The SL PLUS® MIA Stem with and without Ti/HA is indicated for individuals undergoing primary and 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 epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The SL PLUS° MIA Stem with and without Ti/HA is for single use only and is intended to be implanted without bone cement.

Device Description

The SL-PLUS MIA Femoral Stem with Ti/HA is based on the uncoated design of SL-PLUS MIA Femoral Stem cleared via K082371. The subject stems are made from forged titanium alloy Ti-6Al-4Nb with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite. The Ti/HA coating is identical to the Ti/HA coating on the SL-PLUS® Standard and Lateral Femoral Stems with Ti/HA cleared via premarket notification K120211.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device (SL-PLUS® MIA Femoral Stem with Ti/HA) and not a study describing the performance of an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this submission.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through a comparison of technological characteristics and, in the case of implantable devices, mechanical testing to ensure the device can withstand expected in vivo loading. It does not involve a clinical study as would be performed for a novel AI/ML algorithm.

However, I can extract the relevant information that is present in the document.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the nature of this 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices and withstanding mechanical stresses. The "reported device performance" is not a quantitative clinical outcome here, but rather a successful demonstration of mechanical integrity.

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Devices	Demonstrated through comparison of design, materials, and indications for use.
Capability to withstand expected in vivo loading without failure	Indicated by successful Stem Fatigue Testing and Neck Fatigue Testing.

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is described as a set of mechanical tests and a substantive equivalence comparison with predicate devices.

Mechanism of Proof: The 510(k) submission relies on demonstrating substantial equivalence to previously cleared predicate devices and performing specific mechanical tests to ensure the device's structural integrity.
Tests Performed:
- Stem Fatigue Testing
- Neck Fatigue Testing
- Surface characterization (physical, chemical, or mechanical) are discussed in the Ti/HA Coating Master File MAF - 1762, Amendment 1 (though not detailed in this specific dossier).

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: This is not applicable in the context of this 510(k) submission for a hip implant. The "test set" would refer to the mechanical test specimens. The document does not specify the number of specimens used for fatigue testing.
Data Provenance: Not applicable in the context of an AI/ML study. The data provenance here would be standard engineering test data, likely generated in a lab setting by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth, in the AI/ML sense, is not established for this type of device submission. The "ground truth" for mechanical testing is primarily objective measurements against engineering standards.

4. Adjudication method for the test set:

Not applicable. This concept applies to human expert review in diagnostic studies, not mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks.

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

Not applicable. This device is not an AI algorithm.

7. The type of ground truth used:

Ground Truth (for mechanical testing): The "ground truth" here is the physical integrity and durability of the implant as measured by engineering standards (e.g., fatigue life, strength). The test results are compared against established industry standards or internal specifications that ensure the device can function as intended in the body.

8. The sample size for the training set:

Not applicable. This device is not an AI algorithm, so there is no training set.

9. How the ground truth for the training set was established:

Not applicable. This device is not an AI algorithm, so there is no training set or ground truth to establish for it.

Summary

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2 8 2012 AUG

510(k) Summary Smith & Nephew SL-PLUS° MIA Femoral Stem with Ti/HA

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Summary:	July 26, 2012
Contact Person	John Connor, Regulatory Affairs SpecialistT (901) 399-5944 F (901) 566-7961
Name of Device:	SL-PLUS® MIA Femoral Stem with Ti/HA
Common Name:	Total Hip Joint, Femoral Component,Cementless
Device Classification Name and Reference:	21 CFR 888.3353 – Hip jointmetal/polymer/metal semi-constrainedcemented or nonporous uncementedprosthesis
	21 CFR 888.3390 - Hip joint femoral (hemi-hip)metal/polymer cemented or uncementedprosthesis
	21 CFR 888.3360 - Hip joint femoral (hemi-hip)metallic cemented or uncemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	LZO, KWY, LWJ

Device Description

Intended Use

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K122296 Page 2/2

its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The SL PLUS° MIA Stem with and without Ti/HA is for single use only and is intended to be implanted without bone cement.

Technological Characteristics

A review of the mechanical data indicates that the SL-PLUS° MIA Femoral Stem with Ti/HA is capable of withstanding expected in vivo loading without failure.

Substantial Equivalence Information

The overall design, materials, and indications for use for the SL-PLUS MIA Femoral Stem with Ti/HA are substantially equivalent to the following commercially available predicate devices.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & NephewOrthopaedics AG	SL-PLUS® MIA Femoral Stems	K082371	2/9/09
Smith & NephewOrthopaedics AG	SL-PLUS Standard and Lateral Femoral Stemswith Ti/HA	K120211	7/19/12

The following tests were used as a basis for the determination of substantial equivalence:

Stem Fatigue Testing .
Neck Fatigue Testing .

All tests which are in relation to the surface characterization (physical, chemical or mechanical) are discussed in detail in the Ti/HA Coating Master File MAF - 1762, Amendment 1 and are not included in this dossier.

Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the SL-PLUS® MIA Femoral Stem with Ti/HA. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the commercially available predicate devices listed above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal or logo. It features the symbol of the Department of Health & Human Services (HHS) in the center, which is a stylized depiction of an eagle or bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 28 2012

Smith & Nephew, Incorporated % Mr. John Connor Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K122296

Trade/Device Name: SL-PLUS MIA Femoral Stem with Ti/HA Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Regulatory Class: II Product Code: LZO, KWY, LWJ Dated: July 26, 2012 Received: July 31, 2012

Dear Mr. Connor:

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

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Page 2 - Mr. John Connor

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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INDICATIONS FOR USE Smith & Nephew SL-PLUS° MIA Femoral Stem with Ti/HA

510(k) Number (if known): K122296

Device Name: SL-PLUS® MIA Femoral Stem with Ti/HA

Indications for Use:

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The SL PLUS® MIA Stem with and without Ti/HA is for single use only and is intended to be implanted without bone cement.

× AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ars

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K122296

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INDICATIONS FOR USE

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.