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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 primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact

The Smith & Nephew Cemented Tibia Baseplate no Taper with JRNY Lock are indicated for use with cement only and are single use devices.

The subject devices of this Special 510(k) are the Cemented Tibia Baseplate no Taper with JRNY Lock. The subject Cemented Tibia Baseplate no Taper with JRNY Lock are tibia baseplate components, and a line extension of the ANTHEM Tibia Baseplate cleared under premarket notification K142807 (S.E. 12/22/2014). The subject devices were modified by incorporating the identical JOURNEY II locking mechanism for the JOURNEY II BCS Knee System, cleared under premarket notifications K111711 (S.E. 09/16/2011).

The subject Cemented Tibia Baseplate no Taper with JRNY Lock is designed to be implanted with the use of bone cement and is made of Ti-6Al-4V. The proximal face of the implant includes locking mechanism, dimensions, and size options identical to Smith & Nephew's JOURNEY Nonporous Tibia Baseplate, originally cleared under premarket notification K042515 (S.E. 03/14/2005) and updated under the JOURNEY II BCS Knee System premarket notifications K111711 (S.E. 09/16/2011) respectively. The distal side of the implant has a central stem and two large posterior-directed fins. The subject device includes the same stem length for all sizes, though the fin sizes vary between baseplate sizes. The distal side of the implant has an identical design to Smith & Nephew's ANTHEM Tibia Baseplate, cleared under premarket notification K142807 (S.E. 12/22/2014). The subject Cemented Tibia Baseplate no Taper with JRNY Lock includes multiple sizes in both left and right versions.

The subject inserts of the system, compatible with the subject Cemented Tibia Baseplate no Taper with JRNY Lock, have been previously cleared via premarket notification K220896 (S.E. 04/26/2022) to include the JOURNEY II Locking Mechanism. The articulating surface of the subject inserts have remained identical to the primary predicate system, ANTHEM PS Total Knee System cleared via premarket notification K142807 (S.E. 12/22/2014). Therefore, the existing femoral components cleared for the system via premarket notification K142807 (S.E. 12/22/2014) continue to be compatible and remain unchanged.

This document is a 510(k) summary for a medical device (Cemented Tibia Baseplate no Taper with JRNY Lock), seeking substantial equivalence to predicate devices, not a study performing extensive clinical testing with detailed acceptance criteria and performance data as would be provided for a new, novel AI/ML device. Therefore, much of the requested information regarding acceptance criteria, study design (sample size, experts, ground truth, MRMC), and training sets for AI models is not applicable to this type of submission.

This submission primarily relies on mechanical performance data and comparisons to existing, cleared predicate devices. The conclusion explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."

However, I can extract the relevant information where available and explain why other sections are not applicable.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance (Not Applicable in the context of an AI/ML device)

This document is for a medical device (a knee implant component), not an AI/ML device. Therefore, the concept of "acceptance criteria" and "device performance" as it pertains to statistical measures like sensitivity, specificity, accuracy, or reader improvement, does not apply in the same way.

The "acceptance criteria" here are based on the substantial equivalence to predicate devices through design similarity, material composition, and demonstration of equivalent mechanical performance (via leveraged data).

The "reported device performance" is essentially the successful demonstration that its mechanical performance (specifically the locking mechanism) is equivalent to or better than previously cleared devices and that it meets endotoxin limits.

Table of Acceptance Criteria and Reported Device Performance (as applicable to a physical device):

Study Details (Not Applicable for most AI/ML questions)

2. Sample size used for the test set and the data provenance:

• Not applicable for clinical data. The submission states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."
• For mechanical testing, the "sample size" would refer to the number of physical devices or components tested. This specific number is not provided, but the statement "A review of the leveraged mechanical data" implies that existing or previously generated test data from the predicate devices (K111711) was utilized. The provenance would be from laboratory mechanical testing of these devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This submission does not involve human expert interpretation of data to establish ground truth in the way an AI/ML device would (e.g., radiologists reviewing images). The ground truth for mechanical testing is established by engineering standards and measurements.

