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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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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.

The predicate Pipeline Total Hip System (K112802) and PBP Total Hip System (K122802) are artificial hip replacement systems that include femoral stems (titanium alloy and CP titanium), femoral heads (cobalt chromium or alumina ceramic), acetabular shells (titanium alloy, porous structured technology (PST™)), acetabular liners (ultrahigh molecular weight polyethylene, standard and highly crosslinked Vitamin E), acetabular bone screws (titanium alloy) and dome hole covers (titanium alloy) for the holes in the acetabular shells. This subject 510k adds the following components to the existing hip systems:

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

The provided text describes a 510(k) summary for a hip replacement system, which details its components, intended use, and substantial equivalence to predicate devices, but does not contain information related to a "device" in the context of an AI/ML algorithm or medical imaging diagnostic device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided document is for a mechanical orthopedic implant, not a diagnostic or AI-powered device.

The questions in the prompt (e.g., "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance") are specific to the evaluation of AI/ML or diagnostic imaging devices, which are not relevant to the Pipeline Total Hip System.

The "Performance Testing" section in the document refers to:

• Hip Stem Fatigue Testing: Conducted according to ISO 7206-4:2010 to determine endurance properties.
• Stem Neck Fatigue Testing: Conducted according to ISO 7206-6:1992 and ASTM F2068-03.
  These are mechanical engineering tests to ensure the structural integrity and durability of the implant under physical stress, not a study to prove diagnostic accuracy or AI performance.

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