(192 days)
This device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of function deformity;
- Revision procedures where other treatments or devices have failed; and
- Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The U2 Acetabular Components are designed for uncemented application and single use only.
The U2 Acetabular Component is designated to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Component has 14 sizes, hemispherical design and without or with clustered bone screw holes for variable screw locking angle. The metallic shell is manufactured from forged Titanium alloy (ASTM F620) and its outer surface has two types of coating. Ti plasma spray and IIA/Ti plasma spray. The acetabular liner is machined from extruded UHMWPE bars (ISO 5834/1) and its minimum thickness is 4 18 mm to reduce contact stress. If supplemental bone screw fixation is deemed necessary, Titanium Cancellous Bone Screws (ASTM F136) can be inserted through the screw holes without interfering with the seating of the acetabular liner.
This 510(k) summary for the U2 Acetabular Component describes a medical device, not an AI/ML medical device. Therefore, a study demonstrating the device meets acceptance criteria using the specified AI/ML-centric framework (test set, ground truth, experts, MRMC studies, standalone performance, etc.) is not applicable here.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through design, material composition, HA coating, and a locking mechanism, supported by mechanical test data.
However, I can extract information related to "acceptance criteria" and the "study" conducted from the provided text, reinterpreting them in the context of a traditional medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from Mechanical Test Data) |
|---|---|
| Static Tensile Strength (of HA/Ti plasma spray) | Indicated substantial equivalence to predicate devices. |
| Static Shear Strength (of HA/Ti plasma spray) | Indicated substantial equivalence to predicate devices. |
| Push-out Test Data (for liner-cup locking mechanism) | Indicated substantial equivalence to predicate devices. |
| Lever-out Test Data (for liner-cup locking mechanism) | Indicated substantial equivalence to predicate devices. |
| Torque-out Test Data (for liner-cup locking mechanism) | Indicated substantial equivalence to predicate devices. |
Explanation of "Acceptance Criteria" and "Reported Device Performance":
For this type of device, the "acceptance criteria" are implicitly defined by the performance characteristics of the legally marketed predicate devices. The "reported device performance" demonstrates that the new device's mechanical properties (static tensile, static shear, push-out, lever-out, and torque-out for the liner-cup locking mechanism) are comparable to, and thus "substantially equivalent" to, these predicate devices. The goal is to show it performs at least as well as, or within acceptable limits of, the established predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML algorithm evaluated on a data set of images or clinical data. The "test set" would refer to physical prototypes or samples of the device undergoing mechanical testing. The document does not specify the number of samples used for these mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context is not established by human experts reviewing data, but rather by standardized mechanical testing methods (e.g., ASTM standards for material properties and device performance). The "data provenance" (country of origin, retrospective/prospective) is also not relevant in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Mechanical test results are objective measurements, not subjective evaluations requiring adjudication.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance claims of the U2 Acetabular Component is derived from mechanical testing results, adhering to established engineering standards for orthopedic implants (e.g., ASTM F620 for Titanium alloy, ISO 5834/1 for UHMWPE bars) and comparative performance against legally marketed predicate devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device with a "training set."
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.