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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™M 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 Planning application to include Alliance™ Glenoid implant system as a Pure Planning option (i.e. no Guides and Bone Models). In addition, modifications have been made to the user interface of the overall planning application. The planning process, manufacturing process, materials, sterilization methods, principal of operation, have not changed from previous predicates.

This FDA 510(k) premarket notification for the Signature™ ONE System does not contain the specific acceptance criteria, detailed study results, and statistical information typically required to fully answer your request regarding device performance and its proof. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study proving the device meets predefined clinical acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state quantitative acceptance criteria (e.g., accuracy thresholds, precision ranges) or corresponding reported device performance metrics in a table format for clinical efficacy. The "Device Performance Testing" section mentions "Engineering Analysis" to "ensure the performance of the implemented features and verify related design inputs" but does not provide details on what these performance metrics were or their targets.

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

The document does not specify any sample size for a test set for clinical performance evaluation. It mentions "patient-specific radiological images" are used for planning, but no details about a dedicated test set of patients or images for validation are provided. Therefore, data provenance (country of origin, retrospective/prospective) is also not available here.

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 information is not provided. The application is for a planning and guiding system, where the ground truth regarding surgical accuracy would typically be established by comparing the planned outcome to the actual intraoperative or post-operative outcome, often involving expert surgeons. However, no such study details are present.

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

This information is not provided as there is no described test set of clinical images or cases requiring ground truth adjudication.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a planning and guiding system, not an AI diagnostic tool where human reader performance would typically be enhanced.

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

The document describes the Signature™ ONE System as assisting in "pre-operative planning and/or intra-operative guiding of surgical instruments." This inherently implies a human-in-the-loop system (the surgeon). The "planning application" is a software component, but its performance is not described in a standalone, algorithm-only context of clinical efficacy in this document. The "Software Verification and Validation Testing" addresses the software's compliance with regulations like IEC 62304 and its concern level ("moderate"), implying testing of its functionality and reliability, but not its clinical performance as a standalone entity in terms of accuracy against ground truth.

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

This information is not provided. For a surgical planning and guidance system, ground truth would ideally come from direct measurements of surgical accuracy and alignment post-procedure, or potentially surrogate measures confirmed by expert assessment.

8. The sample size for the training set

This information is not provided. While the system uses "patient-specific radiological images" for planning, the document does not discuss a "training set" in the context of an AI/ML model where a large dataset is used to train an algorithm. The system appears to be based on computational algorithms for planning rather than a deep learning model trained on a vast image dataset.

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

This information is not provided as there is no discussed training set.

Summary of what is present:

• Software Verification and Validation Testing: This was conducted to satisfy FDA guidance and IEC 62304 for medical device software. The software is classified as "moderate" level of concern.
• Engineering Analysis: Performed to ensure performance of implemented features and verify design inputs.
• Usability Engineering: Addressed user interactions.

In conclusion, this 510(k) notification focuses on the substantial equivalence of the Signature™ ONE System to previously cleared predicate devices, asserting that its modifications (like adding Alliance™ Glenoid system compatibility) do not raise new questions of safety and effectiveness. It provides a general overview of verification and validation activities (software, engineering, usability) but lacks the detailed performance study results and specific acceptance criteria that you requested for a comprehensive understanding of the device's proven clinical effectiveness.

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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-overative 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.

Modifications have been made to some of the applications to improve the overall workflow: however, the patient specific guides and bone models remain unchanged from the predicate. In addition, modifications have been made to the user interface of the planning application.

The provided text is a 510(k) summary for the Signature™ ONE System, a device for pre-operative planning and intra-operative guiding for shoulder replacement surgery. It discusses the device's indications for use, its similarity to a predicate device, and modifications made. However, the document does not contain the specific information requested regarding acceptance criteria, detailed study results (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), or the ground truth establishment process.

The section "Summary of Performance Data (Nonclinical and/or Clinical)" only states:

• "Addition of a landmark to the Signature ONE Planner to display the location of the deepest glenoid point"
• "A feature is added to the Signature ONE Planner to display the medial/lateral translation between the backside on the implant and a reference landmark located on the most lateral point of the glenoid"
• "A feature is added to the Signature ONE Planner to display the percentage of contact between the selected implant and the glenoid surface"
• "All of the test steps passed successfully."

This is a very high-level summary and does not provide the detailed study information needed to answer your questions. This type of FDA clearance (510(k)) often relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive, complex clinical trial data as might be seen for novel technologies or PMA (premarket approval) applications.

Therefore, I cannot provide the requested information from the given text. The document indicates that tests were performed and passed, but the specifics of those tests, the acceptance criteria, and how they proved the device meets those criteria are not detailed in this summary.

Ask a specific question about this device

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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