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

• Not applicable. No human adjudication process as implied by this question. Mechanical testing results are objectively measured.

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 physical medical device, not an AI-assisted diagnostic tool.

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):

• Mechanical ground truth: Established through engineering specifications, validated test methods (e.g., force, displacement measurements), and compliance with relevant standards (e.g., ISO, ASTM for medical device mechanical testing).
• Biocompatibility ground truth: Established through laboratory testing for endotoxin levels compared to pre-defined acceptable limits in regulatory guidance (FDA Guidance, ANSI/AAMI ST72).

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this physical medical device submission.

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

• Not applicable.

In summary: This 510(k) submission for a knee implant component primarily leverages existing data from predicate devices and mechanical testing to demonstrate substantial equivalence, rather than conducting a clinical study with human readers/interpreters or training an AI/ML model. Therefore, many of the questions asked, which are highly pertinent to AI/ML device submissions, are not applicable here.

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Total Knee components are indicated for rheumatic arthritis, osteoarthritis, osteoarthritis, or degenerative arthrius; 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 cruciate ligaments are incompetent and the collateral ligaments remain intact. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.

The Smith & Nephew, Inc. Cemented Round Patellae with JRNY Pegs are indicated for use with cement and are single use devices.

The subject of this Special 510(k) is the Cemented Round Patellae with JRNY Pegs. The subject Cemented Round Patella with JRNY Pegs are patella components, and a line extension of the GENESIS II Resurfacing Patellae cleared under the GENESIS II Total Knee System premarket notification K951987 (S.E. 8/22/1995). The subject devices were modified by incorporating the identical patella peg and cement pocket geometry from the JOURNEY BCS Resurfacing Patellae, cleared under Smith & Nephew, Inc. High Performance Knee premarket notification K042515 (S.E. 3/14/2005) respectively.

The subject Cemented Round Patellae with JRNY Pegs have a size range of 26, 29, 32, 35, 38, and 41mm with thicknesses range of 7.5mm and 9.0mm. The Cemented Round Patellae with JRNY Pegs are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE), conforming to ASTM F648 (FDA Recognition Number 8-569), and 316 L Stainless Steel, conforming to ASTM F138 (FDA Recognition Number 8-542), identical to the predicate devices GENESIS II Resurfacing Patellae (K951987, S.E. 8/22/1995) and JOURNEY BCS Resurfacing Patellae (K042515, S.E. 3/14/2005).

The provided FDA 510(k) K221939 summary does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, accuracy).

Instead, this document is a 510(k) submission for a medical device (a knee implant component) seeking substantial equivalence to legally marketed predicate devices. The "performance testing" mentioned refers to mechanical testing to ensure the new device performs similarly to the predicate devices, not clinical performance or diagnostic accuracy.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information. These concepts are not applicable to the type of device and submission described in the provided text.

The "performance testing" section, briefly mentioned, indicates:

• Performance Testing: A review of leveraged mechanical data indicates that the subject Cemented Round Patellae with JRNY Pegs are substantially equivalent to previously cleared predicate devices.
• Evaluated Design Features:
  • Peg Geometry
  • Peg Location
  • Pocket Geometry
• Bacterial Endotoxin Testing: Representative worst-case device met acceptable endotoxin limits as stated in FDA Guidance and ANSI/AAMI ST72.

The conclusion states that the device is substantially equivalent to the predicate devices based on similarities in function, intended use, indications for use, design, and material composition, and mechanical performance. Clinical data was not needed to support safety and effectiveness.

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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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Smith & Nephew Total Knee Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use.

Indications for Cruciate Retaining Cemented Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   Cruciate Retaining Cemented Knee components are indicated for use with cement and are single use devices.

Indications for Cruciate Retaining Cementless Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   Cruciate Retaining Cementless Knee components are indicated for use without cement and are single use devices.

Indications for Posterior Stabilized Cemented Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Posterior Stabilized Cemented Knee components are indicated for use with cement and are single use devices.

Indications for Posterior Stabilized Cementless Knee Replacement:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
   Posterior Stabilized Cementless Knee components are indicated for use without cement and are single use devices.

