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Biomet Comprehensive Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coating are indicated for either cemented or uncemented biological fixation applications.

Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium glenospheres are intents with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coating are indicated for either cemented or uncemented biological fixation applications.

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
5. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
   Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications.

The Comprehensive® Modular Hybrid® Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.

The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.

The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy*

*The Titanium Versa-Dial Humeral Head Prosthesis is not for sale in Canada

Anatomic Applications

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may be suitable or may be inadequate.

Reverse Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Huments with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Biomet Comprehensive Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.

Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixations. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Comprehensive Shoulder System consists of partial and total shoulder replacement components use in cemented and uncemented applications. The devices are modular components consisting of humeral stems, modular heads and glenoid components for anatomic and humeral tray and glenosphere components for reverse configuration. The purpose of the current submission is to add MR Conditional labeling.

Here's an analysis of the provided information, addressing your questions about acceptance criteria and study details.

Important Note: The provided document is a 510(k) FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through extensive clinical trials. Therefore, much of the information you've requested regarding specific acceptance criteria, performance metrics, ground truth, and human reader studies is not present in this type of document because it is not required for a 510(k) submission for this type of device (implants). The "acceptance criteria" here implicitly refer to the device not posing new questions of safety or effectiveness compared to its predicates and meeting established standards for its material properties and MR compatibility.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a shoulder replacement system seeking to add "MR Conditional" labeling, the "acceptance criteria" are related to established safety and performance standards for implants, particularly concerning their interaction with Magnetic Resonance (MR) environments. The performance data provided is entirely non-clinical and related to MR compatibility.

Table of Acceptance Criteria and Reported Device Performance

• Indications for Use: Identical to predicate.
• Materials: Identical to predicate.
• Design Features: Identical to predicate.
• Sterilization: Identical to predicate. |
  | MR Compatibility: The device should not pose an unacceptable risk or generate excessive artifacts in an MR environment and should meet established standards for MR Conditional labeling. | - ASTM F2503-20 (Labeling): Evaluation completed (implies compliance for labeling).
• ASTM F2119-07R13 (Artifact): Evaluation completed (implies acceptable artifact levels).
• ASTM F2213-17 (Torque): Evaluation completed (implies acceptable torque in MR environment).
• ASTM F2052-21 (Displacement Force): Evaluation completed (implies acceptable displacement force in MR environment).
• ASTM F2182-19E02 (RF-heating): Evaluation completed (implies acceptable RF-heating).
• Preliminary Phantom Evaluation: Completed. |

Study Details

As this is a 510(k) for a medical implant and not an AI/software device, many of the requested categories related to diagnostic performance or human reading studies are not applicable.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable in the context of diagnostic data. For the non-clinical MR compatibility tests, the "sample size" would refer to the number of device components tested according to the referenced ASTM standards. This specific number is not provided in the summary but would be detailed in the full test reports.
   • Data Provenance: Not applicable for diagnostic data. The MR compatibility tests are conducted in a controlled laboratory setting (likely in the US, where the company is based), not on patient data.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Not applicable. Ground truth, in the AI/diagnostic context, refers to definitively established diagnoses or classifications. For an implant, "ground truth" relates to material science and engineering principles verified by standard testing methods and accredited labs.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods are used to resolve discrepancies among expert opinions in diagnostic studies.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems, not for physical implants.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • No, a standalone performance study in the AI sense was not done. The "performance" here is for the physical device's interaction with an MR field, which isn't an "algorithm-only" performance.

6. Type of Ground Truth Used:

   • For the core claims of equivalence (materials, design, etc.), the "ground truth" is established engineering and scientific principles, validated by testing against relevant ASTM standards and by comparison to the predicate devices. For MR compatibility specifically, the ground truth is defined by the objective measurements obtained through the standard ASTM test procedures (e.g., measured temperature rise, displacement force, artifact size) and compared against the limits established by those standards to determine "MR Conditional" status.

7. Sample Size for the Training Set:

   • Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set.

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These devices are intended for shoulder joint arthroplasty.
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder (CRS) is a total shoulder replacement system in a reverse configuration. The CRS was designed to provide a complete, seamless system based on the Comprehensive Shoulder platform by avoiding the need to remove a well-fixed humeral stem associated with a prior anatomical shoulder arthroplasty for conversion to reverse shoulder arthroplasty. This is made possible because the CRS can utilize any of the existing Comprehensive stems, including primary, revision, or fracture stems in cemented or uncemented applications. The CRS performs its function by replacing the damaged or diseased articular surfaces of the native shoulder with artificial surfaces with the intent to improve shoulder function and/or reduce shoulder pain.

The provided document is a 510(k) premarket notification for the Biomet Comprehensive® Reverse Shoulder. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a standalone study. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not directly applicable or explicitly stated in this document in the way it would be for a de novo submission or a product with novel technology requiring extensive clinical trials to establish safety and effectiveness.

However, based on the non-clinical tests described, we can infer the acceptance criteria and the "study" (non-clinical testing) that supports the device's performance relative to these criteria.

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

Information not available or not applicable based on the provided document:

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 specified for the fatigue strength or ROM testing. Non-clinical mechanical tests typically use a smaller number of samples sufficient to demonstrate statistical significance or meet a deterministic threshold.
• Data Provenance: The fatigue testing was "performed in the Zimmer Fatigue and Fracture Mechanics Laboratory (Warsaw, IN)". This indicates a U.S.-based, internal laboratory setting for the non-clinical tests. The tests themselves are prospective for the specific design changes.

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 question is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or clinical data requiring expert ground truth establishment. The "ground truth" for these tests is the physical performance under controlled conditions.

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

• This question is not applicable for the same reason as point 3. Adjudication methods are relevant for subjective data interpretation, not for objective mechanical performance tests.

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 MRMC study was done. This is a mechanical implant, not an AI-powered diagnostic device. The document explicitly states "Clinical Tests: None provided."

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

• This question is not applicable as it pertains to AI/software performance. The device is a surgical implant, not an algorithm.

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

• For the non-clinical tests: The "ground truth" is defined by the physical and mechanical properties of the device as measured under controlled laboratory conditions, against established engineering standards (e.g., ASTM F1378-12) and internal test requirements. It's an objective measurement of material and design performance.
• For the overall submission: The primary "ground truth" or basis for clearance is substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as existing ones.

8. The sample size for the training set

• This question is not applicable as the document describes a mechanical implant, not a machine learning model. There is no concept of a "training set" in this context.

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

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

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