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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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The DePuy Attune Total Knee System is intended for cemented use as a total knee replacement system.

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 a polyethylene tibial inserts and patella component made from AOX Polyethylene that mates with existing cemented and noncemented femoral and tibial base components

The provided text does not describe an AI medical device or a study involving AI. It is a 510(k) submission for a Total Knee System and specifically concerns an extension of the product's shelf life (from 5 years to 8 years) for certain components made from AOX Polyethylene that are gamma irradiated.

Therefore, I cannot extract information related to:

• Acceptance criteria for an AI device.
• Sample size for a test set or data provenance for an AI study.
• Number of experts for ground truth establishment for an AI study.
• Adjudication method for an AI study.
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI.
• Standalone performance for an AI algorithm.
• Type of ground truth for an AI study.
• Sample size for a training set for AI.
• How ground truth for a training set was established for AI.

The document discusses non-clinical testing to support the shelf-life extension, specifically:

• Material Oxidation Index/Resistance Testing (ASTM F2102-17, ASTM F2003)
• Wear Testing with Particle Analysis (ISO 14243-2, ISO 14243-3, ASTM F1877-05)

It explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Polyethylene Fixed Bearing Tibia Inserts and Patella components and the predicate devices."

In summary, the provided text does not contain the information requested as it pertains to a mechanical medical device (knee implant) and a shelf-life extension, not an AI device or an AI study.

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The A200 Knee System is intended for use in total knee arthroplasty for the following indications:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
   This device is intended for cemented use only.

The A200 Knee System consists of the following components: Femoral Components - nine (9) sizes in a cruciate-retained (CR) design, each for left and right sides, manufactured from Co-Cr-Mo allov: Tibial Tray Components - nine (9) sizes, each for the left and right sides, and each in two stem designs, a conical design manufactured from Co-Cr-Mo alloy, and a keeled design manufactured from Ti 6Al 4V alloy: Tibial Insert Components - three (3) footprint sizes, each for the left and right sides, with articulating thicknesses ranging from 10 mm to 20 mm, all in CR designs, in standard and deep dish configurations, manufactured from highly crosslinked ultra-high molecular weight polyethylene with and without vitamin E: Patellar Components five (5) sizes, in dome design, manufactured from highly crosslinked ultra-high molecular weight polvethylene with and without vitamin E: and A200 Knee Instrumentation including instruments for use with the system components, trial implant components, and general instruments.
The A200 Knee System implants are manufactured from Co-Cr-Mo alloy conforming to ASTM F75, Ti-6A1-4V alloy conforming to ASTM F136, and ultra-high molecular weight polyethylene conforming to ASTM F648 and ASTM F2695. All UHMWPE is crosslinked by gamma irradiation. The metallic implant components (femoral components and tibial tray components) are sterilized by Co6 gamma irradiation, and all UHMWPE components are sterilized by ethylene oxide.

The provided 510(k) summary for the Renovis Surgical Technologies, LLC A200 Knee System (K120038) does not contain the acceptance criteria or a study proving the device meets those criteria in the format requested.

This document is a premarket notification for a medical device (a knee prosthesis system) and focuses on demonstrating substantial equivalence to legally marketed predicate devices. This type of submission generally does not involve a clinical study with a test set, ground truth, or expert adjudication in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.

Instead, the "proof" is based on non-clinical testing data and a comparison of technological characteristics to existing devices.

Here's a breakdown of why the requested information cannot be fully provided from this document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the document. The general acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices, meaning it is as safe and effective.

• Reported Device Performance: The document lists several types of non-clinical tests performed, such as:

  • Component testing (tibial tray fatigue, contact area, contact stress, constraint, and tibial insert-tray interlock strength)
  • UHMWPE material characterization (density, swell ratio, oxidation index, trans-vinylene index, melting point, crystallinity, vitamin E content, free-radical content, assessment of consolidation, and analysis of extraction residues)
  • UHMWPE mechanical testing (Izod impact resistance, tensile properties, compressive properties, small punch testing, fatigue crack propagation, and environmental stress cracking)
  • Force-control wear testing according to ISO 14243-1 and ISO 14243-2.

  The performance is described qualitatively as "demonstrated the A200 Knee System to be substantially equivalent" or "was substantially equivalent to the predicate devices." No specific numerical results or thresholds are given.