Indications for Constrained Total Knees:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are incompetent.
   Constrained Total Knee components are indicated for use with cement and are single use devices.

Indications for Hinged Total Knees:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. 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.
5. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
   Hinged Total Knee components are indicated for use with cement and are single use devices.

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Total Knee System Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Total Knee Systems and their cleared Indications for Use. Smith & Nephew Total Knee System Instruments can be organized into instrument families which are categorized as follows: Trials, Cutting Instruments and Cutting Guides; Cutting Blocks, Alignment and Sizing Instruments, Impactors and Handles, Clamps, Extraction, Torque, Instrument Guides, and Covers and Protectors.

This document is a 510(k) Summary of Safety and Effectiveness for the Smith & Nephew Total Knee System Instruments. It explicitly states that these instruments are "accessory devices" used to assist in the implantation of Smith & Nephew Total Knee Systems.

The document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor does it provide details about any AI-related performance metrics.

The content is focused on:

• Device classification and regulatory information.
• Listing predicate devices (previously cleared knee systems).
• Device description (types of instruments).
• Intended use and Indications for Use for various knee replacement types (Cruciate Retaining, Posterior Stabilized, Constrained, Hinged).
• FDA clearance letter.

Therefore, I cannot provide the requested information. The document is for mechanical surgical instruments, not an AI/Software as a Medical Device (SaMD) that would typically involve performance studies with ground truth and expert reviews for diagnostic accuracy.

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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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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. Smith & Nephew, Inc. Journey II BCS Knee components are indicated for use only with cement and are single use devices.

Subject of this Abbreviated Premarket Notification is the Journey II BCS Knee system. The Journey II BCS Knee System is a posterior stabilized total knee system which provides the ability for greater flexion (155°) to those patients who have the anatomical capability to allow a greater flexion range. Components of this premarket notification include:

• Posterior stabilized femoral components which will initially be available in sizes 1-10 in right . and left designs in OXINIUM material.
• Posterior stabilized femoral components which will initially be available in sizes 1-9 in right . and left designs in cobalt chrome material
• Posterior stabilized 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 BCS articular inserts will be offered in 9-21 mm thicknesses and manufactured from cross-linked polyethylene (XLPE) material and conventional non-cross-linked Ultra-High Molecular Weight Polyethylene (UHMWPE) material.
  The Journey II BCS Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515) and may also be used with existing patellar components of the Genesis II Knee System (K951987).

The provided text is a 510(k) Premarket Notification for a medical device, the Journey II BCS Knee System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with a full-fledged acceptance criteria and performance study as might be done for a novel device.

Therefore, many of the typical questions regarding acceptance criteria, study design, expert ground truth, and training sets from an AI/imaging device perspective are not applicable to this document. The "study" here refers to mechanical testing for equivalence, not a clinical trial or AI model validation.

Here's a breakdown based on the information provided and addressing the non-applicability:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size: Not applicable in the context of clinical data for this 510(k) submission. The "test set" here refers to mechanical testing of device components. The document does not specify the number of components tested for each mechanical analysis, but it's not a human patient "test set."
• Data Provenance: Not applicable for clinical data. The mechanical testing would have been performed in a laboratory setting.

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. Ground truth in this context is established through engineering and mechanical testing standards and comparison to predicate devices, not expert human interpretation of data for diagnostic purposes.

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

• Not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving human interpretation or uncertain outcomes. Mechanical testing relies on measurable physical properties and engineering standards.

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 document is for a knee prosthesis, a physical implant. It does not involve AI or human readers for diagnostic interpretation. The submission explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this device's performance demonstration is based on mechanical engineering principles and standards, comparison to predicate device performance, and the absence of new safety/effectiveness issues revealed by those mechanical tests.

8. The sample size for the training set

• Not applicable. This is a physical medical device; there is no "training set" in the context of an AI/machine learning model.

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

• Not applicable. As there is no training set for an AI model, this question is not relevant.

