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 theumatoid 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 is intended for cementless use only.

b-ONE® 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; and, optional 6.5mm acetabular screws. Acetabular Shell options include no-hole and multiple hole configurations.

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.

The Tapered Wedge Stem, Acetabular Shells, and Acetabular Bone Screws are made from Ti-6AI-4V-ELI. Stem and shell coatings include CPTi Plasma Porous Spray with or without HA. Femoral heads are made from CoCr or Ceram Tec Biolox® delta. Acetabular Shell Liners are made from conventional UHMWPE and UHMWPE with Vitamin E.

All system components are supplied sterile and are single use devices.

AI/ML Overview

This FDA 510(k) summary describes the b-ONE® Total Hip System, a total hip replacement device. It does not contain information about a study based on AI/ML. There is no mention of acceptance criteria or details of a study proving the device meets said criteria in the context of AI/ML performance.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through bench testing and comparison of technological characteristics.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document. I cannot fill in the table or provide answers to the specific questions as they relate to AI/ML performance.

However, I can extract the information provided about the device's performance testing for its substantial equivalence claim, which is based on traditional engineering and biocompatibility testing:

Device Performance Information from the Provided Document (Not AI/ML related):

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the way one might expect for an AI/ML product (e.g., sensitivity, specificity, AUC). Instead, it lists various non-clinical performance tests conducted to demonstrate the device's safety and effectiveness compared to predicate devices. The implicit "acceptance criterion" for each test is that the b-ONE® Total Hip System performs comparably to or within acceptable limits for a device of its kind, thereby not raising new questions of safety or effectiveness relative to the predicates. The "reported device performance" is the successful completion of these tests.

Test Category	Specific Test	Implied Performance/Outcome
Mechanical/Biological Performance	Endurance and Performance	Demonstrated acceptable mechanical endurance and overall performance.
	Sustained Endurance	Demonstrated acceptable sustained endurance.
	Burst Test	Demonstrated acceptable resistance to bursting forces.
	Fatigue Test	Demonstrated acceptable resistance to fatigue.
	Post Fatigue Burst Test	Demonstrated acceptable resistance to bursting after fatigue.
	Axial Pull-off	Demonstrated acceptable resistance to axial pull-off forces.
	Rotational Stability	Demonstrated acceptable rotational stability.
	Acetabular liner/shell disassembly	Demonstrated acceptable resistance to disassembly.
	Impingement Test	Demonstrated acceptable performance under impingement conditions.
	Range of Motion Studies	Demonstrated acceptable range of motion.
	Accelerated Wear	Demonstrated acceptable wear characteristics.
	Torsional Strength	Demonstrated acceptable torsional strength.
	Axial Pull-out	Demonstrated acceptable resistance to axial pull-out.
	Bacterial Endotoxin Testing	Demonstrated acceptable endotoxin levels (biocompatibility).
	Shelf Life Studies	Demonstrated acceptable shelf life.
	Biocompatibility	Demonstrated acceptable biocompatibility.
	Characterization of Vitamin E	Vitamin E material characterized (for UHMWPE with Vitamin E liners).
	Characterization of Conventional Polyethylene Liner Material	Conventional polyethylene liner material characterized.
	Coating Characterization Study	Coatings (CPTi Plasma Porous Spray, HA) characterized.

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

Not applicable. The tests listed are non-clinical, bench-top tests, and material characterization studies, not studies involving patient data or AI/ML test sets.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This information is relevant for AI/ML performance evaluation based on expert-labeled data, which is not described in this document.

4. Adjudication Method:

Not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for the type of bench testing described here.

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

No. An MRMC study is not mentioned as this document describes a traditional medical device (hip implant), not an AI/ML device or software for interpretation.

6. Standalone (Algorithm Only) Performance:

Not applicable. There is no algorithm or software component mentioned that would have standalone performance.

