(111 days)
The indications for the Corin TriFit™ CF Hip Stem as a total hip arthroplasty and as a hip hemiarthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- · Correction of functional deformity
- · Treatment of non-union and femoral neck fractures of the proximal femur
- · Developmental Dysplasia of the Hip (DDH)
- Previously failed hip surgery
The Corin TriFit™ CF Hip Stem is indicated for cementless use only.
The Corin TriFit™ CF Hip Stem is a tapered stem design manufactured from titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2:1999, ASTM F1580-01) and calcium phosphate coating (ASTM F1609-08) applied. The Corin TriFit™ CF Hip Stem is available in a range of sizes in a 127° standard offset and a 127° lateralized high offset. The device is intended to be used with Corin 12/14 modular taper heads.
The TriFit™ CF Hip Stem is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
This looks like a 510(k) summary for a medical device (Corin TriFit™ CF Hip Stem), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. For such submissions, clinical efficacy studies as one might find for an AI/ML device demonstrating diagnostic performance are typically not required or performed. Instead, the focus is on demonstrating substantial equivalence through non-clinical testing (e.g., mechanical properties, biocompatibility) and comparing features to existing devices.
Therefore, the specific information requested about acceptance criteria, study sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details typical for an AI/ML diagnostic device will not be found in this document.
Here's how to address your request based on the provided document:
1. Table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria or specific numerical performance metrics in the way one would expect for an AI/ML diagnostic algorithm (e.g., sensitivity, specificity, AUC). Instead, substantial equivalence is demonstrated through non-clinical testing and comparison to predicate devices.
| Acceptance Criteria Category | Reported Device Performance (Summary from K173880) |
|---|---|
| Mechanical Performance | "Mechanical fatigue testing of the neck and stem" showed the device is "expected to be safe and effective." (No specific numerical criteria or results provided in this summary). |
| Biocompatibility/Safety | "Bacterial Endotoxin Testing (BET) has been conducted on finished product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology." (No specific acceptance criteria or quantitative results provided, but the implication is that it met relevant standards). |
| Material Equivalence | Manufactured from titanium alloy (Ti6Al4V) (ASTM F136) with commercially pure titanium (ISO 5832-2:1999, ASTM F1580-01) and calcium phosphate coating (ASTM F1609-08). This is equivalent to predicate device coatings. |
| Design Equivalence | Tapered stem design, available in standard and lateralized high offset, intended for use with Corin 12/14 modular taper heads. Neck design identical to TriFit™ TS Hip Stem (K121563, K153772). |
| Intended Use/Indications Equivalence | Indications for use are substantially equivalent to the predicate devices (Ortho Development Corporation Alpine Hip Stem K141001, Corin TriFit™ TS Hip K121563 and K153772). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable. This submission relies on non-clinical (mechanical, materials) testing and comparisons to predicate devices, not a test set of patient data for diagnostic performance.
- Data Provenance: Not applicable. The "data" refers to engineering test results and design/material specifications, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There was no "test set" requiring expert ground truth establishment for diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no "test set" 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:
- No. This is a medical device for hip replacement, not an AI/ML diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device for hip replacement, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of diagnostic performance. The "ground truth" for this device relates to established engineering standards for mechanical strength, material composition, and biocompatibility, as well as the safety and effectiveness profile of the predicate devices.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm.
§ 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.