Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital eiphysis, fused hip, fracture of the pelveis, and diastrophic variant; congenital dysplasia; 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 osteoeomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

HA Coated Reflection Acetabular Shells and HA Coated Reflection InterFit Acetabular Shells are for single use only and are intended for cementless fixation.

Device Description

The Reflection acctabular shells are hemispherical in shape. Shells are available with and without holes. Multi-hole shells are designed to accommodate metallic cancellous screws. HA Reflection Acetabular Shells and HA Reflection InterFit Shells are used with existing Reflection UHMWPE liners.

AI/ML Overview

This document describes a 510(k) premarket notification for Hydroxyapatite (HA) Coated Reflection® Acetabular Shells and HA Coated Reflection InterFit® Shells. This submission outlines the substantial equivalence to existing devices, primarily focusing on materials and intended use rather than specific performance studies against acceptance criteria.

Therefore, many of the requested sections regarding acceptance criteria, study data, sample sizes, and expert review are not explicitly present in the provided text. The document refers to "Performance characteristics: Data indicate that HA Reflection Acetabular Shells and HA Reflection InterFit Acetabular Shells are substantially equivalent to predicate devices," but does not detail the specific performance data or the acceptance criteria used to establish this substantial equivalence.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document.

The submission asserts "substantial equivalence" based on similar materials and technological characteristics to legally marketed predicate devices. It states: "Performance characteristics: Data indicate that HA Reflection Acetabular Shells and HA Reflection InterFit Acetabular Shells are substantially equivalent to predicate devices."

However, specific quantitative acceptance criteria for performance (e.g., mechanical strength thresholds, adhesion values, wear rates) and the actual reported device performance values against these criteria are not detailed in the provided text. The two ASTM standards (F1472, F67) are identified as "materials' specification only," implying they relate to the composition and properties of the HA coating and/or core material, but not necessarily to the device's functional performance as a whole.

Acceptance Criteria Category	Specific Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
Substantial Equivalence	Device is as safe and effective as predicate devices based on similar technological characteristics and materials.	"Data indicate that HA Reflection Acetabular Shells and HA Reflection InterFit Acetabular Shells are substantially equivalent to predicate devices."
Material Specifications (ASTM F1472, F67)	Material properties meet specified ASTM standards for the materials used (e.g., composition, mechanical properties of HA coating and/or core material).	Conformity to ASTM F1472 and F67 is declared (implied by listing the standards).
Biocompatibility	Device materials are biocompatible. (Implicit for implantable devices)	No specific data provided, but implied by regulatory clearance and use of established materials.
Mechanical Performance (e.g., strength, durability, fixation)	Device meets mechanical performance appropriate for an acetabular shell in total hip replacement. (Implicit for implantable devices)	No specific data provided, but implied by substantial equivalence claim.

2. Sample Size Used for the Test Set and Data Provenance

Not explicitly provided in the document.

The text mentions "Data indicate" but does not specify any clinical or non-clinical test sets used, their sample sizes, or their provenance (e.g., country of origin, retrospective/prospective). As this is a 510(k) for substantial equivalence, it's possible the data relied heavily on existing literature for the predicate devices and general material properties, rather than a specific new clinical study with a defined test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable/Not provided in the document.

Since no specific test set or clinical study requiring ground truth establishment by experts is detailed, this information is not present. The regulatory review process involves FDA experts, but this is distinct from experts establishing ground truth for a device's performance study.

4. Adjudication Method for the Test Set

Not applicable/Not provided in the document.

Without a described test set or study involving human readers/assessors, an adjudication method is not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable.

This device (a hip implant component) is not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human performance with and without AI assistance is irrelevant and not mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable.

As this is a physical medical device (hip implant), not a software algorithm, standalone performance (in the context of AI) is not relevant.