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

• This information is not applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of a clinical trial used to evaluate an AI algorithm. The device is a physical implant. The "testing" refers to laboratory-based, non-clinical mechanical and material characterization.

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. There is no "ground truth" established by experts in this context. The "proof" is based on engineering and material science standards and comparisons to accepted devices.

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

• Not applicable. There is no adjudication in this type of submission.

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 device is a physical knee implant, not an AI software. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant to this submission.

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

• Not applicable. This is not an algorithm or software.

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

• Not applicable in the typical sense. The "ground truth" for a knee implant's safety and effectiveness in a 510(k) context is established by adherence to recognized standards (e.g., ASTM, ISO), mechanical properties, material biocompatibility, and demonstrated performance (e.g., wear rate, fatigue strength) compared to devices already on the market that have a known safe and effective history.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable.

Summary of what the document does provide regarding "proof" of meeting requirements:

The "study that proves the device meets the acceptance criteria" in this context is the compilation of non-clinical testing data that demonstrates the A200 Knee System is substantially equivalent to legally marketed predicate devices.

• Acceptance Criteria (Implicit): The device must be as safe and effective as the predicate devices, and any differences in technological characteristics must not raise new issues of safety or efficacy.
• Study Design/Methodology: Non-clinical (benchtop) testing, material characterization, and comparison to predicate devices.
• Key Findings: The document states that:
  • Constraint, contact area, and contact stress testing demonstrated substantial equivalence to predicate devices K923277, K892800, K932837, and K935080.
  • Wear rate testing of the UHMWPE with vitamin E was substantially equivalent to predicate devices K103223 and K100048.
  • Overall, the device "has the same intended use," "uses the same operating principles," "incorporates the same basic designs," "incorporates the same or very similar materials," and "has similar packaging and is sterilized using the same materials and processes" as the predicate devices.

In essence, for a physical implant like the A200 Knee System, "meeting acceptance criteria" in a 510(k) means successfully proving substantial equivalence through a battery of engineering tests and a detailed comparison to existing, cleared devices.

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The Movation Knee System is Indicated For: Joint replacement is indicated for patients suffering from disability due to: - degenerative, post-traumatic or rheumatoid arthritis; . - 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; ● - treatment of fractures that are unmanageable using other techniques. . This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications.

The Movation Highly Cross Linked Vitamin E Tibial Inserts are manufactured from HXL VE (75KgY) ultra high molecular weight polyethylene (UHMWPE). The tibial inserts are available in 11 sizes (1,2,3,4,5,6,7,8,10,12, and 14) and 6 thicknesses (9mm -21mm) and are provided neutral in orientation. The tibial insert is identical in design to the compression molded UHMWPE Movation tibial insert cleared via K100900. The tibial insert is identical in materials to the Highly Cross-Linked Vitamin E UHMWPE Tibial Insert cleared via K091956.

The provided document describes a medical device, the "Movation Highly Cross Linked Vitamin E Tibial Insert," and its substantial equivalence to predicate devices, not a study evaluating a device's performance based on specific acceptance criteria as you'd typically find for AI/software-as-a-medical-device (SaMD).

This document is a 510(k) Premarket Notification summary for an orthopedic implant. It focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through non-clinical testing (mechanical, physical, chemical, and wear testing) and comparisons of design and materials. It explicitly states "Clinical Testing: None provided."

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the context of an AI/SaMD, as this document does not contain that type of information.

Here's what I can extract from the provided text, highlighting why the requested information for acceptance criteria and a "study" (in the AI/SaMD sense) isn't present:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this type of device are generally related to demonstrating substantial equivalence to predicate devices through various non-clinical engineering and material tests. For example, ensuring mechanical properties (tensile strength, impact resistance, crack propagation) fall within acceptable ranges and are comparable to predicate devices.
• Reported Device Performance: The document reports results for various non-clinical tests (Tensile, Small Punch, Izod Impact, crack propagation, Oxidation Index, Compressive Modulus, Poisson's Ratio, Surface Roughness, Density, Melting Temperatures, Delta H, Degree of Crystallinity, Crosslink Density, Swell Ratio, Molecular Weight, Polydispersity Index, Lamallae Thickness, Free Radical Concentration, Vitamin E Concentration, Vitamin E Consolidation, Vitamin E Elution/Extraction, Trans-vinylene Index, tibial insert peel-out strength, wear testing, and biocompatibility). The document states, "All testing has demonstrated the device is substantially equivalent to the predicate devices." This is the ultimate "performance" reported in this context – equivalence to existing devices, not a standalone clinical performance against a ground truth.

