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The EVOLUTION® Revision CCK System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

EVOLUTION® Revision CCK (Constrained Condylar Knee) is being introduced to supplement MicroPort Orthopedics' knee product lines to provide options in the case of revision or complex primary total knee replacements. The design features are summarized below:

• Components manufactured from cobalt chrome alloy, titanium alloy, and UHMWPE conforming to ASTM F75, F136, and F648, respectively
• . Available in 8 standard sizes, left and right
• Available in 2 plus sizes, left and right
• . System includes femoral component, augments, stem offset adapters, tibial insert and stem cap

The provided text describes the MicroPort Orthopedics EVOLUTION® Revision CCK System, a knee joint prosthesis. However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the typical format of a diagnostic or AI/software device.

Instead, this 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on design features, materials, and non-clinical performance testing. The information provided is primarily related to mechanical and material performance rather than diagnostic accuracy or human performance with or without AI.

Therefore, I cannot fulfill all parts of your request as posed because the document is not an "acceptance criteria study" in the sense you are asking for. It is a regulatory submission demonstrating substantial equivalence.

Based on the provided text, I can extract information relevant to non-clinical performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for each test in a pass/fail format alongside numerical performance values. Instead, it describes comparative performance against a predicate device. The general "acceptance criteria" can be inferred as performing "as well as" or "greater than" the predicate device for various mechanical properties to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical (laboratory) testing, not a test set derived from patient data. The "samples" would be the manufactured device components themselves, tested in a lab setting. The provenance is internal laboratory testing by MicroPort Orthopedics Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert-established ground truth.

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. This device is a physical knee prosthesis, not an AI/software device for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "truth" for these non-clinical tests would be the measurement results against established engineering and material standards or comparisons to predicate devices' performance.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

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The Implex Revision Hedrocel® Patella is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, 5) treatment of fractures that are unmanageable using other techniques, and 6) complications from failed prosthesis.

This device is intended for use with bone cement and supplemental fixation by means of suture attachment. Supplemental suture attachment may be used in cases where additional device support can be obtained.

The Revision Hedrocel® Patella is a modular porous backed patella consisting of a Hedrocel® Patellar Backing with titanium alloy suture ring and the current commercially available Continuum® Patella. The Revision Hedrocel® Patella provides the surgeon a method for augmenting defects in the patella typically encountered during revision surgery of the knee.

The provided text describes a 510(k) premarket notification for a medical device, the Implex Revision Hedrocel® Patella. The information focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, many of the requested details about acceptance criteria, device performance results, sample sizes for test/training sets, expert qualifications, ground truth establishment, and MRMC studies are not present in the provided document. This is common for 510(k) submissions, which often rely on similarities to previously cleared devices and existing performance data for those predicate devices.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of acceptance criteria and the reported device performance

This information is not explicitly stated in the document as a set of defined acceptance criteria with corresponding performance metrics from a new study. The submission relies on "similarities in design" and "performance testing submitted in K882322 and K971879, and Hedrocel® materials' data found in MAF #920" of predicate devices to conclude that the new device "will perform as intended."

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

• Sample size for test set: Not applicable/Not provided. No new performance study or test set data is described for the Implex Revision Hedrocel® Patella itself in this document. The submission relies on data from predicate devices.
• Data provenance: Not applicable/Not provided for a new test set for this device. The referenced predicate device data (K882322, K971879, MAF #920) would have their own provenance, but these details are not in the current document.

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

Not applicable/Not provided. No new performance study requiring expert adjudication to establish ground truth for a test set is described.

4. Adjudication method for the test set

Not applicable/Not provided.

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 implant device, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

Not applicable/Not provided for this device's performance. The submission makes a "substantial equivalence" claim based on:

• "materials, design and articulating surface geometry" being "similar and/or identical" to predicate devices.
• Performance data of predicate devices (K882322 and K971879) and "Hedrocel® materials' data found in MAF #920."
  The "ground truth" here is essentially the prior FDA clearance and established performance of the predicate devices and materials.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI algorithm that undergoes training.

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

Not applicable/Not provided.

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The Continuum Patellar is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, and 5) treatment of fractures that are unmanageable using other techniques. This device is intended for use with bone cement.

The Continuum Patellar is fabricated from Hedrocel® and UHMWPE. The UHMWPE is direct compression molded into the Hedrocel®, thereby creating the articulation surface. The Continuum Patellar is intended for use with bone cement when performing total knee arthroplasty or revisions with legally marketed Implex Continuum Femoral and Tibial components.

The Implex Continuum Patellar is a knee joint patellofemorotibial prosthesis. The 510(k) summary states that "Performance testing of the Continuum Patellar demonstrates its equivalence to the claimed predicate devices." This implies that the acceptance criteria for the device are met if its performance is comparable or non-inferior to the predicate devices.

However, the provided text does not explicitly define specific "acceptance criteria" in terms of quantitative metrics or performance thresholds. Instead, it relies on the concept of "substantial equivalence" to predicate devices.

Here's an analysis of the information requested, based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

The document mentions "Performance testing of the Continuum Patellar demonstrates its equivalence to the claimed predicate devices," but it does not provide details about a specific study in the format of a clinical trial or a detailed bench testing report. It's a summary statement rather than a detailed study description.

Based on the provided text, the following information is not available or implicitly handled by the substantial equivalence argument:

1. Sample size used for the test set and the data provenance: Not specified. The "performance testing" is not detailed.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. This typically applies to image-based diagnostic devices. For a prosthetic device, "ground truth" would likely refer to engineering specifications, material properties, and clinical outcomes, which are not outlined in a study format here.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified.
4. 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 prosthetic device, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a prosthetic device, "ground truth" would generally involve meeting engineering specifications, material tests, and potentially biomechanical evaluations, comparing them to established predicate devices. The document only states "Performance testing" without detailing methodology.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided K971789 document details a 510(k) submission where "substantial equivalence" to predicate devices is the primary means of demonstrating safety and effectiveness. It does not contain detailed information about a specific quantitative study with predefined acceptance criteria, sample sizes, and expert panel ground truth verification as typically seen for diagnostic devices or more complex clinical trials. The "performance testing" mentioned is general and not elaborated upon in this summary document. The FDA's decision emphasizes the "cemented use only" limitation as a critical aspect of its substantial equivalence finding.

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