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The VERTICALE® Triangular Fixation System, when used in combination with the VERTICALE® Posterior Spinal Fixation System, is intended for immobilization of the spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The VERTICALE® Triangular Fixation System is intended to treat the following conditions: trauma (i.e., fracture or dislocation); tumor, pseudoarthrosis; and failed previous fusion.

The VERTICALE® Triangular Fixation System is intended for iliac fixation and must be attached to the VERTICALE® Posterior Spinal Fixation System to treat the conditions listed above.

Refer to the labeling for the VERTICALE® Posterior Spinal Fixation System for limitations and instructions for use.

The VERTICALE® Triangular Fixation System consists of iliac screws with a UHMWPE lined slot, a polyaxial head as well as related instruments. The VERTICALE® Triangular Fixation System is intended to be used with VERTICALE® Posterior Spinal Fixation System (K171421).

The implants of the VERTICALE Triangular Fixation System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and Ultra-High-Molecular-Weight Polyethylene according to ASTM F648 / ISO 5834-1 and -2.

The provided text describes a 510(k) premarket notification for a medical device called the "VERTICALE® Triangular Fixation System." However, the document focuses on regulatory approval based on substantial equivalence to predicate devices through non-clinical testing and engineering rationales, rather than a clinical study evaluating AI software or diagnostic performance against specific acceptance criteria for an AI/ML device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product.

The listed aspects in your prompt (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, ground truth types) are typically associated with the rigorous validation of AI/ML-driven medical devices. This document describes a more traditional mechanical device approval process based on non-clinical performance testing (e.g., strength, durability).

To directly answer your prompt, I would need a different type of document, specifically one detailing the clinical or technical validation of an AI/ML medical device.

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INDICATIONS
The SIGMA High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

The DePuy SIGMA® High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint.

The unicompartmental femoral components are Co-Cr-Mo metal implants, available with or without a porous coating. The metal backed tibial components are Co-Cr-Mo and polyethylene and are available without a porous coating. The all-polyethylene unicompartmental tibial component manufactured from polyethylene.

The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).

The provided text describes a 510(k) premarket notification for a medical device, the SIGMA High Performance (HP) Partial Knee System. While the document outlines information about the device itself and its equivalence to predicate devices, it does not contain the acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML-driven device's performance.

The document states:

• "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE": This lists a number of engineering and material tests (Biocompatibility, UHMWPE Material Property Characterization, Range of Motion/Constraint, Contact Area/Stress, Wear Testing, Pull-Off, Bacterial Endotoxin testing).
• "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION - Clinical testing was not necessary to demonstrate substantial equivalence."

This indicates that the submission is focused on demonstrating substantial equivalence based on material properties, design, and manufacturing processes, rather than the performance of an AI/ML algorithm. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not present in the provided text, as these are typically associated with the evaluation of AI/ML software performance.

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Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The subject device is an all polyethylene tibia component made from AOX Polyethylene that mates with existing ATTUNE cemented (K101433) and cementless (K140881) femoral components, and existing ATTUNE patella components (K103756).

The document provided is a 510(k) premarket notification for a medical device, the ATTUNE All Polyethylene Tibia, and does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance data.

Here's why the requested information cannot be extracted from this document:

• Device Type: The device is a "Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis," which is a physical implant for total knee replacement, not a software or AI/ML-driven device.
• Study Type: The studies mentioned are "non-clinical tests" related to mechanical properties and material performance of the physical implant (e.g., Contact Area/Pressure, Wear, Constraint on tibiofemoral interface, Spine Fatigue, C2 Fixation Testing, Range of Motion, and bacterial endotoxin testing). These are not studies to evaluate AI/ML performance.
• Lack of AI/ML Specifics: There is no mention of AI, machine learning, algorithms, or any form of software performance evaluation.
• Clinical Testing: The document explicitly states: "No clinical testing was conducted to demonstrate substantial equivalence." This further indicates that the type of clinical performance study typically associated with AI/ML device validation (e.g., impact on human readers, standalone performance) was not performed.

Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this 510(k) submission for a knee implant.

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Candidates for total knee replacement include patients with:

• A severely painful and/or severely disabled joint resulting from osteoarthritis, post-● traumatic arthritis, or rheumatoid arthritis
• Moderate valgus, varus, or flexion deformities
• Avascular necrosis of the femoral condyle
• A previous unsuccessful knee replacement, osteotomy, or other knee procedure ●

ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with:

• Absence or loss of both cruciate ligaments ●
• Moderate varus-valgus or flexion instability that requires a bearing surface with increased ● constraint in the clinical judgment of the surgeon
• Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

Any non porous-coated components are intended for cemented use only.

