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Total knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicoment, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Smith & Nephew Journey II Mid-Level Tibial Inserts consist of Journey II Articular Stabilized XLPE Articular Inserts Size 1-8 Right and Left (9mm-21mm) and Journey II Medial Dished XLPE Articular Inserts Size 1-8 Right and Left (9-18mm).

The provided text describes a 510(k) premarket notification for a medical device called "Journey II Mid-Level Tibial Inserts." This submission aims to demonstrate that the new device is substantially equivalent to previously cleared predicate devices. Since this is a submission for substantial equivalence based on similar design, material, and performance characteristics compared to existing devices, it primarily relies on preclinical testing rather than clinical studies involving human patients, multi-reader multi-case (MRMC) comparative effectiveness studies, or extensive standalone algorithm performance evaluations.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the overall device in terms of specific performance metrics with numerical thresholds. Instead, the "acceptance criteria" are implied by demonstrating that the new device's performance in various preclinical tests is comparable to or within acceptable limits relative to existing predicate devices. The "reported device performance" is the outcome of these preclinical tests, showing that the subject device performs similarly to the predicates.

• OR-21-060: Journey II BCS femoral component with Journey II AS Inserts compared to Journey II BCS inserts.
• OR-21-061: Journey II CR femoral component with Journey II Medial Dished (MD) Inserts compared to Journey II CR Standard and Deep Dish Inserts. Implicitly, contact area characteristics were found to be comparable. |
  | Tibiofemoral Constraint (A/P Draw, M/L Constraint, Rotary Laxity): Constraint characteristics are comparable to predicate devices. | Tibiofemoral Constraint Testing (OR-21-062): Evaluated A/P draw, medial/lateral (M/L) constraint, and rotary laxity (R/L) torsional constraint of flexion. Implicitly, the Journey II MD insert was found comparable to the Journey II CR insert and the Journey II Deep Dished insert. |

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

The studies described are preclinical tests, meaning they are conducted in a laboratory setting using physical devices, not human patients. Therefore, terms like "test set" in the context of human data, "country of origin," and "retrospective or prospective" do not directly apply here. The "sample size" would refer to the number of device samples tested for each study. While the specific number of units tested per study (e.g., how many AS Inserts were tested for fatigue) is not explicitly provided in this summary, the studies were conducted by Smith & Nephew, Inc. in the US, as indicated by the submission information.

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

This information is not applicable as the studies are preclinical, bench-top tests, not clinical evaluations requiring expert consensus for ground truth. The "ground truth" in these studies is derived from physical measurements and accepted engineering standards (e.g., ASTM F1223-20).

4. Adjudication Method for the Test Set:

This is not applicable as the studies are preclinical tests, not clinical evaluations that typically involve adjudication of human reader findings.

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 AI-powered diagnostic devices involving human interpretation of medical images. The device in question is a knee implant component, and the evaluations are preclinical performance tests.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical knee implant component, not an algorithm. The "standalone" performance here refers to the physical properties and mechanical performance of the implant itself, which is what the preclinical tests evaluated.

7. The Type of Ground Truth Used:

The ground truth used for these preclinical tests is based on engineering measurements, physical properties, and established industry standards (e.g., ASTM F1223-20 for tibiofemoral constraint testing). The performance of the subject device is compared to these standards or to the known performance of predicate devices.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical medical implant, not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

This is not applicable for the same reason as point 8.

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Total Knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartment, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Smith & Nephew Legion Inserts with JRNY Lock are single use devices.

The subject of this Special 510(k) is the LEGION Inserts with JRNY Lock (LEGION Inserts). The subject LEGION Inserts are tibia insert components, and a line extension of the LEGION CR High Flex and Deep Dish inserts cleared under premarket notification K071071. The subject devices were modified by incorporating the identical JOURNEY II locking mechanism from the JOURNEY II CR and JOURNEY II BCS inserts, cleared under premarket notifications K121443 and K111711 respectively.

The subject LEGION Inserts have a size range of 1-2, 3-4, 5-6, 7-8mm with thicknesses of 9, 10, 11, 12, 13, 15, 18, 21mm, and come in cruciate-retaining high flexion (CR HF) and Deep Dish varieties. The LEGION Inserts are manufactured from 7.5MRad Cross-linked Polyethylene (XLPE) conforming to ASTM F648 and ISO 5834-2, as the predicate LEGION CR Inserts cleared under a premarket notification K071071.

