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510(k) Data Aggregation
(126 days)
Journey II XR Knee Instrument
Journey II XR Instruments are accessory devices and intended to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared indication for use.
Total knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II XR Knee system components are indicated for use only with cement and are single use devices.
The subject of this Traditional 510(k) is a design modification (i.e. tip geometry) to the Journey II XR Tibial Posterior Keel Punch. The Journey II XR Tibial Posterior Keel Punch are reusable instrument and are intended to be used to prepare for the posterior keel of the tibia baseplate implant and act as a guide for the Anterior Keel Punch. The Journey II XR Keel Punch were previously cleared for market notification K173331.
The Journey II XR Keel Punch are available in same size range as the predicate.
The provided text describes a 510(k) premarket notification for a design modification to the Journey II XR Knee Instrument, specifically the Tibial Posterior Keel Punch. This document does not describe a study involving AI or human readers. Instead, it outlines a traditional medical device clearance process focused on demonstrating substantial equivalence to a predicate device through non-clinical bench testing.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set information) are not applicable or cannot be extracted from this document, as they pertain to clinical or AI-based performance studies, which were not conducted or described here.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated by) |
|---|---|
| Device performs as intended (mechanical integrity and function). | Finite Element Analysis (FEA) |
| No new issues related to safety and effectiveness compared to predicate. | Stress Distribution Test |
| Substantially equivalent to predicate device in design, material, and performance. | Review of mechanical data and technical memo indicated substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document refers to "non-clinical bench (mechanical) testing" and "review of the mechanical data," but does not provide specific sample sizes for these tests (e.g., number of punches tested).
- Data Provenance: Not specified, but implied to be from internal lab testing ("bench testing") conducted by Smith & Nephew, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood for clinical performance or AI evaluation (e.g., expert consensus on medical images) is not relevant for this type of mechanical device testing. The "ground truth" here is adherence to mechanical engineering principles and performance specifications.
4. Adjudication method for the test set
Not applicable. No clinical adjudication method was used. The evaluation centered on engineering analysis and test results.
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, as this document describes the clearance of a mechanical surgical instrument, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This document does not describe a standalone algorithm or AI performance study.
7. The type of ground truth used
For mechanical device testing, the "ground truth" is typically defined by engineering specifications, design requirements, and a comparison to the established performance of the predicate device, as demonstrated through the specified testing (Finite Element Analysis, Stress Distribution Test).
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for a training set.
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(24 days)
JOURNEY II XR Knee Instruments
Smith & Nephew Journey II XR Instruments are accessory devices intended to be used to assist in the implantation of Smith & Nephew Journey II XR Knee System and their cleared Indications for Use.
Total knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement.
The Journey II XR Knee system components are indicated for use only with cement and are single use devices.
Subject of this Special Premarket Notification are modified Journey II XR Instruments. The subject devices are modifications of existing instrumentation cleared for use with the Journey II XR Knee system.
The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This document is a 510(k) premarket notification clearance letter from the FDA for the JOURNEY II XR Knee Instruments.
It primarily states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use, design features, and operational principles, and therefore does not require clinical data to support its safety and effectiveness.
Here's what the document does state regarding performance and testing:
- Biocompatibility assessments were conducted per ISO 10993-1 and FDA guidance (June 16, 2016).
- Testing was performed to evaluate impact resistance of the proposed tibial impactor design compared to a previously tested current design.
- Testing was performed to evaluate the performance of modified keel prep instruments as compared to predicate keel prep instruments.
The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices." This implies that no studies involving human subjects or extensive clinical trials with specific acceptance criteria as you've outlined were conducted or required for this particular submission.
Therefore, for your requested information points, most would be "N/A" or "Not provided in this document" as a standalone study with acceptance criteria and results as typically described for efficacy or performance claims was not part of this 510(k) clearance process.
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