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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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Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Oxinium DH femoral heads are for single use only.

The Oxinium DH femoral heads are designed for use with existing Smith & Nephew hip stems featuring a 12/14 taper and will articulate against existing acetabular shell and liner constructs. A complete list of hip stems and acetabular components intended for use with the Oxinium DH heads is provided in Tables 1 and 2, respectively. The overall design of the Oxinium DH femoral heads is based upon the existing Total Hip 12/14 Taper Femoral Heads cleared via K021673 and the Oxinium femoral heads cleared as part of K022958 for Total Hip Femoral Heads & Liners.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Oxinium DH Femoral Heads:

The provided document (K081566) is a 510(k) Summary of Safety and Effectiveness for a medical device. It's important to understand that 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, rather than proving stand-alone clinical efficacy through randomized controlled trials. Therefore, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of performance metrics like sensitivity, specificity, human reader improvement with AI, etc., will likely not be present in this type of regulatory submission.

Instead, the "acceptance criteria" for a 510(k) device like this are typically related to:

• Mechanical performance: Ensuring the device meets strength, durability, and biocompatibility standards.
• Indications for Use: Confirming the device is intended for the same or similar purposes as the predicate device.
• Design and Materials: Demonstrating similarity in overall design and materials to a legally marketed predicate.

The "study" proving these criteria are met is often a combination of mechanical testing and a comparison to predicate devices.

Given this context, here's the information extracted from the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Note: As explained above, "acceptance criteria" for a 510(k) submission are generally not expressed in clinical performance metrics (like sensitivity/specificity) but rather in engineering and design equivalence.

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

• Test Set Sample Size: Not applicable in the context of clinical performance evaluation (like for diagnostic AI). The "test set" here refers to the samples used in mechanical testing. The document states "A review of the mechanical testing results," implying tests were conducted, but does not specify the sample size (e.g., number of heads tested for fatigue, static strength, etc.).
• Data Provenance: Not applicable in the context of clinical data. The "data" primarily comes from mechanical laboratory testing performed on the device prototypes or production samples. The country of origin for such testing is not specified. It is a prospective test in the sense that the device was manufactured and then tested to confirm its properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. For mechanical testing, "ground truth" is established by engineering standards, specifications, and physical measurements, not by expert consensus in a clinical sense. The review of these results would be done by internal engineers, potentially external consultants, and ultimately FDA reviewers.
• Qualifications of Experts: Not specified. If "experts" refers to those who designed or evaluated the mechanical tests, they would typically be biomechanical engineers, materials scientists, or other relevant technical professionals.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth (e.g., diagnosis from imaging). For mechanical testing, the "adjudication" is typically a direct comparison of measured values against established engineering specifications or performance of predicate devices. There isn't a "consensus" process for adjudicating if a material broke at a certain load.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools or AI systems where human readers interpret results. This submission is for a physical implantable device (femoral head) and focuses on mechanical and material equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. This question is irrelevant to the device described. This is a physical orthopedic implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • For mechanical performance: Engineering specifications, material properties, and performance data from predicate devices. The "ground truth" is that the device must withstand "expected in vivo loading without failure," which is assessed via standardized biomechanical testing (e.g., fatigue testing, static load testing to ISO or ASTM standards, though specific standards aren't cited in this summary).
  • For design, materials, and indications: The characteristics and performance of the legally marketed predicate devices (K021673 and K022958).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document is not describing an AI/machine learning model, so there is no "training set" in that context. If interpreted very broadly as the historical data used to design the device, it would be the cumulative knowledge and clinical experience with previous hip prostheses, but specific numbers are not given.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the common understanding for an AI/ML device. The "ground truth" for the design of the device is based on established biomechanical principles, historical clinical performance of similar devices, and regulatory standards for orthopedic implants.

In summary: The K081566 document is a regulatory submission for substantial equivalence for a physical medical device. It relies on a comparison to existing, legally marketed predicate devices and demonstrates equivalence through mechanical testing and design/material similarity, rather than clinical performance studies (like those used for diagnostic AI or new drug approvals). The terms "acceptance criteria" and "study" in this context are interpreted differently than they would be for software-as-a-medical-device (SaMD) or AI medical devices.

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