Total hip components are indicated for uncemented use in 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; diastrophic variant; 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

Subject of this Traditional 510(k) are the Smith & Nephew Radiopaque Trial Necks. The Radiopaque Trial Necks are intended to be used to determine the correct modular neck implant option for the femoral stems developed as part of the Smith & Nephew SMF Hip Stem System and MDF Revision Hip System cleared via premarket notifications K080625 and K081124, respectively.

The subject devices are manufactured from polyphenylsulfone (PPSU) with 6% of the radiopacifier barium sulfate, which makes them visible on an x-ray in the instance that they become dislodged during the trialing process. Colorants are blended with the PPSU resin to differentiate the various radiopaque trial necks.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Radiopaque Trial Necks" and demonstrates substantial equivalence to predicate devices rather than providing a study that proves the device meets specific acceptance criteria in the traditional sense of a performance study with quantitative metrics.

Therefore, many of the requested sections about explicit acceptance criteria, performance data, sample sizes, and expert ground truth are not applicable or cannot be extracted from this type of regulatory document. The document focuses on demonstrating biocompatibility and substantial equivalence in materials, sterilization, and design features, rather than a performance study measuring accuracy, sensitivity, or specificity of an algorithm.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission like this is demonstrating substantial equivalence to existing, legally marketed predicate devices. This involves showing similar indications for use, material equivalence (or demonstrating safety if different), sterilization equivalence (or demonstrating safety of the chosen method), and comparable design features and intended use.
Reported Device Performance:
- Biocompatibility: "Biocompatibility testing has been conducted on the subject devices according to ISO 10993:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process."
- Conclusion of Biocompatibility: "A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the Radiopaque Trial Necks."
- Clinical Data: "Clinical data was not needed to support the safety and effectiveness of the devices."
- Substantial Equivalence: The device is considered substantially equivalent to the predicate devices based on similarities and acceptable biocompatibility testing.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	No new issues related to safety. Biocompatibility per ISO 10993:2009.	Biocompatibility testing conducted according to ISO 10993:2009. "A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the Radiopaque Trial Necks." The material (PPSU with Barium Sulfate) is compared to the predicate's material (PPSU for shoulder trials), and the radiopacifier is an added feature for visibility on X-ray if dislodged, implying an enhancement in safety/utility during a specific use case.
Effectiveness	Effectiveness for its intended use (determining correct modular neck implant option), comparable to predicate devices.	The device's intended use is to "determine the correct modular neck implant option" for specific hip stem systems. The document states, "Clinical data was not needed to support the safety and effectiveness of the devices," implying that the recognized equivalence to predicate trial instruments (Promos Reverse Shoulder System Trial Inserts - K081016) regarding material and sterilization and the known function of trial instruments are sufficient to establish effectiveness.
Substantial Equivalence	Similar indications for use, comparable design features, material equivalence (or demonstrated safety of different materials), and equivalent sterilization methods compared to predicate devices.	- Indications for Use: Same as SMF Hip Stem System (K080625) and MDF Revision Hip System (K081124). - Material: Polyphenylsulfone (PPSU) with 6% Barium Sulfate (Color Added). Compared to Promos Reverse Shoulder System Trial Inserts (K081016) which also use Polyphenylsulfone. The addition of Barium Sulfate provides radiopacity. - Sterilization: Non-sterile (as are the Promos Shoulder Trial Inserts). - Design Features: Functionally similar as trial instrumentation. Comparison table in the document details these aspects and finds them similar or equivalent enough for substantial equivalence.

2. Sample sized used for the test set and the data provenance

Not Applicable. This document describes a 510(k) submission for mechanical/instrumentation devices, not an AI/algorithm-based diagnostic device requiring a specific "test set" in the context of performance metrics like sensitivity/specificity. The evaluation relies on biocompatibility testing and comparison to predicate devices, not statistical analysis of a data set.

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

Not Applicable. As above, no "ground truth" and expert review for a test set were conducted for this type of device and submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or adjudication method as described for an AI/algorithm.

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 not an AI-assisted device.

