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When used with an appropriate humeral stem from the Coffeld2 Total Shoulder System, 3D Humeral Heads are indicated for use as orthopedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glonoid component from the Cofield or Neer III Total Shoulder Systems, respectively. When used with an appropriate humeral stem, 3D Humeral Heads are intended for use with bone cement only (i.e. cemented fixation) and for single use only. 3D Humeral Heads are intended for the following indications:

Proximal Humeral Prosthesis - (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, non-union of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.

Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component as described above) - severe destruction of the glenohumeral articular surfaces with intractable chronic pain in theumatoid arthritis, osteoarthritis, traumatic arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.

3D humeral heads are manufactured from forged cobalt chrome (CoCr) material (ASTM F799) and can be used with existing cobalt chrome humeral stem components from the Cofield' Total Shoulder System previously cleared from market. 3D taper sleeves are manufactured from titanium (Ti-6Al-4V) material conforming to the requirements of ASTM F1472.

Here's an analysis of the provided text regarding the 3D Humeral Heads device, structured to address your specific questions about acceptance criteria and the supporting study:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical trial or detailed performance study against specific acceptance criteria. Therefore, the information regarding acceptance criteria and the study proving the device meets them is limited.

1. Table of Acceptance Criteria and Reported Device Performance

Missing/Not Provided:

• Specific quantitative acceptance thresholds for mechanical performance (e.g., minimum distraction force, maximum displacement).
• Specific quantitative acceptance thresholds for ion release (e.g., maximum allowable concentration of specific ions).
• Detailed test methods used for mechanical and ion release testing.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size used for the mechanical humeral head distraction testing or ion release analysis. It simply states these tests were "performed."
• Data Provenance: The document does not specify the country of origin of the data. Given it's a 510(k) submission to the FDA, it implies the data was generated or compiled for US regulatory purposes, but the actual location of the testing laboratories is not mentioned. The data is retrospective in the sense that the testing was performed, and the results are being reported as part of a premarket submission. It is not a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable or not provided in this 510(k) summary. For device approvals based on substantial equivalence, particularly for mechanical components like humeral heads, "ground truth" is typically established through recognized engineering standards, material specifications (like ASTM F799, ASTM F1472), and established testing methodologies, rather than expert consensus on a test set of clinical cases. The "experts" involved would be materials scientists, engineers, and quality assurance personnel responsible for conducting and interpreting the mechanical and chemical tests, but their specific number or qualifications are not detailed here.

4. Adjudication Method for the Test Set

This is not applicable or not specified. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective assessments (e.g., image interpretation, symptom severity) require consensus among multiple observers. For mechanical and material property testing, the "adjudication" is based on objective measurements and comparison against predefined engineering standards.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for diagnostic imaging devices often involving AI assistance. The 3D Humeral Heads are orthopedic implants, not a diagnostic tool or an AI-assisted system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, this is not applicable. The device is a physical orthopedic implant and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

For this device, the "ground truth" is primarily based on:

• Engineering Standards: Adherence to material specifications (ASTM F799, ASTM F1472).
• Mechanical Test Results: Objective measurements from distraction testing, compared against implied or unstated "acceptable performance" thresholds.
• Chemical Analysis: Objective measurements from ion release analysis, compared against implied or unstated "acceptable performance" thresholds.
• Comparison to Predicate Devices: Performance characteristics and safety profiles of previously approved, legally marketed devices.

It does not rely on expert consensus on clinical cases, pathology, or direct patient outcomes data in the context of this 510(k) summary.

8. The Sample Size for the Training Set

Not applicable. This device is a physical orthopedic implant, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As a physical orthopedic implant, there is no "training set" or "ground truth for a training set" in the context of machine learning.

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