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The Signature Personalized Patient Care System - Glenoid Guide System is intended to be used as a surgical instrument to assist in the positioning of glenoid components intra-operatively using anatomical landmarks of the shoulder that are identifiable on preoperative imaging scans.

The Signature Personalized Patient Care System - Glenoid Guide System can be used in conjunction with the Comprehensive Total and Reverse Shoulder Systems (including the Modular Hybrid Glenoid, Bio-Modular Heads and Stems), and their respective components, which require placement of an initial center pin or hole to guide the associated system instruments.

The Signature Glenoid Guide is intended for single use only.

Patient specific guides are designed and manufactured in plastic using additive manufacturing. The guides are developed using patient imaging scans, software, and the clinician approved/finalized pre-surgical plan. The guides facilitate the placement of metallic pins and can be used in conjunction with existing anatomic and reverse Biomet instrumentation and surgical techniques. Intraoperative placement of metallic bone pins in arthroplasty procedures.

The provided text describes the "Signature™ Personalized Patient Care System - Glenoid Guide System". However, it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in a tabular format. The document is a 510(k) summary for a medical device and typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full performance study with acceptance criteria.

Based on the provided information, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the given text. The document states: "Accuracy performance testing (cadaver lab) and Guide verification of post processing techniques and autoclave sterility deformation dimensional stability testing was performed to determine substantial equivalence. ... Testing verified that the accuracy and performance of the system is adequate to perform as intended."

This indicates that acceptance criteria existed and the device met them, but the specific metrics, targets, and actual results are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "accuracy performance testing (cadaver lab)," implying a test set was used, but the number of cadavers or individual measurements is not given.
• Data Provenance: The "accuracy performance testing" was conducted in a "cadaver lab." This suggests the data is prospective in nature using cadaver models. The country of origin is not specified, but the submission is to the U.S. FDA, implying the testing was likely conducted in or for the U.S. market.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the text. The device involves a "clinician approved/finalized pre-surgical plan," and the guides are intended to "assist in the positioning of glenoid components intra-operatively." This implies medical expertise is involved in the planning and surgical application, but specialists establishing ground truth for a test set are not mentioned.

4. Adjudication Method for the Test Set:

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No mention of an MRMC comparative effectiveness study is made. The document focuses on the device's accuracy and performance, not a comparison of human readers with and without AI assistance. The device itself is a surgical guide rather than an AI-driven image interpretation tool that would typically be evaluated with MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device is a "surgical instrument" designed to "assist in the positioning of glenoid components intra-operatively." It generates patient-specific guides using "imaging scans, software, and the clinician approved/finalized pre-surgical plan." This strongly implies that the device is not a standalone algorithm, but rather a tool that works as part of a human-in-the-loop process (surgeon + guide). The "accuracy performance testing" likely evaluated the guide's ability to accurately translate the surgical plan, which is a key component of the overall system.

7. The Type of Ground Truth Used:

The ground truth for the "accuracy performance testing" on cadavers is not explicitly defined in terms of how it was established (e.g., expert consensus, direct measurement, etc.). However, given that it's a surgical guide system, the ground truth would typically relate to the actual achieved position of pins/components in relation to the planned position as determined by the pre-operative imaging and surgical plan. This would likely involve direct physical measurement on the cadaver models post-use of the guide, referencing anatomical landmarks or planned targets.

8. The Sample Size for the Training Set:

This information is not provided. The document describes the system as using "patient imaging scans" and "software" to create models and guides. This suggests an underlying algorithm or system that would likely have been developed and "trained" or validated using a dataset, but the size of that dataset is not mentioned.

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

This information is not provided.

Summary of what is known and unknown:

• Provenance: "cadaver lab" testing, implying prospective data acquisition using cadaver models. Country not specified. |
  | 3. Number of Experts & Qualifications (for Test Set Ground Truth) | Not provided. |
  | 4. Adjudication Method (for Test Set) | Not provided. |
  | 5. MRMC Comparative Effectiveness Study (AI vs. without AI assistance) | No. The device is a surgical guide system, not an AI for image interpretation that would typically warrant such a study. |
  | 6. Standalone (Algorithm Only) Performance Study | No. The device is described as a "surgical instrument to assist" and works with "clinician approved/finalized pre-surgical plan," indicating a human-in-the-loop system. |
  | 7. Type of Ground Truth Used (for Test Set) | Implied to be direct physical measurement of pin/component placement in cadaver models against the pre-operative surgical plan. (Not explicitly stated as expert consensus, pathology, or outcomes data). |
  | 8. Training Set Sample Size | Not provided. The system uses "patient imaging scans, software" to create models and guides, suggesting an underlying system development that would use a training set, but its size is not mentioned. |
  | 9. How Ground Truth for Training Set Was Established | Not provided. |

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