(254 days)
The LINK® SP-CL® and LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated is indicated for patients with mobility-limiting hip diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The hip system is indicated for the following conditions: Primary and secondary coxarthrosis, Osteoarthritis, Necrosis of the femoral head, Femoral neck fractures. The stems are indicated for cementless use only.
The LINK® SP-CL® and LCU® Systems include a straight stem (LCU® Hip Prosthesis) and an anatomically curved stem (SP-CL® Hip Prosthesis). Both stems are comprised of titanium alloy (Ti6A14V, ISO 5832-3, ASTM F136) available with corundum blasted PoroLink® (microporous) surface or HX® (calcium phosphate) (ASTM F1609) coated. The stems are available in a range of sizes, lengths, and offsets. The stems connect to femoral heads that are manufactured from Cobalt Chromium Molybdenum casting alloy (CoCrMo) or ceramic (BIOLOX® forte and BIOLOX® delta) via 12/14 Morse taper. In total joint use, the femoral head articulates against Signature Orthopedics' Origin crosslinked acetabular liners (#K121297) fixed in a cementless shell. Femoral heads part of this submission (BIOLOX® forte / delta head and LINK® Prosthesis Head B) are not intended for hemiarthroplasty use. Both the LCU® and SP-CL® stems are intended for cementless use to replace the hip joint.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the LINK® SP-CL® and LCU® Hip System:
Summary of Acceptance Criteria and Device Performance (as reported):
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way one might see for digital health or AI-based devices with clear statistical thresholds (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicit in the adherence to established international standards and the demonstration of substantial equivalence to predicate devices. The device performance is deemed acceptable if it meets the requirements of these standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicitly Met) |
|---|---|
| Mechanical Performance (Fatigue Strength) | - Femoral stem fatigue tests per ISO 7206-4 and ISO 7206-8 were conducted. |
- Femoral neck segment fatigue tests per ISO 7206-6 were conducted.
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| Modular Connections (Fretting Corrosion) | - Modular Connections, Fretting Corrosion Testing per ASTM F1875-98 was conducted. |
| Range of Motion | - Range of Motion analysis of the LINK® SP-CL® and LCU® Hip Systems was conducted. |
| Component Testing (Ceramic Heads) | - Component Testing of ceramic heads was conducted. |
| Sterilization & Cleaning Effectiveness | - Procedures validated per AAMI ST 77:2006, AAMI ST79, ISO 17665-1, ISO 11138-3, AAMI TIR 12:2010, and AAMI TIR 30. |
| Endotoxin Levels | - Routine Endotoxin Testing performed according to AAMI ST 72. |
| Substantial Equivalence to Predicate Device (Overall Safety & Effectiveness) | - "The results of non-clinical performance testing demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate device." - "The minor technological differences between the LINK® LCU® and SP-CL® Systems and its predicate device do not raise any new issues of safety or effectiveness."
- Compared to DePuy Orthopaedics' Corail AMT Hip Prosthesis (#K123991, #K070554, #K042992) and LINK® Contour Ribbed Hip Prosthesis (#K854465). The subject device has "the same intended use and the same or similar indications, technological characteristics, and principles of operation as the predicate devices." |
Study Information:
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Sample size used for the test set and the data provenance:
- The document describes non-clinical performance testing which typically involves testing of physical samples (devices or components) rather than patient data. The specific number of devices tested for each non-clinical test (e.g., number of stems for fatigue testing) is not specified in this summary.
- Data Provenance: Not applicable in the context of clinical data. For non-clinical tests, the tests were conducted according to international standards (ISO, ASTM, AAMI). The location of the testing laboratories is not specified, but the manufacturing company is based in Norderstedt, Germany.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a submission for a hip prosthesis based on non-clinical performance testing and substantial equivalence, not a study evaluating a diagnostic device that requires expert-established ground truth from clinical data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no human adjudication of a test set in the context of the described non-clinical performance testing for a medical implant device.
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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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/radiology devices where human interpretation is involved. This submission is for a physical medical implant (hip prosthesis).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic or AI-based device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance tests, the "ground truth" is established by the specifications and pass/fail criteria defined within the referenced international standards (e.g., ISO 7206, ASTM F1875, AAMI standards). The device's performance is compared against these predetermined engineering and material science specifications.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for 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.