The ATTUNE® Revision Knee System is a total knee replacement prosthesis consisting of various components including ATTUNE REVISION CRS FEMORAL COMPONENTS, ATTUNE REVISION CRS FIXED BEARING INSERTS, ATTUNE REVISION FIXED BEARING TIBIAL BASES, ATTUNE REVISION STEMS, ATTUNE REVISION FEMORAL SLEEVES, ATTUNE REVISION FEMORAL AUGMENTS, ATTUNE REVISION TIBIAL AUGMENTS, and ATTUNE REVISION OFFSET ADAPTOR. These components are made from materials such as cast Co-Cr-Mo alloy, UHMWPE, and Ti-6Al-4V ELI alloy. The system is designed for use in total knee arthroplasty to replace the damaged knee joint articulation.

The provided document is a 510(k) Premarket Notification for a medical device, the ATTUNE® Revision Knee System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets clinical acceptance criteria through a formal clinical study with ground truth and expert consensus. The FDA document explicitly states, “Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Revision Knee System and the predicate devices.”

Therefore, the requested information regarding acceptance criteria, study data, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be found in this document.

The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices. Below is a summary of the non-clinical performance information provided.

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

The document describes functional testing performed in compliance with FDA Guidance for Knee Joint Prostheses. While explicit numerical acceptance criteria values are not provided, the general statement below indicates that the measured performance met the necessary thresholds.

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

Not applicable. This document refers to non-clinical, in-vitro mechanical and material testing, not human-subject testing involving datasets.

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

Not applicable. No ground truth based on expert review was established in this submission.

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

Not applicable.

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:

Not applicable. No MRMC comparative effectiveness study was performed or required for this device.

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

Not applicable. This is a knee implant, not an AI/algorithm device.

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

Not applicable. The "ground truth" in this context is adherence to established engineering standards (ASTM F75, F136, F648, F620, F1537, F799, ANSI AAMI ST-72:2011) and FDA Guidance for mechanical performance testing for knee prostheses.

8. The sample size for the training set:

Not applicable. No training set for an algorithm was used.

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

Not applicable.

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The ATTUNE Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE total knee replacement system.

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant (provided that adequate bone is present).

The ATTUNE Cementless cruciate retaining (CR) and posterior stabilized (PS) femoral components have an asymmetric trochlear groove and are available in sizes 1-10 in right and left options. Sizes 3-6 are available in standard and narrow options. The fixation surface is porous coated with Porocoat. The porous coated fixation surface comprises: the bone cut surfaces of the anterior flange, anterior chamfer, distal surface, posterior chamfer, posterior condylar resection, as well as the lugs for additional stability. The fixation of the femoral component to the femoral bone is achieved by biologic fixation via ingrowth into the Porocoat porous coating. The ATTUNE femoral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The ATTUNE Cementless CR Femoral Components are compatible with the ATTUNE CR Fixed Bearing inserts (K101433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE Cementless PS Femoral Components are compatible with the ATTUNE PS Fixed Bearing inserts (K111433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE CR Total Knee is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. The ATTUNE PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.

This document pertains to the 510(k) premarket notification for the ATTUNE® Knee System-Cementless CR and PS Femoral Components. It describes the device and its substantial equivalence to predicate devices, focusing on the lack of need for new studies rather than describing the acceptance criteria or studies of the device itself.

Based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those acceptance criteria for the ATTUNE® Knee System-Cementless CR and PS Femoral Components.

The document explicitly states:

• "Non-Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices. As the coating for the subject device is identical to that in K062654, the characterization in K062654 also applies to this 510(k)." (Page 6)
• "Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices." (Page 6)

The submission argues for substantial equivalence based on existing predicate devices:

• The ATTUNE Cementless CR and PS Femoral Components are "identical in design to the ATTUNE CR and PS Femoral Components cleared for cemented use only in K101433 and K111433."
• "The Porocoat porous coating of the ATTUNE Cementless CR and PS Femoral Components is identical to the Porocoat porous coating used on the SIGMA CR Porocoat Femoral Components cleared for Cementless use in K062654."

Therefore, I cannot provide the requested information from the given text as it explicitly states that new testing was not performed for this 510(k) submission.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  Porous coated tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplates and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.

