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EXULT Knee Replacement System is intended for the treatment of diseases as follows:

• Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis.
• Post-traumatic loss of knee joint configuration and function.
• . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• . Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure

EXULT Knee Replacement System is intended for cemented application only.

The purpose of the submission is a line extension of the EXULT Tibial Insert (CPS-type) to the EXULT Knee Replacement System (K192507). The CPS-type Tibial Inserts are designed based on the design of the other previously cleared Tibial Inserts of the EXULT Knee Replacement System (PS-type, CR-type and UC-type). The CPS-type, which is constrained posterior stabilized, has a thicker and wider post which provides additional constraint as compared to the PS-type insert. The CPS-type Tibial Insert matches with Femoral Components of one-size up and down. The CPS-type Tibial Insert is symmetrical and used in both the right and left knee. It is only used in combination with the Femoral component/Tibial baseplate of the predicate device (K192507).

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for software or AI/ML-driven medical device performance.

The document is a 510(k) premarket notification for the EXULT Knee Replacement System, a physical orthopedic device. It discusses the device's indications for use, technological characteristics, and non-clinical testing performed to establish substantial equivalence to predicate devices (other knee replacement systems).

The "Non-Clinical Testing" section lists various engineering tests (wear testing, fatigue testing, constraint testing, range of motion, surface roughness, disassembly) and references ISO and ASTM standards. These are traditional mechanical engineering tests for orthopedic implants, not performance studies for AI/ML algorithms.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (for AI/ML).
• Sample size for the test set and data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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The MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions:

• · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic arthritis
• · Post-traumatic loss of knee joint configuration and function
• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• · Revision of previous unsuccessful knee replacement or other procedure
• · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture- management techniques

Additional Indications for the Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+):

• · Ligamentous instability requiring implant bearing surface geometries with increased constraint
• · Absent or nonfunctioning posterior cruciate ligament
• · Severe anteroposterior instability of the knee joint

The MOBIO Total Knee System is intended for implantation with bone cement only. MOBIO Total Knee System components are not intended for use with other knee systems.

The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial trav, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. This submission is to add a condylar stabilizing (CR+) Tibial Insert device type to the system. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies.

The CR PLUS Tibial Inserts are offered in a total of 50 sizes, size A/1-3 through HJ/8-10, with 10 thicknesses ranging from 9 to 25mm. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.

All system components are supplied sterile and are single use devices.

Acceptance Criteria and Study Proving Device Meets Criteria: MOBIO Total Knee System (K210483)

Based on the provided FDA 510(k) summary, the device in question is a Total Knee System, not an AI/software medical device. Therefore, the traditional acceptance criteria and study design for AI/software (e.g., MRMC studies, ground truth establishment for images, training/test sets) do not apply to this submission.

The FDA 510(k) process for a physical medical device like a knee replacement focuses on substantial equivalence to a previously cleared predicate device. This is demonstrated through a comparison of technological characteristics and performance data from non-clinical studies (bench testing) rather than clinical studies with human subjects or AI model validation.

Here's a breakdown of the acceptance criteria and study information as it pertains to this orthopedic implant:

1. Table of Acceptance Criteria and Reported Device Performance

For an orthopedic implant seeking 510(k) clearance, the "acceptance criteria" are generally met by demonstrating that the new device's performance is equivalent to, or better than, the predicate device across relevant performance metrics. These metrics are often derived from recognized consensus standards and ensure the device is safe and effective for its intended use.

Note: The FDA 510(k) summary typically lists the types of studies performed, but the detailed results and specific numerical acceptance thresholds are part of the full submission, not the public summary. The "Reported Device Performance" here refers to the fact that supporting data was submitted and found acceptable by the FDA to demonstrate equivalence.

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

• Sample Size: Not applicable in the context of human "test sets" as this is a non-clinical (bench) study for a physical device. The "sample size" would refer to the number of devices or components tested for each specific non-clinical study (e.g., how many locking mechanisms were tested for strength). This specific number is not provided in the 510(k) summary.
• Data Provenance: The data is generated from bench testing in a laboratory setting, not from human subjects or clinical data in a specific country. The studies are typically conducted by the manufacturer or a contract research organization following recognized standards (e.g., ISO, ASTM).

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

This concept is not applicable to a physical medical device bench study. "Ground truth" in this context is established by:

• Engineering specifications and design requirements.
• International and national consensus standards (e.g., ISO 21536 for Knee joint prostheses, ASTM standards for material testing).
• Validated test methods and equipment.

