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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 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.

Indications for RSP Humeral Stem Adapters:
The Reverse® Shoulder Prosthesis (RSP) is indicated for treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy 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.
During primary surgery, after the humerus is prepared for the RSP humeral stem (modular and monoblock), if purchase to the glenoid bone is insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP humeral stem to hemiarthroplasty prosthesis as a salvage procedure. During revision surgery of an RSP (modular or monoblock), if the glenoid bone stock appears to be insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP device to hemiarthroplasty prosthesis as a salvage procedure. For modular RSP stems, the Foundation Shoulder hymeral head should be used. For the monoblock stem, the Turon humeral head should be used. This stem/adapter construct is not approved for use as a surrogate for traditional hemiarthroplasty or anatomic replacement indications.

The RSP Monoblock system 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 that is joined to the humeral stem. The components included in this system are a glenoid head, a humeral socket joined with humeral stem, a glenoid baseplate screws.
The modification outlined in this application consists of an addition to the Indications for Use for the humeral stem to allow for cementless implantation. There is no change to the fundamental scientific technology of the RSP Monoblock with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufacture.

The provided text is a 510(k) summary for a medical device called the "Reverse® Shoulder Prosthesis Monoblock." This document is a regulatory submission to the FDA for market clearance and does not describe an AI/ML device or a study involving acceptance criteria and device performance in the context of an AI model.

Instead, it details a modification to an existing shoulder prosthesis (allowing cementless implantation of the humeral stem) and asserts its substantial equivalence to predicate devices based on comparable features (material, indications, surgical technique, intended use).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance for an AI/ML device from this document. The sections you asked about pertain to AI/ML device evaluations, which are not present here.

Here's why each point cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: This document discusses a physical medical implant, not a software device with performance metrics like accuracy, sensitivity, or specificity against predefined criteria.
2. Sample sized used for the test set and the data provenance: Not an AI/ML device; no test set in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device; no ground truth establishment for a test set.
4. Adjudication method for the test set: Not an AI/ML device; no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Testing: None provided."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device.
7. The type of ground truth used: Not an AI/ML device; no ground truth in the AI/ML sense.
8. The sample size for the training set: Not an AI/ML device; no training set.
9. How the ground truth for the training set was established: Not an AI/ML device; no ground truth for a training set.

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