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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the Signature™ ONE System.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal Reverse Plus® Shoulder. Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance® Glenoid System.

The Signature™ ONE System pre-operative planning is also compatible with the humeral components of the following shoulder implant systems in accordance with their indications: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, and Identity™ Shoulder System.

The Signature™ ONE System Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides and bone model) if desired in skeletally mature individuals for Total Shoulder Arthroplasty. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Models are designed and manufactured of polyamide (nylon) using additive manufacturing selective laser sintering (SLS), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provided nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan on the scapula. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty workflow.

The Signature™ ONE System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

The purpose of this submission is to introduce new hardware kits for the existing compatible Comprehensive Reverse Augment implants and to include the addition of pre-operative planning of humeral components. A Rotational Guide component will be available as part of these two kits. Modifications have been made to the software applications to accommodate the new guide ordering option. The overall manufacturing process, materials, sterilization methods, have not changed from the previous primary predicate and principal of operation remains similar.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific performance metrics typically found in such documents. The "Summary of Performance Data (Nonclinical and/or Clinical)" section is quite generic, listing categories of tests rather than specific results or acceptance criteria.

Therefore, I cannot fulfill all components of your request with the information provided. However, I can extract what is available and highlight what is missing.

Here's a summary of the available information and what is absent:

Missing Information:

• Specific Acceptance Criteria and Reported Device Performance (Table): The document lists categories of tests (Performance Tests, Engineering Analysis, Usability Engineering, Validation, Software V&V) but does not provide quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) or the actual reported performance values for the device against these criteria.
• Sample size for the test set and data provenance: The document mentions "Verification and Validation Testing" but does not specify the number of cases or subjects in the test set, nor the country of origin or whether the data was retrospective or prospective.
• Number of experts used to establish ground truth and their qualifications: No information is provided about the experts involved in establishing ground truth for any test sets.
• Adjudication method for the test set: No information is provided regarding adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not mention an MRMC study or any results regarding human reader improvement with AI assistance.
• Standalone (algorithm-only) performance: While software verification and validation are mentioned, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) for the algorithm are not provided.
• Type of ground truth used: The description of "Validation... to validate related user needs, intended use and safety and effectiveness" is generic and does not specify how ground truth was established (e.g., expert consensus, pathology, outcome data).
• Sample size for the training set: There is no mention of a training set or its size.
• How the ground truth for the training set was established: Since a training set is not mentioned, the method for establishing its ground truth is also not provided.

Available Information (Indirectly related to performance):

The document primarily focuses on establishing substantial equivalence to a predicate device (K212560 and K211359) by demonstrating that the new device, the Signature™ ONE System, does not raise new questions of safety or effectiveness despite new features.

The performance data mentioned in the document is categorized as:

• Device Performance Testing:
  • Performance Tests: Documented to ensure performance of implemented features and verify related design inputs.
  • Engineering Analysis: Documented to ensure performance of implemented features and verify related design inputs.
  • Usability Engineering: Performance of the system in regards to human factors engineering.
  • Validation: Performed to validate related user needs, intended use, and safety and effectiveness.
• Software Verification and Validation Testing: Conducted to satisfy requirements of the "Content of Premarket Submissions for Device Software Functions Guidance" and IEC 62304. This testing aims to demonstrate the system "does not raise any new issues of safety and effectiveness as compared to the predicate devices."

Conclusion from the document:

The conclusion drawn by the submitter is that "any differences between the subject and predicate devices do not raise different questions of safety and effectiveness and the proposed device is at least as safe and effective as the legally marketed predicate devices." This implies that the performance data (though not detailed here) was sufficient to demonstrate this equivalence.

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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance™ Glenoid System.

The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in preoperative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation.

The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

Modifications have been made to include guides and bone models for the Alliance Glenoid System, to the planning application and user interface, and the inclusion of an additional glenosphere size for the Comprehensive Reverse Implant System within the Signature™ ONE planning software application. The overall planning process, manufacturing process, materials, sterilization methods, principal of operation, have not changed from previous predicates.

The provided text describes a 510(k) premarket notification for the Signature™ ONE System, a device used for pre-operative planning and intra-operative guiding in shoulder replacement surgery. However, the text does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document lacks a table of acceptance criteria with reported device performance metrics, sample sizes for test and training sets, details about ground truth establishment (number/qualifications of experts, adjudication methods), and information about MRMC studies or standalone algorithm performance.

The document primarily focuses on explaining the device's indications for use, its substantial equivalence to predicate devices, and the general types of testing performed (engineering analysis, performance tests, system validation, and software verification/validation).

Here's what can be extracted and what is missing based on your prompt:

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

• Missing. The document states that "Performance Tests- Design verification tests were O documented to ensure the performance of the implemented features and verify related design inputs" but does not provide specific acceptance criteria or the measured performance outcomes.

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

• Missing sample size for the test set.
• Missing data provenance details. The document mentions "Cadaveric validation performed" but doesn't specify the number of cadavers or their origin. It also doesn't specify if other data used for software testing was retrospective or prospective, or its geographic origin.

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):

• Missing. The document does not describe how ground truth was established for any performance testing, nor does it mention the involvement of experts in defining a gold standard.

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

• Missing. No information on adjudication methods for establishing ground truth is provided.

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:

• Missing. The document does not mention any MRMC studies or comparative effectiveness studies involving human readers with and without AI assistance. The device is described as assisting in planning and guiding, implying human interaction, but no such study details are provided.

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

• Implicitly yes, partially, but no metrics are provided. The software verification and validation would involve algorithm-only testing to ensure its functionality. However, specific standalone performance metrics (e.g., accuracy of anatomical landmark identification by the algorithm alone) are not reported. The device's function is to "assist" which suggests a human-in-the-loop system.

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

• Not explicitly stated. For the "Cadaveric validation," the ground truth would likely be based on physical measurements or surgical outcomes on the cadavers, but this is not detailed. For software testing, the ground truth for image processing tasks would typically be pre-annotated data, but the source or method of annotation is not mentioned.

8. The sample size for the training set:

• Missing. The document does not provide any information about a training set since it focuses on verification and validation of a cleared device, not the development or training phase of an AI model per se. While the device has "planning application" and "user interface" modifications, and "overall workflow remains unchanged from the predicate devices," it isn't explicitly stated that a "training set" in the machine learning sense was used for this particular submission.

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

• Missing. As no training set information is provided, no details on how its ground truth was established are present.

In summary, the provided document is a regulatory approval letter and a summary of the 510(k) submission, confirming substantial equivalence. It outlines the device's purpose and general testing activities but does not delve into the detailed performance study methodology, acceptance criteria, and specific results you've requested for an AI/ML device. This level of detail is often found in the full 510(k) submission or associated study reports, which are typically not included in the public-facing FDA clearance letter.

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