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Archer^R PSI System is indicated as an orthopedic instrument to assist the physician in the intraoperative positioning of total shoulder replacement components and in guiding the drill and the cut of the bone.

Archer^R PSI System must only be used conjointly with Archer™ CSR Total Shoulder (K152825, K173812, K181287, K182500, K191811), Catalyst EA Convertible Stemmed Shoulder (K222317) and Archer™ R1 Reverse (K202611, K211991, K213349, K223655, K232583) components in the context of primary total shoulder replacement and following a delto-pectoral approach only. Archer^R PSI System is manufactured from a pre-operative planning validated by the surgeon in the 'Archer™ 3D Targeting' platform (K213779). Archer^R PSI System is indicated for patient population fulfilling the Archer™ CSR Total Shoulder, Catalyst EA Convertible Stemmed Shoulder and Archer™ R1 Reverse indications and for which CT images are available with identifiable placement anatomical landmarks and compliant with imaging protocol provided by Archer 3D Targeting.

The device is intended for single use only.

The device is intended for adult patients.

The device has to be used by a physician trained in the performance of surgery.

The "Archer PSI System" device is a patient-matched additively manufactured single use surgical instrument (PSI). Archer PSI System is an instrument set containing a glenoid guide and its bone model and/or a humeral guide and its bone model. This patient-specific medical device is designed to fit the patient's anatomy to transfer a patient-specific pre-operative plan to the operating room. It is intended for surgical interventions in orthopaedic procedures for total shoulder arthroplasty.

The Archer PSI system instruments are designed from a draft treatment plan available via the Archer™ 3D Targeting' platform. Based on computed tomography (CT) of the shoulder anatomy, 3D CAD models of the bones and positioning and sizing of the glenoid and humeral components are submitted for evaluation to the surgeon. Upon the surgeon's approval, the guides and bone models are designed based on the validated planning and are manufactured using additive manufacturing.

The provided FDA 510(k) summary for the "Archer PSI System" does not contain the detailed acceptance criteria or the specific study that directly proves the device meets those criteria in a quantitative manner as typically expected for medical device performance studies involving sensitivity, specificity, accuracy, etc. However, it does outline the types of non-clinical and cadaveric testing performed to demonstrate substantial equivalence to a predicate device.

Here's an attempt to structure the information based on the request, extracting what is available and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not overtly state quantitative "acceptance criteria" (e.g., "accuracy must be > 95%") nor does it provide "reported device performance" in terms of explicit metrics like sensitivity, specificity, or error rates. Instead, the "performance" is described in terms of demonstrating "substantial equivalence" through various engineering and cadaveric tests.

A more accurate representation, based on the provided text, would be:

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Cadaveric Testing: The document states that "Cadaveric testing was executed" but does not specify the sample size (number of cadavers or procedures) used for this testing.
• Data Provenance: The cadaveric testing is implied to be prospective in nature, as it was "executed to demonstrate the substantial equivalence." There is no information provided regarding the country of origin of the cadaveric data.

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

• Number of Experts: The document states that "a pre-operative planning validated by the surgeon" is part of the process. For the cadaveric testing, it does not explicitly state the number of experts (e.g., surgeons) involved in establishing the "ground truth" or assessing the "substantial equivalence."
• Qualifications of Experts: The document mentions that the device is to be used by a "physician trained in the performance of surgery." For the validation of the pre-operative plan, the expert is identified as "the surgeon." While this indicates a medical professional, specific qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the cadaveric testing or any other performance evaluation. The "validation by the surgeon" for the pre-operative plan suggests a form of single-expert consensus at the planning stage, but not for the overall performance assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No.
• Effect Size: As no MRMC study was performed, no effect size of human readers improving with AI vs. without AI assistance is reported. The Archer PSI System is a patient-specific instrument, not an AI diagnostic or assistive tool in the MRMC sense. The comparison was between manual surgical techniques and PSI-assisted techniques in cadavers.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Not explicitly in terms of an "algorithm only" performance study. The device itself is a physical, patient-specific instrument derived from a digital plan. The document describes "Cadaveric testing" which evaluates the combined PSI system (planning software output + physical guide) in a simulated surgical environment, not just the planning algorithm in isolation from its physical manifestation or use.
• The "Intra- and Inter-Designer Variability testing" and "Mechanical Integrity" tests are standalone evaluations of aspects of the device's design and manufacturing, but not of the surgical guidance algorithm's performance on its own.

