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The Equinoxe Humeral Augmented Tray is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in skeletally mature individuals with an intact medial calcar for whom the rotator cuff is irreparable or grossly deficient, a functional deltoid muscle is present, and proximal humeral bone loss is present in cases of:

• · 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 humeral stem fixation can be achieved)
• · Displaced three- and four-part upper humeral fractures
• · Failed ORIF requiring rTSA with an absent or deficient greater tuberosity
• Revision of failed previous reconstructions when distal anchorage is required
• · Treatment of unplanned proximal bone loss during a revision
• · To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Humeral Augmented Tray can be used in either primary or revision arthroplasty procedures.

The Exactech Equinoxe Humeral Augmented Trays are intended for use in total shoulder arthroplasty in skeletally mature patients with proximal humeral bone loss. Specifically, Equinoxe Humeral Augmented Trays are used in combination with Equinoxe Reverse Shoulder System components to compensate for proximal humeral bone loss in presence of an intact medial calcar, irreparable or grossly deficient rotator cuff and a functional deltoid muscle. One of the overall goals of the anatomically designed Equinoxe Humeral Augmented Trays is to improve joint mechanics and stability by providing increased deltoid muscle wrapping and adequate soft tissue tensioning in patients with proximal humeral bone loss.

The Equinoxe Humeral Augmented Trays are consisted of a humeral tray component, a modular extension (augment) and a universal locking screw for use in primary and revision cases. To accommodate patients' various anatomical needs. Equinoxe Humeral Augmented Trays are anatomically designed with two offsets/thicknesses and multiple lateralizations of left and right humeral trays and left and right modular extensions. Per surgeon evaluation, the modular extension secured with a locking screw is used to replace greater and more severe proximal humeral bone loss than can be adequately addressed with use of humeral tray component alone. When the modular extension is used, the locking screw must be used to secure it to the humeral tray component. All three components of the Equinoxe Humeral Augmented Trays are manufactured from Titanium Alloy (Ti-6Al-4V).

The provided text describes a medical device submission (K191561) for Exactech® Equinoxe® Humeral Augmented Trays. This document is a regulatory filing, and as such, it does not contain acceptance criteria or study results in the manner typically associated with AI/ML device performance. The device described is a physical implant for shoulder arthroplasty, not an AI or software device that would have performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested points are not applicable to this document. I will extract the relevant information from the provided text.

Here's an analysis based on the assumption that the request is looking for "acceptance criteria" and "study results" related to the mechanical performance and regulatory clearance of this physical implant, rather than an AI/ML diagnostic system.

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

The document describes non-clinical testing performed to demonstrate substantial equivalence, but it does not explicitly state quantitative "acceptance criteria" with numerical targets and then report performance against those targets. Instead, it lists the types of tests done to ensure the product performs as intended and is comparable to previously cleared devices.

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 a quantifiable manner typical for clinical trials or AI/ML studies. The device underwent non-clinical testing, which includes:

• Mechanical testing: Likely involved a specified number of devices tested on a test rig, but the specific sample size for each test (e.g., how many augmented trays underwent fatigue testing) is not detailed.
• Engineering analysis: This is a computational/design review rather than a "sample."
• Cadaveric evaluation: This would involve a certain number of cadaver specimens, but the exact count is not specified in the document.

The provenance (country of origin, retrospective/prospective) is not relevant for these types of non-clinical tests.

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 section is not applicable. The device is a physical implant, and its performance is assessed through mechanical tests and cadaveric evaluation, not through interpretation by human experts to establish "ground truth" for a diagnostic purpose.

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

This is not applicable. Adjudication methods like "2+1" are used in diagnostic consensus for things like image interpretation, which is not relevant to the mechanical and cadaveric testing of a shoulder implant.

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. An MRMC study is designed for evaluating diagnostic devices, particularly AI/ML systems that assist human readers. This document concerns a physical orthopedic implant.

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

This is not applicable. The device is a physical implant, not an algorithm.

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

For the non-clinical testing mentioned:

• Mechanical Testing: The "ground truth" would be the engineering standards for fatigue, strength, and range of motion.
• Cadaveric Evaluation: The "ground truth" would relate to anatomical fit, surgical procedure, and biomechanical function as observed by the evaluating surgeons/researchers in the cadaver models.

