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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 CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis ●
• Rheumatoid Arthritis ●
• Post-traumatic Arthritis
• Correction of functional deformity

The Catalyst CSR humeral and glenoid implants are intended for cemented use.

The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.

This submission adds Press-Fit Humeral Components to the CSR Shoulder System. The press-fit humeral components have a non-spherical polished surface for articulation with the glenoid component or the glenoid cavity of the scapula. The humeral components incorporate 4 pegs which assist with alignment and provide rotational stability. The four plane geometry of the back side of the humeral component matches four cut surfaces on the humeral head to recreate the geometry and thickness of the removed bone. The CSR Press-Fit Humeral Components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The undersurface of the head and the proximal portion of the alignment pegs are coated with a plasma sprayed coating of CP Ti conforming to ASTM F1580.

The CSR humeral components are compatible with previously cleared CSR 3 Peg glenoid components.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Catalyst CSR Press-Fit Humeral Components:

Summary of Device and Context:

The document is an FDA 510(k) clearance letter and a 510(k) Summary for the Catalyst CSR Press-Fit Humeral Components, which are an addition to the existing Catalyst CSR Shoulder System. This device is a shoulder prosthesis intended for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint, where the humeral head, neck, and glenoid vault have sufficient bone stock, and the rotator cuff is intact or reconstructable. The key new feature here is the "Press-Fit" capability, allowing for uncemented or cemented use, and the device incorporates a plasma sprayed coating of CP Ti. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

Detailed Analysis of Acceptance Criteria and Study Information:

Based on the provided text, the focus is on non-clinical testing to demonstrate substantial equivalence, as clinical testing was deemed unnecessary.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Correction of functional deformity
  Both components of the Catalyst CSR Shoulder System are intended for cemented use only.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.
This submission adds 3 peg glenoids to the CSR Shoulder System. The Catalyst CSR 3 peg glenoid components are manufactured from UHMWPE conforming to ASTM F648. Three sizes of glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to provide implant fixation within the dense cortical and subchondral bone. Two versions of the 3 peg glenoid are available with the pegs angled at either 17 or 25 degrees.

The provided text is a 510(k) summary for the Catalyst CSR 3 Peg Glenoids, a shoulder prosthesis. It details the device, its intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML medical device.

The document discusses non-clinical testing for the glenoid components (static lever-out, static torque-out, dynamic shear testing, and Bacterial Endotoxin Testing) and concludes that "the performance of the Catalyst CSR Shoulder System is adequate for its intended use." However, it does not provide specific quantitative acceptance criteria or detailed results of these tests.

It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices." This means a clinical study to establish performance against acceptance criteria in a human population, or a comparative effectiveness study, was not performed for this submission.

Therefore, many of the requested sections regarding AI/ML device performance are not applicable based on the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

• Cannot be created. The document states that non-clinical tests (static lever-out, static torque-out, dynamic shear testing, bacterial endotoxin testing) were performed and indicated "adequate performance for its intended use." However, it does not provide specific quantitative acceptance criteria (e.g., minimum load for lever-out, maximum endotoxin level) nor does it report the specific performance values achieved by the device in these tests.

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

• Not applicable for clinical performance. Clinical testing was not deemed necessary. For the non-clinical tests, the sample sizes and data provenance are not detailed in this summary document.

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)

• Not applicable. No clinical test set or ground truth establishment by experts was performed for this 510(k) submission.

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

• Not applicable. No clinical test set or adjudication was performed.

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

• No. An MRMC comparative effectiveness study was not performed. This device is a shoulder prosthesis, not an AI/ML diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical medical device (shoulder prosthesis), not an algorithm or AI.

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

• Not applicable. No clinical ground truth was established for this submission. The "ground truth" for the non-clinical tests would be the established engineering standards or physical properties being measured.

8. The sample size for the training set

• Not applicable. This device is a physical prosthesis, not an AI/ML algorithm requiring a training set.

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

• Not applicable. This device is a physical prosthesis, not an AI/ML algorithm requiring a training set or its associated ground truth establishment.

Summary of relevant information from the document related to "acceptance criteria" and "study":

The document focuses on establishing substantial equivalence to predicate devices for a shoulder prosthesis, rather than demonstrating performance against novel acceptance criteria in a clinical study.

Non-Clinical Testing:

• Tests Conducted:
  • Static lever-out
  • Static torque-out
  • Dynamic shear testing (per ASTM F2028-14)
  • Bacterial Endotoxin Testing
• Reported Performance: "The results of these tests indicate that the performance of the Catalyst CSR Shoulder System is adequate for its intended use." (Specific quantitative results or formal acceptance criteria are not provided in this summary.)
• Bacterial Endotoxin: "endotoxin limit of 20EU/device was met." (This is the only explicit acceptance criterion given, and the device met it for the predicate component, with the new glenoids not creating a new worst case).
• Clinical Testing: Explicitly stated as "Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst CSR 3 Peg Glenoids to the predicate devices."

In essence, the "study" proving the device met "acceptance criteria" for this 510(k) was a set of non-clinical, mechanical, and biocompatibility tests intended to show that the new components perform similarly to the predicate devices and meet basic safety and performance requirements for the indicated use, without requiring new clinical data.

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