7. Type of Ground Truth Used:

For the mechanical and material tests, the "ground truth" is defined by established industry standards (e.g., ASTM, ISO guidelines) and regulatory requirements for orthopedic implants, ensuring the device meets specific physical and chemical properties and performs as intended under simulated physiological conditions. Biocompatibility is assessed against recognized standards.

8. Sample Size for the Training Set:

Not applicable. There is no AI/ML training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no AI/ML training set.

In summary, the provided document is a 510(k) summary for a physical medical device (an orthopedic implant) and does not describe an AI/ML-driven device or study. Therefore, most of the questions related to AI/ML acceptance criteria and study design are not relevant to this content.

Summary

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b-One Ortho Corp. Allison Geick RAC b-ONE Ortho Corp. Regulatory Affairs Manager 3 Wing Drive Suite 259 Cedar Knolls, New Jersey 07927

Re: K173380

Trade/Device Name: b-ONE® Total Hip System 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 Dated: August 1. 2018 Received: August 2, 2018

Dear Allison Geick:

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/ofdocs/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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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.

Daniel S. Ramsey -S 2018.08.30 16:41:44 -04'00'

For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K173380

Device Name b-ONE® Total Hip System

Indications for Use (Describe)

Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NID), 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 is intended for cementless use only.

b-ONE® 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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K173380 TRADITIONAL 510(K) SUMMARY

Submitter Information:

Submitter's Name:	b-One Ortho
Address:	3 Wing DriveSuite 259Cedar Knolls, NJ 07927
Telephone:	866-276-4538
Contact Person:	Allison Gecik
Telephone:	973-587-8431
Date Prepared:	July 31, 2018
Proprietary Name:	b-ONE® Total Hip System
Classification:	Class II
Classification Panel:	Orthopedic
Common Name:	Total Hip Joint Replacement
Product Code(s):	LZO, HWC, MEH
ClassificationName(s):	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (888.3353)Screw, fixation, bone, smooth or threaded metallic bone fixationfastener (888.3040)
Legally Marketed PredicateDevices to Which SubstantialEquivalence is Claimed:	K052718, StrykerV40TM Biolox® delta Ceramic Femoral HeadsK010757, Stryker V40™ Femoral Head ComponentsK103479 Accolade II Hip StemK001448 Stryker Trident Acetabular Shells: HA over PPSK121874 Biomet G7 Acetabular SystemK120370 Zimmer Continuum Acetabular System (UHMWPE+VitE)K091508 Zimmer Continuum Acetabular System (UHMWPE)K873251Stryker Self-Tapping Acetabular Screw
Legally Marketed ReferenceDevices Used to SupportSubstantial Equivalence:	K082844 Biolox Ceramic Femoral HeadsK161569 Stryker Trident Acetabular ShellsK112802, K122158 Pipeline Total Hip SystemK111546, United Orthopedic Corp. U2 Hip Sytem

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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:

The b-ONE® Total Hip System is intended for cementless use only.

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

Device Description/Technological Characteristics:

All system components are supplied sterile and are single use devices.

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 and the predicate devices share the following characteristics:

. Materials of construction
Manufacturing processes ●
Sizes offered
Product design for shape and macrostructures
Coatings (titanium and hydroxyapatite coating options)
. Sterilization methods

Performance Testing - Bench

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

Non-Clinical Studies

• Endurance and Performance	• Accelerated Wear
• Burst Test	• Torsional Strength
• Fatigue Test	• Axial Pull-out
• Post Fatigue Burst Test	• Bacterial Endotoxin Testing

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• Axial Pull-off	• Shelf Life Studies

• Rotational Stability	• Biocompatibility
• Acetabular liner/shell disassembly	• Characterization of Vitamin E

Polyethylene Liners	Polyethylene Liner Material
• Impingement Test	• Characterization of ConventionalPolyethylene Liner Material
• Range of Motion Studies	• Coating Characterization Study

Conclusion

The information provided above supports that the b-One® Total Hip System 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 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.