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The REDAPT Sleeved Monolithic Revision Stems 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 (NID) ) 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™ Revision Hip System (formerly MDF) is intended to be used without cement.

Subject of this Abbreviated premarket notification is the addition of a new stem design to the Smith & Nephew REDAPT Revision Femoral System which are Femoral Components part of Smith & Nephew's Total Hip System. The REDAPT Revision Femoral System currently consists of the Modular Proximally Fluted Hip Stems cleared by K113789, the Modular Sleeved Revision Hip Stems cleared by K121627, and the Monolithic Sleeveless Hip Stems cleared on K151902. The proposed devices are the REDAPT Sleeved Monolithic Revision Stems, new hip stems that will be marketed as part of the REDAPT Revision Femoral System.

The provided text is a 510(k) premarket notification for a medical device (REDAPT Sleeved Monolithic Revision Stems). It describes the device, its intended use, and its technological characteristics. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered diagnostic device, which your request implies.

The document focuses on the mechanical and material performance of a hip implant device, comparing it to predicate devices to establish substantial equivalence. It explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This means there was no multi-reader multi-case (MRMC) study, no standalone algorithm performance, and no ground truth established by expert consensus or pathology data in the way you're asking for an AI/diagnostic device.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria and performance studies for an AI/diagnostic device based solely on the provided text. The information you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size of AI assistance) is characteristic of AI/CAD (Computer-Aided Detection/Diagnosis) device submissions, not mechanical implants like the one described.

If you have a document related to an AI/diagnostic device, please provide that, and I would be happy to analyze it according to your requested criteria.

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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 (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.

Smith & Nephew REDAPT™ Revision Hip System components are intended for single use only and are to be implanted without bone cement.

Subject of this Abbreviated premarket notification is the addition of a new stem design to the Smith & Nephew REDAPT™ Revision Femoral System. The REDAPT Revision Femoral System currently consists of the Modular Proximally Fluted Hip Stems cleared by K113789 and the Modular Sleeved Revision Hip Stems cleared by K121627. The proposed devices are REDAPT Sleeveless Monolithic Revision Stems, new hip stems that will be marketed as part of the REDAPT Revision Femoral System.

The REDAPT Sleeveless Monolithic Revision Stems are a modification of the primary predicate REDAPT Modular Proximally Fluted Hip Stem and reference predicate REDAPT Modular Sleeved Revision Hip Stem. The Sleeveless Monolithic Revision Stem is very similar to the predicate REDAPT hip stems in that it is a tapered, distally fixed femoral stem that is manufactured from forged titanium allov (Ti-6Al-4V) and has a grit blast finish. The subject device will be available in lengths of 190mm, 240mm, and 300mm and sizes 12-27, in 1mm increments. The REDAPT Sleeveless Monolithic Hip Stems will feature a non-modular, fixed neck with a 12/14 taper.

This document is a 510(k) premarket notification for a medical device, the Smith & Nephew REDAPT™ Revision Femoral System. Such notifications typically aim to demonstrate substantial equivalence to previously cleared devices rather than prove performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria and clinical study details is not present in this type of regulatory submission.

However, based on the provided text, I can infer and state the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific acceptance criteria (e.g., specific thresholds for wear, fatigue life, or other mechanical properties) for the REDAPT™ Sleeveless Monolithic Revision Stems, nor does it typically report detailed device performance metrics against such criteria in this format. Instead, it refers to performance testing conducted in accordance with guidance documents.

The document indicates that the device has undergone performance testing. The "reported device performance" in this context is that the device met the requirements of the referenced tests, thereby demonstrating substantial equivalence.

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

The document does not detail the sample sizes used for performance testing (e.g., the number of stems tested for fatigue strength). These are typically bench tests rather than clinical studies.

The "data provenance" mentioned refers to non-clinical, mechanical, and material testing data, not human patient data. Therefore, concepts like country of origin of data (for patients) or retrospective/prospective do not apply here.

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

Not applicable. The "ground truth" for mechanical testing is established by engineering standards, test methods, and material properties, not by expert medical consensus, as no human data is involved in this document.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretation of medical images or patient outcomes. This document discusses bench testing of a medical implant.

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

No. This document describes the premarket notification for a
hip prosthetic stem, which involves mechanical and material testing, not an MRMC study comparing human reader performance with and without AI assistance for interpretation.

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

No. This document pertains to a physical medical device (hip implant), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing of the REDAPT™ Revision Femoral System components would be engineering specifications, material standards, and benchmark performance of predicate devices under the conditions outlined in the referenced guidance documents and test methods (e.g., specific load cycles for fatigue testing, displacement limits for range of motion).

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a physical hip implant. Training sets are relevant for machine learning algorithms.

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

Not applicable, as there is no training set for this device.

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