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510(k) Data Aggregation
(87 days)
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:
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence to Predicate Device | Design, Manufacturing Material (CP Titanium, Ti-Plasma coated), Uncemented Use, Intended Medical Indications are similar to predicate device (LPC-PLUS Acetabular Cup, K003274). | "The MPF Acetabular Cup is substantially equivalent to the LPC-PLUS Acetabular Cup (K003274 - S/E 4/6/2001). Both cups are similar in design. They both are manufactured from CP Titanium conforming to ASTM F67 and are Ti-Plasma coated. In addition, both cups are for uncemented use and are intended for the same medical indications." |
| Biomechanical Performance | Equivalent to other similar implants; sufficient for in vivo loading. | "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." |
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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(29 days)
The SL-PLUS® Stem primary component is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. The SLR-PLUS® Stem, a revision component, is also available to replace previously failed femoral hip arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The SL-PLUS® and SLR-PLUS® Femoral Stems are of a double taper design and are manufactured from Ti-6AI-7Nb titanium alloy according to ASTM F136-98. The primary stem SL-PLUS® is available in 14 sizes ranging from size 01 through 12. The SLR-PLUS® revision stem is available in 11 sizes ranging from size 1 through 11. The femoral ball heads are manufactured from CoCrMo alloy according to ASTM F799-99. They are available in 22 mm, 28 mm, and 32 mm diameters and five different lengths, namely small (S), medium (M), long (L), extra long (XL) and extra-extra long (XXL). In addition, the INTRAPLANT ceramic ball heads with 28 mm and 32 mm diameter may be used with the SL-PLUS® and SLR-PLUS® stems.
The provided document is a 510(k) Summary for the SL-PLUS® and SLR-PLUS® Stems, a medical device for total hip arthroplasty. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed data from clinical trials or performance studies with acceptance criteria in the same way an AI/ML device would. Instead, it relies on demonstrating that the new device is as safe and effective as a previously approved device.
Therefore, the specific information requested about acceptance criteria, study design, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance, as one would find for an AI/ML diagnostic or assistive device, is not present in this document.
The relevant section regarding performance is:
- Performance data: "Biomechanical Testing has been done. All test results are sufficient for in vivo loading."
This statement is very general and does not provide quantitative acceptance criteria or detailed study results. The FDA's 510(k) process for mechanical devices often relies on bench testing (biomechanical testing) and comparisons to predicate devices based on design, materials, and established performance standards, rather than clinical efficacy studies with human subjects that generate metrics like sensitivity/specificity or human reader improvement with AI.
To directly address your request given the provided document:
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Table of acceptance criteria and reported device performance:
Acceptance Criteria Reported Device Performance Not specified in provided document, likely based on internal engineering specifications and relevant ASTM standards for hip implants. "Biomechanical Testing has been done. All test results are sufficient for in vivo loading." -
Sample size used for the test set and the data provenance: Not applicable. Biomechanical testing typically involves physical samples of the device and testing under simulated physiological loads, not patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biomechanical testing is typically established by engineering standards and measurement equipment, not expert opinion.
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Adjudication method for the test set: Not applicable.
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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 mechanical implant, not an AI/ML diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: For biomechanical testing, ground truth refers to the accuracy of the measurements against known physical properties or against established standards for mechanical failure/performance.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable.
In summary, this document pertains to a medical device (hip stem) seeking 510(k) clearance based on substantial equivalence and biomechanical testing, not an AI/ML medical device requiring clinical performance metrics often associated with AI studies.
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