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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; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, 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 Abbreviated Premarket Notification are the Journey II Knee system. This 510(k) was prepared in accordance with the Agency's, "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses," dated April 1993. The subject device is a cruciate retaining (CR) total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include the following components: Cruciate retaining femoral components which will initially be available in sizes 1-10 in right and left designs in OXINIUM material. Cruciate retaining femoral components which will initially be available in sizes 1-9 in right and left designs in cobalt chrome material Cruciate retaining 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 CR articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene or UHMWPE. The Journey II CR Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515), Journey II Deep Dished articular insert components (K113482), and existing patellar components of the Genesis II Knee System (K951987)

The provided text describes a 510(k) premarket notification for the "Journey II CR Knee System." The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than conducting a de novo study against explicit acceptance criteria for device performance. Therefore, the information requested regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment, as typically found in studies for novel algorithms or AI devices, is not applicable in this context.

Here's an analysis based on the provided document:

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

• Not Applicable. This submission is based on demonstrating substantial equivalence to predicate devices, not on meeting specific, predefined performance acceptance criteria for a novel device. The "performance" assessment here is a comparison of design and mechanical characteristics to existing products.

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

• Not Applicable. No human or animal test sets are mentioned. The "testing" referred to is mechanical testing of the device components.

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)

• Not Applicable. No test set with ground truth established by experts is mentioned.

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

• Not Applicable. No test set requiring expert adjudication for ground truth is mentioned.

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

• Not Applicable. This is a mechanical device submission, not an AI/software device. No MRMC study was conducted.

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

• Not Applicable. This is a mechanical device submission, not an AI/software device.

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

• Not Applicable. For a mechanical device submission demonstrating substantial equivalence, the "ground truth" is typically the established performance and safety profiles of the predicate devices and the results of various mechanical tests performed on the new device (e.g., patellofemoral contact area, tibiofemoral constraint). The document states: "A review of the mechanical data indicates that the Journey II CR Knee System is capable of withstanding expected in vivo loading without failure."

8. The sample size for the training set

• Not Applicable. This is a mechanical device submission, not a machine learning or AI device.

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

• Not Applicable. This is a mechanical device submission, not a machine learning or AI device.

Summary of the Study and "Acceptance Criteria" (in the context of a 510(k) for a mechanical device):

The "study" conducted for the Journey II CR Knee System was primarily a mechanical testing and comparison study to demonstrate substantial equivalence to previously cleared predicate devices. The "acceptance criteria" are implied by the regulatory requirements for substantial equivalence, meaning the device must be as safe and effective as a legally marketed predicate device.

Device Performance Measures (Mechanical Testing):

The document explicitly states that the following mechanical testing was performed to demonstrate the device's capability of withstanding expected in vivo loading:

• Patellofemoral Contact Area Analysis
• Tibiofemoral Contact Area Analysis
• Patellofemoral Resistance to Lateral Subluxation
• Tibiofemoral Constraint Testing

The report concludes: "A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

Table of "Acceptance Criteria" (Substantial Equivalence Aspects) and Reported Device "Performance" (Comparison):

Missing Information & Key Points:

• No specific numerical acceptance criteria for the mechanical tests are provided in the document. The conclusion is a qualitative statement of "no new issues." This is typical for a 510(k) where the primary goal is to show similarity to an already cleared device, implying that if the new device performs within the established range of the predicate, it is deemed acceptable.
• No clinical data was required or presented to support the safety and effectiveness, as explicitly stated in the document ("Clinical data was not needed to support the safely and effectiveness of the subject devices"). This reinforces that the submission relies on substantial equivalence through material and design similarity, and mechanical testing.

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