(111 days)
The indications for the Trinity Acetabular System as a total hip arthroplasty include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
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, acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW, ceramic and Co-Cr modular heads and titanium femoral stems.
The purpose of this submission is to add smaller acetabular shell sizes, highly crosslinked ultra-high molecular weight liners and large diameter Co-Cr and Biolox delta ceramic modular heads to the Trinity Acetabular System.
The provided text is a 510(k) summary for a medical device (Corin Trinity Acetabular System with HXLPE Liners), not a study evaluating software or an AI algorithm. Therefore, many of the requested fields are not applicable to this document. The document describes a traditional medical device (hip prosthesis) and its regulatory submission, which relies on non-clinical testing and substantial equivalence to predicate devices, rather than clinical studies with human readers or AI performance metrics.
Here's a breakdown of the relevant information from the provided text according to your request:
1. Table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, not on specific acceptance criteria or performance metrics for a particular study with reported results in a table format.
2. Sample size used for the test set and the data provenance
Not Applicable. This document describes non-clinical testing of a physical medical device. There is no "test set" in the context of data for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. No ground truth established by experts for a test set is mentioned.
4. Adjudication method for the test set
Not Applicable. No adjudication method is mentioned as there is no test set in the context of data analysis.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the additional components of the Trinity Acetabular System and the predicate devices." (Section 11, page 1).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
Not Applicable. No ground truth in the context of data for an AI algorithm is mentioned. For the physical device, "substantial equivalence" is the regulatory benchmark, demonstrated through non-clinical testing.
8. The sample size for the training set
Not Applicable. This is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
Not Applicable. There is no training set.
Summary of what is present in the document related to "acceptance criteria" and "study":
The "acceptance criteria" in this context are implicitly that the new components of the Trinity Acetabular System with HXLPE Liners demonstrate substantial equivalence to existing legally marketed predicate devices.
The "study" that proves the device meets (this implicit) acceptance criteria is described as non-clinical testing. This includes:
- Characterization of the HXLPE material
- Testing of the locking mechanisms between the Trinity Acetabular Shells and the HXLPE liners
- Range of motion analysis
- Impingement testing
- Wear testing
- Testing of shell stiffness
- Liner insertion and extraction testing
- Burst, fatigue and axial pull-off testing of the Biolox delta ceramic heads
The document essentially states that based on these non-clinical tests, the device is "substantially equivalent to the predicate devices" in terms of "intended use and indications, materials, sizes, designs and performance."
§ 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.