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Total knee components are indicated for:

1. Rheumatoid arthritis
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
4. The posterior-stabilized knee system is 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 BCS STD Inserts are indicated for use without bone cement, and are single use devices.

Subject of this premarket notification is a review of changes to the High Performance Knee (previously cleared for market via premarket notification K042515) to result in the Revision Journey BCS STD Inserts. The subject devices are articular inserts manufactured from UHMWPE material. The devices will be available in left and right configurations in sizes 1-2, 3-4, 5-6, and 7-8 and thicknesses from 9-18mm.

When compared to the predicate High Performance Knee, the Revisoin Journey BCS STD Inserts have been modified as follows:

• Utilization of a modified articular insert-tibial baseplate locking mechanism
• Post Height Changes
• Increase in the blend radius at the bottom of the post

This document is a 510(k) premarket notification for a medical device called "Revision Journey BCS STD Inserts," which are components of a total knee prosthesis. It's a submission for changes to an already cleared device, the "High Performance Knee." The primary purpose of this type of submission is to demonstrate that the modified device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics in the sense of accuracy, sensitivity, specificity, or similar statistical outputs found for AI/software devices. This document deals with mechanical changes to a physical implant.

Instead, the "acceptance criteria" are implied by the regulatory framework for medical devices, particularly regarding substantial equivalence (SE). The criteria revolve around demonstrating that the modified device's safety and effectiveness are not adversely affected by the changes, and that it performs comparably to its predicate.

The reported device performance is described as:

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

This document describes a submission for a physical medical device (knee implant components), not a software or AI device. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they apply to AI/software performance studies do not apply here.

The "testing" mentioned refers to design verification testing on the physical components, likely involving mechanical tests, fatigue tests, wear tests, etc., in a lab setting rather than clinical trials with human subjects. The details of these specific tests (e.g., number of cycles, number of samples per test) are not provided in this summary.

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

This is not applicable for this type of device and submission. "Ground truth" established by experts is a concept primarily used in evaluating diagnostic accuracy for AI/software, where human expert interpretation is the gold standard. For physical device modifications, the "truth" is established through engineering and biomechanical testing standards.

4. Adjudication Method for the Test Set

This is not applicable for this type of device validation. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in diagnostic studies, which is not relevant here.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human readers' diagnostic performance. This submission is for a physical orthopedic implant component, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This question pertains to AI algorithm performance in isolation. This document is about a physical implant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For this physical device, the "ground truth" (or demonstration of safety and effectiveness) is established through:

• Compliance with recognized engineering and biomechanical test standards: The document explicitly mentions "requirements outlined in FDA's Draft Guidance For the Preparation of Premarket Notifications (510(k)s) For Cemented, Semi-Constrained total Knee Prostheses dated April 1993." This guidance would specify the types of mechanical, material, and performance tests required.
• Comparison to a legally marketed predicate device: The core of a 510(k) is demonstrating "substantial equivalence," meaning that the new device performs similarly and is as safe and effective as a device already on the market. The predicate device (K042515 - High Performance Knee) serves as the benchmark.

8. The Sample Size for the Training Set

This is not applicable as this describes a physical medical device, not an AI/software device that would require a training set.

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

This is not applicable for the same reasons as #8.

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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthrilis; failed osteotomies, unicompartmental replacement, or total knee replacement.

Smith & Nephew, Inc. Journey CR Knee System components are indicated for use only with cement and are single use devices.

Subject of this Abbreviated 510(k) premarket notification is the Journey. CR Knee System. The subject device is a cruciate retaining (CR) total knee system which is designed to provide the potential ability for greater flexion to those patients who have the anatomic capability to allow a greater flexion range. Components of this premarket notification include the following components:

• Cruciate retaining femoral components available in sizes 1-10 in right and left designs in . OXINIUM material.
• Cruciate retaining femoral components available in sizes 1-9 in right and left designs in cobalt chrome material
• Cruciate retaining articular inserts available in sizes 1-2, 3-4, 5-6, and 7-8 in right and left . designs. Journey CR articular inserts will be offered in 9-21mm thicknesses (9, 10, 11, 13, 15, 18, 21) and manufactured from UHMWPE.

