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

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis;
• correction of functional deformity;
• femoral fracture.
  This device may also be indicated in the salvage of previously failed surgical attempts.
  The Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemiarthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications.

The modification consists of a change to the Instructions for Use for the devices listed above to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.

This document is a 510(k) Premarket Notification from Encore Medical, L.P. to the FDA for a change to their "Encore Medical Hip System IFU" (Instructions For Use). It is not a study proving device performance against acceptance criteria for a new device.

The FDA letter (K070050) explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates a substantial equivalence determination, not an assessment of a device's performance against specific acceptance criteria through a study.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as this type of documentation is typically associated with performance studies for new or significantly modified medical devices, especially those requiring clinical trials or rigorous testing.

Here's an explanation based on the provided text:

• This submission is for a change to the Instructions for Use (IFU), not for a new device or a significant modification requiring a new performance study. The core devices (various hip systems) were cleared previously under different 510(k) numbers (e.g., K910010, K934169, K962560, etc.).
• The criteria for clearance in this K070050 submission are primarily related to "substantial equivalence" to legally marketed predicate devices, meaning the modified IFU (and implicitly the affected devices) are as safe and effective as predicate devices. The comparable features highlighted are "same materials, design, indications, packaging, and sterilization."

In summary, there is no performance study described in this document against a set of acceptance criteria, as this is a filing for an IFU update based on substantial equivalence to previously cleared devices.

However, I can extract information related to the "Indications for Use" which serve as a type of acceptance criteria for patient suitability for the device, and the comparable features to predicate devices which form the basis of the substantial equivalence determination.

Analysis of Provided Document:

This document describes a 510(k) premarket notification regarding a modification to the Instructions for Use (IFU) for the Encore Medical Hip System. This is not a study demonstrating device performance against acceptance criteria in the way you've described (e.g., for a novel AI algorithm or a new physical device requiring a clinical performance study).

The FDA's clearance (K070050) is based on a determination of substantial equivalence to previously cleared predicate devices. Therefore, the "acceptance criteria" here are largely implicit in the claim of substantial equivalence and relate to the device's design, materials, indications, packaging, and sterilization being comparable to existing devices. This document does not contain efficacy or performance data from a study designed to meet specific metrics.

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

Since this is an IFU update for existing, substantially equivalent devices, there are no new performance acceptance criteria or reported device performance results from a dedicated study in this document. The "criteria" are primarily the established indications for use, which define when the device should be used.

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 (N/A): This document does not describe a performance study with a test set. The clearance is based on substantial equivalence.

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 (N/A): No test set or ground truth establishment is described in this document.

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

• Not applicable (N/A): No test set or adjudication method is 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 (N/A): This device relates to hip implants, not an AI software. No MRMC study was conducted or described in this document.

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

• Not applicable (N/A): This is not an AI algorithm.

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

• Not applicable (N/A): No ground truth is described, as there is no performance study. The "truth" for this submission is that the updated IFU accurately reflects the device's intended use and that the device itself is substantially equivalent to predicates.

8. The sample size for the training set

• Not applicable (N/A): No training set is described.

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

• Not applicable (N/A): No training set or ground truth establishment is described.

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