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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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