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The REDAPT Modular Acetabular Shells 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 Modular Acetabular Shell is for single use only and is intended for cementless use.

The subject of this Traditional 510(k) is the REDAPT Modular Acetabular Shells. The REDAPT Modular Acetabular Shells are a line extension to the REDAPT Porous Acetabular Shells to allow the un-cemented use of R3 Poly liners. The REDAPT Porous Acetabular Shells were previously cleared for market via premarket notification K150790.

The REDAPT Modular Acetabular Shells are available in same size range as REDAPT Porous Acetabular Shells from 48 mm to 80 mm. The REDAPT Modular Acetabular Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and has identical porous structure as the predicate REDAPT Porous Acetabular Shell. The inner surface of the subject REDAPT Modular Acetabular shell is modified by a machining process to have an identical inner geometry and locking mechanism as the R3 Multi-hole shells to allow the uncemented use of R3 poly liners that are cleared to use with R3 Multi-hole Shell. The R3 Multi-hole Shells are most recently cleared under premarket notification K092386.The R3 XLPE liners were cleared under 510(k) K070756 and K113848 and the R3 Constrained Liners were cleared under K111635, K122139 and K162641.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the REDAPT Modular Acetabular Shell.

It's important to note that this document is a Traditional 510(k) submission, which aims to demonstrate substantial equivalence to predicate devices, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" are interpreted within the context of showing equivalence to existing, cleared devices.

Summary of Acceptance Criteria and Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document describes non-clinical bench (mechanical) testing and Finite Element Analysis (FEA). It does not specify sample sizes (e.g., number of shells tested) for each individual mechanical test. For FEA, it's a computational model, so a "sample size" in the traditional sense doesn't apply.
   • Data provenance: Bench testing results are typically generated in a controlled laboratory environment. The document does not specify the country of origin of the data
   • Retrospective or Prospective: These are laboratory-based mechanical tests, not clinical studies, so the terms "retrospective" or "prospective" are not applicable.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This submission relies on bench testing and comparison to predicate devices. It does not involve establishing a "ground truth" based on expert consensus for clinical interpretation or diagnosis. The "ground truth" for these tests are objective measurements against established engineering standards or comparisons to the performance of predicate devices.
   • The "experts" involved would be engineers, material scientists, and quality assurance personnel responsible for conducting and interpreting the mechanical tests. Their specific numbers and qualifications are not detailed in this summary, but would be expected to be highly experienced in medical device testing.

3. Adjudication method for the test set:

   • Not applicable. This is not a study requiring adjudication of expert opinions (like 2+1 or 3+1 consensus). The "adjudication" is based on whether the devices meet pre-defined engineering specifications or perform comparably to predicate devices in controlled bench tests.

4. 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, an MRMC comparative effectiveness study was not done. This is a mechanical device, not an AI or imaging diagnostic tool. Therefore, human reader performance or AI assistance effects are irrelevant here.

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

   • Not applicable as this is a mechanical medical device, not an algorithm or AI system.

6. The type of ground truth used:

   • The "ground truth" can be considered as:
     • Objective engineering standards and specifications: For mechanical tests like fatigue, dissociation, and biocompatibility, there are defined standards and acceptable limits.
     • Predicate device performance: The ultimate "ground truth" for this 510(k) is the demonstrated safe and effective performance of its predicate devices, K150790, K092386, and K920430, which the new device aims to be substantially equivalent to.
     • Laboratory measurements: Empirical data derived from the bench testing.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of mechanical bench testing for a physical medical device. Training sets are relevant for machine learning algorithms.

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

   • Not applicable (see point 7).

In conclusion, the study supporting the REDAPT Modular Acetabular Shell primarily consists of non-clinical bench (mechanical) testing and analysis (including Finite Element Analysis) to demonstrate substantial equivalence to existing, legally marketed predicate devices. The "acceptance criteria" are met if the device performs comparably to or within the established safety and performance envelopes of the predicate devices and relevant engineering standards.

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· 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 (NIDID) 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, atthritis 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 Cemented Liner is intended for single use only and is to be implanted with bone cement.

The REDAPT Anteverted 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the REDAPT Anteverted Cemented Liner, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining explicit, quantitative acceptance criteria for novel performance. However, it does mention various mechanical tests and their successful completion, which imply meeting internal or industry-standard acceptance criteria.

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

The document does not explicitly state the sample sizes for the mechanical tests. For medical devices like hip liners, samples often refer to the number of devices tested. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are in vitro mechanical tests.

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

Not applicable. This device is a mechanical implant, and the "ground truth" for its performance is established through objective engineering standards and mechanical testing, not expert clinical consensus or interpretation of images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication is typically relevant for studies involving human interpretation or clinical endpoints. Mechanical tests have pass/fail criteria based on engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a hip implant, not an AI diagnostic device. An MRMC study is not relevant here.

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

Not applicable. This is a medical device, not an algorithm. Its performance is assessed through its physical properties and mechanical behavior.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established through established engineering principles, material specifications (e.g., ASTM F648 for highly cross-linked polyethylene), and industry-standard mechanical testing protocols. These tests simulate in vivo conditions to assess properties like fatigue, push-out strength, lever-out resistance, torque-to-failure, range of motion, impingement, and wear. The success criteria are typically defined by these standards or comparative data from predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable, as there is no training set for a physical medical 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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