(26 days)
The TaperSet™ Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System.
The indications for use are:
- A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
- B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
- C. Proximal femoral fractures.
- D. Avascular necrosis of the femoral head.
- E. Non-union of proximal femoral neck fractures.
- F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The TaperSet™ hip stem is indicated for cementless use.
The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CPTi coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes designated as 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. The TaperSet Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is compatible with previously cleared CoCr heads, zirconia or Biolox delta ceramic heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups. The modification addressed here is the addition of a line of stems with a reduced distal profile (RDP) in sizes 10.5mm to 24mm.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the TaperSet™ Hip System RDP Stems, structured according to your request.
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as might be typical for AI/ML device submissions. Therefore, some of your requested information (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance with specific metrics) is not applicable or not provided in this type of regulatory submission for a traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Material Equivalence | The new device must utilize materials equivalent to the predicate device. | "The new Reduced Distal Profile (RDP) stems for the TaperSet Hip System have the identical neck and taper design, porous coating, and sizing as the predicate TaperSet stems cleared under K 102399 in design and indications." |
| (Implied: Material is titanium alloy with CPTi coating, same as predicate). | ||
| Design Equivalence | The new device's design features, where modified, must not introduce new safety or efficacy considerations that differ significantly from the predicate, or must be demonstrably safe and effective through engineering analysis. | "The new Reduced Distal Profile (RDP) stems for the TaperSet Hip System have the identical neck and taper design, porous coating, and sizing as the predicate TaperSet stems cleared under K 102399 in design and indications." |
| "A reduced distal profile femoral hip stem design was previously cleared by FDA under K101086 for the Biomet Taperloc Complete Hip System." | ||
| Indications for Use | The indications for use of the new device must be identical or substantially similar to the predicate device. | The indications for use listed are identical to those of the predicate device (K102399). |
| Functional Equivalence | Performance characteristics affected by the modification (e.g., mechanical properties, fit) must be demonstrated as equivalent or superior through appropriate testing or analysis. (Implied: No adverse impact on mechanical integrity or fit due to RDP). | "No additional non-clinical testing was performed because there was no proximal design change from the predicate TaperSet and distally the new smallest size is still larger than the smallest predicate TaperSet stem which was previously tested." |
| "Based upon engineering analysis of the design modification the new reduced distal profile stems... are substantially equivalent." | ||
| Safety and Effectiveness | The new device must be as safe and effective as the legally marketed predicate device(s). This is the overarching criterion for 510(k) clearance, demonstrated by equivalence in materials, design, indications, and performance (or justification for lack of new testing). | "Therefore, the device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates." |
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 an "engineering analysis of the design modification" and comparison to predicate devices, rather than a specific "test set" of patient data as might be used for software or diagnostic devices.
- Data Provenance: Not applicable. The "study" here is a regulatory submission demonstrating substantial equivalence based on prior clearances and engineering analysis.
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 "ground truth" was established by experts for a test set in the context of this 510(k) submission. Regulatory experts at the FDA ("Division of Surgical, Orthopedic, and Restorative Devices") reviewed the submission for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no test set requiring ground truth 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 traditional orthopedic implant, not an AI/ML device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical orthopedic implant. There is no algorithm or standalone performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the conventional sense of clinical ground truth. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices and the regulatory framework that deems substantial equivalence as sufficient for clearance. The "truth" is established by demonstrating that the modified device does not raise new questions of safety or effectiveness compared to legally marketed devices.
8. The sample size for the training set
- Not applicable. There is no training set as it's a physical device, not a software or AI/ML product.
9. How the ground truth for the training set was established
- Not applicable for the reasons stated above.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" in this context is the 510(k) premarket notification process itself, which relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.
The proof described is:
- Comparison to Predicate: The new TaperSet™ Hip System RDP Stems were compared to the predicate TaperSet stems (K102399) and another previously cleared RDP stem design (Biomet Taperloc Complete Hip System, K101086).
- Identical Features: The new RDP stems maintain "identical neck and taper design, porous coating, and sizing" with the predicate TaperSet stems.
- Engineering Analysis: Consensus Orthopedics performed an "engineering analysis of the design modification."
- Justification for No Additional Testing: No new non-clinical testing (like mechanical bench testing) was deemed necessary because:
- There was "no proximal design change from the predicate TaperSet."
- Distally, the "new smallest size is still larger than the smallest predicate TaperSet stem which was previously tested." This implies that the previous testing on the predicate covered potentially more challenging (smaller) scenarios.
- Conclusion of Substantial Equivalence: Based on this engineering analysis and comparison, the manufacturer concluded and the FDA agreed that the device is "substantially equivalent" to legally marketed predicates, and therefore "as safe, as effective, and performs at least as safely and effectively as legally marketed predicates."
This type of submission avoids extensive new clinical trials or performance testing by leveraging the safety and efficacy track record of existing, similar devices.
§ 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.