This document describes a 510(k) premarket notification for LEGION Inserts with JRNY Lock, which are tibial insert components for total knee replacement. The submission argues for substantial equivalence to existing predicate devices based on technological characteristics and mechanical performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance testing section mentions the types of tests performed and concludes that the subject device is "substantially equivalent" to the predicate devices.

• Very similar in overall design. |
  | No new issues related to safety and effectiveness. | - No new issues related to the safety and effectiveness of the subject devices demonstrated by review of technological characteristics and testing. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "leveraged non-clinical bench (mechanical) testing." This indicates the use of physical samples or models for mechanical tests, not human data. The specific sample size for each test (e.g., number of inserts tested for range of motion) is not specified.
There is no information about the country of origin of the data as it's non-clinical bench testing, and it's not applicable to human data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study is non-clinical bench testing of a medical device (knee inserts) and does not involve establishing ground truth from expert readings of patient data. The "ground truth" for these tests would be the design specifications and performance characteristics of the predicate devices and relevant industry standards (ASTM, ISO).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the study is non-clinical bench testing. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of medical data to resolve discrepancies.

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 submission is for a knee implant component and relies on non-clinical mechanical testing and comparison to predicate devices, not AI assistance or human reader evaluations.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done. This is not an AI-enabled device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on:

• Established performance of predicate devices: The comparison standard for substantial equivalence.
• Industry Standards: ASTM F648 and ISO 5834-2 for material properties (XLPE), and FDA Guidance/ANSI/AAMI ST72 for bacterial endotoxin testing.
• Design Specifications: The documented design and intended function of both the subject device and the predicate devices.

8. The sample size for the training set

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

9. How the ground truth for the training set was established

Not applicable. (See point 8).

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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthrilis, or degenerative arthritis; failed osteotomies, unicompartment, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Journey II Total Knee system components are indicated for use only with cement and are single use devices.

Subject of this Traditional Premarket Notification are the Journey II Deep Dished articular inserts. The Journey II Deep Dished articular insert is a cruciate stabilizing tibial insert that is intended to be used with the Journey II BCS (K111711) and Journey BCS (K042515) knee systems when the posterior cruciate ligament (PCL) is sacrificed and an insert with a post is not a viable option for the patient. Components of this premarket notification include:

• Cruciate substituting (deep dished) articular inserts which will initially be available in sizes 1-2, . 3-4, 5-6, and 7-8 in right and left designs. Journey II Deep Dished inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene (7.5 Mrad XLPE) material and conventional non-cross-linked Ultra-High Molecular Weight Polyethylene (UHMWPE) material.
• . Cruciate substituting (deep dished) articular insert trial implants manufactured from Radel.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Journey II Deep Dished Articular Inserts:

Acceptance Criteria and Device Performance

The provided document describes the Journey II Deep Dished Articular Insert as a cruciate stabilizing tibial insert. The acceptance criteria are indirectly established through mechanical testing designed to demonstrate the device's capability to withstand "expected in vivo loading without failure."

Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria (e.g., minimum load capacity, specific contact area values, or constraint ranges). Instead, it refers to the performance by indicating that the device "is capable of" meeting the implicit criteria.

Study Details

The document refers to mechanical testing that was performed to support the substantial equivalence of the new device to previously cleared predicate devices.

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

The document does not provide specific sample sizes (number of inserts tested) for the mechanical tests.
The data provenance is not explicitly stated as originating from a specific country or being retrospective/prospective. However, as this is a 510(k) submission to the U.S. FDA, the testing was likely conducted in accordance with recognized U.S. or international standards for medical device testing.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the described studies are mechanical bench tests, not clinical studies involving human subject data or expert assessment for ground truth.

3. Adjudication Method for the Test Set

This information is not applicable for mechanical bench tests.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed, nor is it applicable. The submission focuses on the mechanical properties and substantial equivalence to predicate devices, not on the improvement of human reader performance with or without AI assistance.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not performed, nor is it applicable. The device is a physical knee implant component, not an algorithm or AI-powered system meant for diagnostic or assistive purposes.

6. Type of Ground Truth Used

The "ground truth" for the mechanical tests would be the physical measurements and observations derived directly from the laboratory testing (e.g., force-displacement curves, contact area measurements, failure modes). This is an objective, empirically derived ground truth based on engineering principles, not expert consensus, pathology, or outcomes data in a clinical sense.

7. Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.

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

This information is not applicable as no training set was used.

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