FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Total hip components are individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Device Description

The intended use, type of interface, and design features of The Reflection® Cross-linked UHMWPE Acetabular Components are substantially equivalent to the subject identical predicate counterparts fabricated from conventional UHMWPE.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Reflection® Cross-linked UHMWPE Acetabular Components:

This document ([K991026](https://510k.innolitics.com/search/K991026)) is a 510(k) summary, which is a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than a clinical study proving efficacy against a "ground truth" as you might find for an AI/diagnostic device. As such, many of your requested items, particularly those related to expert consensus, MRMC studies, and training/test sets for AI, are not directly applicable to this type of device submission.

However, I will extract the relevant information closest to your request format, interpreting "acceptance criteria" as the performance claims made for the device and "study" as the testing reported in the submission.

Acceptance Criteria and Device Performance (for a medical implant, not an AI diagnostic):

Acceptance Criterion (Claim Made by Manufacturer)	Reported Device Performance (as tested)
Meets all ASTM F648 minimum standards.	The device is stated to meet all ASTM F648 minimum standards. (No specific values reported for each standard, only the general compliance.)
No free radicals detectable when analyzed by the ESR technique of the final product.	No free radicals detectable (detection limit approximately 10^13^ spins/gram).
No detectable oxidation as measured by FTIR up to 21 days of accelerated aging at 74℃.	No detectable oxidation as measured by FTIR up to 21 days of accelerated aging at 74℃.
91.9% reduction in volumetric wear rate versus the identical predicate counterpart fabricated from conventional UHMWPE.	91.9% reduction in volumetric wear rate. Testing was performed in a multiaxial hip joint simulator for min. 3.8 million - max. 5.1 million cycles using a 32mm wrought CoCr head, a 32mm ID, 56mm OD, minimum thickness 7mm liner with 20-degree overhang, and Hyclone bovine calf serum as a lubricant. (This is the specific test result that supports the claim).

Regarding the other requested information:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials or data sets. For the wear claims, the "test set" consists of the physical samples of the Reflection® Cross-linked UHMWPE Acetabular Components and their predicate counterparts subjected to various laboratory tests.
  - Wear Rate Test: "min. 3.8 million - max. 5.1 million cycles per individual test." This indicates the duration/extent of the simulation, not a number of distinct device samples, though multiple samples would be implied for such testing. The specific number of devices tested is not provided.
- Data Provenance: This is not relevant for a device performance claim based on laboratory testing. The data originates from Smith & Nephew's internal testing facilities.
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. For this type of medical device (an implant), "ground truth" is established through physical, chemical, and mechanical testing in a controlled laboratory environment, comparing the device to established standards (ASTM F648) and predicate devices. There is no expert consensus involved in determining, for instance, the presence of free radicals or the volumetric wear rate in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical trials or studies where human interpretation of data is involved and discrepancies need resolution. This document describes laboratory performance testing.
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 an orthopedic implant, not an AI diagnostic tool. Therefore, no MRMC study, human readers, or AI assistance is involved.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is an orthopedic implant, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the claims made:
  - ASTM F648 compliance: Ground truth is defined by the physical and chemical specifications and testing methodologies outlined in the ASTM F648 standard.
  - Free Radical Detection/Oxidation Measurement: Ground truth is based on the results of validated analytical laboratory techniques (ESR, FTIR) with established detection limits.
  - Volumetric Wear Rate: Ground truth is established by the direct measurement of material loss after simulated mechanical cycling under controlled laboratory conditions, compared to the wear of a conventional UHMWPE predicate.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the manufacturing process would be the development and validation batches, but this is not typically disclosed as a "sample size" in this context.
How the ground truth for the training set was established:
- Not applicable. As there is no training set in the AI sense, this question is not relevant. The "ground truth" for the device's development would be its adherence to design specifications and initial performance targets, assessed through engineering and quality control processes.

Summary

Regulation Number and Section

§ 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.