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

• Not applicable. This document describes non-clinical laboratory testing (material characteristics, mechanical properties, wear, biocompatibility). These tests typically use material specimens or prototypes, not clinical "test sets" of patient data. There is no concept of country of origin for "data" in this context.

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

• Not applicable. This relates to clinical performance evaluation, which was not performed or submitted.

4. Adjudication Method for the Test Set:

• Not applicable. This relates to clinical performance evaluation, which was not performed or submitted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a premarket notification for an implantable medical device, not an AI or diagnostic software. Clinical studies, especially MRMC studies, are not mentioned and are often not required for 510(k) clearances if substantial equivalence can be demonstrated through other means (like non-clinical testing for implants). The document explicitly states: "Clinical Testing: None provided."

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

• No. This is for a physical medical device (tibial insert), not an algorithm or software.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" implicitly refers to established engineering standards, material specifications, and performance characteristics of the predicate devices. The testing confirmed the new device met these criteria and was comparable. There's no biological or clinical "ground truth" (e.g., pathology, outcomes data) used in this submission.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, no training set or associated ground truth.

In summary, the provided document details a 510(k) submission for a physical orthopedic implant. Its "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through extensive non-clinical (laboratory and materials) testing, not through clinical studies of performance against ground truth, which would typically be included for an AI/SaMD product.

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Joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• 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;
• treatment of fractures that are unmanageable using other techniques.
  This device may also be indicated in the salvage of previously failed surgical attempts.
  This system is to be used for cemented applications.

This submission is to request clearance for a line extension to the current patella product line to include a highly cross linked polyethylene patella infused with pharmaceutical grade alphatocopheral.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, recognizing that this document describes a medical device (a knee implant patella), not an AI algorithm. Therefore, many of the requested fields pertinent to AI algorithm evaluation (like MRMC, ground truth establishment for training data, expert consensus, etc.) will not be applicable.

Device Name: Highly Cross Linked Patella with Vitamin E

Device Type: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This submission relies on non-clinical (bench) testing and comparison to predicate devices, not on a clinical test set with patient data or an algorithm's performance on a dataset.
• Data Provenance: Not applicable. The "data" comes from engineering and laboratory tests, not patient data sets.

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

• Not applicable. Ground truth, in the context of an AI algorithm, usually refers to labels established by human experts on a dataset. For this medical device, performance is established through physical and material testing, not expert-labeled data.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" in the context of human interpretation or algorithm output requiring adjudication.

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 medical device (implant), not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Engineering/Material Science Ground Truth: Performance was judged against established engineering standards, material specifications, and the performance characteristics of previously cleared predicate devices. Examples include:
  • Quantifiable mechanical properties (e.g., strength, wear rates, impact resistance).
  • Biocompatibility standards (e.g., absence of cytotoxicity).
  • Comparability to existing devices as defined by design, materials, and intended use.

8. The Sample Size for the Training Set

• Not applicable. This is a medical device, not an AI algorithm. There is no concept of a "training set" for physical bench testing.

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

• Not applicable. As above, no training set for an AI algorithm was involved. The "ground truth" for the development of the device itself would stem from engineering specifications, industry standards, and clinical needs for knee joint replacement, guiding the design and material selection.

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The DePuy Attune™ Knee System is intended for cemented 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, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The Attune™ 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 textured. It incorporates two lugs (pegs) to provide additional stability and recessed cement pockets for enhanced cement fixation. The Attune femoral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The Attune PS fixed bearing tibial insert is designed with a topography that, in the sagittal view, consists of multiple radii. The sagittal anterior radii are relatively conforming to the femoral component to aid in anterior constraint while the posterior radius is less conforming to allow rollback. The Attune PS fixed bearing tibial inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, 18, 20, and 22mm. The inserts are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The Attune PS femoral components and PS fixed bearing inserts are compatible with the Attune FB tibial bases (K101433) and patellae (K103756). 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 is a 510(k) premarket notification for a medical device, specifically the DePuy Attune Total Knee System – PS Femoral Components and PS Fixed Bearing Inserts. It does not describe a study involving algorithms, AI, or human-in-the-loop performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical functional testing for mechanical properties.

