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The Howmedica Humeral Intercalary System is intended to be used in the management of segmental bone loss of the humerus in Oncology patients secondary to radical bone loss and/or resection due to tumors. This system is intended to be used in the management of shoulder girdle resections such as the Tikhoff-Linberg procedure, which involves removal of the bone and soft tissues of the proximal humerus and shoulder girdle. The Howmedica Humeral Intercalary System is intended to be used with bone cement. There is no glenoid component associated with this system.

The Howmedica Humeral Intercalary System consists of a stem section with a body that may be attached to: 1) another stem section with body; or 2) a proximal bone cap. The stem section of the Humeral Intercalary System is fluted, and is available in diameters of 9mm and 11mm, with multiple body lengths. Both the stem segment and the proximal bone cap contain lap joints, which are joined by the use of machine screws that are available in diameters of 3 - 5 mm, and lengths of 15-20 mm. The attachment of one stem segment to another stem segment is used when there is bone loss/resection of the mid-section of the humerus. The distal stem segment is cemented into the distal segment of the humerus, and the proximal portion is cemented into place in the proximal fragment of the humerus. The stem segments are joined by the use of the machine screws noted above. If the proximal portion of the humerus is not present or has been resected, the bone cap segment is used proximally. There are suture holes in the bone cap to allow the passage of sutures to anchor the device proximally to the shoulder girdle (if this remains in place), or to the chest wall. The distal stem segment is cemented in place in the distal segment of the humerus. The bone cap is attached to the distal stem segment by the use of the screws noted above. These components will be manufactured from titanium allov (Ti-6Al-4V) which conforms to ASTM F-136.

This document describes a 510(k) premarket notification for the Howmedica Humeral Intercalary System, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness with human readers or standalone AI performance.

Instead, this document focuses on demonstrating substantial equivalence to predicates based on intended use, material, design, and relative indications and contraindications. The "study" mentioned is "Physical and Finite Element Analysis testing of the device," which is a type of engineering and biomechanical testing, not a clinical study to assess diagnostic performance or reader improvement.

Therefore, much of the requested information cannot be extracted from the provided text.

Here is what can be inferred or directly stated from the document, with explanations for what cannot be found:

1. 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):

• Sample Size: Not applicable in the context of clinical performance evaluation. The "test set" here refers to the physical device prototypes or models used for engineering analysis. No human participants or patient data are mentioned for this type of testing.
• Data Provenance: Not applicable. The "testing" refers to lab-based physical and finite element analysis.

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

• Not applicable. The ground truth for engineering tests (physical and finite element analysis) is based on established engineering principles, material properties, and biomechanical models, not expert consensus from medical professionals in a diagnostic context.

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

• Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of medical data, which is not the type of testing described here.

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, an MRMC comparative effectiveness study was not done. This device is a physical implant (Humeral Intercalary System), not a diagnostic algorithm or AI-assisted tool. Therefore, the concept of "human readers improve with AI" is not relevant.

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):

• For the "Physical and Finite Element Analysis testing," the "ground truth" would be the theoretical and empirical mechanical properties of the materials, the design specifications, and established biomechanical principles. It is not related to clinical outcomes, pathology, or expert consensus on medical images.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of what the document does provide regarding device evaluation:

The document indicates that the Howmedica Humeral Intercalary System underwent Physical and Finite Element Analysis testing. These are engineering studies designed to evaluate the mechanical integrity, stress distribution, and potential failure modes of the device under simulated physiological conditions. The success of these tests (though specific results are not provided in this summary) contributed to the FDA's "substantially equivalent" determination, implying the device meets appropriate safety and performance standards for its mechanical function. The substantial equivalence was also based on its similarity in intended use, materials, design, and indications/contraindications to existing, legally marketed predicate devices.

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