(207 days)
The PROCOTYL® L-O Acetabular System is intended for use in total hip arthroplasty for reduction or relief of pain and/ or improved hip function in skeletally mature patients with the following conditions:
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non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:
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inflammatory degenerative joint disease such as rheumatoid arthritis;
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correction of functional deformity; and.
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revision procedures where other treatments or devices have failed
The PROCOTYL® L-O Acetabular System utilizes single use components. intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty.
The PROCOTYL® L and O acetabular cup designs are based off the LINEAGE™ Acetabular System (K002149) which was designed from the TRANSCEND® product line. The subject PROCOTYL® acetabular system of this submission includes the PROCOTYL® L Acetabular Cup, the PROCOTYL® O Acetabular Cup, RIM-LOCK "A-CLASS®" Acetabular Poly Liner and BIOLOX® delta Ceramic Femoral Head.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:
Device: PROCOTYL® L-O Acetabular System (Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis)
Based on the provided document, the device approval is based on substantial equivalence to predicate devices, not on a study proving it meets specific, predefined acceptance criteria for novel performance. Therefore, many of the requested categories will be answered with "Not Applicable" or similar.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from the document) | Reported Device Performance (from the document) |
|---|---|
| Mechanical/Physical Performance: | |
| Static Compression to Failure | Evaluated per ISO 7206-10. Device was "deemed acceptable." |
| Range of Motion | Evaluated per ISO 21535. Device was "deemed acceptable." |
| Material Equivalence: | |
| Material (general) | Identical Titanium Alloy, Ti6Al4V, wrought or forged (ASTM F136 or ASTM F620 respectively) as the predicate device. |
| Coating | Identical titanium plasma spray coating (ASTM F1580) or beaded coating (ASTM F1580/F67) as the predicate device. |
| Functional Equivalence: | |
| Indications for Use | Identical to those for the predicate devices (K130376 and K140043 for heads; K002149 for shells/liners). |
| Fundamental Scientific Technology | Identical to those of the predicate devices. |
| Design Features | Substantially equivalent to those of the predicate devices (based on design from a referenced product line and similar predicate designs, e.g., LINEAGE™ Acetabular System, TRANSCEND® product line, DYNASTY® Acetabular System). |
Note: The document explicitly states that "Clinical data was not provided for the subject devices." This significantly impacts the answers to the following questions.
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 (No clinical test set was used/provided). For non-clinical testing, specific sample sizes for tests like static compression or range of motion are not detailed, only that the tests were conducted.
- Data provenance: Not applicable (No clinical data provided). For non-clinical, it's typically lab-based testing.
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 (No clinical test set or ground truth determination by experts was described in the provided document).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable (No clinical test set requiring adjudication was described).
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
- Not applicable (This device is a physical hip implant, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned).
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 or AI system).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable (No clinical ground truth was established, as no clinical data was provided). For non-clinical tests, the "ground truth" is typically defined by the standards (ISO 7206-10, ISO 21535) and the mechanical properties observed.
8. The sample size for the training set
- Not applicable (No training set was used, as this is a physical device submission based on substantial equivalence, not a machine learning model).
9. How the ground truth for the training set was established
- Not applicable (No training set was used).
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.