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Software: The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit presurgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels.

Hardware: The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection. The Precision AI Guides and Biomodels are indicated for single use only. The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only. The Precision AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components: Enovis and Lima.

The Precision AI Surgical Planning System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific guides and models to transfer the plan to surgery. The subject device is a system composed of the following: The Precision AI Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operatively then create a physical Patient Specific Instrument (or Guide), using 3D printing by selective laser sintering. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm. The surgeon can visualise the deformity of the diseased joint, on this 3D render and CT scan images, and determine the inherent deformity of the joint. They are then able to virtually place the artificial implants in an optimal position to correct the measured deformity for that specific patient. The Precision AI Guides, which are a patient-specific guide and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Patient-specific guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery.

The provided text is an FDA 510(k) summary for the Precision AI Surgical Planning System (PAI-SPS). It describes the device and its intended use, but it does NOT contain specific acceptance criteria, detailed study designs, or performance results in terms of metrics like sensitivity, specificity, accuracy, or effect sizes for human reader improvement.

The document states that "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements and validation against user needs." It also mentions that "Design verification and validation testing demonstrated that the PAI-SPS meets all design requirements and is as safe and effective as its predicate device (K233992)."

However, it does not explicitly lay out the acceptance criteria (e.g., "model must achieve 90% accuracy") or the results against those criteria. It focuses more on demonstrating substantial equivalence to a predicate device (PAI-SPS K233992) by showing that the technology and intended use are similar, with the main differences being the addition of compatibility with more implant systems.

Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. I will provide information based on what is available and indicate where information is missing.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

Based on the provided FDA 510(k) summary, the PAI-SPS device is being cleared primarily through demonstrating substantial equivalence to an already cleared predicate device (PAI-SPS, K233992). The key claim for equivalence rests on similar intended use, fundamental scientific technology, design, functionality, operating principles, and materials, with the primary difference being expanded compatibility with additional implant systems.

The document implicitly suggests that the "acceptance criteria" are tied to demonstrating that these technological differences "do not raise any different questions of safety and effectiveness." The studies cited are primarily focused on software verification and validation, ensuring the new compatible implant systems do not negatively impact the established safety and effectiveness.

Here is a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy percentages, specific error bounds) or detailed performance metrics. The performance is largely framed as demonstrating that the device "meets all design requirements and is as safe and effective as its predicate device."

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

• The document does not specify the sample size for any test set (e.g., for software validation or hardware accuracy).
• Data Provenance: Not explicitly stated for specific test sets. Given the company is "Precision AI Pty Ltd" in Australia, and the document discusses "previous cadaver testing and composite bone model testing," it's likely a mix of lab-based/simulated data and potentially some retrospective clinical imaging data for initial AI development/testing, but this is not detailed. The document implies that new testing was not extensively conducted for this submission, relying heavily on the predicate device's prior validation and the minor changes to compatibility.

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

• The document does not specify the number of experts or their qualifications used to establish ground truth for any test set.
• It mentions that the software allows a "qualified surgeon" to approve pre-surgical plan data, implying that expert surgical review is part of the workflow.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The focus of this 510(k) is substantial equivalence based on technological similarity and expanded compatibility, not a comparative study against human readers or performance improvement with AI assistance.

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

• The document states that the AI algorithm performs "auto segmentation via a locked, or static, artificial intelligence algorithm." While this indicates a standalone AI component, the document does not provide standalone performance metrics for this AI segmentation. The overall system is described as a "pre-surgical planner" where the surgeon can "visualize, measure, reconstruct, annotate and edit pre-surgical plan data," suggesting a human-in-the-loop workflow.

7. The Type of Ground Truth Used

• For software, the implicit ground truth appears to be expert consensus or approved surgical plans for judging the accuracy of the software's representations and planning capabilities. The document states "The software allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data."
• For hardware, "previous cadaver testing and composite bone model testing" were used, implying physical measurements against a known standard or "true" position established in these models.

8. The Sample Size for the Training Set

• The document does not specify the sample size used for the training set for the AI segmentation algorithm.

9. How the Ground Truth for the Training Set was Established

• The document does not specify how the ground truth for the AI training set was established. It only mentions that the AI algorithm for auto-segmentation is "locked, or static," implying it was trained previously.

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The Reverse® Shoulder Prosthesis (RSP®) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy, a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

• · In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. (For cemented implantation only)
• In cases of bone defect in proximal humerus.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.

The RSP system is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulations fits into a metal cup that is joined to the humeral stem. The components included in this system are a glenoid bead, a humeral stem. The component baseplate, and baseplate screws. The standard RSP system consists of a modular components which include a humeral stem, humeral socket inset, glenoid baseplate, glenoid baseplate, which screws. The RSP Monoblock stem includes a bument test glenoid baseplate, glenoid he screws. The RSP Monoblock socket hiser, greend baseplate, glenoid baseplate, and humeral socket and humeral socket

The modification outlined in this application consists of an addition of a humeral socket insert infused with pure liquid pharmaceutical grade alpha-tocopheral into the material.