7. Type of Ground Truth Used

• For Pre-operative Planning: The ground truth for the design of the PSI System is based on a "pre-operative planning validated by the surgeon" using CT images and anatomical landmarks. This can be considered a form of expert consensus/validation on the desired surgical outcome/instrument design.
• For Cadaveric Testing: The "ground truth" for the cadaveric study would be the actual anatomical targets and the achieved drill/cut placements, compared to the planned placements and traditional manual techniques. While experts (surgeons) would perform and assess these, the ultimate "truth" is the physical reality within the cadaver. The document implies comparison to "manual techniques" as a reference.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set sample size." The Archer PSI System is described as being "designed from a draft treatment plan" and "manufactured from a pre-operative planning validated by the surgeon." This suggests a patient-specific design process rather than a machine learning model trained on a large dataset. The underlying "Archer™ 3D Targeting' platform (K213779)" (a separate cleared device) would be the system performing the planning, and its own 510(k) might contain training data details if it uses AI/ML. However, for the Archer PSI System itself, no training set information is present.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned for the Archer PSI System in this document, no information is provided on how its ground truth would have been established.

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The Catalyst EA Convertible Stemmed Shoulder is intended for use as a replacement of shoulder joints in anatomic or reverse arthroplasty. Should the need arise for a conversion from an anatomic total shoulder to a reverse total shoulder, the humeral stem can remain in place, while the articulating surfaces are exchanged.

The Catalyst EA Convertible Stemmed Shoulder is an anatomic designed total shoulder prosthesis that mates with the Catalyst R1 humeral stems cleared in K202611. This submission adds conversion adapters, locking screw and humeral heads to mate with the previously cleared Catalyst R1 humeral stems. The humeral head components are compatible with previously cleared CSR 3 Peg glenoid components or for articulation with the glenoid cavity of the scapula. When the humeral stem (cleared K202611), adapter and humeral head are mated together, this creates a hemiarthroplasty (product code HSD). When the humeral stem, adapter and humeral head are used in conjunction with the CSR glenoid components (cleared K191811 and K173812), this creates a total shoulder arthroplasty (product code KWS). The adapters and locking screw are manufactured from Ti-6A1-4V ELI conforming to ASTM F136. The humeral components are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.

The provided document describes a 510(k) premarket notification for the "Catalyst EA Convertible Stemmed Shoulder" device. This is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices, not a study proving the device meets explicit acceptance criteria in the context of a clinical trial or AI performance.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory document. Specifically, there is no mention of acceptance criteria related to AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies.

However, I can extract the information that is relevant to the non-clinical testing performed for this device.

Acceptance Criteria and Device Performance (Non-Clinical)

Study Details (Non-Clinical)

Your prompt asks for specific details related to AI/clinical studies that are not present in this 510(k) summary. Here's a breakdown of why and what information is available:

1. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical bench testing of a medical implant, not AI or clinical data. The "test set" would refer to the physical prototypes or samples used for mechanical testing. The specific number of samples for each test (e.g., how many constructs for fatigue testing) is not detailed in this summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI or diagnostic studies is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and specifications.
3. Adjudication method for the test set: Not applicable. There is no expert review or adjudication process described for the lab-based mechanical tests.
4. 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: No. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices." This is a mechanical implant, not a diagnostic AI device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is not an algorithm or AI device.
6. The type of ground truth used: For the non-clinical testing, the "ground truth" would be established by engineering specifications, material standards (e.g., ASTM F136, ASTM F1537), and predetermined acceptance criteria for mechanical performance (e.g., fatigue life, disassembly forces).
7. The sample size for the training set: Not applicable. No AI training was performed.
8. How the ground truth for the training set was established: Not applicable. No AI training was performed.

Context from the Document:

The document clearly states:

"Non-Clinical Testing: Range of motions analyses, biocompatibility assessment and construct fatigue testing were all conducted. Axial disassembly tests were performed pre-fatigue and post-fatigue testing. The construct fatigue testing demonstrated that the construct of the Catalyst EA Convertible Stemmed Shoulder humeral heads with conversion adapter, met the pre-determined acceptance criterion. All testing has determined that the device is substantially equivalent to the predicate device."

And:

"Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst EA Convertible Stemmed Shoulder to the predicate devices."

This indicates that the FDA cleared this device based solely on non-clinical (i.e., lab/mechanical) testing and comparison to predicate devices, and not on AI performance, clinical trials, or human diagnostic studies.

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