(256 days)
This femoral stem is for total or hemi-hip arthroplasty and is indicated for the following conditions; Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory degenerative joint disease (I.D), e.g., rheumatoid arthritis; those patients with failed previous surgery where pain, deformity, or dysfunction persists; revision of previously failed hip arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled pattents with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
This stem is for uncemented use only.
The Zimmer Porolock MIS Stem is a modular femoral stem intended for total or hemi-hip arthroplasty. The curved, uncemented stem and is coated proximally with Titanium Vacuum Plasma Sprayed (Ti-VPS) and rough-blasted distally. The 12/14 femoral stem is available in multiple sizes in order to address different patient morphologies.
The provided documentation for the Zimmer® Porolock™ MIS Stem (K071723) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proving device performance against those criteria.
Therefore, the requested information regarding specific acceptance criteria, a standalone study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment cannot be fully extracted from this document.
The document states: "Non-clinical testing demonstrated that the Zimmer Porolock MIS Stem met performance requirements and is as safe and effective as the predicate devices," but it does not specify what those performance requirements (acceptance criteria) were or detail the study methodology.
Here's what can be gathered, with caveats for missing information:
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be fully provided as the specific acceptance criteria (performance requirements) and detailed results are not disclosed in this 510(k) summary.
The document generally states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meeting performance requirements (unspecified) | Met performance requirements (unspecified) |
| As safe as predicate devices (unspecified safety metrics) | As safe as predicate devices (unspecified safety metrics) |
| As effective as predicate devices (unspecified effectiveness metrics) | As effective as predicate devices (unspecified effectiveness metrics) |
Note: The 510(k) process relies on demonstrating substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as the predicate device(s) for the same intended use. The "acceptance criteria" here are inherently tied to the performance of those predicate devices, but the specific metrics are not elaborated upon.
Missing Information from the Document:
Due to the nature of a 510(k) summary, the following information is not provided:
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable, as no human-read test set requiring ground truth establishment is described for a medical imaging AI device. This device is a hip implant, for which "ground truth" would relate to its physical and biomechanical properties.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
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
- MRMC Study: No, this is not an AI/medical imaging device. It is a hip implant.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable for a hip implant. The performance assessed would be for the physical device itself (e.g., mechanical properties, wear, corrosion). The document states "Non-clinical testing demonstrated that the Zimmer Porolock MIS Stem met performance requirements," which implies standalone testing of the device's physical properties.
7. The type of ground truth used
- Type of Ground Truth: For a hip implant, "ground truth" would typically refer to established engineering standards, material specifications, and biomechanical test results (e.g., fatigue life, static strength, wear rates compared to benchmarks). The document does not detail the specific "ground truth" or reference standards used for the "non-clinical testing."
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning product that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.