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The indications for the Osteonics Solar™ Shoulder Bipolar System are:

• Aseptic necrosis of the humeral head .
• Painful, disabling joint disease of the shoulder resulting from: degenerative ● arthritis, rheumatoid arthritis or post-traumatic arthritis.
• . Proximal humeral fracture and/or dislocation
• Clinical management problems where arthrodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.
• Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.

The Osteonics" Solar™ Shoulder Bipolar System consists of an Osteonics Solar™ Shoulder Bipolar Humeral Head Component, an Osteonics 22 mm Solar™ Shoulder Bipolar Modular Head and an Osteonics Solar™ Shoulder Humeral Stem. The humeral stem was determined substantially equivalent via 510(k) K955731. There have been no modifications made to the humeral stem. The bipolar head component consists of three preassembled pieces: a metal shell, UHMWPE insert and locking ring. The component will be sold preassembled. The metallic shell is manufactured from ASTM F75 cobalt chromium alloy. The 22 mm bipolar modular head is manufactured from ASTM 1537 cobalt chromium alloy. The Osteonics Solar™ cobalt chromium Shoulder Bipolar Components (Bipolar Head Component and 22 mm Bipolar Modular Head) are intended to be used in cementless applications and as a hemi-shoulder system. Used as a hemi-shoulder replacement device, the Osteonics Solar™ Shoulder, Bipolar Humeral Head Components are intended to articulate directly with the anatomic glenoid.

This document is a 510(k) Premarket Notification summary for the Osteonics® Solar™ Shoulder Bipolar System. It outlines the device description, intended use, and claims of substantial equivalence to a predicate device. This type of submission generally does not include detailed performance studies with acceptance criteria in the way that, for example, a submission for diagnostic software would.

Here's an analysis of why the requested information is largely absent in this document, based on the nature of a 510(k) for a medical implant:

• Medical Device Class III (Prosthesis): The device is classified as Class III (Shoulder joint metal/polymer Semi-constrained cemented prosthesis and Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis). For Class III devices, substantial equivalence is key in a 510(k). This typically involves demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness. This often relies on bench testing, materials testing, and mechanical/wear testing rather than clinical studies with "acceptance criteria" and "device performance" in the terms usually associated with AI or diagnostic device performance.

• Focus on Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the Osteonics® Solar™ Shoulder Bipolar System is "substantially equivalent" to an existing, legally marketed device (the Biomet Bi-Angular Bi-Polar Shoulder System). This means the focus is on comparing the design, materials, and intended use to the predicate, not necessarily on new, independent clinical studies with performance metrics.

• Missing Information: The document does not contain the following information as it is generally not required for this type of 510(k) submission:

  • Table of acceptance criteria and reported device performance: This document doesn't provide specific performance metrics like sensitivity, specificity, or accuracy that would be found in a study for a diagnostic device. The "performance" in this context would likely refer to mechanical and material properties compared to the predicate.
  • Sample size and data provenance for a "test set": There isn't a "test set" in the context of clinical images or patient data for algorithmic performance.
  • Number of experts and qualifications for ground truth: Ground truth in this context would likely involve engineering specifications, material standards, and clinical outcomes from the predicate device's history, not expert consensus on image interpretation.
  • Adjudication method: Not applicable for this type of device.
  • Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for a physical implant, not a diagnostic algorithm involving human readers.
  • Standalone algorithm performance: Not applicable, as this is not an algorithm.
  • Type of ground truth used: For mechanical devices, ground truth is typically engineering specifications, material properties, and established clinical success of predicate devices.
  • Sample size for training set/How ground truth for training set was established: Not applicable, as this is not an AI/ML device requiring training data.

Summary of Information Available in the Provided Text (and what is not):

Based on the provided text, the device is a medical implant (shoulder bipolar system), and the submission is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the questions related to clinical study performance metrics, AI/ML algorithms, and expert ground truth are not addressed in this type of document.

What is present:

• Predicate Device: Biomet Bi-Angular Bi-Polar Shoulder System.
• Intended Use/Indications: Aseptic necrosis of the humeral head; Painful, disabling joint disease of the shoulder (degenerative, rheumatoid, post-traumatic arthritis); Proximal humeral fracture and/or dislocation; Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results; Pathological conditions or age considerations that indicate a more conservative glenoid procedure and avoidance of bone cement in the glenoid.
• Device Components & Materials: Bipolar Humeral Head Component, 22 mm Solar™ Shoulder Bipolar Modular Head, and Solar™ Shoulder Humeral Stem. Metallic shell is ASTM F75 cobalt chromium alloy. Modular head is ASTM 1537 cobalt chromium alloy. UHMWPE insert and locking ring in the bipolar head component.
• Claim of Equivalence: The subject devices (Bipolar Humeral Head and Bipolar Modular Head) are substantially equivalent to the bipolar components of the predicate (Biomet Bi-Angular Bi-Polar Shoulder System Components) in all material and design aspects, indications, and intended use.

In conclusion, the requested information regarding "acceptance criteria" through a "study that proves the device meets the acceptance criteria" as defined by performance metrics (like sensitivity/specificity) and clinical study design (sample sizes, expert ground truth, MRMC, etc.) is not present in this 510(k) summary because this type of submission for a physical implant does not typically involve such studies. Instead, the "proof" for substantial equivalence relies on comparison of design, materials, manufacturing, and intended use to a legally marketed predicate device, along with bench testing/materials testing to ensure equivalent safety and performance.

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Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, theumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.

The New Zimmer Shoulder features modular and monoblock cobalt-chrome alloy humeral stems intended for use with or without cement in total shoulder arthroplasty. The cobaltchrome alloy humeral heads feature female Morse-type tapers which facilitate assembly with the modular humeral stems. The keeled glenoid component is manufactured from UHMWPE. It is intended for cemented use only.

The provided text describes a 510(k) submission for the "New Zimmer Shoulder System." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics for the New Zimmer Shoulder System. Instead, it states:

2. Sample Size for the Test Set and Data Provenance

The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Performance Testing" section states that "Testing performed on the taper and the glenoid component demonstrated that the New Zimmer Shoulder System is safe and effective and substantially equivalent to predicate devices," but it does not specify what type of testing or how many samples were involved.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth or their qualifications. The testing described appears to be device-specific mechanical or functional testing rather than clinical evaluation requiring expert consensus on patient data.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as there is no indication of human-reviewed test sets or expert evaluations requiring adjudication.

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

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through component testing, not direct comparison of human reader performance with and without AI assistance.

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

This is not applicable as the device is a physical shoulder joint prosthesis, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device would be based on engineering specifications, material science standards, and biomechanical parameters that define the safety and effectiveness of the components (taper and glenoid). The summary indicates that the testing demonstrated "safe and effective and substantially equivalent to predicate devices," implying that the performance was measured against established standards for shoulder prostheses.

8. Sample Size for the Training Set

This is not applicable as the device is a physical shoulder prosthesis, not an AI algorithm requiring a training set.

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

This is not applicable as the device is a physical shoulder prosthesis, not an AI algorithm.

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