The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised.

Device Description

The BIRMINGHAM HIP Dual Mobility Insert prosthesis is a cross-linked UHMWPE (XLPE) insert intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where a BHR acetabular cup is retained and the femoral component revised. The device consists of an XLPE insert component designed to articulate against the retained BHR acetabular cup. The insert is also designed to interface with Smith & Nephew femoral heads and THA femoral stems. During low level activity the articulation occurs between the femoral ball head and the insert with the insert remaining in a neutral position. During high level activities requiring a larger range of motion the femoral stem contacts the insert and articulation between the insert and shell will occur. The inserts are supplied in 11 sizes between 38-58mm to match the core BHR acetabular cup size range.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Smith & Nephew BH Dual Mobility Insert, based on the provided document:

This document is a 510(k) summary for a medical device (BH Dual Mobility Insert), which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results often associated with AI/software devices. Therefore, several of your requested points (like sample size for training, number of experts for ground truth, MRMC studies, standalone performance with AI, etc.) are not applicable to this type of submission.

The "study" here refers to non-clinical bench (mechanical) testing and biocompatibility evaluation, not a clinical trial involving human subjects or an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit from context)	Reported Device Performance
Dislocation Analysis	Met pre-determined acceptance criteria	Met acceptance criteria
Range of Motion	Met pre-determined acceptance criteria	Met acceptance criteria
Wear Testing	Met pre-determined acceptance criteria	Met acceptance criteria
Biocompatibility	In accordance with ISO-10993	In accordance with ISO-10993
Bacterial Endotoxin	Met acceptable endotoxin limits	Met acceptable endotoxin limits

Note: The document states "The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests." The specific numerical or descriptive acceptance criteria themselves are not detailed in this summary document.

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

Sample Size for Test Set: The document does not specify the exact number of devices (samples) used for each mechanical test.
Data Provenance: Not applicable, as this refers to mechanical bench testing and not human subject data.

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

Not Applicable. This device is a mechanical implant; "ground truth" as it pertains to expert consensus on images or diagnoses is not relevant. The "ground truth" for mechanical properties is typically established by engineering specifications and standards.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not Applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation). Mechanical tests are objective measurements against established standards.

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

Not Applicable. This is a medical device (implant), not an AI/software device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used

Engineering Specifications and Industry Standards: For mechanical testing (dislocation, range of motion, wear), the "ground truth" or reference for acceptance is compliance with established engineering and performance specifications and relevant ASTM/ISO standards for hip implants.
ISO-10993: For biocompatibility, the ground truth is adherence to the principles and testing methods outlined in ISO-10993.
FDA Guidance/ANSI/AAMI ST72: For bacterial endotoxin testing, the ground truth is meeting the acceptable endotoxin limits specified in these guidelines.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

Not Applicable. As there is no training set for a machine learning model, this question is not relevant.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's substantial equivalence and performance claims are supported by a combination of non-clinical (bench) testing and material characterization:

Biocompatibility Evaluation: Conducted in accordance with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process." The device is classified as a permanent implant (>30 day body contact). The subject inserts are manufactured from identical polyethylene XLPE materials as the predicate devices, in accordance with ISO 5834-2: 2011. Biocompatibility testing rationales were provided.
Mechanical Testing: Non-clinical bench tests were performed on the proposed BH Dual Mobility Insert, including:
- Dislocation Analysis
- Range of Motion
- Wear Testing
  The document explicitly states that "The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests."
Bacterial Endotoxin Testing: Completed and met the acceptable endotoxin limits as stated in FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.

The conclusion is that based on these test results and additional verification evidence, the BH Dual Mobility Inserts are substantially equivalent to the legally marketed predicate devices (K110135 and K070278).

Summary

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Smith & Nephew, Inc. Mike Scott Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K171934

Trade/Device Name: Birmingham Hip (BH) Dual Mobility Insert Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, JDI, KWY Dated: October 26, 2017 Received: October 27, 2017

November 30, 2017

Dear Mike Scott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171934

Device Name BH Dual Mobility Inserts

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Smith & Nephew BH Dual Mobility Inserts

SUBMITTER:I.	Smith & Nephew, Inc.Orthopaedic Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
	Phone: (901) 396-1633Fax: (901) 566-7159
	Contact Person: Michael ScottDate Prepared: October 26, 2017
II.DEVICE
Name of Device:Common Name:Regulatory Class:	BH Dual Mobility InsertAcetabular Component2
Classification Name,Regulation Number,Product Codes,	Hip joint metal/polymer/metal semi-constrained porous- coateduncemented prosthesis (21 CFR 888.3358), LPHHip joint metal/polymer semi-constrained cemented prosthesis(21 CFR 888.3350), JDIHip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis (CFR 888.3390), KWY
III.PREDICATE DEVICE	Primary Predicate - K110135 (S.E. 10/14/2011) POLARCUP DualMobility SystemPredicate 2 - K070278 (S.E. 04/16/2007) POLARCUP DualMobility System

The predicate devices have not been subject to a design related recall.