The Journey CR Knee system will use existing cemented Journey tibial tray and patellar components currently used with the Journey BCS Knee System (K042515) and may also be used with existing patellar components of the Genesis II Knee System (K951987).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew Journey CR Knee System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) submission for the Smith & Nephew Journey CR Knee System (K101499) does not explicitly list quantitative "acceptance criteria" in the way a diagnostic AI device would. Instead, it refers to a "review of the mechanical data indicates that the Journey CR Knee System is capable of withstanding expected in vivo loading without failure" and that "a review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices."

The "performance" is demonstrated through various mechanical tests, implicitly aiming to show the device is as safe and effective as its predicate devices.

• Journey CR femoral lugs (mechanical testing, removal torque, push-out and torque to failure)
• Journey CR tibial insert locking mechanism (static testing)
• Tibiofemoral contact area analysis
• Tibiofemoral constraint testing
• Patellofemoral contact area analysis
• Patellofemoral lateral subluxation
  Conclusion: "a review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices." |
  | Substantial equivalence to predicate devices in safety and effectiveness. | The submission states that "The substantial equivalence of the Journey CR Knee System is based on its similarities in indications for use, design features, operational principles, and material composition to the predicate systems listed in the table." This is supported by the mechanical testing results, which are deemed sufficient to show no new issues. |

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

This is a medical device (knee implant), not a diagnostic AI algorithm. Therefore, the concept of a "test set" with clinical data provenance does not directly apply in the same way. The evaluation relies on mechanical testing of the device components.

• Sample Size for Test Set: Not specified in terms of number of patient cases. The testing was performed on physical components of the Journey CR Knee System. The document implies a sufficient number of samples were tested to gain confidence in the mechanical properties, but the exact number isn't stated.
• Data Provenance: The "data" comes from in vitro mechanical tests conducted on the physical device components. There is no mention of country of origin for clinical data, as clinical data was not required for this submission. The study is in vitro (bench testing) rather than retrospective or prospective clinical.

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

Again, this is a mechanical device, not an AI diagnostic. Therefore, the concept of "ground truth" derived from expert consensus on patient data is not applicable. The "ground truth" for mechanical testing is established by engineering standards and validated testing protocols. The experts involved would be qualified engineers and test technicians in a laboratory setting, but their number and specific qualifications are not detailed in this regulatory document.

4. Adjudication Method for the Test Set

Not applicable, as this is a mechanical device undergoing bench testing, not a clinical study involving human readers or expert consensus on medical images. The "adjudication" is implicitly done by the engineers and regulatory affairs personnel reviewing the raw mechanical test data against established engineering principles and relevant standards.

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 knee prosthesis, not an AI diagnostic system. There were no human readers or AI involved in the evaluation of this device.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device evaluation is based on mechanical engineering principles, established material properties, and standardized mechanical testing protocols designed to simulate in vivo loading conditions. The performance is compared against known characteristics of predicate devices that have a history of safe and effective use.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no AI model with a training set. The "design" and "development" of the device would involve engineering iterations, but these are not referred to as a "training set."

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

Not applicable. As there is no AI model or training set, this question is not relevant. The "ground truth" for engineering design would be based on biomechanical principles, clinical requirements for knee function, material science, and the performance characteristics of existing, successful knee implants.

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Smith & Nephew's Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.

The Patient Matched Cutting Blocks are intended for use with existing Smith & Nephew, Inc. knee systems and their cleared indications for use.

The Patient Matched Cutting Blocks are intended for single use only.

Subject of this premarket notification are Smith & Nephew's Patient Matched Cutting Blocks. The Patient Matched Cutting Blocks are designed and manufactured from patient imaging data (MRI, CT, X-Ray).

This 510(k) submission for Smith & Nephew's Patient Matched Cutting Blocks is for a physical medical device (patient-specific surgical instrumentation) and not an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria, study details, human reader improvement with AI assistance, standalone algorithm performance, training set, and ground truth establishment, are not applicable here.

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