(67 days)
The Metha® Short Stem 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, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head 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 .
Metha® is a femoral short stem intended to replace the hip joint in total hip arthroplasty. The femoral stem is collarless, conical shaped and is intended for cementless, press-fit application. The femoral stem is manufactured from titanium alloy and is available in various sizes. The proximal area of the femoral stem is plasma sprayed (Plasmapore®) with a secondary coating of Calcium Phosphate(u-CaP®). It is designed for use with currently available Aescular Implant Systems femoral heads, acetabular components and Bipolar cups.
This is a 510(k) premarket notification for a medical device (hip implant), which typically relies on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria in the way an AI/software device would. Therefore, most of the requested fields are not applicable or cannot be extracted from the provided text.
Here is what can be inferred and stated based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated in a Quantitative Form) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices based on technological characteristics and performance testing. | Performed a range of required tests as per FDA guidance documents for orthopedic devices and specific guidelines for metallic surfaces, plasma-sprayed coatings, modular implant components, femoral stem prostheses, and calcium phosphate coatings. The device materials and range of shapes/sizes are similar to predicate devices. |
Explanation: The concept of "acceptance criteria" for a 510(k) clearance of a mechanical implant like this is not about meeting specific numerical performance targets in a clinical study with a predefined sample size and ground truth, as it would be for a diagnostic AI. Instead, it's about demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through engineering performance testing (e.g., mechanical, material, biocompatibility) and comparison of technological characteristics. The document states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable," along with several other specific guidance documents. This implies that the device successfully met the benchmarks or standards outlined in those guidances.
2. Sample size used for the test set and the data provenance
Not applicable. The clearance is based on mechanical and material testing, not a clinical test set with human data that would have provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for AI/diagnostic studies is not relevant here.
4. Adjudication method for the test set
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
Not applicable. This is a medical implant, not an AI/diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an AI/diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical "ground truth" for diagnostic performance. For mechanical implants, the "ground truth" for safety and effectiveness is established through adherence to national/international standards and FDA guidance documents for material properties, mechanical integrity, and biocompatibility, as well as comparison to predicate devices.
8. The sample size for the training set
Not applicable. This is a medical implant, not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable.
§ 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.