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510(k) Data Aggregation
(112 days)
The SLR-PLUS Hip Stem is indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Orthopaedics AG SLR-PLUS Hip Stems are intended for single use only.
Subject of this Traditional 510(k) premarket notification is the SLR-PLUS Standard and Lateral Femoral Stems. The subject devices are intended for primary hip arthroplasties and to replace previously failed femoral hip arthroplasties. The SLR-PLUS Standard Femoral Stems are designed for prosthetic arthroplasty in primary and revision surgery. The SLR-PLUS Lateral stem has been designed to optimize the lateralization of the femur (offset) in hip arthroplasty surgery. Both stems are manufactured from Ti-6Al-7Nb titanium alloy.
The provided document is a 510(k) summary for a medical device (femoral stems), and it does not describe an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device evaluations, such as ground truth, sample sizes for training/test sets, expert qualifications, adjudication methods, or MRMC studies, are not applicable.
The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing.
Here's an attempt to answer the questions based solely on the provided text, recognizing the limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance | Comments |
|---|---|---|
| Neck fatigue testing per ASTM F 2068-03 | Implied to meet or exceed. | "A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure." |
| Neck fatigue testing per ISO 7206-6 | Implied to meet or exceed. | "A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure." |
| Distal fatigue testing per ISO 7206-4/8 | Implied to meet or exceed. | "A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure." |
| Range of Motion per EN ISO 21535 | Implied to meet or exceed. | (See above) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the mechanical tests. The data provenance is not mentioned, but it would typically be from laboratory testing rather than clinical data for this type of device.
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)
This is not applicable for a mechanical device. The "ground truth" for mechanical testing is established by compliance with the specified international standards (ASTM and ISO). No human experts are used to interpret the "ground truth" in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Mechanical tests have objective outputs that are compared directly to standard specifications, not adjudicated by human experts.
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 hip stem, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical hip stem, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of this device is adherence to mechanical performance standards (ASTM F 2068-03, ISO 7206-6, ISO 7206-4/8, EN ISO 21535). The performance is assessed against the requirements and specifications defined in these standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(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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