This submission describes the Zimmer Persona Personalized Knee System. The device is a modular knee prosthesis for resurfacing the articulating surfaces of the femoral, tibial, and patellar bones. The submission focuses on non-clinical performance and a comparison of the device's material characteristics to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: The document does not specify exact sample sizes for each test. However, it indicates that "bench testing outlined below was conducted according to FDA guidance documents," which implies that appropriate sample sizes were used as per relevant standards (e.g., ISO 14243 for wear testing).
• Data Provenance: The data is from non-clinical bench testing performed by Zimmer, Inc., a company located in Warsaw, IN, USA. This is prospective data generated specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This submission relies on non-clinical bench testing, not expert-derived ground truth from human data. The "ground truth" for these tests comes from established engineering and biocompatibility standards and predicate device performance.

4. Adjudication Method:

• Not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/experts to resolve discrepancies in interpretation. This submission focuses on objective bench testing.

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

• No. This submission describes the clearance of a medical device based on non-clinical performance data and substantial equivalence to predicate devices, not a comparative effectiveness study involving human readers or AI.

6. Standalone Performance (Algorithm Only):

• Not applicable. This device is a physical knee prosthesis, not an AI algorithm. Its "performance" is assessed through its mechanical, wear, and material characteristics, not through algorithmic accuracy.

7. Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests is derived from:
  • Established engineering standards: Such as ISO 14243 for wear testing.
  • FDA guidance documents: Which outline appropriate test methodologies and performance expectations for orthopedic implants.
  • Predicate device characteristics: The Vivacit-E material characteristics for the Persona Knee System are stated to be "identical to the predicate Zimmer Vivacit-E Acetabular Polyethylene Liners (K120370)," and other performance metrics are compared to "Persona Conventional UHMWPE articular surfaces."

8. Sample Size for Training Set:

• Not applicable. This submission describes a physical medical device, not an AI system that requires a "training set."

9. How Ground Truth for Training Set was Established:

• Not applicable. As above, there is no AI training set involved.

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The TruMatch™ Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting.

The anatomical landmarks necessary for the creation of the TruMatch™ Patient Specific Instruments must be present and identifiable on CT.

The TruMatch™ Patient Specific Instruments are intended for use with Sigma® Total Knee Implants and Attune™ Total Knee Implants and their cleared indications for use.

The TruMatch™ Patient Specific Instruments are intended for single use only.

Subject of this premarket notification are TruMatch™ Patient Specific Instruments which are designed and manufactured from patient imaging data and used with other DePuy Orthopaedics implants.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TruMatch™ Personalized Solutions, focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text states: "The tests results demonstrate that all acceptance criteria were met." However, it does not explicitly list the specific acceptance criteria or the quantitative reported performance metrics for each test. It only names the types of non-clinical tests performed.

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

The document does not specify the sample size for any of the non-clinical tests or provide details about the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions a "Cadaver Accuracy Study."

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

The document does not mention the use of experts to establish ground truth for any test set or their qualifications. The studies described are non-clinical, focusing on device performance rather than clinical interpretation.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method as it does not involve human interpretation or subjective assessment that would require such a process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done or mentioned. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the TruMatch™ Patient Specific Instruments and the predicate devices."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The primary focus of the document is on the physical instruments and their design/software validation. While "Software Validation and Verification Summary" is mentioned, the text does not elaborate on a standalone algorithm-only performance study in the context of interpreting medical images or making diagnostic judgments. The instruments assist in surgical positioning, but the decision-making and interpretation of CT data for their creation likely involve human oversight.

7. The Type of Ground Truth Used

The document does not detail the specific "ground truth" used for each non-clinical test. However, based on the nature of the tests:

• TruMatch™ Dimensional Stability Test: Ground truth would likely be established through engineering specifications and measurements using calibrated equipment.
• Cadaver Accuracy Study: Ground truth would likely be established through physical measurements and anatomical landmarks on the cadaver, potentially compared to pre-operative imaging or established surgical standards.
• Design Process and Design Software Repeatability Study: Ground truth would involve comparing outputs against known input parameters or established design tolerances.
• Software Validation and Verification Summary: Ground truth would be based on software requirements, specifications, and expected outputs based on established algorithms and calculations.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is likely because the device is a patient-specific surgical instrument, and its development focuses on design, manufacturing, and accuracy based on individual patient imaging data, rather than a machine learning model trained on a large dataset.

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

As no training set is mentioned in the context of the device's development or studies, this information is not applicable and therefore not provided in the document. The instruments are designed using individual patient CT data directly, rather than being "trained" on a dataset.

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