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510(k) Data Aggregation
(90 days)
The Klassic 110 BiPolar System is intended for use in combination with a Total Joint Orthopedics Femoral Stem for primary or revision hemiarthroplasty of the hip, without the use of bone cement, for treatment of the following conditions:
- o Femoral neck and trochanteric fractures of the proximal femur
- Osteonecrosis of the femoral head
- Revision procedures where other devices or treatments for these indications have failed.
The Klassic™ BiPolar System includes the Klassic™ BiPolar System BiPolar Head, Klassic 110 BiPolar System Femoral Head (12-14 Taper), 22mm, and Klassic 100 BiPolar System Femoral Head(12-14 Taper), 28mm implant components ("Klassic"") BiPolar System Implants").
The Klassic"10 BiPolar System BiPolar Head includes a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner, cobalt chrome outer shell, and a UHMWPE retention ring with a Ti6A14V spring. The Bipolar Head includes an outer diameter range from 38 to 43 mm with an inner diameter which mates with the 22 mm femoral head, and an outer diameter range from 44 to 60 mm with an inner diameter which mates with the 28mm femoral head. The Bipolar Heads are offered in 1 mm outer diameter size increments.
The Klassic™ BiPolar System Femoral Heads include a 12/14 Taper for interfacing with TJO's Klassic HD10 Femoral Stems (K100445), and TJO's Klassic HD™ Offset Femoral Stems (K133832). These heads available with offsets of Neutral, +3.5mm and +7.0mm for the 22mm Femoral Head, and -3.5, Neutral, +3.5mm and +7.0mm for the 28mm Femoral Head.
This document does not describe a study involving an algorithm or AI. It is a 510(k) premarket notification for a medical device called the "Klassic™ BiPolar System," a hip joint femoral prosthesis. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and non-clinical testing.
Therefore, I cannot provide the requested information about acceptance criteria for an algorithm, study design for AI performance, sample sizes for AI development/testing, expert adjudication, MRMC studies, or standalone algorithm performance.
The document does mention "Non Clinical Testing, including fatigue, disassembly and range of motion," which was completed to demonstrate that the Klassic™ BiPolar System did not create a new worst case. However, this refers to mechanical device testing, not AI performance.
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(219 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable (No explicit performance criteria or metrics are defined for these accessory instruments in the context of a clinical study within this document. The focus is on substantial equivalence to predicate devices based on design and function.) | Not applicable (No specific device performance metrics are reported in this document.) |
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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