(32 days)
The ULTIMA* Unipolar Head is indicated for use in conjunction with a modular femoral stem in partial hip replacement procedures for patients suffering severe pain and disability due to:
- femoral neck fracture,
- avascular necrosis of the femoral head,
- osteoarthritis,
- abnormalities where:
- the major pathology affects the femoral head,
- the acetabular cavity is normal and not deformed or weakened,
- acetabular replacement is not required or desirable.
The ULTIMA* Unipolar Head is provided in a size range of 38mm to 63mm (outer diameter), in 1mm increments. Sizes from 44mm through 63mm are manufactured as a twopiece assembly. The two pieces are made of cast cobalt-chromium-molybdenum alloy conforming to ASTM F75. Both pieces are treated with hot isostatic pressing and solution annealing. The two cast pieces are machined and then joined permanently by electron beam welding to form a hollow unipolar head. Sizes from 38mm through 43mm are cast from cobalt-chromium-molybdenum alloy as a solid head, and are isostatic pressed and solution annealed before machining. Both of these size ranges are finish machined to the outer diameter size. The outer diameter is highly polished for articulation with the implant recipient's natural acetabulum.
The ULTIMA* Unipolar Head has a tapered bore which can receive a variety of Adapter Sleeves. The adapter sleeves can be tapered on the outside to the mate with the unipolar head, and tapered on the inside to mate with the appropriate femoral stem trunnion. The adapter sleeves are available in a 10/12 taper, in size increments for -3mm, +0mm, +5mm. and +10mm neck lengths; in a 11/13 taper, in size increments for +0mm, +6mm, and +12mm neck lengths: and in a 12/14 taper, in size increments for +0mm, +3.5mm, and +7mm neck lengths. The adapter sleeves are machined from cobalt-chromium-molybdenum alloy in wrought bar form conforming ASTM F799.
The provided text describes the ULTIMA* Unipolar Head and Adapter Sleeves, a medical device for hip replacement procedures. The document focuses on establishing substantial equivalence to previously approved devices rather than presenting a study with specific acceptance criteria and performance metrics in the way one would for a diagnostic AI device.
Therefore, an analysis cannot be provided based on the requested format as it is not applicable to the given text.
Here's why and what information can be extracted:
- No Acceptance Criteria and Reported Device Performance Table: The document does not define specific performance metrics (e.g., accuracy, sensitivity, specificity) or acceptance thresholds for these metrics. Its purpose is to demonstrate substantial equivalence, not to prove standalone performance against defined criteria.
- No Sample Size for Test Set or Data Provenance: This is not a study involving patient data for performance evaluation. It's a regulatory submission for a medical device's physical and functional equivalence to existing devices.
- No Experts Used for Ground Truth: The concept of "ground truth" as it applies to diagnostic or AI performance evaluation is not relevant here. The ground truth for this device would be its mechanical and material properties, which are evaluated through engineering tests and adherence to standards, not expert consensus on patient data.
- No Adjudication Method: Not applicable for a device equivalence submission.
- No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is for evaluating observer performance (e.g., radiologists) with and without AI assistance. The ULTIMA* Unipolar Head is a physical implant, not a diagnostic tool or AI algorithm.
- No Standalone Performance Study: The document focuses on equivalence to existing devices, not a standalone performance evaluation against clinical outcomes or diagnostic accuracy.
- No Type of Ground Truth (Expert Consensus, Pathology, Outcomes Data): As stated, the "ground truth" for this device relates to its engineering specifications and material properties, not typical clinical or AI ground truth.
- No Sample Size for Training Set: There is no "training set" in the context of this device. This is a manufactured product, not a machine learning model.
- No Ground Truth Establishment for Training Set: Again, not applicable.
Information that can be extracted from the document related to "acceptance" (in the sense of regulatory approval) and "study" (in the sense of engineering analysis):
1. Acceptance Criteria and Reported Device Performance (as inferred from "substantial equivalence"):
The document states: "Furthermore, analysis results demonstrate that the ULTIMA* Unipolar Head and Adapter Sleeves meets the set criteria for the establishment of 'substantial equivalence'."
While not explicitly tabular acceptance criteria like for an AI device, the document implies that the device "meets the set criteria" by demonstrating similarity and comparable intended use, design, and materials to predicate devices. The "performance" is implicitly its ability to meet the same functional requirements as the predicate devices.
| Criterion Category (Inferred from Substantial Equivalence) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as or comparable to predicate devices (partial hip replacement for specific conditions). | Meets: Indicated for "partial hip replacement procedures for patients suffering severe pain and disability due to: femoral neck fracture, avascular necrosis of the femoral head, osteoarthritis, and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal." (Matches predicate devices like ULTIMA* Unipolar Modular Head and Howmedica Unitrax Unipolar System). |
| Design Characteristics (e.g., size range, adapter sleeve) | Comparable to predicate devices, addressing potential design differences through equivalence analysis. | Meets: Sizes 38mm-63mm (1mm increments). Includes adapter sleeves for increased neck length (10/12 taper, 11/13 taper, 12/14 taper with various neck lengths). Morse-taper locking mechanism confirmed. (Shown to be comparable to predicate devices in Table 1). |
| Materials | Same as or comparable to predicate devices (Co-Cr-Mo alloy conforming to ASTM standards). | Meets: Manufactured from cast/wrought cobalt-chromium-molybdenum alloy conforming to ASTM F75 and ASTM F799. (Matches predicate devices). |
| Manufacturing Processes | Processes (e.g., hot isostatic pressing, solution annealing, electron beam welding) yield materials and components meeting specifications. | Meets: Components undergo casting, hot isostatic pressing, solution annealing, machining, and electron beam welding to form the final product. Implicitly, these processes result in a device that meets the required physical properties for its intended use. |
| Safety and Effectiveness | Substantially equivalent to predicate devices, implying comparable safety and effectiveness outcomes. | Meets: "The safety and effectiveness of the ULTIMA * Unipolar Head and Adapter Sleeves is substantially equivalent... Furthermore, analysis results demonstrate that the ULTIMA* Unipolar Head and Adapter Sleeves meets the set criteria for the establishment of "substantial equivalence"." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set: Not applicable. This document refers to the physical and material properties of the device, not a test set of patient data.
- Data Provenance: The "data" pertains to engineering specifications, material standards (ASTM), and comparative analysis with previously approved devices (K940190 and K902365).
The document is a regulatory submission for a physical medical device, not a clinical study or an AI performance evaluation. The "study" referenced is the analysis performed to demonstrate substantial equivalence based on engineering, material, and design comparisons.
§ 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.