(99 days)
The indications for the Trinity Acetabular System as a total hip arthroplasty include:
- o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis o
- o Correction of functional deformity
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) o
The Trinity Acetabular System is intended for cementless use only.
The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell (48mm through 68mm in 2mm increments) for use with ultra high molecular weight polyethylene (UHMWPE) liners (28mm and 32mm inner diameters in neutral, +4mm offset, EPW and 10° hooded designs) and a dedicated range of 28mm and 32mm modular 12/14 taper femoral heads providing ceramic (i.e., zirconia and Biolox delta in the USA) or metal on UHMWPE articulation for use in total hip replacement procedures using Corin titanium femoral stems with a 12/14 taper connection. The acetabular shell is coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit™). The acetabular shell is provided with screw holes permitting the use of dedicated titanium bone screws to provide additional fixation if required. Titanium occluders are provided to occlude unused screw holes and an apical introducer hole.
The purpose of this submission is to modify the labeling for the Trinity Acetabular System to include additional Corin titanium femoral stems with a 12/14 taper connection as compatible components, intended for use with the Trinity Acetabular Cup and Liner and the Trinity CoCr Femoral Heads.
The Trinity Acetabular System is intended for use in total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The provided text describes a 510(k) submission for the Trinity Acetabular System, which proposes to modify the labeling to include additional Corin titanium femoral stems as compatible components. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations. This submission is for a medical device (hip prosthesis) and its expanded compatibility, not a diagnostic or prognostic AI system.
However, based on the provided text, I can infer the acceptance criteria and the study in the context of demonstrating substantial equivalence for this device modification.
Acceptance Criteria and Study for K103518: Trinity Acetabular System
Given that this is a 510(k) submission primarily focused on modifying the labeling of an existing device to include additional compatible components, the "acceptance criteria" revolve around demonstrating that the modified device (Trinity Acetabular System with new femoral stems) is substantially equivalent to the previously cleared Trinity Acetabular System.
Here's an interpretation based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (as demonstrated by comparison) |
|---|---|---|
| Intended Use | The device with the additional femoral stems maintains the same intended use as the predicate device. | The additional, compatible Corin titanium femoral stems have the same intended use as the previously cleared Tri-Fit femoral stems for the Trinity Acetabular System. |
| Materials | The materials of the additional femoral stems are comparable to the predicate device's compatible stems. | A comparison of materials was conducted between the additional, compatible Corin titanium femoral stems and the Corin Tri-Fit femoral stems, demonstrating substantial equivalence. (Specific details of material comparison are not provided beyond this statement). |
| Design | The design of the additional femoral stems is comparable to the predicate device's compatible stems. | A comparison of designs was conducted between the additional, compatible Corin titanium femoral stems and the Corin Tri-Fit femoral stems, demonstrating substantial equivalence. (Specific details of design comparison are not provided beyond this statement). |
| Taper Characteristics | The taper characteristics of the additional femoral stems are comparable to the predicate device's compatible stems. | A comparison of taper characteristics was conducted between the additional, compatible Corin titanium femoral stems and the Corin Tri-Fit femoral stems, demonstrating substantial equivalence. |
| Indications for Use | The device with the additional femoral stems maintains similar indications for use as the predicate device. | The additional, compatible Corin titanium femoral stems have similar indications as the previously cleared Tri-Fit femoral stems. |
| Range of Motion | The range of motion achieved with the additional femoral stems is equivalent to or greater than that of the predicate. | A range of motion study was conducted, showing that the ranges of motion achieved with the additional femoral stems are equivalent to or greater than those achieved with the Tri-Fit femoral stems. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not applicable in the context of a traditional "test set" for AI. The "test" for this device was a combination of direct comparisons of specifications and specific non-clinical evaluations. The document does not specify a "sample size" for the range of motion study, but it would involve a limited number of test configurations or specimens rather than a large patient dataset.
- Data Provenance: The studies mentioned ("comparison of materials, designs and taper characteristics" and "range of motion study") are non-clinical tests. This means they were likely conducted in a laboratory setting (e.g., in vitro, cadaveric, or simulation) rather than using patient data. The country of origin for the data is not explicitly stated but would presumably be associated with the manufacturer's R&D facilities.
3. Number of Experts and Qualifications for Ground Truth
- Experts: Not applicable. The "ground truth" for this submission is established through engineering specifications, material science principles, and biomechanical testing standards, rather than expert clinical consensus on patient data.
- Qualifications: N/A
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable in the traditional sense for AI/ML performance. The "adjudication" for substantial equivalence would be performed by the FDA based on the submitted non-clinical test reports and comparisons.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This is not an AI/ML diagnostic or image analysis device, so a MRMC study is irrelevant to this submission.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: No. This is a physical medical device (hip prosthesis components), not a software algorithm.
7. Type of Ground Truth Used
- Ground Truth: The "ground truth" for this submission is based on:
- Engineering specifications and material properties for component comparisons (materials, design, taper characteristics).
- Biomechanical performance standards and measurements from the range of motion study.
- The predicate device's established safety and effectiveness as the benchmark for substantial equivalence.
8. Sample Size for Training Set
- Sample Size: Not applicable. There is no "training set" as this is not an AI/ML device. The development of the components would involve engineering design and iterative testing, but not machine learning training.
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment: Not applicable. There is no "training set" for ground truth establishment.
§ 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.