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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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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 Femoral System components are intended for single use only and are to be implanted without bone cement.

The Redapt Revision Femoral System is comprised of a stem, modular neck, and modular sleeve component. The components of the revision hip system modularly connect together to form the complete Redapt Revision Femoral System construct. Subject of this Abbreviated premarket notification are the Redapt Modular Sleeved Revision Hip Stems and size 26/27 Modular Sleeves. The Modular Sleeved Revision Hip Stem is a modification of the MDF Revision Hip Stem cleared via premarket notification K081124. The Modular Sleeved Revision Hip Stem is a straight, tapered, distally fixed, modular stem. The subiect device is manufactured from titanium alloy (Ti-6Al-4V), has a grit-blast finish, and is available in lengths of 240mm and 300mm in sizes 11-27. The Modular Sleeved Revision Hip Stems has a modular 12/14 female neck taper that mates with the cobalt chrome modular necks previously cleared in premarket notification K0811124.

The size 26/27 Modular Sleeves are line additions to the Modular Sleeves cleared in K081124. The subject devices lock onto the proximal end of the stem to aid in proximal fixation. The size 26/27 Redapt Modular Sleeves are identical in design to the current modular sleeves cleared by K081124 and are also offered in the same small, medium, and large cone sizes. The subject devices are proportionally larger to accommodate the size 26/27 stems. The subject devices contain the Smith & Nephew Stiktite coating. A Hydroxyapatite (HA) coating will be applied to the Stiktite coated areas of the size 26/27 Redapt Modular Sleeves.

This submission describes a medical device, the Smith & Nephew Redapt® Revision Femoral System, and its substantial equivalence to a previously cleared predicate device (K081124). As such, it does not describe an AI/ML device or a study involving human readers. Therefore, several requested sections are not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical "acceptance criteria" for performance in the typical sense of an AI/ML device. Instead, it relies on demonstrating substantial equivalence to a predicate device and meeting performance testing standards for orthopedic implants. The "reported device performance" is essentially the successful completion of these tests.

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

This is a materials science and mechanical engineering performance study of physical orthopedic implants, not a study involving a "test set" of data in the AI/ML sense. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable. The testing would have involved a specific number of manufactured components designed for mechanical and material property evaluation.

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

Not applicable. Ground truth for an AI/ML system is irrelevant for this type of medical device submission, which focuses on the physical properties and safety of an implant. The "ground truth" here is established by engineering standards and validated testing protocols.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of an AI/ML model being evaluated by experts.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic assist AI/ML devices, not for physical orthopedic implants.

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

Not applicable, as this is not an algorithm or AI/ML device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is established through objective engineering standards, validated testing methodologies, and material specifications (e.g., ASTM standards for materials and testing). It's based on physical measurements and performance under controlled conditions, not on clinical expert consensus, pathology, or outcomes data in the sense of an AI diagnosis. The document states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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