The b-ONE™ Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions:

Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), 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 and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip.

The b-ONE™ Total Hip System KOSMO™ HA coated stems are intended for cementless use only. The b-ONETM Total Hip System KOSMOTM stainless steel stems are intended for cemented use only.

b-ONETM Total Hip System components are not intended for use with other total hip systems.

Device Description

The b-ONE Total Hip System is an artificial hip replacement system comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; optional acetabular bone screws. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. Compatibility of the femoral head to the stem is only claimed for the b-ONE Total Hip System. There is no allowed interchangeability with systems manufactured by other companies.

This 510(k) premarket notification is being submitted as a line extension to the current b-ONE Total Hip System by adding a bone compacting Femoral Stem component. The KOSMO™ Femoral Stem is compatible with the b-ONE™ Primary Acetabular components. The KOSMO™ Cementless Femoral Stem components are compatible with the b-ONE™ 12/14 Taper CoCr or Ceramic Femoral Heads. The KOSMO™ Cemented Femoral Stem components are compatible with the b-ONE™ 12/14 Taper Ceramic Femoral Heads only.

b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The KOSMO Femoral Stem is composed of HA coated titanium alloy Ti-6Al-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stem. All system components are supplied sterile and are single use devices.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (KOSMO Femoral Stem, a hip joint prosthesis), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth for an AI/ML model is not applicable.

The provided text describes a submission for a traditional medical device and focuses on establishing substantial equivalence to legally marketed predicate devices through material properties, design features, manufacturing processes, sterilization methods, and bench performance testing.

However, to directly answer your request based only on the provided text, and assuming the question is about the acceptance criteria and supporting studies for the medical device itself (not an AI/ML component lacking in this document), here is what can be inferred:

Acceptance Criteria and Study Information for the KOSMO Femoral Stem (Medical Device)

The document does not explicitly state quantitative "acceptance criteria" in the format one might expect for an AI/ML performance study (e.g., minimum sensitivity, specificity, or AUC). Instead, for this traditional medical device, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices through various non-clinical studies. The "performance" being assessed is the physical and mechanical integrity and biological compatibility of the implant.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Implicit)	Reported Device Performance (as demonstrated by studies)
Substantial Equivalence to Predicate Devices	Demonstrated through comparison of materials, design, manufacturing, sizes, coatings, and sterilization methods.
Mechanical Strength and Durability	Endurance and Performance testing conducted. (Specific values not provided in this summary, but presumed to meet standards for hip stems).
Biocompatibility	Biocompatibility testing conducted. (Presumed to meet ISO 10993 or equivalent standards for implantable devices).
Range of Motion	Range of Motion Study conducted. (Presumed to demonstrate functionality comparable to predicate devices).
Impingement	Impingement Testing conducted. (Presumed to demonstrate acceptable mechanical interaction within the joint).
Sterility & Safety	Bacterial Endotoxin Testing conducted. (Presumed to meet limits for sterile implants).
Shelf Life	Shelf Life Studies conducted. (Presumed to demonstrate stability over the intended storage period).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in this 510(k) summary. For bench testing of medical devices, sample sizes are typically determined by relevant ISO standards (e.g., ISO 7206 for hip implants) but are not detailed in this high-level summary.
Data Provenance: The studies are "Non-Clinical Studies," meaning they are bench tests (mechanical, chemical, biological) performed in a lab setting, not on human patients. Therefore, country of origin of data or retrospective/prospective clinical data are not applicable here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable as this is not an AI/ML application or a clinical study requiring expert ground truth for interpretation of complex clinical data. The "ground truth" for a mechanical device is based on engineering specifications, material science, and established test methods.

4. Adjudication Method for the Test Set

Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for bench testing of a traditional medical device.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are used to assess the impact of an AI algorithm on human reader performance, which is not relevant for this traditional medical device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is for an AI/ML algorithm. This device is a physical implant. The "standalone performance" refers to its mechanical and material properties as assessed by bench tests. The summary indicates that "Performance Testing - Bench" was done.

