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• Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
• Fracture or avascular necrosis of the femoral head
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement
• All forms of osteoarthritis
• Patients with hips at risk of dislocation
• Femoral neck fracture or proximal fracture to hip joint

The REDAPT Porous Acetabular Shell for use with the POLACUP Dual Mobility System is intended for single use only and is to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with bone cement.

The REDAPT Porous Acetabular Shell is designed for cementless use on the boneinterfacing surface and is made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process. The device design allows for the cementing of liners into the shell and incorporates screw holes for fixation.

The POLARCUP Dual Mobility System consists of a metal shell and plastic liner (or insert). POLARCUP Shell is made from Stainless Steel. The inside of the metal shell is polished, and the outside of the plastic liner is able to articulate against this polished surface. The POLARCUP™ Dual Mobility System is an acetabular hip cup prosthesis.

The subject device consists of a REDAPT Porous Acetabular Shell for use with the POLACUP Dual Mobility System. The REDAPT Porous Acetabular Shell is intended to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with bone cement.

The purpose of this 510(k) submission is to modify the indications for the REDAPT Porous Acetabular Shell to allow for a dual mobility use when used with the POLARCUP Dual Mobility System.

This is a premarket notification for a medical device (hip implant components), not an AI/ML powered device. As such, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth for AI/ML models is not applicable to this document.

The document discusses the substantial equivalence of the REDAPT Porous Acetabular Shell with the POLARCUP Dual Mobility System to existing predicate devices based on:

• Technological Characteristics: The subject device components are stated to be identical to previously cleared devices. The assessment focused on the compatibility of the two systems.
• Biocompatibility: An evaluation was conducted according to FDA Draft Guidance and ISO-10993 for permanent implants.
• Mechanical Testing: Non-clinical bench testing was performed.

Here's a summary of the requested information that can be extracted from the document, with an emphasis on why other points are not applicable:

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

   Test Type	Acceptance Criteria	Reported Device Performance
   Bacterial Endotoxin Testing	Met acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72. (Implicit)	Met the acceptable endotoxin limits.
   Biocompatibility	Adherence to FDA Draft Guidance and ISO-10993 (Implicit - for permanent implants, >30 days)	Evaluation completed, summary rationale provided.
   Mechanical Testing	Pre-determined acceptance criteria (Specific criteria not detailed in the document)	Met the acceptance criteria for all outputs. The proposed devices are substantially equivalent to the predicate.

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

   • Sample Size: Not specified in the document for any of the tests.
   • Data Provenance: Not applicable. The tests are non-clinical bench and biocompatibility evaluations, not human data studies.

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. This is not an AI/ML powered device requiring expert-established ground truth.

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

   • Not applicable. This is not an AI/ML powered device requiring 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:

   • No. Not applicable, as this is not an AI/ML powered device.

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

   • No. Not applicable, as this is not an AI/ML powered device.

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

   • Not applicable. For this type of device, "ground truth" is typically defined by engineering specifications, material standards (ASTM, ISO), and established testing protocols for mechanical and biocompatibility performance.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML powered device.

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

   • Not applicable. This is not an AI/ML powered device.

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The REDAPT Porous Acetabular Shell and Cemented Liner are indicated for:
. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, 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, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The REDAPT Porous Acetabular Shell is intended for single use only and is to be implanted without bone cement. The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.

The REDAPT Porous Acetabular Shell designed for cementless use is made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process. The device design allows for the cementing of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation. The REDAPT Cemented Liner is manufactured from highly cross-linked polyethylene (ASTM F648) via standard machining processes. The liners incorporate integral polyethylene spheres that create a 1.5 mm gap between the porous shell or natural acetabulum for a consistent bone cement mantle.

This document is a 510(k) summary for the REDAPT Porous Acetabular Shell and Cemented Liner, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device against existing ones rather than detailing a traditional study with acceptance criteria and a detailed analysis of performance metrics in clinical trials.

Therefore, the requested information categories (#1-7 for a study and its acceptance criteria, and specific details for #8-9 for training sets) are generally not applicable in the context of this medical device submission. The FDA 510(k) process for devices like this typically relies on bench testing, material characterization, and comparisons to predicate devices to establish substantial equivalence, rather than extensive human clinical trials or AI performance evaluations.

However, I can extract the information provided that is relevant to the nature of this submission:

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

The document does not provide a table of acceptance criteria for a study with reported device performance in the way one might expect for a clinical trial or AI performance evaluation. Instead, it lists various tests performed to establish substantial equivalence. The "performance" is implied by the successful completion of these tests and the determination of substantial equivalence to predicate devices, meaning the device performed comparably or met established standards for the indicated tests.

The listed tests are:

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

• Sample Size: Not specified for each test. For mechanical and material tests of medical devices, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., 5-10 samples per test group). The document does not provide these details.
• Data Provenance: Not specified. Standard practice for such tests would be laboratory testing conducted by the manufacturer or a contracted testing facility in a controlled environment.

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. This is a submission for a physical medical device (hip implant components), not for an interpretative AI/imaging device. "Ground truth" in this context would refer to the validated material properties, mechanical performance under specified loads, and biocompatibility, which are established through standardized laboratory testing protocols, not expert consensus on interpretations.

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

Not applicable, as this is not a study requiring adjudication of expert opinions.

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. The device is a physical hip implant.

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

Not applicable. The device is a physical hip implant.

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

The "ground truth" for this device's evaluation relies on:

• Physical and Chemical Material Standards: Adherence to established ASTM (e.g., ASTM F648 for cross-linked polyethylene) and ISO standards for materials like titanium alloy and polyethylene.
• Mechanical Test Standards: Compliance with relevant mechanical testing standards (e.g., for fatigue, screw fixation, wear simulation) that simulate in vivo conditions.
• Biocompatibility Standards: Compliance with ISO 10993 series or similar standards for biological evaluation of medical devices.
• Comparison to Predicate Devices: Performance characteristics (e.g., wear, mechanical strength) found to be substantially equivalent to those of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no AI component or "training set" in the context of this device's submission.

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

Not applicable.

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