(358 days)
The ATLAS® III Acetabular Cup is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, and revision of previously failed hip arthroplasties. The device is designed for cementless application.
The ATLAS® III Acetabular Cup is available in twelve (12) outer diameter (O.D.) sizes from 46 mm to 68 mm in two (2) mm increments. The polyethylene insert is available in four (4) possible inner diameter (I.D.) size options, 22.2 mm, 26 mm, 28 mm and 32 mm. The ATLAS® III Acetabular Cup instrumentation system is utilized for proper impaction of the device.
This document is a 510(k) summary for the ATLAS® III Acetabular Cup, a medical device. It describes the device, its intended use, and its comparison to predicate devices. It also briefly mentions performance data.
However, the provided text does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria, as it relates to performance metrics, statistical analyses, or human expert involvement typically found in AI/ML device submissions.
Here's a breakdown of why and what information is missing:
Information NOT present in the provided text:
- Acceptance Criteria Table: There is no table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, etc.) and no reported device performance against such criteria. The document focuses on mechanical and material characteristics and comparison to predicate devices.
- Sample size for the test set and data provenance: No information about a "test set" in the context of AI/ML evaluation. The "performance data" mentioned refers to material and mechanical testing, not an algorithmic evaluation.
- Number of experts used to establish ground truth & qualifications: N/A, as there's no AI/ML component described that would require expert-established ground truth.
- Adjudication method: N/A.
- Multi-reader multi-case (MRMC) comparative effectiveness study: N/A. The device is a physical implant, not an AI/ML diagnostic tool.
- Standalone performance: N/A.
- Type of ground truth used: N/A.
- Sample size for the training set: N/A.
- How the ground truth for the training set was established: N/A.
Information provided related to "Performance Data" (but not in AI/ML context):
The document states:
"Testing conducted to characterize the materials, the hydroxylapatite coating, and the performance characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence."
This indicates that:
- "Study" (of a sort): Laboratory testing was performed.
- Purpose: To characterize materials, coating, and mechanical performance. This is typically done to ensure the device meets engineering specifications and standards for biocompatibility, strength, durability, and other physical properties.
- Acceptance Criteria (implied): While not explicitly stated in a table with metrics, the "performance characteristics" and "defined laboratory conditions" imply there were pre-defined criteria that the device had to meet for its materials and mechanical functions to demonstrate "substantial equivalence." These criteria would be based on recognized standards for orthopedic implants.
- "Proof": The results of these laboratory tests served as the "proof" that the device met these implicit performance criteria, thereby supporting the claim of substantial equivalence to predicate devices.
Conclusion:
The provided 510(k) summary for the ATLAS® III Acetabular Cup describes a physical medical device (an acetabular cup for hip replacement), not an AI/ML-driven diagnostic or treatment planning system. Therefore, the specific questions related to AI/ML performance metrics, expert ground truth, training/test sets, and MRMC studies are not applicable to this document. The "study" mentioned refers to laboratory testing of the physical properties and materials of the implant.
§ 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.