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Device Description IV.

The BIRMINGHAM HIP Dual Mobility Insert prosthesis is a cross-linked UHMWPE (XLPE) insert intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where a BHR acetabular cup is retained and the femoral component revised. The BIRMINGHAM HIP Resurfacing (BHR) received initial PMA Approval under P040033 (05/09/2006).

The device consists of an XLPE insert component designed to articulate against the retained BHR acetabular cup. The insert is also designed to interface with Smith & Nephew femoral heads and THA femoral stems. During low level activity the articulation occurs between the femoral ball head and the insert with the insert remaining in a neutral position. During high level activities requiring a larger range of motion the femoral stem contacts the insert and articulation between the insert and shell will occur.

The inserts are supplied in 11 sizes between 38-58mm to match the core BHR acetabular cup size range.

The purpose of this 510(k) submission is to add a revision option for the BHR System in cases where an acetabular cup is retained and the femoral component revised.

INDICATIONS FOR USE V.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject BH Dual Mobility Inserts have a similar intended use to the predicate POLARCUP Dual Mobility System implants (S.E. K110135 (S.E. 10/14/2011)). Additionally, the subject BH Dual Mobility Insert contains identical internal surface designs compared with the predicate POLARCUP XLPE Inserts as they relate to articulation against a femoral head. The subject BH Dual Mobility Insert size range is within the range of the existing POLARCUP insert sizes.

The subject BH Dual Mobility Insert is manufactured from identical XLPE material and follows an identical sterilization method as the predicate POLARCUP Dual Mobility System implants (S.E. K110135 (S.E. 10/14/2011)). Both the BH Dual Mobility Insert and the POLARCUP Dual Mobility System implants are available for use with metal, ceramic or Oxinium, 22 and 28mm femoral ball heads. Both the subject and predicate devices are manufactured, packaged and sterilized in the same locations and follow an identical manufacture process flow.

The Subject BH Dual Mobility Insert differences from the predicate POLARCUP Dual Mobility System implants consist of: The BH Dual Mobility Insert is intended for use against a fixed CoCrMo BH Acetabular cup whilst the POLARCUP Dual Mobility Insert is intended to articulate against the stainless steel POLARCUP Acetabular shell. Additionally, the BH Dual Mobility Insert is intended for use in a revision scenario for use against an insitu BHR Acetabular Cup whereas the POLARCUP Dual Mobility Insert is intended for use in both primary and revision cases against a new POLARCUP shell.

Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.

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Therefore, the technological characteristics of the subject device are the similar to the technological characteristics of the predicate device POLARCUP Dual Mobility System implants (S.E. K110135 (S.E. 10/14/2011)).

VII. PERFORMANCE DATA

The following performance data are provided in support of the substantial equivalence determination.

Biocompatibility

The biocompatibility evaluation for the BH Dual Mobility Insert was conducted in accordance with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process".

The subject BH Dual Mobility Inserts are permanent implants and will be classified as permanent, >30 day body contact according to ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process".

The subject BH Dual Mobility Inserts are manufactured from identical polyethylene XLPE materials as the predicate devices, in accordance with the following ASTM standard: ISO 5834-2: 2011. Biocompatibility testing and rationales have been provided for the subject BH Dual Mobility Inserts.

Mechanical testing

To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted on the proposed BH Dual Mobility Insert. Test results demonstrated that the proposed devices are substantially equivalent to the predicate POLARCUP Dual Mobility System.

Mechanical tests/assessments completed were:

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Dislocation Analysis .
Range of Motion ●
Wear Testing .

The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests.

VIII. CONCLUSIONS

Based on the test results and additional verification evidence activities provided in the premarket notification, the subject BH Dual Mobility Inserts are substantially equivalent to the legally marketed predicate devices: Primary predicate: K110135 (S.E. 10/14/2011) and Predicate 2: Predicate 2 - K070278 (S.E. 04/16/2007).

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.