The SurgTech Bipolar Head system is intended for use for cases of:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia.

· Inflammatory degenerative joint disease such as rheumatoid arthritis.
Correction of function deformity.
· Revision procedures where other treatments or devices have failed.
· Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

The SurgTech Bipolar Head System is used for hip hemiarthroplasty in skeletally mature individuals. The system consists of a CoCr alloy shell (38-58mm outer diameters), a polyethylene bearing insert (22mm and 28mm inner diameters) and retaining ring, and CoCr alloy femoral heads (22mm and 28mm) in various offsets. Instrumentation necessary for proper implantation is also included.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the SurgTech Bipolar Head System. This type of regulatory submission in the US focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.

As such, the document does not describe acceptance criteria for a study or a study proving the device meets those criteria in the way one would expect for an AI algorithm or a device requiring new clinical efficacy data.

Here's an analysis based on the information provided, explaining why certain sections of your request cannot be fulfilled:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices. This is achieved primarily through non-clinical testing comparing physical and mechanical characteristics. The document does not list specific numerical acceptance criteria (e.g., minimum accuracy score, sensitivity thresholds) because it's not a performance study of that nature.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical properties comparable to predicate devices	Femoral Head/Bipolar Liner Pull Out/Lever Out: Evaluated
	Femoral Head/Femoral Stem Pull Off: Evaluated
	Range of Motion: Evaluated
Biocompatibility and sterility comparable to predicate devices	Bacterial Endotoxins: Evaluated
(General similarity in intended use, design, materials, packaging, sterilization)	"The SurgTech Bipolar Head system is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, packaging, sterilization and mechanical performance."

Explanation of Missing Information for an AI/Clinical Efficacy Study:

The following points cannot be addressed from the provided text because this is a 510(k) submission for a physical orthopedic implant, not an AI or diagnostic device that typically undergoes such efficacy studies.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. Clinical testing was not required or performed for this 510(k). The "test set" here refers to physical devices undergoing mechanical tests.
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. Ground truth for a physical implant's mechanical properties is typically established through standardized testing procedures, not expert consensus on medical images or diagnoses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical testing, the "ground truth" is adherence to established engineering standards and test methods (e.g., ASTM, ISO) for mechanical properties and biocompatibility.
The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Summary from the Document:

Non-clinical testing: The device underwent non-clinical testing for "Femoral Head/Bipolar Liner Pull Out/Lever Out," "Femoral Head/Femoral Stem Pull Off," "Range of Motion," and "Bacterial Endotoxins." These tests are typical for orthopedic implants to demonstrate mechanical integrity and biocompatibility.
Clinical testing: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This explicitly states that no human clinical trials were conducted for this submission.
Basis for Substantial Equivalence: The manufacturer believes the device is substantially equivalent based on "similarities in intended use, design, materials, packaging, sterilization and mechanical performance" to the identified predicate devices. The technological characteristics "do not raise any new questions of safety and efficacy."

In conclusion, the document describes a regulatory submission for a physical medical device (hip prosthesis) where substantial equivalence is demonstrated through non-clinical performance testing against predicate devices and adherence to established material and mechanical standards, not through clinical efficacy studies involving human subjects or AI-specific validation.

Summary

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SurgTech, Inc., % Kellen Hills Quality and Regulatory Consultant Orchid Design 4600 E Shelby Drive Memphis. Tennessee 38118

June 14, 2018

Re: K173455

Trade/Device Name: SurgTech Bipolar Head System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY Dated: May 2, 2018 Received: May 7, 2018

Dear Kellen Hills:

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

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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 (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.

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 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) K173455

Device Name

SurgTech Bipolar Head System

Indications for Use (Describe) The SurgTech Bipolar Head system is intended for use for cases of:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia.

· Inflammatory degenerative joint disease such as rheumatoid arthritis.
Correction of function deformity.
· Revision procedures where other treatments or devices have failed.

· Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

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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K173455 Page 1/2

(a)(1)	Submitted By:	SurgTech, Inc.24600 Center Ridge Road, Suite 195Westlake, OH 44145
	Phone:	440-899-2922
	Date:	June 8, 2018
	Contact Persons
	Primary:	Kellen Hills (Orchid Design Consulting)901-433-1990
	Secondary:	Brian Hewko (SurgTech, Inc.)
(a)(2)	Proprietary Name:Common Name:	SurgTech Bipolar Head SystemBipolar Hip Prosthesis
	Classification Name and Reference:	21CFR 888.3390 - Hip Joint femoral (Hemi-
		Hip) Metal/Polymer Cemented or
		Uncemented Prosthesis
	Product Code:	KWY
(a)(3)	Predicate Devices:
	Primary:	J&J ORTHOPAEDICS-PFC BIPOLAR (K931655)
	Additional:	United Orthopedic-U2 BIPOLAR (K152439);
	Additional:	Stryker-UHR Bipolar (K800207);
	Additional:	Howmedica - CENTRAX (K855231)

*No predicate has been subject to a design related recall.

(a)(4) Device Description:

Reference:

SurgTech-MALUC (K162125);

28mm femoral heads as well as all femoral stems used in conjunction with the SurgTech Bipolar Head System were cleared previously in K162125.

The purpose of this submission is to gain initial marketing authorization in the United States.

Indications for Use: (a)(5)

The SurgTech Bipolar Head system is intended for use for cases of:

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia.
Inflammatory degenerative joint disease such as rheumatoid arthritis.
Correction of function deformity.
Revision procedures where other treatments or devices have failed.

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Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
(a)(6) Comparison of Technological Characteristics:

The SurgTech Bipolar Head system is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, packaging, sterilization and mechanical performance. The technological characteristics do not raise any new questions of safety and efficacy.

(b)(1) Non-clinical testing:

The subject devices were evaluated for the following performance characteristics:

Femoral Head/Bipolar Liner Pull Out/Lever Out
Femoral Head/Femoral Stem Pull Off
Range of Motion
Bacterial endotoxins

(b)(2) Clinical testing:

Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.

(b)(3) Conclusions:

Based on the information provided in this premarket notification, we believe that the subject SurgTech Bipolar Head system demonstrates substantial equivalence to the identified predicate devices.

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.