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

Not Applicable. This is not an AI/algorithm. This is a physical surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. The "ground truth" in this context is the established safety and effectiveness of the existing predicate devices and the ISO standards for biocompatibility.

8. The sample size for the training set

Not Applicable. This is not an AI/algorithm.

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

Not Applicable. This is not an AI/algorithm.

Summary

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K113039

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5 2012

Smith & Nephew, Inc. Summary of Safety and Effectiveness Radiopaque Trial Necks

Date of Summary: 05/29/2012

Contact Person and Address

Natalie P. Williams Sr. Regulatory Affairs Specialist Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 (901) 399-5161

Name of Device: Radiopaque Trial Necks Common Name: Surgical Instrumentation

Device Classification Name and Reference: 21 CFR 888.3353 - Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis; 21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Device Class: II Panel Code: Orthopaedics/87 LPH, MEH Predicate Devices: SMF Hip Stem (K080625), MDF Revision Hip System (K081124), Promos

Reverse Shoulder System Trial Inserts (K081016)

Device Description

Component Description	Color
Radiopaque Trial Neck Standard Offset	Natural
Radiopaque Trial Neck High Offset	Natural
Radiopaque Trial Neck Left Anteverted	Green
Radiopaque Trial Neck Right Anteverted	Red
Radiopaque Trial Neck High Offset +10MM	Natural

			Table 1: Radiopaque Trial Neck Options
--	--	--	----------------------------------------	--	--	--

Intended Use

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K 113039

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fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteolomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Performance Data

Biocompatibility testing has been conducted on the subject devices according to ISO 10993:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the Radiopaque Trial Necks. Clinical data was not needed to support the safely and effectiveness of the devices.

Substantial Equivalence Information

The Radiopaque Trial Necks have the same indications for use as the Smith & Nephew SMF Hip Stem System and MDF Revision Hip System. The material and sterilization of the subject devices is substantially equivalent to the Trial Inserts included in the Smith & Nephew Promos Reverse Shoulder System cleared by K081016. The design features of the Radiopaque Trial Necks have been compared to the previously cleared devices in Table 2 below.

Feature	Subject RadiopaqueTrial Necks - K113039	Predicate SMFHip Stem System- K080625	Predicate MDFRevision Hip StemSystem - K081124	Promos ReverseShoulder SystemTrial Inserts -K081016
Same Indicationsfor Use	Yes	Yes	Yes	No
Implant/Instrument	Hip Trial Instruments	Hip Implants	Hip Implants	Shoulder TrialInstruments
Material	Polyphenylsufone (PPSUI)with 6% Barium Sulfate(Color Added)	Ti-6Al-4V - StemCobalt Chrome -Modular Necks	Ti-6Al-4V - Stem andModular SleevesCobalt Chrome -Modular Necks	Polyphenylsufone(Color added)
Sterilization	Non-sterile	GammaSterilization	Gamma Sterilization	Non-sterile
Single Use orReusable	Reusable	Single Use	Single Use	Reusable

Table 2: Comparison to Predicate Devices

Conclusion

This Traditional 510(k) premarket notification is being submitted to request clearance for the Smith & Nephew Radiopaque Trial Necks. Based on the similarities to the predicate devices and acceptable biocompatibility testing, the subject devices are considered substantially equivalent to the devices currently marketed under premarket notifications K080625, K081124, and K081016.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

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

OCT
. 5
2012

Smith & Nephew, Incorporated % Ms. Natalie P. Williams Sr. Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K113039

Trade/Device Name: Radiopaque Trial Necks Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis; Regulatory Class: Class II Product Code: LPH, MEH Dated: October 4, 2012 Received: October 5, 2012

Dear Ms. Williams:

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

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Page 2 – Ms. Natalie P. Williams

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 (QS) 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/CDRH/CDRHOffices/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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K113039
Indications for Use

510(k) Number (if known):

Device Name: Smith & Nephew Radiopaque Trial Necks

Indications for Use:

Prescription Use Over-The-Counter Use × AND/OR (Part 21 CFR 801 Subpart D) (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)

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

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510(k) Number K113039

Regulation Number and Section

N/A