new components (3D Tibial Plates, 3D+ Tibial Plates, and 3D/3D+ Locking Clips) have comparable safety and effectiveness to the predicate device, despite minor design and manufacturing differences (e.g., additive manufacturing, additional sizes).
• Methodology: A battery of tests was performed on the device components, adhering to recognized ASTM standards for total ankle replacement devices. These tests evaluated:
  • Fatigue strength of tibial plates and locking mechanisms.
  • Fixation stability of tibial plates.
  • Characteristics of porous surfaces (stereological evaluation, shear, tension, abrasion resistance, compression).
  • Residual particulate count.
  • Pyrogenicity.
• Conclusion: The tests concluded that the strength of the new components is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The pyrogenicity test demonstrated endotoxin levels below the specified limit (

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

• The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation.
• . The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
• . The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
• Humeral Heads are intended for use in cemented and press-fit applications. ●
  Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
  | P | L | F | Indications |
  |---|---|---|---|
  | √ | √ | | Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems |
  | √ | √ | | Congenital abnormalities in the skeletally mature |
  | √ | | | Primary and secondary necrosis of the humeral head. |
  | √ | | √ | Humeral head fracture with displacement of the tuberosities |
  | √ | √ | 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) | |
  | | | √ | Displaced three-part and four-part upper humeral fractures |
  | | √ | | Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases) |
  | √ | √ | | Revision of failed previous reconstructions when distal anchorage is required |
  | √ | √ | | To restore mobility from previous procedures (e.g. previous fusion) |
  The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
  The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The Equinoxe Laser Cage Glenoids are intended to be used with Exactech Equinoxe Humeral Head components in Total Shoulder Arthroplasty. The Laser Cage Glenoids are composed of an Ultra High Molecular Weight Polyethylene (UHMWPE) body molded onto Ti-6Al-4V peripheral pegs and a central cage. The central cage and peripheral pegs of the implant are additively manufactured using direct metal printing (DMP) technology. The Laser Cage Glenoids are available in four sizes and four augment angle options.

The provided text describes a 510(k) premarket notification for the Exactech® Equinoxe® Laser Cage Glenoid, which is a medical device for shoulder arthroplasty. The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested categories (acceptance criteria, device performance, sample size, ground truth, experts, adjudication, MRMC studies, standalone performance, training set) are not applicable in the context of this 510(k) submission, as it is not a clinical study assessing an AI/ML diagnostic device.

Here's an analysis based on the information available:

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

The document does not provide a table of acceptance criteria with reported device performance in a clinical or diagnostic sense. The "acceptance criteria" in a 510(k) submission for a device like this are related to demonstrating substantial equivalence, primarily through:

• Identical Indications for Use
• Identical Biocompatible Materials
• Same Design Features
• Dimensionally Comparable
• Provided sterile for single use only
• Conformity to the same recognized performance standards

The "reported device performance" in this context refers to the results of non-clinical (bench) testing to confirm the physical and mechanical properties, as well as sterility.

Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

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. This is a 510(k) submission for a medical implant, not a study of an AI/ML diagnostic device with a test set of data. The "test set" in this context refers to the physical devices undergoing bench testing. The sample size for these bench tests is not specified in the summary document, and data provenance in terms of country of origin or retrospective/prospective is not relevant.

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. No "ground truth" as typically defined for diagnostic performance studies was established. The assessments in this submission are based on engineering, material science, and regulatory compliance, not expert clinical interpretation of data.

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

Not applicable. No adjudication method for a test set of data was performed, as this is not a diagnostic performance study.

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 submission is for a physical medical implant (shoulder prosthesis), not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI-based device.

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

Not applicable in the conventional sense of diagnostic performance studies. The "ground truth" for this device's substantial equivalence claim relies on established engineering principles, material specifications, and validated manufacturing processes, all demonstrating that the new device is as safe and effective as the predicate devices. For non-clinical testing, the "ground truth" is defined by the recognized performance standards and internal engineering specifications, e.g., a peg must withstand a certain pull-off force.

8. The sample size for the training set

Not applicable. This is not an AI/ML device where a "training set" would be used.

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

Not applicable. No training set was used.

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