Therefore, many of the requested categories related to AI/algorithm performance and clinical studies are not applicable to this document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific numerical acceptance criteria or reported performance metrics in a readily comparable table format for each characteristic against a defined threshold. Instead, it states that "Functional testing was conducted... to verify that the implant performance would be substantially equivalent to predicate devices for anticipated in vivo loading via various constraint, contact, wear, and fatigue tests." This implies the acceptance criterion was "substantially equivalent" to predicate devices, and the reported performance met this criterion.

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

• Sample Size: Not explicitly stated as this was non-clinical functional testing, not a clinical study with patient samples. The "test set" would refer to the physical components tested in a lab.
• Data Provenance: The testing was conducted by DePuy Orthopaedics, Inc. in Warsaw, IN, USA. It is non-clinical (laboratory) data.

3. 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 in AI/algorithm studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for non-clinical functional testing is based on engineering specifications, material standards (e.g., ASTM F75, ASTM F648), and design parameters, which are evaluated by engineers and technical staff during the testing process.

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

• Not applicable. This concept applies to human expert disagreements in interpreting data, which is not relevant for non-clinical mechanical testing.

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 510(k) for a knee replacement system, not an AI or imaging diagnostic device. No MRMC study was performed.

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

• Not applicable. This document is about a physical medical device, not an algorithm.

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

• The "ground truth" or reference for this device's performance is based on engineering standards (ASTM F75, ASTM F648), pre-defined design specifications, and the performance characteristics of predicate devices as demonstrated through established non-clinical functional tests (constraint, contact, wear, and fatigue tests).

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. There is no training set for this type of device.

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The DePuy Attune™ Total Knee System is intended for cemented 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.

The 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 Attune CR Knee System is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.

The provided text describes a 510(k) premarket notification for a medical device, the DePuy Attune™ Total Knee System, specifically focusing on the medialized dome and medialized anatomic patellae components. The submission aims to establish substantial equivalence to previously marketed devices.

Based on the provided information, here's an analysis regarding acceptance criteria and study details:

The document does not describe acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) or a study proving the device meets these criteria in the context of an AI/human reader study.

Instead, this is a Premarket Notification (510(k)) for a physical medical device (knee implant components). The "acceptance criteria" here refer to the regulatory thresholds for establishing substantial equivalence to predicate devices. The "study" proving acceptance is the non-clinical functional testing performed to demonstrate this equivalence.

Therefore, many of the requested points (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone algorithm performance, AI assistance) are not applicable to this type of device submission.

Here's a breakdown of the relevant information provided:

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

The "acceptance criteria" in this context are for demonstrating substantial equivalence to predicate devices for a physical orthopedic implant. They are not defined by specific performance metrics like sensitivity or specificity.

• Articular Surface Offset: "medial" for the new device, "medial" for Kinemax predicate.
• Fixation Surface: "Cemented" for the new device, "Cemented" for Sigma predicate.
• Sizes: Available in 29, 32, 35, 38, 41 mm, which is comparable to predicate sizes (e.g., Attune predicate: 29, 32, 35, 38, 41mm; Sigma: 32, 35, 38, 41mm; NexGen: 29, 32, 35, 38, 41mm).
• Overall Design: "similar to the predicate devices including design and AOX material." |
  | Functional Performance Equivalence: Must perform similarly to predicate devices under anticipated in vivo loading. | Met: "Functional testing was conducted in compliance with FDA guidance... to verify that the implant performance would be substantially equivalent to predicate devices for anticipated in vivo loading via constraint and contact tests." |
  | Intended Use & Indications for Use Equivalence: Must have the same fundamental intended use and indications. | Met: Intended use is "Total knee replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation..." and indications for use cover "patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant," which is standard for total knee replacements and aligns with the purpose of predicate devices. |

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

• Test Set (Non-Clinical): Not applicable in the sense of a patient data set for AI. The "test set" here refers to the physical devices subjected to non-clinical functional testing. The document does not specify the number of physical samples tested.
• Data Provenance: Not applicable in the sense of patient data. The "data" comes from engineering and biomechanical testing of the physical implant components.

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. Ground truth in this context is established through engineering specifications, material standards (ASTM F648), and biomechanical testing protocols defined by FDA guidance for orthopedic implants ("Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA"). It does not involve human expert interpretation of images or clinical data for performance assessment.

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

• Not applicable. Adjudication is not relevant for this type of non-clinical, functional testing.

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, not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.

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

• No, not applicable. This is a physical medical device.

