(282 days)
The SurgTech MALUC™ System is intended for use for cases of severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and/or total arthroplasty), and certain cases of ankylosis.
The MALUC™ Total Hip Arthroplasty System is used for primary total hip replacement in skeletally mature individuals. The system consists of monolithic cemented and press-fit femoral stems, modular CoCr and BIOLOX® delta femoral heads in various sizes and offsets, uncemented acetabular shells and conventional polyethylene liners. Accessory components include distal centralizers, cancellous bone screws and cement restrictors. Instrumentation necessary for proper implantation is also included.
This document is a 510(k) premarket notification for the MALUC™ Total Hip Arthroplasty System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria in a study. Therefore, much of the requested information regarding acceptance criteria, device performance, and study design for clinical effectiveness is not present in this submission.
Here's a breakdown of what information can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The submission states that non-clinical mechanical testing was performed in accordance with several ISO and ASTM standards, and the device "met all predetermined acceptance criteria." It also mentions bacterial endotoxin testing which "met the predetermined acceptance criteria." However, the specific numerical acceptance criteria and the reported device performance values are not provided in this public summary.
| Acceptance Criteria Category | Reported Device Performance | Specific Criteria & Performance Values (not provided) |
|---|---|---|
| Mechanical Testing | Met all predetermined acceptance criteria | N/A |
| Bacterial Endotoxin Testing | Met predetermined acceptance criteria | N/A |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as no clinical test set or data provenance is mentioned for device performance. The submission explicitly states: "(b)(2) Clinical testing: Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." The tests performed are non-clinical (mechanical and endotoxin).
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 information is not applicable as no clinical study involving human interpretation or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical test set requiring adjudication 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
This information is not applicable as this is a hip arthroplasty system, not an AI-assisted diagnostic device, and no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a medical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable as no clinical ground truth was established for device performance in this submission. The "ground truth" for the non-clinical tests would be the established standards and specifications (e.g., ISO 21535, ASTM F2996, USP ), and the device's ability to meet those.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. As above, this is not an AI model.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.