7. Type of Ground Truth Used

For the non-clinical studies mentioned (Endurance, Impingement, Biocompatibility, etc.), the "ground truth" is derived from:
- Engineering Specifications: Design tolerances, material properties, and mechanical performance requirements derived from national and international standards (e.g., ISO, ASTM) for hip implants.
- Pre-defined Pass/Fail Criteria: Established by industry standards and regulatory expectations for the safety and effectiveness of such devices.

8. Sample Size for the Training Set

Not applicable. This refers to AI/ML model training data. For a traditional medical device, there is no "training set" in this context. Device design and manufacturing processes are refined through engineering, prototyping, and testing, but not in the sense of training an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the device's development and validation relies on established biomechanical principles, material science, regulatory standards for medical device safety and effectiveness, and comparisons to legally marketed predicate devices.

Summary

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b-One Ortho Corp. Allison Gecik Regulatory Affairs Associate Director 3 Wing Drive Suite #259 Cedar Knolls, New Jersey 07927

Re: K202768

Trade/Device Name: KOSMO Femoral Stem 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, MEH Dated: February 25, 2021 Received: February 26, 2021

Dear Allison Gecik:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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 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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Indications for Use

510(k) Number (if known)

K202768

Device Name b-ONE™ Total Hip System

Indications for Use (Describe)

The b-ONE™ Total Hip System KOSMO™ HA coated stems are intended for cementless use only. The b-ONETM Total Hip System KOSMOTM stainless steel stems are intended for cemented use only.

b-ONETM Total Hip System components are not intended for use with other total hip systems.

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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TRADITIONAL 510(K) SUMMARY As required by 21 CFR 807.92

Submitter Information:

Submitter's Name:	b-ONE ORTHO, Corp.
Address:	3 Wing Drive
	Suite 259
	Cedar Knolls, NJ 07927
Telephone:	866-276-4538
Contact Person:	Allison Gecik
Telephone:	973-587-8431
Date Prepared:	September 18, 2020
Proprietary Name:	b-ONE TM Total Hip System
Classification:	Class II
Classification Panel:	Orthopedic
Common Name:	Total Hip Joint Replacement
Product Code(s):	LZO, MEH
Classification Name(s):	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis	(888.3353)
Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed:	K070554, K042992 DePuy Corail Stem; DePuy Corail AMT Stem
Legally Marketed Reference Devices Used to Support Substantial Equivalence:	K192189, K182048 Zimmer Biomet Avenir Complete Hip Stem

Intended Use: The b-ONE™ Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions:

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Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip.

The b-ONE Total Hip System KOSMO™ HA coated stems are intended for cementless use only. The b-ONE™ Total Hip System KOSMO™ stainless steel stems are intended for cemented use only.

b-ONE™ Total Hip System components are not intended for use with other total hip systems.

Device Description/Technological Characteristics:

Comparison of Technological Characteristics (compared to Predicate(s))

The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The b-ONE Total Hip System KOSMO™ Femoral Stem and the predicate devices share the following characteristics:

Materials of construction
Manufacturing processes
Sizes offered
Product design for shape
Coatings ●
Sterilization methods

Performance Testing - Bench

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Studies

• Endurance and Performance	• Range of Motion Study
• Impingement Testing	• Bacterial Endotoxin Testing
• Biocompatibility	• Shelf Life Studies

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Conclusion

The information provided above supports that the b-ONE™ Total Hip System KOSMO™ Femoral Stem is as safe and effective as the predicate devices with the same intended use. Some minor differences in design and technology exist between the subject and predicate devices, however applicable reference devices have been cited to support the conclusion that these differences do not raise any new questions of safety and effectiveness. The b-ONE™ Total Hip System KOSMO™ Femoral Stem is substantially equivalent to the predicate devices.

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.