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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.

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.

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.

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.

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The PIPELINE Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
• Acute traumatic fracture of the femoral head or neck.
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

This 510(k) addresses the addition of the following components (already cleared under 510(k) #K130353) to the subject hip system:

• A size 1 femoral stem;
• Hip stems (all sizes, 1-12) with the option of 3 tantalum beads, to allow the surgeon to perform radiostereometric analysis(RSA) to measure implant migration; and
• Optional acetabular screw hole occluders provided either separately (for assembly by the surgeon), or pre-assembled to the acetabular shells.

These components are compatible with the total hip system determined substantially equivalent as the Pipeline Total Hip System in 510(k) #K12802 and K131237 and as the PBP Total Hip System in 510(k) #K122158.

The provided text is a 510(k) summary for a medical device (Pipeline Total Hip System - Line Extension) and a subsequent FDA clearance letter. It does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/software devices.

Instead, this submission is a Special 510(k) for a line extension, where the key argument for substantial equivalence is that the new components are identical to previously cleared components under a different subsidiary name of the same parent company (Pipeline Biomedical Holdings).

Therefore, many of the requested points regarding AI/software performance studies are not applicable to this type of device clearance. Below is an attempt to answer the questions based on the provided text, while acknowledging the inherent mismatch due to the nature of this 510(k) submission.

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

This information is not provided in the document as it's a line extension based on identity to a predicate, not a new device requiring performance testing against specific criteria. The "performance" is implicitly deemed to be identical to the predicate device.

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. No new performance testing was conducted for this submission. The device's "performance" is considered identical to a previously cleared device (K130353).

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. No test set or ground truth establishment relevant to AI/software performance.

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

Not applicable. No test set for adjudication.

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 a total hip replacement system, not an AI/software device intended to assist human readers.

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

Not applicable. This device is a total hip replacement system, not an algorithm.

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

Not applicable. No new performance validation studies were conducted as the components are stated to be identical to previously cleared predicate devices. The "ground truth" for this submission is the identity of the components to the legally marketed predicate.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/software requiring a training set.

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

Not applicable. As above, no training set.

Summary of the 510(k) Submission (K132626) based on the provided text:

This 510(k) is a Special 510(k) for a line extension to the Pipeline Total Hip System. The purpose is to add specific components (a size 1 femoral stem, hip stems with tantalum beads for RSA, and acetabular screw hole occluders) to the existing system.

The core argument for substantial equivalence is that these added components are identical to components already cleared by the FDA under 510(k) #K130353, which were marketed by a different subsidiary (Pipeline Orthopedics) of the same parent company (Pipeline Biomedical Holdings).

Because the components are claimed to be identical in "intended use, materials, design features, component sizing, or manufacturing methods," no additional nonclinical or clinical testing was conducted or deemed necessary for this particular submission (K132626). The "acceptance criteria" and "performance" are therefore assumed to be met by virtue of their identity to the predicate device cleared under K130353.

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