8. The sample size for the training set

This is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative development and testing, analogous to "training" in an engineering sense, but not a data-driven training set.

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

This is not applicable for the same reason as point 8.

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The Equinoxe Humeral Reconstruction Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Revision where other devices or treatments have failed
• Correction of functional deformity
• Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
• Traumatic arthritis
• Oncology applications including bone loss due to tumor resection.
• Significant humeral resection which are unmanageable using other treatment methods

The Equinoxe Humeral Reconstruction Prosthesis System can be used in either primary or revision arthroplasty procedures.

The Equinoxe Humeral Reconstruction Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreplaceable and grossly deficient, and a functional deltoid muscle is present.

In the USA, the Equinoxe Humeral Reconstruction Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.

The Equinoxe Humeral Reconstruction Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Humeral Reconstruction Prosthesis Distal Stem Collars are only for uncemented, press-fit use.

The proposed Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies represent a modification of the predicate Exactech Equinoxe Humeral Reconstruction Prosthesis Proximal Bodies cleared in K143659. Both the predicate and proposed devices have the same intended use, general design features and basic fundamental scientific technology. The only difference between the predicate and the proposed device is a decreased tuberosity thickness.

Based on the provided text, the device in question is the Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies, which is a type of shoulder joint prosthesis. The document is a 510(k) premarket notification summary submitted to the FDA.

It is crucial to understand that a 510(k) submission for this type of device (a Class II orthopedic implant) focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, primarily through engineering analysis and mechanical testing, rather than clinical performance (like an AI/software device would). This means the type of acceptance criteria and supporting studies are very different from what one would expect for an AI/ML medical device.

Therefore, many of the requested points regarding AI/ML device performance (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) are NOT applicable to this document as it describes a hardware orthopedic implant, not an AI/ML software.

Here's an analysis based on the provided text, addressing the relevant points:

Acceptance Criteria and Study for Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies

The document describes the acceptance criteria and study to demonstrate substantial equivalence of a modified orthopedic implant to a predicate device. The focus is on mechanical and material integrity, not clinical effectiveness of an AI/ML algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not applicable in the context of clinical trial or AI/ML test sets. The "sample size" here refers to the number of test articles/specimens used for the mechanical tests. The exact number of specimens tested for each mechanical test (e.g., how many constructs were subjected to fatigue testing) is not explicitly stated in this summary document.
• Data Provenance: The tests are described as "engineering analysis" and "pyrogen testing" conducted by the manufacturer, Exactech Inc., in Gainesville, Florida, USA. These are laboratory studies, not retrospective or prospective patient data studies.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable. This submission focuses on the safety and performance of a physical implant through engineering tests, not on diagnostic accuracy requiring expert image interpretation or clinical outcomes. Ground truth for mechanical properties is established by engineering standards and measurements, not expert consensus from medical professionals.

4. Adjudication Method for Test Set

• Not applicable. There is no "test set" in the sense of patient data requiring adjudication for diagnosis or outcomes. The "test set" consists of physical specimens undergoing standardized mechanical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is relevant for evaluating the impact of AI on human readers for diagnostic tasks (e.g., interpreting medical images). This document describes a physical orthopedic implant and its mechanical properties.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

• Not applicable. This is not an AI/ML algorithm. The "performance" is the mechanical integrity of the implant itself.

7. Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on engineering standards and regulatory limits for mechanical properties (e.g., material strength, fatigue life, pull-off force) and biocompatibility (e.g., pyrogen levels). It's essentially "performance against established engineering specifications and predicate device performance."

8. Sample Size for Training Set

• Not applicable. There is no AI/ML model being "trained" here.

9. How Ground Truth for Training Set was Established

• Not applicable. (See #8)

Summary of Relevant Information from the Document:

The acceptance criteria for the Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies are primarily functional and material-based, demonstrating that the modified device performs similarly to or better than the predicate device under specific mechanical challenges and meets biocompatibility standards. The study proving this involved engineering analyses and mechanical bench testing, focusing on parameters like taper, suture abrasion, axial pull-off, fatigue, and torsion, along with pyrogen testing. The ultimate "acceptance" is the FDA's determination of substantial equivalence to the predicate device K143659.

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