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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: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System and Comprehensive® Reverse Augmented Baseplates.

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

The Signature™ ONE System is developed to assist in pre-operative 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.

The provided text describes the 510(k) premarket notification for the Signature™ ONE System, a device intended to assist in pre-operative planning and intra-operative guiding for shoulder replacement surgery. However, the document does not contain specific acceptance criteria, detailed study results proving device performance against those criteria, or information regarding AI/algorithm performance metrics.

It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and principles of operation, rather than providing a detailed performance study with quantitative acceptance criteria and results.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: Not specified, although testing on "cadaveric specimens" is mentioned. The country of origin of the data is not provided. It is presented as nonclinical performance data, and the general nature of such testing typically implies prospective testing on the device model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the provided text.

4. Adjudication method for the test set

Not specified in the provided text.

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

• MRMC Study: Not mentioned.
• Effect Size of Human Readers with AI vs. without AI assistance: Not applicable, as no MRMC study or AI performance improvement claims are detailed. The device is described as assisting in pre-operative planning and intra-operative guiding, not as an AI for reading or interpreting medical images in the context of improving human reader performance.

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

• The document implies a "human-in-the-loop" system where the surgeon reviews, modifies, and approves the plan. It states the system "assist[s] in pre-operative planning and/or intra-operative guiding" and surgeons "interact with to review, modify and approve the plan."
• No standalone algorithm-only performance is detailed.

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

The term "ground truth" is not explicitly used. However, the validation lab performed studies "under full simulated use on cadaveric specimens," implying that the performance was assessed against known anatomical structures and surgical targets within those specimens, likely guided by expert surgical opinion and established anatomical references for accuracy.

8. The sample size for the training set

Not applicable. The document describes a medical device for surgical planning and guidance, not an AI/machine learning algorithm with a distinct "training set."

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

Not applicable. See #8.

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