Smith & Nephew Global Femoral Head Trials are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems in their cleared Indications for Use as provided below.

Smith & Nephew Uncemented Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Uncemented Hip Systems and their cleared Indications for Use.

Uncemented Femoral Stems 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; 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.

Smith & Nephew Cemented Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Cemented Hip Systems and their cleared Indications for Use.

Cemented Femoral Stems are indicated for cemented 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 ioint 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; 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.

Smith & Nephew PLUS Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PLUS Hip Systems and their cleared Indications for Use.

Smith & Nephew Inc PLUS Femoral Stems are indicated for:

The SL-PLUS Stem Primary is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.
The SLR-PLUS STEM, a revision component, is also available to replace previously failed femoral him arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute). These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The SL-PLUS MIA Stem 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.
The POLARSTEM Standard and Lateral Femoral Stems are indicated for: advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, all forms of osteoarthritis, patients with hips at risk of dislocation, and femoral neck fracture or proximal fracture to hip joint.

Device Description

Per U.S Food and Drug Administration (FDA) regulation, device-specific instruments are accessory devices and take on the classification of the device(s) with which they are used. Instruments that are designed to assist in the implantation of Class II Smith & Nephew Hip Systems are classified as Class II devices and are subject to premarket notifications and regulations.

The subjects of this 510|k) are the Smith & Nephew Global Femoral Head Trials. The femoral head trials are instruments used to assist in the implantation of cleared Smith & Nephew hip systems.

The subject devices are similar to existing femoral head trials currently being used by surgeons when implanting femoral hip systems. The trials are manufactured from polyphenylsulfone (PPSU) with up to 10% of the radiopacifier barium sulfate. In addition, colorants are blended into the PPSU resin to allow for differentiation between the various sizes. The same materials are used in the manufacturing of existing hip system trials.

AI/ML Overview

This document is a 510(k) premarket notification for the Smith & Nephew Global Femoral Head Trials. It's a regulatory submission, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would for a diagnostic or therapeutic device.

The document describes Technological Characteristics and Substantial Equivalence Information to argue that the new device is as safe and effective as previously cleared predicate devices. It states: "The subject devices are similar to existing femoral head trials currently being used by surgeons when implanting femoral hip systems. The trials are manufactured from polyphenylsulfone (PPSU) with up to 10% of the radiopacifier barium sulfate. In addition, colorants are blended into the PPSU resin to allow for differentiation between the various sizes. The same materials are used in the manufacturing of existing hip system trials." And further: "When compared to the previously cleared device-specific instruments listed in Table 2, the proposed instruments utilize the same raw materials, manufacturing processes, and sterilization methods (where applicable). It should also be noted that the nature of body contact is the same as found with the predicate devices that have been identified in this premarket notification."

Here's an attempt to answer your questions based on the provided text, but it's crucial to understand that this document does not contain a study report with performance metrics or acceptance criteria as typically requested for AI/diagnostic devices.

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

This document does not provide a table of acceptance criteria and reported device performance in terms of quantifiable metrics (e.g., sensitivity, specificity, accuracy, precision, etc.). The submission relies on demonstrating substantial equivalence to existing devices, implying that if the new device is technologically similar and has the same intended use, its performance is assumed to be acceptable by virtue of its similarity to already cleared devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission for an orthopedic surgical instrument (femoral head trials), not a study evaluating performance against a test set of data.

3. 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. There is no test set or ground truth established for performance evaluation in this document.

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

Not applicable.

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 device is not an AI or diagnostic device that involves human "readers" or AI assistance.

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

Not applicable. This is a physical surgical instrument.

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

Not applicable. The submission focuses on substantial equivalence based on material composition, manufacturing processes, and intended use, rather than performance against a "ground truth."

8. The sample size for the training set

Not applicable. There is no training set mentioned or implied as this is not an AI or data-driven device.

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

Not applicable.

Summary of Device Acceptance Rationale from the Document:

The acceptance criteria for the Smith & Nephew Global Femoral Head Trials are implicitly met by demonstrating substantial equivalence to existing, legally marketed predicate devices. The "study" (or rather, the justification) provided by the manufacturer can be summarized as:

"When compared to the previously cleared device-specific instruments listed in Table 2 [Radiopaque Trial Necks, K113039, cleared 10/5/2012 by Smith & Nephew], the proposed instruments utilize the same raw materials, manufacturing processes, and sterilization methods (where applicable). It should also be noted that the nature of body contact is the same as found with the predicate devices that have been identified in this premarket notification."

The materials used are "polyphenylsulfone (PPSU) with up to 10% of the radiopacifier barium sulfate," and "colorants are blended into the PPSU resin to allow for differentiation between the various sizes." The document explicitly states: "The same materials are used in the manufacturing of existing hip system trials."

Therefore, the "acceptance criteria" is that the new Global Femoral Head Trials are technologically similar and intended for the same use as existing cleared devices (specifically, the Radiopaque Trial Necks, K113039). The "proof" is the detailed comparison of materials, manufacturing, sterilization, and intended use, which are deemed identical or sufficiently similar to the predicate device to warrant a finding of substantial equivalence by the FDA.

