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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. All devices are intended for cemented applications except for the FOUNDATION® Porous Coated Femur, FOUNDATION® Porous Coated Tibia Stemmed, FK/3DKNEE™ Porous Coated Downsize Tibia, 3DKNEE™ Porous Coated Femur, 3DKNEE™ Porous Coated Tibia, EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia and Patella - Metal Backed which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The Porous Patella e+TM is a sterile, single-use, non-modular metal-backed patella that is manufactured from moderately crosslinked UHMWPE blended with Vitamin E and titanium alloy. The device is offered in a symmetric, domed, design available in multiple sizes. The device is intended for cemented or uncemented applications.

Non-sterile surgical instruments are supplied with the implant.

The provided text describes a 510(k) premarket notification for the "Porous Patella e+™" device. This is a medical device submission, and the content focuses on regulatory approval rather than the results of a study demonstrating the device meets a specific set of acceptance criteria in a clinical setting.

Therefore, the input document does not contain the acceptance criteria or a study proving the device meets said criteria in the context of clinical performance or diagnostic accuracy.

The "Non-clinical Testing" section lists various types of engineering and material tests performed to demonstrate the device's substantial equivalence to a predicate device, which is a different type of evaluation from a clinical study for acceptance criteria.

Here's the breakdown of why the requested information cannot be fully provided based on the given text:

• Acceptance Criteria and Reported Device Performance: This document describes the device (Porous Patella e+™) and its indications for use, and then lists engineering tests performed to show substantial equivalence to a predicate device. It does not provide specific acceptance criteria related to a clinical outcome or diagnostic performance, nor does it report device performance against such criteria. The tests mentioned (e.g., Chemical Composition, Stereological Evaluation, Mechanical Properties, Abrasion, Initial Implant Stability, Durability) are laboratory-based engineering evaluations.
• Sample size for the test set and data provenance: Not applicable. No clinical test set is described.
• Number of experts used to establish ground truth & qualifications: Not applicable. No ground truth for a test set is discussed.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "Clinical testing was not required" and "No animal data submitted." Therefore, no MRMC study was performed or is reported.
• Standalone performance: Not applicable. This refers to algorithm-only performance, and the device is a physical medical implant, not an algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as there's no machine learning algorithm described.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) document is a regulatory submission focused on demonstrating substantial equivalence through non-clinical (engineering and materials) testing for a physical implant, not a clinical study to establish performance against acceptance criteria typically associated with diagnostic or therapeutic effectiveness in a human population.

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For treatment of patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

The modification consists of an addition of a size 44mm glenoid head and size 44mm humeral poly socket. There is no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission. This includes no changes to materials, design, or method of manufacture.

This document is a 510(k) premarket notification for a medical device called the "Reverse® Shoulder Prosthesis." It describes a modification to an existing device, specifically the addition of a size 44mm glenoid head and a size 44mm humeral poly socket.

Based on the provided text, there is no acceptance criteria or study that proves the device meets acceptance criteria in the traditional sense of an AI/ML device evaluating performance against specific metrics. This document is for a mechanical medical device (a prosthetic joint), and the submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the structure provided in your prompt, highlighting why many sections are not applicable to this type of device submission:

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

   • Not Applicable. This document does not establish performance criteria in terms of accuracy, sensitivity, specificity, etc., as would be done for an AI/ML device. The "performance" for this mechanical device is assessed through "Non-Clinical Testing" which demonstrated its ability "to perform under expected clinical conditions."
   • The submission is for a modification, and the core claim is "no change to the intended use or fundamental scientific technology...no changes to materials, design, or method of manufacture" other than the size addition.

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

   • Not Applicable. No human clinical "test set" data is mentioned. The "Non-Clinical Testing" likely refers to bench testing (mechanical strength, wear, etc.). The sample size for such tests would be for the number of prostheses tested, not patient data.

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" establishment in the context of diagnostic interpretation or algorithmic output for this mechanical device.

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

   • Not Applicable. No human interpretation or adjudication of a test set is discussed.

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 not an AI-assisted device.

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

   • Not Applicable. This is not an algorithm.

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

   • Not Applicable. For mechanical devices like this, the "ground truth" often relates to engineering specifications and material properties verified through non-clinical testing. While clinical outcomes are ultimately important, they are not part of this specific 510(k) submission to demonstrate substantial equivalence for a minor modification.

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. There is no "training set" for this mechanical device.

Summary of what is provided in the document:

• Device Name: Reverse® Shoulder Prosthesis
• Regulation Number/Name: 21 CFR 888.3660, Shoulder joint metal/polymer semi-constrained cemented prosthesis
• Regulatory Class: Class II
• Product Code: PHX, KWS
• Modification: Addition of a size 44mm glenoid head and size 44mm humeral poly socket.
• Claim: "no change to the intended use or fundamental scientific technology of the RSP with the modifications in this Special 510(k) submission. This includes no changes to materials, design, or method of manufacture."
• Non-Clinical Testing: "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions." (No specifics on the nature or results of this testing are provided in this summary document).
• Clinical Testing: "None provided."
• Predicate Device: DJO Surgical Reverse Shoulder Prosthesis (K041066 & K051075)

This document is a formal communication from the FDA to the manufacturer regarding a 510(k) submission. It confirms the FDA's determination of "substantial equivalence" based on the information provided by the manufacturer. The core of this type of submission for a mechanical device modification is to show that the modified device is as safe and effective as a legally marketed predicate device, often relying heavily on non-clinical (bench) testing rather than human clinical studies for minor changes.

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