7. The Type of Ground Truth Used

Implicit: Substantial Equivalence to Predicate Devices

For this 510(k), the "ground truth" for demonstrating the device's safety and effectiveness is largely based on its substantial equivalence to legally marketed predicate devices, whose safety and effectiveness are already established. This means that if the materials, technological characteristics, and intended use are sufficiently similar to approved predicates, specific new clinical "ground truth" data for every performance aspect might not be required. The "data indicate" statement likely refers to engineering analyses, material testing (as per ASTM standards), and potentially preclinical animal or bench testing that supports the equivalence claim.

8. The Sample Size for the Training Set

Not applicable/Not provided in the document.

As this is a physical medical device and not an AI/machine learning system, the concept of a "training set" is not applicable.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided in the document.

As this is a physical medical device and not an AI/machine learning system, the concept of a "training set" and its ground truth establishment is not applicable.

Summary

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Standards Data Form for Abbreviated 510(k)s

510(k) Number:

K990666

Standard Organization No:	ASTM
Standard Identification No:	F1472, F67
CDRH Internal Reference No:	433, 411

Comment: These two ASTM standards are materials' specification only.

Declaration of Conformity Elements:
Any Adaptations Applied	yes	no	x
Any Requirements Not Applicable	yes	no	x
Any Deviations Applied	yes	no	x
Any Differences in Device Tested and Finished Product	yes	no	x
*Is There a Third Party or Test Lab Involved	yes	no	x

Was there another standard used in the review of this submission? yes no X

If another standard was used, please fill out an additional form.

This is not the third party that reviews 510ks

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K990666

510(k) Summary Hyaroxyapatite (HA) Coated Reflection® Acetabular Shell Hydroxyapatite (HA) Coated Reflection InterFit® Shell

Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared: Trade or proprietary device name: Smith & Nephew. Inc.. Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901/399-5153 Janet Johnson Green February 26, 1999 HA Coated Reflection Acetabular Shell HA Coated Reflection InterFit Shell

Common or usual name: Classification name:

Acetabular Shell Title 21 CFR 888.3358 Hip joint metal/ polymer/ metal, semi-onstrained porous-coated uncemented prosthesis

Device Product Code and Panel Code: 87MEH - Panel: Orthopaedics/87

Substantially Equivalent, Legally Marketed Predicate Devices: Reflection Acetabular Shell - Smith & Nephew, Inc. Reflection InterFit Actebular Shell - Smith & Nephew, Inc. Osteonics® SecurFit™HA Hydroxylapatite Coated Shell Osteonics® Normalized AD-HA Acetabular Component System Osteonics® HA Generation II Acctabular component System Osteonics® Restoration HA Hip Stems APR Porous HA Hip Stem - Sulzar Orthopedics, Inc.

Subject device description:

Subject device intended use:

HA Coated Reflection Acetabular Shells and HA Coated Reflection InterFit Acetabular Shells are for single use only and are intended for cementless fixation.

Technolocgical Characteristics:

HA Reflection Acetabular Shells and HA Reflection InterFit Acetabular Shells are sinilar to legally marketed devices listed above in that all of these devices are indicated for total hip replacement, are manufactured from similar or like materials, and are similar in technological characteristics. Performance characteristics:

Data indicate that HA Reflection Acetabular Shells and HA Reflection InterFit Acetabular Shells are substantially equivalent to predicate devices.

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AUG -6 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Trude C. McLean Sr. Regulatory Affairs Specialist Smith & Nephew, Incorporated 1450 Brooks Road Memphis, Tennessee 38116

Re: K990666

Trade Name: Hydroxyapatite Reflection® Acetabular Shells Regulatory Class: II Product Code: MEH Dated: May 28, 1999 Received: June 2, 1999

Dear Ms. McLean:

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 control provisions of the Act. The general control provisions 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 regulatory action. In addition, FDA may publish further announcements 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.

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

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Page 2 – Ms. Trude C. McLean

If you desire specific advice for your device on our labeling regulation (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 at (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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INDICATIONS STATEMENT

HA Coated Reflection® Acetabular Shell HA Coated Reflection InterFit® Acetabular Shell

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

bcoee

Prescription Use
(Per 21 CFR 801.109) X

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.