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The Triathlon AS-1 patient specific cutting guides are disposable, single-use surgical instruments intended to assist orthopedic surgeons in the positioning of femoral and tibial total knee arthroplasty components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. They are intended for use with the Cruciate Retaining (CR), Condylar Stabilizing (CS), Posterior Stabilized (PS) and Tritanium® components of the Triathlon® Total Knee System and the Total Stabilizer (TS) and Posterior Stabilized Rotation (PSR) Triathlon® tibial inserts.

The subject device, Triathlon AS-1, is a new Conformis Inc. device offering. The Triathlon AS-1 is comprised of patient matched single-use disposable cutting guides (also referred to as instruments or jigs) with corresponding surgical documentation which includes the Instructions for Use, Surgical Protocol and Surgical Plan. The single-use patient-matched instruments (including documentation) are similar to those of the legally marketed predicate device Knee Replacement Systems by Conformis Inc. (predicate devices K180906, K201023).

The subject device, Triathlon AS-1, does not include an implant or reusable instrumentation associated with knee replacement systems. The subject device, however, is designed to be compatible with selected legally marketed Triathlon Total Knee implants and reusable instrumentation from Stryker Orthopaedics. While no implant is part of this subject device, the subject device utilizes software to determine the size and position of the compatible implant for an individual patient and then design the subject device around the patient's anatomy to prepare for the identified implant.

For the subject device, the predicate Conformis design software, surgical plan, and single-use cutting guides (instrumentation) are being modified to accurately size, position, and prepare the bone for off-the-shelf Triathlon femoral and tibial implants. Using patient imaging (CT scans), a Triathlon Total Knee implant set is sized and positioned to best meet the unique anatomic requirements of the specific patient. The Triathlon AS-1 planning process allows for efficient 3D planning, providing optimized fit of an off-the-shelf Triathlon implant and providing the design of the patient-matched, single-use guides to prepare for the planned implant in the planned position.

Jigs are designed to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. The design of the instrumentation will be modified as needed to be compatible with the Stryker Orthopaedics Triathlon manual surgical instrumentation.

Each set of instruments is designed for single use, specifically for one patient. The disposable single-use instrument set is manufactured from biocompatible nylon material and supplied sterile.

Note: The provided text is a 510(k) summary for a medical device (surgical cutting guides). It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner of an AI/ML algorithm evaluation (e.g., performance metrics like sensitivity, specificity, or AUC).

Therefore, I cannot fully address all aspects of your request, particularly those related to the performance of an AI/ML device, such as sample sizes for test/training sets, ground truth establishment methods, expert adjudication, or MRMC studies. The document describes a traditional medical device (patient-specific cutting guides) whose "performance" would relate to its physical properties, manufacturing quality, and usability.

Based on the provided text, I will address what information is available and indicate where it is not provided.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

Overview: The provided document is a 510(k) summary for the Triathlon AS-1 patient-specific cutting guides. The "acceptance criteria" in this context are primarily related to demonstrating substantial equivalence to legally marketed predicate devices, ensuring the device is safe and effective, and performs as well as the predicate. The "study" described is a series of non-clinical tests and evaluations rather than a traditional clinical trial or AI/ML performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (surgical cutting guides) and the 510(k) submission, the "acceptance criteria" are not presented as quantitative performance metrics for an AI/ML model. Instead, the focus is on functional equivalence and safety.

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

• Test Set Sample Size: Not explicitly stated in the document. The testing involved "Cadaver testing" and "Implant sizing and positioning testing," but the number of cadavers or patient cases used for these tests is not provided.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data appears to be from non-clinical testing (cadavers, software validation).

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

• Number of Experts: Not specified. "Surgeon evaluation" is mentioned for cadaver testing, implying expert involvement, but the number or specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed. Given the device, these would likely be orthopedic surgeons.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC study was not stated to be done. This device is a surgical cutting guide, not an AI-assisted diagnostic or interpretation tool for human readers. Its evaluation would focus on the accuracy of the cuts, fit to anatomy, and ease of use in surgery, rather than improving human "reading" performance.

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

• Standalone Performance: The device itself (the physical cutting guides) is the output of a CAD design process that utilizes patient imaging (CT scans) and an algorithm for sizing and positioning. The "software verification and validation" would assess the standalone performance of this design algorithm in terms of accurately generating the guides for the planned implant position. However, specific metrics for this standalone performance (e.g., precision of cuts, deviation from plan) are not detailed in this summary.

