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The Tornier Pyrocarbon Humeral Head associated with the Tornier Flex Stem is indicated for use as a replacement of deficient humeral heads disabled by:

• Non-inflammatory degenerative joint diseases (osteoarthritis, avascular necrosis) .
• . Traumatic arthritis.

The Tornier Pyrocarbon Humeral Head Shoulder Prosthesis, combined with the Tornier Flex Humeral Stem, are to be used only in patients with an intact or reconstructable rotator cuff and if the native glenoid surface is intact or sufficient, where they are intended to increase mobility, stability, and relieve pain.

Note: The coated humeral stem is intended for cementless use. The noncoated humeral stem is for cemented use only

The Tornier Pyrocarbon Humeral Head is a prescription use device that is comprised of the pyrolytic carbon (pyrocarbon) articulating surface and a cobalt chromium alloy double taper neck. The humeral head is provided pre-assembled to the double taper to the end user and is compacted onto 510(k) cleared compatible humeral stems (K151293) for replacement of deficient humeral heads disabled by noninflammatory arthritis, or traumatic arthritis. The pyrocarbon articulating surface is made of a graphite substrate core, coated with a layer of pyrolytic carbon deposited onto the substrate via chemical vapor deposition. The pvrocarbon articulating surface is pressed into the cobalt chromium alloy double taper neck during the manufacturing process, is provided as a singular construct to the end user, and is not intended to be disassembled by the end user. Compatible monoblock humeral stems are available in titanium plasma spray coated or uncoated versions. The humeral stems are designed with a female taper connection to accept the mating male taper connection of the pyrocarbon humeral heads.

The provided text describes the acceptance criteria and a clinical study that proves the Tornier Pyrocarbon Humeral Head device meets these criteria. However, it does not detail a study involving AI or human readers for diagnostic image analysis. Instead, the "study" referenced is a clinical trial evaluating the safety and effectiveness of a medical implant.

Therefore, many of the requested points related to AI model evaluation, such as "number of experts used to establish ground truth," "adjudication method," and "MRMC comparative effectiveness study," are not applicable to this document's content.

I will provide the information that is available in the document regarding the acceptance criteria and the clinical study of the implant.

Acceptance Criteria and Device Performance for Tornier Pyrocarbon Humeral Head (Hemiarthroplasty Implant)

The acceptance criteria for this medical device are primarily defined through bench testing (non-clinical performance) and clinical study endpoints (safety and effectiveness in patients).

1. Table of Acceptance Criteria and Reported Device Performance

A. Bench Testing (Non-Clinical Mechanical Performance)

B. Clinical Performance (Primary Endpoint for Clinical Success at 24 Months)

1. Change in Constant score is ≥ 17;
2. No revision surgery;
3. No radiographic evidence of system disassembly or fracture;
4. No system-related serious adverse event. | Composite Clinical Success (CCS):

• Intent to Treat (ITT): 82.7%
• Per Protocol (PP): 87.9%

Component Success Rates:

• Free of Revision: 98.1% (154/157)
• Constant Score improved 17+ points (among those with evaluable scores): 84.6% (121/143)
• Free of disassembly or fracture: 100.0% (157/157)
• Free of device related SAE: 96.8% (152/157) | Composite Clinical Success (CCS):
• Intent to Treat (ITT): 66.8%
• Per Protocol (PP): 63.1%

Component Success Rates:

• Free of Revision: 94.7% (160/169)
• Constant Score improved 17+ points (among those with evaluable scores): 73.1% (49/67)
• Free of disassembly or fracture: 100.0% (169/169)
• Free of device related SAE: 94.7% (160/169) |

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

• Sample Size (Test Set):
  • Pyrocarbon (Investigational) Group: 157 subjects enrolled.
  • Control Group: 169 subjects selected after Propensity Score (PS) matching from a historical dataset.
• Data Provenance:
  • Pyrocarbon Group: Prospective, multi-center, single-arm investigational study (IDE G140202 - Pyrocarbon IDE Study). Data collected from 18 sites within the US.
  • Control Group: Retrospective, derived from the Aequalis Post-Market Outcomes Study dataset. The exact country of origin for the Aequalis dataset is not explicitly stated, but given context with US-based clinical trials, it is likely also primarily US data or from similar western healthcare systems.

3. Number of Experts and Qualifications for Ground Truth

This question is not applicable as the document describes a clinical trial for a medical implant, not an AI model requiring human expert labeling of data. The "ground truth" for the clinical study is the patient's actual clinical outcome, measured through direct observation (e.g., revision surgery, radiographic findings) and patient-reported outcomes (e.g., Constant score changes).

4. Adjudication Method for the Test Set

This question is not applicable in the context of diagnostic performance evaluation for an AI model. For the clinical study of the implant:

• The primary endpoint was a composite outcome, objectively defined.
• "Unanticipated Adverse Device Effects" were determined by an independent medical monitor.
• Clinical data collection and evaluation would have followed standard clinical trial protocols, typically involving investigators at sites and a data monitoring committee. Explicit "adjudication" in the sense of resolving disagreements among multiple human readers of image data is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to evaluating the diagnostic performance of AI or other tools when used by human readers (e.g., radiologists interpreting images). The study described is a clinical trial comparing a new implant to a historical control.

6. If a Standalone (Algorithm Only) Performance Study was done

No, this question is not applicable as the document is about a physical medical implant, not an AI algorithm. Its "standalone performance" is demonstrated through bench testing (mechanical performance, biocompatibility, sterility) rather than diagnostic accuracy.

7. The Type of Ground Truth Used

For the clinical study:

• Clinical Outcomes Data: This includes hard endpoints such as occurrence of revision surgery, radiographic evidence of system disassembly or fracture, and presence of system-related serious adverse events.
• Patient-Reported Outcomes (PROs): These are quantitative measures of patient experience and function, such as the Constant score, ASES score, SANE, EQ-5D, and VAS pain scale. Improvement in these scores contributes to the definition of "success."

For the bench testing:

• Direct Measurement/Observation: Mechanical properties are empirically measured (e.g., force to cause disassembly, visual inspection for cracks, measured ROM).
• Comparative Data: For some tests without absolute acceptance criteria (e.g., taper disassembly, fretting/corrosion, third-body wear), performance was compared to another cleared humeral head with the same intended use.

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device (implant) and its clinical evaluation, not an AI model that requires a "training set" of data in the machine learning sense. The "training" for this device would refer to its manufacturing process and quality control, and the "data" is the clinical and bench testing data.

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

This question is not applicable for the reasons stated above.

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