(88 days)
The TaperFit Hip Stem is indicated for the relief of pain and restoration following the effects of femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis and total hip The TaperFit Hip Stem is indicated for hemi-arthroplasty when used in combination with Corin Bipolar revision. Prosthesis hemi-arthroplasty femoral heads.
The TaperFit Hip Stem is indicated for cemented, single use only.
The TaperFit Hip Stem is a highly polished, double tapered, collarless, stainless steel femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from stainless steel in accordance with ISO 5832-9 -Implants for surgery -- Metallic materials -- Part 9: Wrought high nitrogen stainless steel and is provided with a polymethylmethacrylate (PMMA) Stem Centralizer. The stem is designed to be used in conjunction with Corin Eurocone (E100.XXX cleared in K003666) and Trinity CoCrMo modular femoral heads (E321.XXX cleared in K093472, K110087, K122305, K123705, K130128, K130343 and K131647). The stem is available in sizes, 0 through 4 with 3 offsets 50mm, 45mm, and 38mm, as well as a CDH option with a 36mm offset.
The TaperFit Hip Stem was originally cleared in K142761. This submission is being made to modify the indications for use to include hemi-arthroplasty when used with previously cleared Corin hemi-arthroplasty femoral heads as compatible components. The Corin CoCr Modular 26mm heads (E100.X26) have been cleared as compatible components of the Taper-Fit Hip stem (K003666). The Corin CoCr Modular 26mm heads (E100.X26) are part of the construct of the bipolar heads. Included in this submission is the Corin Bipolar Femoral Head (K925897) as a compatible component, which is indicated for hemi-arthroplasty.
This document is a 510(k) premarket notification for a medical device called the "TaperFit Hip Stem". It's a regulatory submission to the FDA, not a study evaluating device performance against acceptance criteria in the way described in the prompt. Therefore, much of the requested information (acceptance criteria, sample sizes for test/training sets, expert qualifications, etc.) is not present in this document because it pertains to a different type of evaluation.
Here's a breakdown of the information that is available or can be inferred, and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
- Absent. This document does not present a table of acceptance criteria or report specific performance metrics for the device. It refers to non-clinical testing data from previous submissions for establishing substantial equivalence.
2. Sample size used for the test set and the data provenance
- Absent. This document does not describe a "test set" in the context of an AI/algorithm performance evaluation. The "non-clinical testing" mentioned involved mechanical and fatigue testing, not a data-driven test set with human-equivalent performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Absent. Not applicable to this type of regulatory submission. The ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images or data.
4. Adjudication method for the test set
- Absent. Not applicable.
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
- Absent. This is a hardware device (hip stem), not an AI algorithm. Therefore, MRMC studies and AI-assisted reading are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Absent. This is a hardware device, not an algorithm.
7. The type of ground truth used
- For the non-clinical testing mentioned, the "ground truth" would be engineering standards, material specifications (e.g., ISO 5832-9 for stainless steel), and the results of mechanical fatigue, static, rotational torque, and fretting/corrosion tests.
8. The sample size for the training set
- Absent. Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Absent. Not applicable.
Summary of available information related to the device and its evaluation (from the document):
- Device Name: TaperFit Hip Stem
- Type of Device: Hip joint metal/polymer semi-constrained cemented prosthesis
- Indications for Use: Relief of pain and restoration of hip function following femoral neck fracture, osteo, rheumatoid and inflammatory arthritis, post-traumatic disease effects, avascular necrosis, and total hip revision. Also indicated for hemi-arthroplasty when used with Corin Bipolar Prosthesis hemi-arthroplasty femoral heads. Indicated for cemented, single use only.
- Predicate Devices:
- Substantial Equivalence Claim: The TaperFit Hip Stem (subject of this submission) is claimed to be identical in design, materials, coating, and sizes to K142761, and similar in intended use/indications. It's also claimed to be identical in materials and coating, and similar in design, sizes, and intended use/indications to K992234 and K003666. The main modification in this submission is an expanded indication for use to include hemi-arthroplasty with compatible Corin hemi-arthroplasty femoral heads.
- Non-Clinical Testing Mentioned: FEA (Finite Element Analysis), mechanical fatigue testing, static testing, rotational torque testing, fretting and corrosion testing, and range of motion testing. These tests were performed and submitted in previous TaperFit and Taper-Fit Hip Stem submissions (K142761, K992234, and K003666).
- Clinical Testing: "Clinical testing was not necessary in this Traditional 510(k)."
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.