7. The type of ground truth used

• Type of Ground Truth: For the "Implant sizing and positioning testing" and "Software verification and validation," the ground truth would likely be based on established anatomical landmarks, implant specifications, and potentially manual measurements or a "gold standard" 3D model derived from the patient's CT scan. For "Cadaver testing (surgeon evaluation and usability)," the ground truth would be based on surgical assessment of fit, alignment, and ease of use, likely against pre-defined surgical goals or standards.

8. The sample size for the training set

• Training Set Sample Size: Not applicable or not provided. This device involves a patient-specific design process initiated from a CT scan for each individual patient, rather than a machine learning model that is trained on a large dataset and then applied. The underlying CAD design software is a rule-based or algorithmic system that may have been developed and validated over time, but the concept of a distinct "training set" in the context of an AI/ML model is not directly applicable here.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no explicitly mentioned "training set" in the context of an AI/ML model. The "ground truth" for the design software would be established through engineering design principles, anatomical studies, and clinical experience informing the parameters and rules within the CAD system.

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The iTotal Identity® Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

• · Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
• · Post traumatic loss of joint function.
• · Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
• · Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

The iTotal PS Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartments.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.

· Post traumatic loss of joint function.

• · Moderate varus, valgus or flexion deformity.
  · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.

· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

iTotal Identity® Cruciate Retaining (CR) Knee Replacement System (KRS) and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System (KRS) are patient specific tri-compartmental faceted knee replacements systems. The iTotal Identity CR KRS is a faceted posterior cruciate ligament retaining knee replacement system. It is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components. iTotal Identity® PS KRS is a semi-constrained, cemented knee implant consisting of femoral, tibial, patellar and articular tibial insert components.

Using patient imaging and a combination of proprietary and off-the-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel cap manufactured from polyethylene (UHMWPE) and either one or two polyethylene inserts (Two piece is CR only). The polyethylene inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked vitamin E stabilized UHMWPE). The patellar component is provided in either a round or oval dome shape and may be manufactured from either UHMWPE or iPoly® XE.

For user convenience, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity® CR KRS or iTotal Identity® PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

The provided document is a 510(k) summary for a medical device (Conformis iTotal Identity® Cruciate Retaining (CR) Knee Replacement System and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System). It describes a modification to an already cleared device, specifically changing the raw material for the patellar component and tibial inserts.

*Crucially, this document does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts in an AI/ML context.

Therefore, I cannot extract the information requested regarding:

• Acceptance criteria related to AI/ML device performance metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets where AI performance is evaluated against ground truth.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods for test sets.
• MRMC comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size or ground truth establishment for the training set.

What the document does describe regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" relates to the material equivalency of a knee implant component, not an AI system.

Here's a breakdown of what can be gleaned from the document regarding the device and its "proof":

1. Acceptance Criteria and Reported Device Performance (related to material equivalency):

The document states:

• "The difference between the subject raw material and the predicate raw material is that the subject raw material will not be mechanically annealed."
• Acceptance Criteria (implicit for material equivalency): The new raw material (iPoly® XE without mechanical annealing) must have "no statistically significant impact on the physical or chemical properties when compared to the predicate material" and "raises no new issues regarding safety or effectiveness."
• Reported Device Performance (for material equivalency): "Testing to compare the subject raw material to the predicate material was conducted." and "The absence of an annealing step in the processing of the raw material does not have a statistically significant impact on the physical or chemical properties when compared to the predicate material and supports that the materials are equivalent."

2. Sample Size and Data Provenance:
Not applicable in the context of AI/ML. The "data" refers to physical and chemical properties of materials. The document does not specify the number of material samples tested or their provenance in terms of country or retrospective/prospective collection, as this is a material science characterization, not a clinical data study for AI.

3. Number of Experts and Qualifications for Ground Truth:
Not applicable. Ground truth here is established by material science testing and characterization, not expert human review of medical images for diagnostic purposes.

4. Adjudication Method:
Not applicable. This is not a study requiring adjudication of expert opinions.

5. MRMC Comparative Effectiveness Study:
Not applicable. No AI component or human reader study described.

6. Standalone Performance:
Not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used:
The "ground truth" here is the established physical and chemical properties of the predicate material, against which the new material is compared. This is based on material characterization standards and laboratory testing, not medical expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for Training Set:
Not applicable. There is no training set for an AI/ML model.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set.

In summary, the provided text is for a material modification to a knee implant, demonstrating substantial equivalence through material testing, not for an AI/ML medical device. Therefore, most of the requested information regarding AI/ML device acceptance criteria and study methodology is not present in this document.

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