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The MPF Acetabular Cup Generation 2 is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.

We have added 10 sizes MPF Standard Cup (without screw holes), sizes 46 mm to 64 mm in 2 mm increments and 14 sizes MPF Revision Cup (with 10 screw holes), sizes 46 mm to 72 mm in 2 mm increments. In addition, we have included the following PE inserts: 5 insert for 28 mm ball heads, sizes 39 mm. 41 mm. 44 mm. 48 mm and 52 mm outside diameter. 3 inserts for 32 mm ball heads, sizes 44 mm, 48 mm and 52 mm outside diameter, 5 hooded insert for 28 mm ball heads, sizes 39 mm, 41 mm, 44 mm, 48 mm and 52 mm outside diameter 3 hooded insert for 32 mm ball heads, sizes 44 mm, 48 mm, and 52 mm outside diameter Instead of 7 sizes non-sterile cancellous (spongiosa) bone screws, sizes 20 mm to 50 mm in 5 mm increments for the predicate device, 6 sterile cancellous (spongiosa) bone screws, sizes 25 mm to 50 mm in 5 mm increments are now available with the MPF 2nd generation cup:

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set specifics. The document is a 510(k) summary for a medical device modification (MPF Acetabular Cup Generation 2), and it primarily focuses on describing the device, its modifications, indications for use, and a declaration of substantial equivalence to a predicate device. It does not contain the kind of detailed study data or performance metrics you are requesting.

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The MPF Acetabular Cup is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.

The MPF Acetabular Cup is a cementless, press-fit cup. It is available in 10 sizes ranging from 46 mm to 64 mm in 2 mm increments. It is manufactured from CP Titanium according to ASTM F 67. UHMWPE inserts are available in neutral and 20° hooded versions. Cancellous bone screws manufactured from Ti6Al4V are available in 7 sizes ranging from 20 mm to 50 mm in length. They have a standard 6.5 mm thread diameter. The cup has 3 screw holes for optional fixation. The open, unused screw holes can be closed with threaded screw hole covers. The MPF cup may be used with the following ball heads manufactured by PLUS and INTRAPLANT that are cleared for marketing by the U.S. FDA: CS-PLUS® Stem with CoCrMo Ball Head (K936214 - 6/15/94) SL/SLR-PLUS® Stem with CoCrMo Ball Head (K932481 - 6/8/94) SL/SLR-PLUS® Stem with Biolox Ceramic Head (K930963 - 17794) INTRAPLANT Ceramic Ball Heads (K990261 - 8/27/99) MODULAR-PLUS® Revision Stem (K994126 - 5/4/00) PLUS CoCrMo Ball Heads (K001942 - 7/25/00)

The provided 510(k) summary (K011836) for the MPF Acetabular Cup is for a medical device that replaces part of a hip joint. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a clinical study or complex algorithm validation. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the context of this 510(k) submission. The document states:

Note: For medical devices cleared via 510(k), especially for implants like this, the focus is often on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting novel performance criteria established through efficacy studies. Performance is often assessed through bench testing (biomechanical, material compatibility, etc.) and comparison to the predicate.

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

Not applicable. This device relies on biomechanical testing and comparison to a predicate, not a clinical "test set" in the context of algorithm performance or clinical trial data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in the context of clinical expert consensus for image analysis or diagnostic algorithms is not relevant for this device. The regulatory review process involves FDA experts, but that's a different context.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the sense of clinical cases requiring adjudication for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned and is typically not applicable for a hip replacement component. This type of study is more common for diagnostic imaging algorithms.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (an acetabular cup for hip replacement), not a software algorithm.

7. Type of Ground Truth Used

For the biomechanical tests, the "ground truth" would be established by engineering standards and accepted biomechanical principles for orthopedic implants (e.g., ability to withstand physiological loads, fatigue resistance, material properties meeting ASTM standards).

For the substantial equivalence claim, the "ground truth" is the performance and safety profile of the predicate device.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or algorithms for this device.

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

Not applicable.

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