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The DePuy Attune Total Knee System is intended for use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.

A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint.

Femoral Components
The ATTUNE CR and PS Femoral Components are a metal femoral knee component intended for cemented use. The Femoral Component may be used with the native patella or a resurfaced patella. The congruency is variable and optimized throughout the range of motion.

Fixed Bearing (FB) Tibial Base
The ATTUNE FB Tibial Base is designed to utilize a central universal locking mechanism intended for cemented use. The tibial base incorporates a stem and keel to provide additional stability and recessed cement pockets for enhanced cement fixation. The tibial base fixation surface is textured.

Fixed Bearing (FB) Tibial Insert
The ATTUNE CR and PS FB Tibial Insert is a polyethylene component. The FB Tibial Inserts are secured to the metal FB Tibial Base.

Patella Components
The ATTUNE Medialized Dome Patella and Medialized Anatomic Patella is a polyethylene component. The patellar components are cemented to the native patella and articulate with the trochlear groove and condyles of the Femoral Component.

The subject Attune medialized dome and medialized anatomic patellae are available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates 3 pegs to provide stability and recessed cement pockets for enhanced cement fixation. The patella components are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The articular surface is offset medially proportional to the size of the component.

The provided text does not describe a study involving a device that requires ground truth establishment by experts, adjudication methods, or MRMC studies. The document is an FDA 510(k) clearance letter for a medical device (DePuy ATTUNE™ Total Knee System), which involves demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing.

Therefore, the requested information regarding acceptance criteria for a study proving the device meets the criteria, including details like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth, training set sample size, and ground truth establishment for the training set, is not available in the provided document.

The document focuses on:

• Device Description: A total knee replacement system composed of individually packaged femoral, tibial, and patellar components.
• Reason for 510(k) Submission: Modification of the sterilization dosing method for a subset of the knee implants (Attune Medialized Anatomic and Medialized Dome Patellar components) from a single high dose to two doses (crosslinking and terminal sterilization).
• Substantial Equivalence: Claimed because the change in sterilization method does not impact intended use, performance, safety, effectiveness, biocompatibility, standards compliance, or labeling.
• Performance Data (Non-Clinical): A list of numerous ASTM, ISO, and ANSI AAMI standards that were followed for testing, indicating that evaluations were performed to determine the impact of the split sterilization dose. These tests likely cover aspects like wear, particle characterization, endurance, material properties (density, crystallinity, oxidation, trans-vinylene yield), and tensile properties.
• Clinical Data: Explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence."

In summary, this document is for a medical device seeking 510(k) clearance through non-clinical performance testing, not an AI/software-based device that would typically involve the detailed study design (e.g., ground truth, MRMC) you are asking about.

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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, rheumatoid arthritis, or a failed previous implant.

A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.
The ATTUNE Medial Stabilized FB Insert is an asymmetrical fixed bearing tibial insert that will form part of the ATTUNE Knee system. It is designed to work with the ATTUNE CR femur and any of the ATTUNE Fixed Bearing Tibial Base options. The insert can be used with or without the posterior cruciate ligament.

Here's a breakdown of the requested information based on the provided text. It's important to note that this document is a 510(k) summary for a medical device (a knee implant insert), not typically a submission for an AI/ML powered device. Therefore, many of the requested AI/ML specific details (like sample size for test set, number of experts, adjudication, MRMC, standalone performance, training set details) are not applicable or not present in this type of submission.

Device Name: ATTUNE Medial Stabilized Fixed Bearing (MS FB) Insert

Device Type: Knee implant insert (part of a total knee replacement system)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a knee implant and not an AI/ML device, the "acceptance criteria" are related to mechanical and physical performance, demonstrating substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.

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 is a physical medical device. The "tests" refer to non-clinical laboratory and mechanical testing of the physical implant components, not data analysis on a "test set" of patient data for an AI/ML algorithm.

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

• Not Applicable. Ground truth in the context of AI/ML diagnostic devices is typically established by medical experts reviewing cases. For this physical knee implant, "ground truth" relates to engineering specifications and performance standards established through mechanical and material testing, not expert interpretation of patient data.

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

• Not Applicable. Adjudication is a process for resolving discrepancies among expert readers in AI/ML studies. This is a non-clinical, mechanical performance study.

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 done. This type of study is relevant for AI/ML diagnostic tools that assist human readers. This submission is for a physical knee implant.

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

• Not Applicable. This is a physical knee implant, not an algorithm.

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

• Engineering Specifications and Performance Standards. The "ground truth" for this device's performance would be the established engineering specifications for material properties, mechanical integrity, and kinematic behavior, as well as the performance of the legally marketed predicate device to which it claims substantial equivalence. These are assessed through physical and mechanical tests.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.

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

• Not Applicable. (See #8)

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The ATTUNE Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology are intended for cementless use within the ATTUNE® Total Knee Replacement System. Porous coated implants may be used with or without cement.

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

The ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology are compatible with the ATTUNE Knee System composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant with or without porous coating. The tibial component may be comprised of a metal tibial base with or without porous coating, and a polyethylene insert and locking components, or be an all polyethylene device. The patella component may be of an all polyethylene design or a polyethylene patella with porous metal backing.

The provided text is a 510(k) summary for a medical device (ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology) and does not describe acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means showing that the new device is as safe and effective as a legally marketed device that does not require premarket approval. The "acceptance criteria" in this context are related to meeting established performance standards for orthopaedic implants and demonstrating similar characteristics to the predicate devices.

Here's a breakdown of what is provided, framed as closely as possible to your request for acceptance criteria and study information, considering that the primary goal here is substantial equivalence, not a standalone performance study with accuracy metrics.

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

The document does not present a table of acceptance criteria in the format typically used for AI/diagnostic device performance (e.g., sensitivity >X%, specificity >Y%). Instead, the "acceptance criteria" are implied by the performance standards for orthopaedic implants to demonstrate substantial equivalence, and "reported device performance" refers to the successful completion of these tests.

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

The document lists various non-clinical tests. For these tests (fatigue, fixation, biocompatibility, coating characterization, etc.), the sample sizes are not explicitly stated in this summary. It is typical for these types of engineering tests to involve controlled laboratory specimens rather than patient data. Data provenance like country of origin or retrospective/prospective is not applicable here as these are laboratory tests, not clinical studies.

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)

This is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI performance studies rather than the engineering and material performance tests described for this knee implant. The "ground truth" for these tests is established by the specifications and acceptance criteria of the ASTM and ANSI/AAMI standards themselves.

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

Not applicable, as this refers to a method used to resolve discrepancies in expert interpretation, which is not relevant for the non-clinical, objective engineering tests described.

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. This is a knee implant, not an AI diagnostic device. No human-in-the-loop performance or MRMC studies were conducted for this type of device.

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

Not applicable, as this is related to AI/diagnostic algorithms, not a knee implant.

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

For the non-clinical tests, the "ground truth" is defined by the established industry standards (e.g., ASTM F1800, ASTM F1044, ANSI/AAMI ST 72:2019). The tests measure physical properties against defined limits or performance benchmarks within these standards.

8. The sample size for the training set

Not applicable. This is a physical device, and the evaluation is based on non-clinical engineering and material tests, not on machine learning or AI models which would require training sets.

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

Not applicable, for the same reason as point 8.

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