(186 days)
The Metha Hip System (uncemented, press-fit fixation) is intended to replace a hip joint.
The device is intended for:
- skeletally mature individuals undergoing primary surgery for total hip replacement .
- patients suffering from severe hip pain and disability due to rheumatoid arthritis, . pationity banoming fromatic arthritis, polyarthritis, collagen disorders, avascular ostcountinties, tradmise and nonunion of previous fractures of the femur.
- patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral epiphysis
- patients suffering from disability due to previous fusion .
- patients with acute femoral neck fractures .
The Metha Hip Systems are a short stem design with either a single piece stem or a The Metha Thip Systems are a short seem beag. These hip systems share common heads in either modular Stemmeck Option: Doll of the Step titanium alloy. The proximal area of Cool of Geranic. The stem to manufacturers with a secondary coating of the lemoral stem is plasma oplaysu (r lasinopolised for cementless use only. Galcium i nosphate (p Oal o). "This etsin a sestems is referred to as The acetabiliar Jup that is VIPE insert with a Titanium plasmaspray shell.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Metha Hip System, structured to address your specific points:
The provided text is a 510(k) summary for the Metha Hip System, focusing on demonstrating substantial equivalence to predicate devices. This type of submission relies heavily on non-clinical performance data (mechanical testing) rather than clinical studies with human subjects or AI-driven evaluation. Therefore, many of your requested fields related to AI, clinical trials, ground truth, and expert consensus are not applicable to this document.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What they aimed to demonstrate) | Reported Device Performance (How it met the criteria) |
|---|---|
| As safe, effective, and performs as well as predicate devices. | "Testing demonstrated that the device is as safe, as effective, and performs as well as the predicate devices." (Implied by meeting or exceeding predicate device performance in the specific tests). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in the document for the fatigue testing. It refers to "testing" performed, but not the number of units tested.
- Data Provenance: Not specified, but implied to be from laboratory testing and not human subject data.
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)
Not applicable. Ground truth in this context refers to mechanical performance parameters established by industry standards (ISO, ASTM) and evaluated in a laboratory setting, not by clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical data and consensus building among human experts, which is not relevant for mechanical testing.
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 is a medical device (hip implant), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (hip implant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance data is established industry standards and predicate device performance. The device's mechanical integrity and durability are compared against the performance requirements outlined in standards like ISO 7206-4 and ASTM F2068-03, and implicit performance of the predicate devices.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of mechanical testing for a medical implant like this.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or corresponding ground truth establishment process relevant to this type of device submission.
Summary of Acceptance Criteria and Study:
The acceptance criteria for the Metha Hip System are demonstrating that its technological characteristics (design, intended use, material composition, function, and range of sizes) and performance data (specifically fatigue testing) are substantially equivalent to legally marketed predicate devices.
The study that proves the device meets these criteria is fatigue testing per ISO 7206-4 and ASTM F2068-03. This testing, a non-clinical evaluation, aims to show the mechanical durability and safety of the implant under simulated physiological loads, demonstrating that it performs "as safe, as effective, and performs as well as the predicate devices." The specific numerical results of this testing and the comparison points to predicate devices are not detailed in this summary but would have been part of the full 510(k) submission.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.