(100 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 TaverSet™ 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 heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.
The provided document is a 510(k) summary for the TaperSet™ Hip System, a porous-coated hip prosthesis. It focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance data (bench testing, materials characterization, mechanical testing, and range of motion analysis). The document does not describe a clinical study involving human patients or AI-driven acceptance criteria for device performance related to diagnostic accuracy or reader improvement.
Therefore, I cannot provide information on acceptance criteria, reported device performance metrics like sensitivity/specificity, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types as these are typically associated with clinical studies or AI/software validation, which are not detailed in this regulatory submission for a physical orthopedic implant.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing performed to establish substantial equivalence for a medical device that is not AI-driven or diagnostic in nature.
Here's a breakdown of what can be extracted from the provided document, framed to address your request in the context of this type of device:
Acceptance Criteria and Study for TaperSet™ Hip System
The TaperSet™ Hip System is a physical orthopedic implant, specifically a hip stem. Its "acceptance criteria" and "study" in this regulatory filing context pertain to demonstrating its physical and mechanical performance, and material compatibility, to be substantially equivalent to existing predicate devices. This is achieved through non-clinical (bench) testing, not clinical trials with human subjects or AI-driven performance metrics for diagnostic or prognostic purposes.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of specific, quantified acceptance criteria (e.g., minimum fatigue strength in Newtons) alongside numerical results for the TaperSet™ Hip System. Instead, it states that the device was tested to conform to relevant standards and guidance documents, and the results indicate substantial equivalence.
General Acceptance Criteria (Implied by Substantial Equivalence): The TaperSet™ Hip System is expected to have material properties, mechanical strength, and functional characteristics (e.g., range of motion) that are comparable to or better than those of the legally marketed predicate devices, and to meet established industry and FDA guidance standards for orthopedic implants.
Reported Device Performance:
The document states the outcome of the performance evaluation rather than providing raw data:
- "All of the observed results indicate that the TaperSet Hip System is substantially equivalent to devices currently marketed."
- "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 Data Provenance
The document describes non-clinical bench testing:
- Sample Size: The exact number of test articles (stems, coatings, modular connections) used for each specific test (e.g., how many stems for proximal fatigue) is not specified in this summary. It refers to "worst case stem" testing.
- Data Provenance: The data is generated from laboratory bench testing performed by Consensus Orthopedics, Inc. (the manufacturer). This is a prospective generation of data explicitly for the purpose of this regulatory submission. Country of origin for the data generation is implied to be within the USA, where the company is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of regulatory submission. There is no "ground truth" established by human experts in the context of interpreting images or clinical outcomes for this physical implant's performance. The "ground truth" for mechanical properties is typically defined by standardized test methods and material specifications.
4. Adjudication Method for the Test Set
This question is not applicable to this type of regulatory submission. Adjudication methods (e.g., 2+1, 3+1) are relevant for reconciling discrepancies in human expert interpretations, typically in diagnostic studies. For bench testing, test results are objective measurements against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. MRMC studies are associated with evaluating human reader performance, often in diagnostic imaging, and comparing it with and without AI assistance. This document describes the regulatory approval process for a physical orthopedic implant based on non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a "standalone" algorithm performance study was not done. This question pertains to AI/software performance validation, which is not relevant to this physical hip implant.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Standardized Test Methods: Adherence to established industry standards (e.g., ASTM, ISO guidelines for orthopedic implants) for mechanical testing (fatigue, fretting, corrosion).
- Material Specifications: Compliance with known properties of biocompatible materials (e.g., titanium alloy, CPTi plasma spray).
- Predicate Device Data/Performance: The performance of the predicate devices in clinical use and their non-clinical test data serve as the benchmark against which the new device's performance is compared for substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of an AI algorithm for this physical implant.
9. How the Ground Truth for the Training Set was Established
This question is not applicable. There is no "training set" or need to establish its ground truth for this device.
§ 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.