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Smith & Nephew Hip Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems and their cleared Indications for Use.

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Hip System Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems and their cleared Indications for Use. Smith & Nephew Hip System Instruments can be organized into instrument families which are categorized as follows: Trials, Reamers, Handles, Impactors, Broaches, Guides, Cutter, Inserter/Extractor, Tightening, and Drills.

The provided document is a 510(k) Premarket Notification for Hip System Instruments from Smith & Nephew, Inc. This document focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a clinical study with specific acceptance criteria and performance metrics for a new device's efficacy or safety.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in this document.

The core of this submission is to demonstrate that the Hip System Instruments (which are surgical tools, not implants) are similar enough in their materials, manufacturing processes, sterilization, and body contact to already cleared predicate instruments, thus not requiring a new detailed clinical performance study.

Here's what can be extracted based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable. This document does not describe a clinical performance study with a test set of data. The "test" for these instruments is demonstrating similarity to predicate devices via design rationale and manufacturing details.
• Data Provenance: Not applicable. There is no mention of clinical data (retrospective or prospective) or country of origin for such data.

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

• Number of Experts: Not applicable. Ground truth establishment for a clinical study is not described.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance

• MRMC Study: No. This document is for surgical instruments, not an AI-assisted device.
• Effect Size: Not applicable.

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

• Standalone Performance: No. This document is for surgical instruments, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No clinical ground truth is established or discussed for these surgical instruments.

8. The Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This document does not describe a machine learning algorithm or a training set.

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

• Ground Truth Establishment (Training Set): Not applicable.

Explanation for Lack of Data:

This 510(k) submission for "Hip System Instruments" is for accessory devices (surgical tools) used to implant Smith & Nephew Hip Systems. The primary regulatory pathway for such devices, when they are similar to already marketed devices, is to demonstrate substantial equivalence.

The key arguments for substantial equivalence are provided in the section titled "Substantial Equivalence Information":

• Shared Raw Materials: The instruments use the same raw materials as predicate devices.
• Same Manufacturing Processes: The instruments are manufactured using the same processes as predicate devices.
• Same Sterilization Procedures: The instruments utilize the same sterilization procedures as predicate devices.
• Similar Nature of Body Contact: The instruments have similar body contact characteristics to predicate devices.
• Similar Design and Function: The instruments are similar in design and function to competing total hip surgical instrumentation already on the market.

Conclusion:

This document is a regulatory submission for surgical instruments based on substantial equivalence, not a clinical study involving performance metrics, acceptance criteria, or AI components. Therefore, the detailed information requested about acceptance criteria and study particulars for a clinical evaluation is not present in this text.

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The Delta Hip Prosthesis is designed for press-fit fixation into the human femur as a component in either total hip or hemi-hip replacement and is indicated for the following:

Total Hip Replacement

Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and acute femoral neck fractures.

Hemi-Hip Replacement

Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

The Delta Hip Prosthesis is a collarless, modular femoral stem manufactured from either Tivanium or Ti-6A1-7Nb alloy both of which are high-fatigue strength materials with a history of successful clinical use and exceptional biocompatibility. Delta Hip stem sizes 9 through 15, 17 and 19 will be available in either material.

The Delta Hip Prosthesis is designed for primary hip replacement in patients with a champagne flute type femur. The trapezoidal geometry provides for maximum metaphyseal fill of the proximal femur and apposition to cortical bone. Rotational stability is enhanced by the wedge fit of the stem in the proximal femur.

The modular connection of the femoral stem is a Morse-type 12/14 neck taper designed to mate with the corresponding 12/14 bore of a femoral head component.

The provided text is a "Summary of Safety and Effectiveness" for the Delta Hip Prosthesis, a medical device submission to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/software-as-a-medical-device (SaMD) submission.

Instead, this document describes a traditional medical device (a hip prosthesis) and focuses on demonstrating its substantial equivalence to previously cleared predicate devices. The "studies" mentioned are literature reports of successful clinical use of similar devices, not a specific performance study for the Delta Hip Prosthesis with defined acceptance criteria.

Thus, I cannot fulfill the request as the information is not present in the provided text. The document is for a hardware medical device from 1996, and the questions posed are geared towards software/AI-based medical devices or clinical trials with specific endpoints, which are not applicable here.

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