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

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OCT 22 1999

K991026

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Reflection® Cross-linked UHMWPE Acetabular Components

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the Reflection® Cross-linked UHMWPE Acetabular Components.

Submitted By:	Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	March 26, 1999
Contact Person:	Ehab M. EsmailRegulatory Affairs Specialist II
Proprietary Name:	Reflection® Cross-linked UHMWPE AcetabularComponents
Common Name:	Polyethylene Acetabular Components
Classification Name and Reference:	21 CFR 888.3350 Prosthesis, Hip, Semi-Constrained,metal/polymer, Cemented – Class II21 CFR 888.3358 Prosthesis, Hip, Semi-Constrained,metal/polymer, Uncemented - Class II
Device Product Code and Panel Code:	Orthopedics/87/LPH, JDI

DEVICE INFORMATION I.

A. INTENDED USE

Image /page/0/Picture/10 description: The image shows a globe with a focus on the continents of Asia and Australia. The globe is black and white, with the land masses appearing dark against a light background. The globe is mounted on a stand, and the image is a close-up view of the globe's surface.

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Leadership in Worldwide Healthcare Smith & Nephew

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B. DEVICE DESCRIPTION

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The Reflection® Cross-linked UHMWPE Acetabular Components are substantially equivalent to the subject identical predicate counterpart. The intended use, material, and design features of The Reflection® Cross-linked UHMWPE Acetabular Components are substantially equivalent to predicate competitive devices.

While the Reflection® Cross-linked UHMWPE Acetabular Components are not identical to all of the predicates, any differences that may exist do not significantly affect the safety and effectiveness.

D. WEAR CLAIMS

The following marketing claims will be made for the Reflection® Cross-linked UHMWPE Acetabular Components:

1. Meets all ASTM F648 minimum standards.
1. No free radicals detectable when analyzed by the ESR technique of the final product. (The detection limit is approximately 1013 spins/gram).
1. No detectable oxidation as measured by FTIR up to 21 days of accelerated aging at 74℃.
1. 91.9% reduction in volumetric wear rate versus the identical predicate counterpart fabricated from conventional UHMWPE. Testing was performed in a multiaxial hip joint simulator for min. 3.8 million - max. 5.1 million cycles per individual test using a 32mm wrought CoCr head articulating counterface, a 32mm ID, 56mm OD, minimum thickness 7mm liner with the 20 degree overhang design and Hyclone bovine calf serum as a lubricant.

E. SUMMARY OF TECHNOLOGICAL COMPARISON

The intended use, material, type of interface, and design features of The Reflection® Cross-linked UHMWPE Acetabular Components are similar to their predicate component counterparts. The raw material used in manufacturing both the subject and predicate devices are UHMWPE per ASTM F-648. The modification to the manufacturing process of this polyethylene resulted in a higher cross-linked polyethylene. The safety and effectiveness of this cross-linked polyethylene in acetabular applications, as well as the proposed wear claims, are adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

Image /page/1/Picture/14 description: The image shows a globe with a focus on the continents of Asia and Australia. The globe is depicted in black and white, with the landmasses appearing in solid black against a white background. The curvature of the Earth is visible, and the globe is mounted on a stand, indicated by a curved line above the globe.

Leadership in Worldwide Healthcare Smith & Nephew

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 22 1999

Mr. Ehab M. Esmail Regulatory Affairs Specialist II Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116

Re : K991026 Trade Name: Reflection Cross-Linked Ultra-High-Molecular-Weight Polyethylene (UHMWPE) Acetabular Components Requlatory Class: II Product Codes: LPH and JDI Dated: July 23, 1999 Received: July 26, 1999

Dear Mr. Esmail:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ehab M. Esmail

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acborizon in postantial equivalence of your device to a legally marketed predicate device results in a classification for your marice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FDA - ABBREVIATED 510(k) Premarket Notification March 26, 1999 Page 13 of 18 1996 Comments of the United The Property of

K991026

INDICATIONS STATEMENT

Reflection® Cross-linked UHMWPE Acetabular Components

Total hip components are indicated for 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; non-union; 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.

eneral Restorative Device O(k) Number

Prescription Use
(Per 21 CFR 801.109)

Image /page/4/Picture/8 description: The image shows a globe with a focus on the continents of Asia and Australia. The globe is set on a stand, and the continents are clearly visible against the dark background of the oceans. The image is a simple representation of the Earth, highlighting the geographical locations of Asia and Australia.

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Leadership in Worldwide Healthcare Smith & Nephew

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.