The iNSitu Bipolar Hip System is intended for use in combination with the iNSitu Total Hip System Femoral Stems for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

Femoral neck and trochanteric fractures of the proximal femur;
. Osteonecrosis of the femoral head;
. Revisions procedures where other devices or treatments for these indications have failed

Device Description

The iNSitu Bipolar Hip System consists of a factory assembled UHMWPE (ASTM F648) liner in a cobalt chrome (ASTM F75) outer shell, and UHMWPE (ASTM F648) retention ring with a Ti-6Al-4V ELI (ASTM F136) spring. These Bipolar Heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller Bipolar Heads (38 to 43 mm) have an inner diameter that mates with the subject 22mm diameter Femoral Head; the larger Bipolar Heads (44 to 60 mm) have an inner diameter that mates with the previously cleared 28 mm diameter Femoral Head. The iNSitu Bipolar Hip System may be used in conjunction with an iNSitu Total Hip System Femoral Stem (K161184/K172501) for hemiarthroplasty.

AI/ML Overview

This document describes the regulatory clearance of a medical device, specifically the iNSitu Bipolar Hip System. It refers to performance testing done for a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The provided text is a 510(k) summary for a traditional medical device (a hip prosthesis), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (the BioPro Bipolar Head) based on identical design, materials, indications for use, and manufacturing methods.

Here's a breakdown of the relevant information provided, adapted to the context of a traditional device:

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

The document does not explicitly state "acceptance criteria" in the way one would for an AI/ML algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it relies on the mechanical and functional equivalence to a predicate device.

Test Performed (using predicate device, identical to subject device)	Reported Performance / Conclusion
Push-Out and Lever-Out Strength	Demonstrates appropriate mechanical characteristics for hip hemi-arthroplasty; Substantially equivalent to predicate.
Assembly Forces	Demonstrates appropriate mechanical characteristics for hip hemi-arthroplasty; Substantially equivalent to predicate.
Range of motion testing (using subject device components)	Confirms appropriate mechanical characteristics for hip hemi-arthroplasty; Substantially equivalent to predicate.

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

Test set sample size: Not specified. The "testing" refers to mechanical and functional tests of the physical device components, not a "test set" of data as in AI/ML.
Data provenance: Not applicable in the context of mechanical device testing.

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. Ground truth as typically defined for AI/ML (e.g., expert consensus on medical images) is not relevant for the mechanical testing of a hip prosthesis. The "ground truth" here is adherence to mechanical and material standards and performance comparable to a predicate device.

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

Not applicable. This concept is for resolving disagreements in expert labeling of data, which is not part of this device's evaluation.

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/ML device, so no MRMC study would be conducted for human reader improvement with AI assistance.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this medical device's performance is adherence to established material specifications (e.g., ASTM F75 for cobalt chromium, ASTM F648 for UHMWPE, ASTM F136 for Ti-6Al-4V) and demonstrated mechanical performance comparable to a legally marketed predicate device as determined through physical testing.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this type of device.

In summary: The provided document is for a traditional hip implant, not an AI/ML powered device. The "acceptance criteria" are implied to be the successful demonstration of mechanical and material properties that are substantially equivalent to a cleared predicate device, as confirmed by physical performance testing. The questions regarding AI/ML specific aspects (sample sizes, experts, adjudication, MRMC, standalone performance, training sets, etc.) do not apply to this submission.

Summary

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September 17, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Theken Companies, LLC % Bob Poggie President BioVera 65 Promenade Saint-Louis Notre-Dame-de-L'lle-Perrot, QC, J7V 7P2 CANADA

Re: K191297

Trade/Device Name: iNSitu Bipolar Hip 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: August 19, 2019 Received: August 20, 2019

Dear Bob Poggie:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
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Indications for Use

510(k) Number (if known)	K191297
Device Name	iNSitu Bipolar Hip System
Indications for Use (Describe)

Femoral neck and trochanteric fractures of the proximal femur;
. Osteonecrosis of the femoral head;
. Revisions procedures where other devices or treatments for these indications have failed

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary 1.

The following 510(k) Summary is provided in accordance with 21 CFR 807.92.