I am sorry, but the provided text does not contain information on acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a shoulder prosthesis, focusing on its substantial equivalence to previously marketed devices. It outlines the device details, indications for use, and a list of non-clinical testing performed, but it explicitly states "Clinical Testing: None provided."

Therefore, I cannot extract any information to fulfill your request regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

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The Reverse Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint:

• . In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3-or 4-part fractures of proximal humerus.
• In cases of bone defect in proximal humerus. .

The patient's joint must be anatomically and structurally suited to receive the selected implant(s).

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The Reverse Shoulder Prosthesis (RSP) is indicated for salvage procedures for irreparable rotator cuff. failed hemi or total shoulder arthroplasty with irreparable rotator cuff, and for fracture in which the tuberosity and rotator cuff are irreparable. The RSP is designed so that the "ball" of the articulation fits into the glenoid baseplate, and the "cup" of the articulation fits into a metal cup attached to the humeral stem. The components included in this system are a glenoid head, a humeral socket, a humeral stem, a glenoid baseplate, and baseplate screws.

The Monoblock design consists of:

• . a non-modular stem designed by joining the humeral socket with the humeral stem (sizes 6, 7, 8, 10 and 12);
• . humeral inserts in size 44 semi-constrained UHMWPe and +4 offset inserts in sizes 32, 36, 40 and 44 (standard and semi-constrained UHMWPe). Currently cleared sizes of inserts (32, 36, 40, and 44 in standard poly and size 32, 36, and 40 semi-constrained UHMWPe) are also compatible with the monoblock design.
• . glenoid components will be the same as currently cleared under K 100741, K092873, K051075, and K041066

Here's an analysis of the provided text regarding the Reverse® Shoulder Prosthesis Monoblock, focusing on the requested acceptance criteria and study information:

Based on the provided text, the device is a medical implant (shoulder prosthesis), and the information is from an FDA 510(k) clearance document. For this type of device, "acceptance criteria" and "device performance" are typically related to mechanical and material properties, biocompatibility, and functional integrity under simulated physiological conditions. The document does NOT describe the acceptance criteria or reported device performance for a software-based AI/ML device. The questions about AI-specific criteria (sample size, experts, adjudication, MRMC, standalone performance, training data) are not applicable to this medical device submission.

Here's a breakdown of what is available in the document related to testing, rephrased to fit the structure of your request where possible, and indicating where information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical medical implant and not a software AI/ML device, the table below reflects the type of information that would be relevant for such a device. The provided text does not include specific numerical acceptance criteria or detailed reported performance values for the device's mechanical properties, as these studies were already completed for previous versions.

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

• Sample Size: Not explicitly stated for specific mechanical tests in this document. The document refers to "prior non-clinical testing" performed for previously cleared components (K100741, K092873, K051075, and K041066). The current submission states no additional testing was necessary.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. For mechanical testing, this typically refers to the lab where the tests were conducted, which is not detailed here.

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

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from data.

4. Adjudication method for the test set

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool that requires adjudication of expert opinions.

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

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML diagnostic or predictive tool. The document explicitly states "Clinical Testing: None provided."

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

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm.

7. The type of ground truth used

• This question is not applicable in the context of AI/ML ground truth from expert consensus, pathology, or outcomes data. For a mechanical device, "ground truth" would be the known mechanical properties of materials, validated engineering models, and the performance of predicate devices against established standards during non-clinical testing.

8. The sample size for the training set

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm.

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

• This question is not applicable as the submission is for a mechanical medical device, not an AI/ML algorithm. The "ground truth" for mechanical testing is established through standardized engineering test methods and material science principles.

Summary of Device-Specific Information from the Text:

The document concerns the "Reverse® Shoulder Prosthesis Monoblock," an update to an existing shoulder implant. The submission is for a 510(k) clearance, indicating it is a "substantially equivalent" device to a predicate (K082120 - Tornier Aequalis@-Reversed Fracture prosthesis).

The key takeaway regarding testing is:

• Non-Clinical Testing: "After completing review of prior non-clinical testing conducted for this system and submitted under K100741, K092873, K051075, and K041066, it was concluded that additional testing was not necessary to support equivalence." This means the current device leverages prior testing data for its components or overall system design, implying that component-level mechanical, material, and biocompatibility requirements were met previously and are assumed to hold for the new configuration due to design similarities to the predicate and previously cleared components.
• Clinical Testing: "None provided." This is common for 510(k) submissions, especially for modifications of existing devices or when non-clinical testing is deemed sufficient to establish substantial equivalence.

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