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

• The "ground truth" for this device, to establish substantial equivalence, is based on:
  • Published ASTM material standards (ASTM F648) for the polyethylene.
  • FDA guidance documents for non-clinical testing of knee implants (e.g., "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA").
  • Established engineering principles and biomechanical testing methods (e.g., constraint and contact tests).
  • Comparison to the known characteristics and approved status of predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI model for this physical device.

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

• Not applicable. There is no "training set" or associated ground truth establishment for an AI model.

Summary of the Study Proving Acceptance:

The submission relies on non-clinical testing to prove the device meets the (implied) acceptance criteria of substantial equivalence.

• Type of Study: Non-clinical functional testing.
• Objective: To verify that the implant performance (specifically the medialized dome and medialized anatomic patellae components) would be substantially equivalent to predicate devices for anticipated in vivo loading.
• Methods: Performed via "constraint and contact tests." The testing was conducted "in compliance with FDA guidance, Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses: Guidance for Industry and FDA."
• Results: The testing presumably demonstrated that the new components perform comparably to the predicate devices, leading to the FDA's determination of substantial equivalence.
• Clinical Testing: "None provided as it was not necessary to determine substantial equivalence between the Attune Knee System's medialized dome and medialized anatomic patellae and the predicate devices." This highlights that for this type of device and the 510(k) pathway, non-clinical data was sufficient to establish equivalence for regulatory clearance.

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Total joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis; .
• 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;
• Treatment of fractures that are unmanageable using other techniques .
  This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

Subject of this Traditional 510(k) Premarket Notification is a request for labeling claims for the DJO Surgical 3DKnee HXL VE Tibial Insert. The in vitro wear claim will be made for the use of the 3DKnee femoral component coupled with a 3DKnee HXL VE Insert. It is important to note that there are no new total knee components being introduced as a result of this Traditional 510(k) premarket notification.

Acceptance Criteria and Study for DJO Surgical HXL VE Tibial Insert

This document analyzes the acceptance criteria and supporting studies for the DJO Surgical Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Insert, based on the provided K103223 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The device demonstrates substantial equivalence to predicate devices based on five key claims. The acceptance criteria and reported performance for each claim are detailed below. It's important to note that the acceptance criteria are generally implied as either not showing significant degradation (for properties like oxidation resistance, mechanical strength after aging) or demonstrating performance at least equivalent to, or superior to, control/predicate materials.

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The DePuy Attune™ Knee System is intended for cemented 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, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The Attune™ femoral components are available in a cruciate retaining (CR) version. The CR 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 textured. It incorporates two lugs (pegs) to provide additional stability and recessed cement pockets for enhanced cement fixation. The Attune Femoral Components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The Attune fixed bearing CR tibial insert is designed with a topography that, in the sagittal view, consists of multiple radii. The sagittal anterior radii are tight to aid in anterior constraint while the posterior radius is larger to allow rollback. The Attune design allows for the retained posterior cruciate ligament and/or balanced posterior capsule to assist in appropriate rollback of the femur. The design offers minimal but appropriate constraint in the posterior direction for maximal rollback and full range of motion. The Attune fixed bearing CR tibial inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, and 18mm. The inserts are manufactured from AOX ultra high molecular weight polvethvlene conforming to ASTM F648. The Attune tibial bases are available in sizes 1-10. The Attune tibial base fixation surface is textured. It incorporates a stem and keel to provide additional stability and recessed cement pockets for enhanced cement fixation. The Attune tibial base utilizes a central universal locking mechanism to capture the tibial insert. The Attune tibial bases are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The Attune 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 Attune Knee System is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. Total knee replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The Attune Knee System is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.

The provided document is a 510(k) premarket notification for the DePuy Attune™ Knee System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. No acceptance criteria with specific performance metrics are explicitly stated in a table format, nor is there a study directly proving the device meets predefined acceptance criteria for clinical performance. Instead, the submission relies heavily on comparisons to predicate devices and various non-clinical tests to show substantial equivalence.

Here's an analysis of the information provided, addressing your requested points where applicable:

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

No explicit table of acceptance criteria with corresponding performance is provided in the document. The document instead focuses on demonstrating similarity in materials, design, and functional performance to predicate devices and adherence to relevant ASTM and ISO standards.

However, the document does report on comparative wear testing with a control device. If we were to infer an "acceptance criterion" from this specific test, it would be performance comparable to or better than the predicate.