1.1 510(k) Owner and Registration

Owner's Name:	Theken Companies, LLCSubsidiary: NextStep Arthropedix
Address:	1800 Triplett Blvd., Akron, OH 44306
Phone Number:	(330) 733-7600
Fax Number:	(330) 733-7602
Date Summary Prepared:	August 12, 2019
Establishment Registration Number:	3002498892

1.2 510(k) Contact

Contact:	BioVera, Inc.
Address:	Notre-Dame-de-L'Ile-Perrot (QC) J7V 7P2, CA
Phone and Fax Number:	514-901-0796
Contact Person:	Robert A Poggie, PhD

1.3 Device Name and Classification

Device Trade Name:	iNSitu Bipolar Hip System
Device Common Name:	Hemi-hip prothesis, uncemented
Regulation Number and Description:	21 CFR 888.3390
Device Class:	Class II
Product Codes:	KWY
Advisory Panel:	87 (Orthopedic)

Legally Marketed Predicate 1.4

NextStep Arthropedix is utilizing the BioPro Bipolar Head as a predicate device (K082705/K100761). The iNSitu Bipolar Hip System features component designs, materials, indications and manufacturing methods that are identical to the BioPro Bipolar Head.

	iNSitu Bipolar Hip System	BioPro Bipolar Head
510(K) Number	K191297	K082705/K100761
FDA Product Code	KWY	KWY
DESIGN
Head-Liner-Shell	CoCr-UHMWPE-CoCr	CoCr-UHMWPE-CoCr
Head Outer Diameter	38 to 60 mm in 1 mm increments	38 to 60 mm in 1mm increments
Self-aligning (eccentric head)	Yes	Yes
Liner Inner Diameter	22.225 or 28 mm	22.225 or 28mm
Liner-Head Assembly	Head snap-fit into bipolar liner	Head snap-fit into bipolar liner
UHMWPE retention	Yes	Yes
MATERIALS
Outer Shell	Cobalt chromium (ASTM F75)	Cobalt chromium (ASTM F75)
Liner and Retention Ring	UHMWPE (ASTM F648), Ti-6Al-4V(ASTM F136), EO sterilized (nothighly crosslinked)	UHMWPE (ASTM F648) and Ti-6Al-4V(ASTM F136), EO sterilized (not highlycrosslinked)
Sterilization Method	Ethylene Oxide	Ethylene Oxide
Hip System Compatibility	iNSitu Total Hip System(K161184/K172501)	BioPro PSL Hip System (K922500)

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1.5 Device Description

1.6 Intended Use

Femoral neck and trochanteric fractures of the proximal femur;
Osteonecrosis of the femoral head;
Revisions procedures where other devices or treatments for these indications have failed

Summary of Technological Characteristics 1.7

The iNSitu Bipolar Hip System has an identical design and is manufactured from the same materials as the predicate device system. The iNSitu Bipolar Hip System components are packaged and sterilized using similar processes. The subject system is substantially equivalent to the predicate based on comparisons of intended use, design features, and technological characteristics.

1.8 Performance Testing

Extensive preclinical performance testing was conducted, and substantial equivalence determined per K082705 and K100761. The components of the subject device are identical to the predicate BioPro Bipolar Head device, and therefore the predicate device testing demonstrates substantial equivalence for the results confirm that all components of the iNSitu Bipolar Hip System exhibit the appropriate mechanical characteristics for hip hemi-arthroplasty and are substantially equivalent to the predicate devices. Range of motion testing was performed using the iNSitu Bipolar Head and the iNSitu Total Hip System Femoral Stems (K161184/K172501).

The following tests were performed using the BioPro Bipolar Head, which is identical to the iNSitu Bipolar Hip System.

Push-Out and Lever-Out Strength
. Assembly Forces

Conclusions 1.9

The iNSitu Bipolar Hip System is identical to the predicate BioPro Bipolar Head (K082705/K100761). The subject device has the same design features, materials and indications for use as the predicate devices. The testing performed for the predicate and subject devices indicate that the subject iNSitu Bipolar Hip System is substantially equivalent to the predicate BioPro Bipolar Head.

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.