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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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Physica total knee system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• · Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
• · Inflammatory degenerative joint disease including rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and
• · Treatment of fractures that are unmanageable using other techniques.

Physica knee system is intended for cemented fixation.

The Physica KR Knee Replacement System is a total knee replacement system consisting of femoral, tibial plate, tibial liner, patella, and tibial stem components; the tibial stem and patella components are optional to be used as required for each individual patient. The Physica KR knee system devices are intended to be used with bone cement.

The femoral components are made of CoCrMo alloy according to the requirements of ISO 5832-4 and ASTM F75. The articulating surface is polished and has asymmetric condyles along the sagittal plane. Conformity between the inner surface of the components and the resected bone of the distal femur and two fixation pegs provide stability. Ten (10) sizes in left and right versions are available. The tibial plates are made of Ti6Al4V alloy meeting the specifications of ISO 5832-3 and ASTM F1472. The inferior aspect of the component has a keel and an optional modular tibial stem, manufactured from Ti6Al4V alloy, provide stability. A plug manufactured from standard UHMWPE (ISO 5834-2 / ASTM F648) is used to fill the female taper hole used to attach the optional stem; the plug is removed if a stem is used. The superior portion of the tibial plate is designed to lock the tibial liner through a snap-fit mechanism; the superior surface of the plate is polished to reduce back-side wear of the liner. Ten sizes of symmetric tibial plates are available.

Liners are made of standard UHMWPE (ISO 5834-2 / ASTM F648). They are characterized by a concave medial hemi-plateau along the sagittal plane while the lateral plateau is slightly convex. The articulating hemi-plateaus are both concave along the frontal plane. The liner is attached to the tibial plate through a snap-fit mechanism The anterior aspect of the liner is shaped to accommodate the patellar tendon during flexionextension movements of the knee. Ten (10) sizes, correspondently to the tibial plate sizes, in six (6) thicknesses, are available in versions for left and right knees.

Tibial stems, in three (3) lengths (20, 40, and 60mm), are made of Ti6Al4V alloy (ISO 5832-3 / ASTM F1472). They stems are 15.5mm in diameter and cylindrical in shape with longitudinal grooves intended to increase the torsional stability of the device and to facilitate the distribution of the bone cement on the device during its insertion. Three lengths are available.

The all-polyethylene patella components, in six (6) diameters (26, 29, 32, 35, 38, and 41mm), are made of standard UHMWPE (ISO 5834-2 / ASTM F648). The components have a biconvex surface to articulate with the trochlear groove of the femoral component. The inferior surface has three (3) pins / pegs and a cement pocket to aid in fixation.

This is a 510(k) premarket notification for the Physica KR knee system, a Class II medical device. The document states that clinical testing was not necessary to demonstrate substantial equivalence to predicate devices, meaning that no human clinical trials were conducted to establish efficacy or safety for this specific submission. The information provided focuses on non-clinical (mechanical) testing only.

Therefore, many of the requested categories related to clinical study design, acceptance criteria based on human performance, expert ground truth, and patient data provenance cannot be extracted from this document as no such studies were performed for this submission.

Here is the information from the document regarding the non-clinical testing:

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

The document does not explicitly state numerical acceptance criteria. Instead, it indicates that "The testing results demonstrated the device's ability to perform under expected clinical conditions." For a 510(k) submission based on substantial equivalence, the performance is generally benchmarked against the predicate devices.

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 "Mechanical testing was performed on worst case components or constructs." However, it does not specify the exact sample sizes (number of components or constructs) for each test. Data provenance is not applicable as this concerns mechanical bench testing, not human patient data.

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. This was mechanical bench testing, not a study requiring expert clinical assessment or ground truth establishment.

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

Not applicable. This was mechanical bench testing.

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. No clinical studies were conducted, and this is a physical medical device, not an AI/software product.

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

Not applicable. This is a physical medical device.

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

For mechanical testing, the "ground truth" would be established engineering standards, material properties, and expected biomechanical performance metrics (e.g., fatigue limits, wear rates, force limits) derived from predicate devices or established biomechanical principles. The document states the tests "demonstrated the device's ability to perform under expected clinical conditions," implying these standards were met.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm requiring a training set.

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

Not applicable. This is a physical medical device.

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