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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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1. Relief of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the clenohumeral joint. 2) Irreducible 3 and 4 part fractures of the proximal humerus. 3) Non-united chronic humeral head fractures or fracture-dislocations. 4) Avascular necrosis of the humeral head. 5) Other difficult clinical management problems, including falled reconstructive procedures, where arthrodesis of resection arthroplasty are not considered acceptable.

The Kirschner Shoulders are all based on the original design concept of the Neer Shoulder. Common design features include Cobalt-Chromium-Molybdenum alloy substrate: smooth. distally tapered stem; grooves in the stem to aid in cement pressurization and provided torsional stability; four proximal fins to provided rotational stability and facilitate positioning insertion; continuous radius of curvature humeral head geometry and; all humeral heads are compatible with all glenoid components. Kirschner II-C Humeral Stems are one piece in that the head and stern are an single component. Modular II-C Humeral Stems are a one piece stem with a modular head attached by a Morse-type taper. Atlas-C Modular Stems are two piece stems composed of a proximal humeral component and a distal stem attached by a screw thread. This component also utilizes a modular humeral head. The Modular Glenoid Metal Backing provides reinforcement to a polyethylene bearing surface. The design is identical to the predicate device.

This 510(k) is for a change from a cobalt alloy plasma spray coating to a titanium alloy coating and a change in the manufacturing location. All other aspects of the device remain the same.

This document is a 510(k) premarket notification for a medical device (Kirschner Shoulders with Titanium Plasma Spray), which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a study or data proving specific acceptance criteria related to device performance in the way requested.

The 510(k) summary describes device modifications (change in plasma spray coating and manufacturing location) and indicates that "All other aspects of the device remain the same." This implies that the performance characteristics, and thus acceptance criteria, are assumed to be identical to the predicate devices. Therefore, a new study to prove updated acceptance criteria is not typically required or presented in such a submission.

Here's a breakdown of why I cannot fulfill your request based on the provided text, and what elements are present:

Why the Request Cannot Be Fully Answered with the Provided Text:

• No Acceptance Criteria or Performance Data: The document presents the device description, indications for use, and potential risks, but it does not explicitly state specific acceptance criteria (e.g., minimum tensile strength, fatigue life, wear rates, clinical success rates, etc.) nor does it provide study results to demonstrate performance against such criteria.
• Focus on Substantial Equivalence: The core of a 510(k) is to prove that a new device is "substantially equivalent" to a legally marketed predicate device. This often means demonstrating that the new device has the same intended use and similar technological characteristics, and does not raise different questions of safety and effectiveness. It doesn't necessarily require new performance studies if the changes are minor and don't affect performance.
• No Clinical Study Details: There is no mention of a clinical study, reader study, or any performance study data that would involve human subjects, readers, ground truth establishment, or sample sizes for testing or training sets.
• Device Type: This device is a shoulder prosthesis, an implantable mechanical device. Performance is typically assessed through mechanical testing (e.g., wear, fatigue, static strength) and sometimes by tracking long-term clinical outcomes, but no such data is present here.

What Information Can Be Extracted/Inferred from the Text (and why it doesn't fit your table):

Since there are no explicit acceptance criteria or performance study results presented, I cannot fill the table or provide the requested details about studies. However, I can explain what the document does convey:

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

• Acceptance Criteria: Not explicitly stated. For a 510(k) modification, the implied acceptance criterion is that the modified device's performance (e.g., mechanical properties, biocompatibility) is at least equivalent to the predicate device and meets established consensus standards for such implants.
• Reported Device Performance: Not reported directly in terms of specific metrics. The assumption is that its performance remains equivalent to the predicate device due to the limited nature of the changes (coating material and manufacturing location).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. No test set or performance data is presented.

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):

• Not applicable. No human-read or image-based test set is described.

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

• Not applicable. No test set requiring expert adjudication is described.

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:

• Not applicable. This device is a physical implant, not an AI or diagnostic imaging device. No MRMC study or AI component is mentioned.

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

• Not applicable. This device is a physical implant, not an algorithm.

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

• Not applicable. No ground truth establishment is described for device performance as typically understood for diagnostic or AI systems. For a physical implant, "ground truth" would relate to its physical properties (e.g., material composition, strength) and clinical outcomes, but no studies proving these are detailed here.

8. The sample size for the training set:

• Not applicable. No training set is mentioned as this is not an AI or learning-based device.

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

• Not applicable.

In summary, the provided text from the 510(k) premarket notification focuses on regulatory approval through substantial equivalence and does not contain the detailed performance study data requested.

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The device is composed of a metallic humeral stem which is designed to articulate with a commercially available glenoid component. There is no linkage across the joint.

The tapered collarless stem follows the natural contours of the canal; the tapered geometry loads the cement mantle in compression and promotes evenly distributed stress off-loading. Proximal fins contribute to maximize rotational stablity while suture holes in the fins allows for proximal reconstruction of complex humeral fractures. The stem is "grit blasted" for a roughened surface of 200 microinches which provides for an improved fixation between the stem/coment interface.

Stems are available in 7 sizes with diameters ranging from 6.5mm to 15.5mm in 1.5mm increments at a length of 115mm. for primary use. Revision stems are available in a range of diameters of 8.0mm to 1.5mm increments at a lenath of 190mm.

The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies for an AI device.

The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device called the "CoCr Bi-Angular Humeral Component," which is a shoulder joint prosthesis. It describes the device, its potential risks, and lists commercially available equivalent devices. It also includes a table of reported complications associated with total shoulder arthroplasty, citing various medical literature.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the provided text.

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