The "experts" involved would be qualified engineers, material scientists, and biomechanical experts who design the device, perform the tests, and interpret the data against established engineering principles and standards. Their qualifications are inherent in their professional roles and adherence to Good Manufacturing Practices (GMP) and quality system regulations (21 CFR 820).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for consensus in subjective human assessments, often in image interpretation. For a physical device, testing involves objective measurements (e.g., force, stress, range of motion) performed according to validated protocols, not subjective interpretation. Any outliers or discrepancies in test results would be investigated through root cause analysis, not adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. MRMC studies are used to assess the impact of AI algorithms on human reader performance, typically in diagnostic imaging. This 510(k) is for a physical orthopedic implant. Clinical studies, if performed, would typically be for PMA (Premarket Approval) applications or for higher-risk devices, not typically for 510(k) clearances that rely on substantial equivalence.

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

Not applicable. This is for a physical knee implant, not a software algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for performance is defined by:

• Engineering Specifications: The design parameters and expected performance characteristics set by the manufacturer.
• Consensus Standards: Performance criteria defined by recognized standards organizations (e.g., ISO, ASTM) for mechanical properties, material properties, wear, and biocompatibility of orthopedic implants.
• Predicate Device Performance: The demonstrated safe and effective performance of the legally marketed predicate device (MOBIO Total Knee System; K202429, and reference devices K063423, K071071, K180446). The new device must meet or exceed these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train an AI algorithm. For a physical device, the equivalent would be the R&D and design verification process, where prototypes are developed and tested, and design iterations are guided by engineering principles and previous test results. There isn't a "training set" in the AI sense.

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

Not applicable. As explained above, "ground truth" for a physical device is established through engineering design, recognized standards, and performance of predicate devices. There is no AI model "training" in this context.

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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.

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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The Genesis II XLPE Resurfacing Patellar Components are intended to be used with Smith & Nephew Total Knee Systems and Patello-Femoral Replacement Knee Systems and their cleared Indications for Use.

Indications for Total Knee Replacement

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. 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.
6. 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.

Indications for Patello-Femoral Replacement

1. Degenerative arthritis in the distal femur and patella;
2. A history of patellar dislocation or patellar fracture; and
3. Failed previous surgery (arthroplasty, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

The Smith & Nephew Patello-Femoral Implants are intended for implantation with bone cement.

Subject of this Premarket Notification are the Genesis II XLPE resurfacing patellar components manufactured from highly cross linked polyethylene (XLPE) material. The Genesis II XLPE resurfacing patellar components are intended to be used with the following knee systems

• Smith & Nephew Total Knee Systems
• Smith & Nephew Patello-Femoral Knee Systems
• Competitor PFJ Patella-Femoral Knee Implants K051086
• Legion Hinge Knee System K081111
• Genesis II Constrained System K962137

Components of this premarket notification include

• Round and Oval Patellar components manufactured from highly cross-linked polyethylene (7.5 Mrad XLPE) material.

This document is a 510(k) Premarket Notification for the Genesis II XLPE Resurfacing Patellar Components. It is a regulatory submission to the FDA, demonstrating substantial equivalence to previously cleared devices. It describes mechanical testing performed to support a material change, not a study proving a device meets specific clinical acceptance criteria or a comparative effectiveness study.

Therefore, many of the requested sections in your prompt (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance, type of ground truth) are not applicable or not explicitly detailed in this type of regulatory submission. The document focuses on showing mechanical equivalency rather than clinical performance.

However, I can extract information related to the acceptance criteria for the mechanical testing and the reported performance from the document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the mechanical tests (Static Shear and Fatigue Shear Testing). Instead, it states that the tests were conducted "to further support a determination of substantial equivalence" and that "Test results demonstrated that the proposed devices are substantially equivalent to the previously cleared predicate device." This implies that the acceptance criterion was the demonstration of performance comparable to the predicate device, although the specific thresholds for "comparable" are not provided.

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

• Sample Size: Not specified in the document.
• Data Provenance: Not explicitly stated, but these would be bench (mechanical) tests performed in a laboratory setting, likely by Smith & Nephew or a contracted testing facility. This is not clinical data (retrospective or prospective from a country of origin).

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

• Not Applicable. Ground truth in this context would refer to clinical or diagnostic accuracy, which is not evaluated here. The "truth" for mechanical testing is derived from engineering principles and standards, not expert clinical consensus.

4. Adjudication method for the test set

• Not Applicable. This is not a clinical study involving human assessment that would require adjudication. Mechanical tests have objective outputs that are compared against predefined engineering specifications or predicate device performance.

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. This is a submission for a medical implant (knee replacement components), not an AI diagnostic device. Therefore, no MRMC comparative effectiveness study was performed or is relevant.

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

• No. This is not a software algorithm; it is a physical medical device.

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

• Not Applicable / Engineering Standards. For mechanical testing, the "ground truth" would be established by industry-accepted mechanical testing standards (e.g., ISO, ASTM) and comparison to the known performance characteristics of the predicate device, rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI device that requires a training set.

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

• Not Applicable. (See #8)

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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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