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

• Wear Testing:

  • Sample Size: Not explicitly stated as a number of devices or cases in a test set. The wear test used specific sizes of the Attune CR and Sigma CR products.
    • Attune CR: Size 5 (all products), 6mm actual insert thickness (for 5 million cycle test), 5mm actual insert thickness (for 10 million cycle test).
    • Sigma CR (control): Size 3 (all products), 8mm actual insert thickness (for 5 million cycle test), 6mm actual insert thickness (for 10 million cycle test).
  • Data Provenance: In-vitro knee simulator wear testing. Not retrospective or prospective in a clinical sense, as it used physical devices in a lab setting. The testing was conducted by DePuy.

• Other Non-Clinical Testing (Physical & Mechanical, Biocompatibility, Functional):

  • Sample sizes for these tests are not provided in the summary.
  • Data provenance is "preclinical data" and in-vitro testing.

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

This information is not applicable as the submission describes non-clinical testing (material characterization, mechanical properties, wear simulation) and does not involve human subjects or expert assessment for "ground truth" in a clinical diagnostic context.

4. Adjudication method for the test set

This information is not applicable as the submission describes non-clinical, objective laboratory testing, not human-read clinical data requiring adjudication.

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 MRMC comparative effectiveness study was done. This submission is for a physical medical device (total knee replacement), not an AI-assisted diagnostic tool.

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

This information is not applicable to this device.

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

For the non-clinical testing:

• Physical and Mechanical Testing: Ground truth is established by the specified ASTM standard methods (e.g., ASTM F648 for UHMWPE characterization). The performance metrics (yield strength, ultimate tensile strength, etc.) are objectively measured against these standards.
• Biocompatibility Testing: Ground truth is established by compliance with ISO 10993 parts and specific USP tests.
• Functional Testing: Ground truth is established by compliance with FDA guidance for knee joint prostheses, specifically conducting various constraint and fatigue tests.
• Wear Testing: Ground truth is the gravimetric wear rate of the test and control devices, measured objectively in the simulator, and particle analysis (LALLS and SEM).

8. The sample size for the training set

This information is not applicable as this device is a physical implant and does not involve AI or machine learning models that require a training set.

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

This information is not applicable as this device is a physical implant and does not involve AI or machine learning models that require a training set or ground truth in this context.

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Joint replacement is indicated for patients suffering from disability due to:

• degenerative, post-traumatic or rheumatoid arthritis; .
• . 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;

This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

The Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) powder that is blended with pure liquid pharmaceutical grade alpha-tocopheral, compression molded and then highly cross-linked. The tibial inserts are available in 9 sizes (2- 12) and 5 thicknesses (9-19) and are provided in right and left orientations. The HXL VE Tibial Insert design is identical to the 3DKnee Tibial Insert cleared via K020114. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle. The baseplate attachment mechanism is the same as the previously cleared 3DKnee System inserts.

The provided document is a 510(k) summary for a medical device called "Highly Cross-Linked Vitamin E UHMWPE Tibial Insert." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study to prove acceptance criteria for a new, innovative device with unique performance claims.

Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets) are not applicable to this type of regulatory submission. This document describes a device approval based on non-clinical testing demonstrating similarity to existing devices.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This report does not define specific discrete "acceptance criteria" in the way a performance study for an AI algorithm or a novel diagnostic might. Instead, it relies on demonstrating that the new device's material properties, design, and indications for use are substantially equivalent to legally marketed predicate devices. The "reported device performance" is the outcome of various non-clinical tests showing these equivalencies.

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

• Sample Size: Not applicable. This was non-clinical testing of materials and device components, not a clinical study on patient data. The "sample size" would refer to the number of physical samples tested for each material or mechanical property. This specific number is not provided in the summary but would be detailed in the full test reports.
• Data Provenance: Not applicable in the context of clinical data. The data originates from laboratory testing. It is neither retrospective nor prospective clinical data.

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

Not applicable. Ground truth, in the context of this device, would be established by validated engineering and scientific testing standards and methodologies, not by expert medical consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There's no clinical test set requiring adjudication in this submission.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is a non-clinical submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. This is a physical medical device (an orthopedic implant), not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Established material science properties.
• Validated mechanical testing standards (e.g., for wear, strength, fatigue).
• Chemical quantification methods.
• Biocompatibility standards.
• Direct comparison of design specifications to the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

Not applicable. There is no "training set" for this device.

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