Summary

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K132435 page 1 of 4

> We are smith&nephew

Submitted by:

Date of Summary:

Contact Person and Address:

Name of Device:

Common Name:

Device Classification Name and Reference:

Smith & Nephew, Inc. Advanced Surgical Devices Division 1450 East Brooks Road Memphis, Tennessee 38116

October 17, 2013

Megan Fessenden
Regulatory Affairs Specialist

T 901-399-1104 F 901-721-2583

OCT 22 2013

Smith & Nephew, Inc. Global Femoral Head Trials

Orthopaedic Surgical Instrumentation

21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis

21 CFR 888.3353 Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis 21 CFR 888,3358 Hip joint metal/polymer metal semiconstrained porous-coated uncemented prosthesis 21 CFR 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 21 CFR 888.3390 Hip joint femoral (hemi-hip) metal/polymer

cemented or uncemented prosthesis

Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	LZO, KWY, LWJ, LPH, JDI, MEH, MBL

Device Description

The subjects of this 510|k) are the Smith & Nephew Global Femoral Head Trials. The femoral head trials are instruments used to assist in the implantation of cleared Smith & Nephew hip systems.

Intended Use

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K132435 page 2 of 4

Smith & Nephew Uncemented Femoral Stems

Smith & Nephew Cemented Femoral Stems

Smith & Nephew Inc. PLUS Femoral Stems

Smith & Nephew PLUS Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PLUS Hip Systems and their cleared Indications for Use.

Smith & Nephew Inc PLUS Femoral Stems are indicated for:

The SL-PLUS Stem Primary is intended for treating patients who are candidates for . total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. The SL-PLUS Stem is intended for advanced hip joint wear due to
Confidential 3

Confidential

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degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.

The SLR-PLUS STEM, a revision component, is also available to replace previously . failed femoral him arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape . of the proximal femur (champagne flute). These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The SL-PLUS MIA Stem 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.
. The POLARSTEM Standard and Lateral Femoral Stems are indicated for: advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, all forms of osteoarthritis, patients with hips at risk of dislocation, and femoral neck fracture or proximal fracture to hip joint.

Technological Characteristics

Substantial Equivalence Information

When compared to the previously cleared device-specific instruments listed in Table 2, the proposed instruments utilize the same raw materials, manufacturing processes, and sterilization methods (where applicable). It should also be noted that the nature of body contact is the same as found with the predicate devices that have been identified in this premarket notification.

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew	Radiopaque Trial Necks	K113039	10/5/2012

Table 2: Substantially Equivalent Predicates to the Global Femoral Head Trials

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K132435 page 4 of 4

Conclusion

This Traditional 510(k) Premarket Notification is being submitted to request clearance for the Global Femoral Head Trials. Based upon the technological and material similarities, the Global Formeral Frontially equivalent to the predicate devices identified in this premarket notification.

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Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is presented in black and white.

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

October 22, 2013

Smith & Nephew, Incorporated Ms. Megan Fessenden Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K132435

Trade/Device Name: Global Femoral Head Trials for use with Smith & Nephew, Inc. Uncemented, Cemented and PLUS Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, KWY, LWJ, LPH, JDI, MEH, MBL Dated: August 26, 2013 Received: August 28, 2013

Dear Ms. Fessenden:

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. Megan Fessenden

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin 原Keith

for

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

Enclosure

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510(k) Number (if known): K 132435 page 1 of 4

Device Name: Global Femoral Head Trials for use with Smith & Nephew Inc. Uncemented Femoral Stems

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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)

Elizabeth L. Frank -S

র্তা - Page Page -

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Giobal Femoral Head Trials Indications for Use

510(k) Number (if known): K132435 page 2 of 4

Device Name: Global Femoral Head Trials for use with Smith & Nephew, Inc. Cemented Femoral Stems

Indications for Use:

Cemented Femoral Stems are indicated for cemented 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; 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.

x 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)

Elizabeth L. Frank -S

Page _________________________________________________________________________________________________________________________________________________________________________

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Global Femoral Head Tria Indications for Us

510(k) Number (if known):

K132435 page 3 of 4

Device Name: Global Femoral Head Trials for use with Smith & Nephew Inc PLUS Femoral Stems

Indications for Use:

Smith & Nephew PLUS Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PLUS Hip Systems and their cleared Indications for Use.

Smith & Nephew Inc PLUS Femoral Stems are indicated for:

The SL-PLUS Stem Primary is intended for treating patients who are candidates for total . hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.
The SLR-PLUS STEM, a revision component, is also available to replace previously failed . femoral him arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape of the . proximal femur (champagne flute). These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _ ol

Elizabeth L. Frank -S

{9}------------------------------------------------

Global Femoral Head Trials Indications for Use

510(k) Number (if known): K132435 page 4 of 4

Device Name: Global Femoral Head Trials for use with Smith & Nephew Inc PLUS Femoral Stems

Indications for Use (continued):

The SL-PLUS MIA Stem 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.
The POLARSTEM Standard and Lateral Femoral Stems are indicated for: advanced . degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, all forms of osteoarthritis, patients with hips at risk of dislocation, and femoral neck fracture or proximal fracture to hip joint.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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)

Elizabeth L. Frank -S

Regulation Number and Section

N/A