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The Smith & Nephew Legion Hinge Knee System is indicated for:

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 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 ligament) are absent or incompetent.
   The Legion Hinge Knee System is for Cemented Use Only.

Subject of this premarket notification is a material change to the femoral component and tibial trav in the Legion Hinge Knee System and design changes to the femoral component and axle. The Legion Hinge Knee System is used to treat gross knee instability resulting from loss of collateral ligament function, gross bone loss possibility including the insertion points of the collateral ligaments or patella tendon, or comminuted fractures of the proximal tibial or distal femur. Components of this premarket notification include the following components:

• The femoral components manufactured from oxidized zirconium allov . (OXINIUM).
• Design changes to the femoral component and axle ●
• Tibial tray manufactured from Titanium alloy (Ti-6Al-4V). ●

The provided document is a 510(k) summary for the Smith & Nephew Legion Hinge Knee System. It describes a medical device, a knee joint femorotibial metal/polymer constrained cemented prosthesis, and its substantial equivalence to predicate devices. The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to the regulatory submission for a physical medical device (knee implant) and focuses on mechanical performance testing and substantial equivalence to existing devices, not on the performance of an AI/ML algorithm or software.

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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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Stem - PSA Type is included in U2 Total Knee System-PSA type. U2 Total Knee System-PSA type is indicated for use in skeletally mature patients with severe knee pain and disability undergoing surgery for knee arthroplasty due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. U2 Total Knee System-PSA type is designed for cemented use only.

"UNITED Stem-PSA Type is an additional size extension of stem to the existing, previously cleared "UNITED" U2 Total Knee system product line (K082424). The materials, design, safety and effectiveness of this subject are identical to the previously cleared U2 Total Knee system. The only difference from the existing products is the length of stem. This subject stem made of Ti-6A1-4V alloy and will be offered in two types which include straight stem and curved stem. The length of extended straight stem distribute to 150, 200 and 240mm, while the curved stem has 240mm only. Each size of stem has fifteen options in diameter which ranging from 10mm to 24mm. Canal filling stems with spline and flute design provide immediate rigid fixation and resistance to torsional movements. Distal taper is designed to address the problems associated with proximal stress shielding, resulting from distal fixation.

The provided text describes a 510(k) premarket notification for a medical device called "Stem, PSA Type" (K100981). This document primarily focuses on establishing substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria and testing methodology as one might find for a novel diagnostic or AI-driven device.

Therefore, many of the requested elements (sample size of test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details, etc.) are not applicable or not provided in this type of submission.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

• Indications for use
• Materials
• Design
• Manufacturing process
• Sterilization
• Comparable locking strength of Morse Taper | The subject device ("Stem, PSA Type") is stated to be identical to the previously cleared "UNITED" U2 Total Knee system in terms of materials, design, safety, and effectiveness, except for the length of the stem.
  The subject device's larger stem lengths (straight stem: 150, 200, 240 mm; curved stem: 240 mm) are substantially equivalent to:
• "UNITED" U2 Total Knee system - PSA Type (straight stem: 30, 75, 100 mm; curved stem: 150, 200 mm)
• "DEPUY" Anatomic Modular Knee (AMK) System (K864671) for the straight stem.
• "SMITH & NEPHEW" LEGION Revision Knee System (K043440) for the curved stem.
  Locking strength test of Morse Taper demonstrated the device is safe and effective and substantially equivalent to the predicate device. |

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable/not provided. This submission is for a new size extension of an existing mechanical implant, relying on substantial equivalence to predicates, not a clinical trial or performance study requiring a test set of patient data.
• Data Provenance: Not applicable/not provided. There are no patient data used for "testing" in the traditional sense. The data relates to mechanical property testing.

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

• Not applicable/not provided. Ground truth, in the context of patient data, is not established for this type of submission. The evaluation is based on engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set

• Not applicable/not provided.

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

• Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic tool or an imaging reader.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a mechanical implant, not an algorithm.

7. Type of Ground Truth Used

• Not applicable in the conventional sense. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior clearances and the engineering standards applied to their design, materials, and manufacturing. For the specific performance data mentioned (locking strength), the ground truth would be established mechanical engineering standards for such components.

8. Sample Size for the Training Set

• Not applicable/not provided. There is no "training set" as this is not an AI/ML device.

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

• Not applicable/not provided.

Summary of the Study (Performance Data):

The "study" referenced in the 510(k) is a locking strength test of the Morse Taper. This mechanical test was performed as part of the design assurance process. The purpose was to demonstrate that the expanded stem sizes maintain similar safety and effectiveness characteristics to the predicate devices. The document states that this test demonstrated the device is safe and effective and is substantially equivalent to the predicate device in this regard. No specific acceptance values or detailed test results are provided in this summary, but the conclusion of substantial equivalence is drawn based on these tests.

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The Competitor Duo Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee.

Indications include:

• post-traumatic arthritis; .
• degenerative arthritis; and .
• failed osteotomies, hemiarthroplasties; and unicompartmental replacement .

These indications will be used for the Competitor Duo Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Competitor Duo Knee Femoral Components are single use only and are intended for implantation only with bone cement

The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Duo will include both CoCr and Oxinium femorals. The overall Knee joint. The Competitor Duo femoral component are based upon the existing Hybrid Knee Femoral Component subject of K042896.

This document is a 510(k) summary for a medical device (Competitor Duo Knee Femoral Components), which focuses on demonstrating substantial equivalence to predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies for AI/algorithm performance.

Therefore, I cannot provide the requested information. This type of regulatory submission historically does not involve such data as it is for mechanical devices demonstrating equivalence, not AI/software performance evaluations.

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