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The LOSPA Modular Knee 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.

The LOSPA Knee System is intended for cemented application only.

The LOSPA Modular Knee System components are similar to "LOSPA Total Knee System" cleared under K110404, K121037 & K130673 which consists of Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and related Instrumentation and are Patella Femoral Tibial Knee Prosthesis Systems, intended for cemented total knee arthroplasty, and all have same indications for use. The subject components, is a line extension to include extension stems with stem plugs and offset adaptors, distal and posterior femoral augments.

The provided text describes a 510(k) premarket notification for the LOSPA Modular Knee System. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in relation to an AI system.

The document is a clearance letter from the FDA, a 510(k) summary, and indications for use for a medical device (a knee replacement system). The "Performance Testing - Bench" section describes mechanical tests performed on the physical knee implant components to demonstrate substantial equivalence to predicate devices, not performance criteria for an AI system.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets those criteria from this document.

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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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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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The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, unicompartmental replacement; or total knee arthroplasties. The components are designed for use 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 Revision Knee Components are for single use only and are intended for implantation with bone cement.

These indications are the same as currently used for the Genesis II Constrained Knee System and Revision Knee System cleared via K962137 and K041106.

The Smith & Nephew Revision Knee System contains femoral knee components, tibial components, angled and offset couplers, stem attachments and wedges. The designs of these devices are based upon existing components of the Genesis II Total Knee System and Revision System, previously cleared for market under K951987, K953274, K962137, and K041106.

This is a 510(k) premarket notification for a medical device, specifically the SMITH & NEPHEW REVISION KNEE SYSTEM. These types of submissions typically demonstrate "substantial equivalence" to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria through clinical trials and statistical analysis.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or how ground truth for the training set was established.

Here's why and what information is present:

• Substantial Equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the differences do not raise different questions of safety and effectiveness.
• Focus of this Document: The document describes the device's intended use, its components, and lists predicate devices to which it claims substantial equivalence. It also lists general safety and effectiveness characteristics.
• No Clinical Study Details: It does not mention any clinical study conducted to establish performance metrics against acceptance criteria. The focus is on comparing the new device to existing, already cleared devices.

Summary of available information related to your prompt, and why other requested information is not present:

1. A table of acceptance criteria and the reported device performance: This is not present. The document doesn't define specific numerical acceptance criteria for performance; rather, it asserts similarity to predicate devices.
2. Sample size used for the test set and the data provenance: This is not present. There's no mention of a "test set" in the context of clinical or performance data for this submission. The submission relies on the established safety and efficacy of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not present. No such "ground truth" establishment is described for a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not present. No adjudication method for a test set 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: This is not present. This device is a knee implant, not an AI-assisted diagnostic tool. MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not present. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This is not present, as no specific performance study with ground truth data is detailed.
8. The sample size for the training set: This is not present. This is not an AI/algorithm-based device that would require training data.
9. How the ground truth for the training set was established: This is not present.

In conclusion, the provided 510(k) summary is a regulatory document focused on proving "substantial equivalence" of a medical device (a knee implant) to already approved predicate devices, rather than a clinical study report detailing performance against specific acceptance criteria.

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The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthrilis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use 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 Revision Knee Components are for single use only and are intended for implantation with bone cement.

The Revision Femoral Knee Components are manufactured from Oxinium. Wedges and screws are also included in the Revision Knee System. The devices are based upon existing components of the Genesis II Total Knee System.

This is a medical device submission (510(k)) for a Revision Knee System. These submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting de novo clinical studies with acceptance criteria and performance metrics in the way that an AI/software device would.

Therefore, the provided document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a device performance study.

Instead, the document focuses on:

• Intended Use: Similar to predicate device (Genesis II Constrained Knee System).
• Device Description: Manufactured from Oxinium, based on existing components of the Genesis II Total Knee System.
• Substantial Equivalence Information: The device (Revision Knee System) is substantially equivalent to existing components of the Genesis II Total Knee System due to similarities in design features, overall indications, and material composition.
• Technological Comparison: Intended use, designs, and materials are substantially equivalent to predicate components. Mentions "Design Control Activities have been completed and the results indicate that the subject devices meet the requirements of the applicable FDA guidance documents," but no specific performance data or acceptance criteria are provided in the public summary.

In summary, this document describes a traditional medical device (knee implant) and its regulatory clearance process based on substantial equivalence, not a software/AI device that would typically have the requested data points.

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The Genesis II Constrained System is indicated for:

1. Rheumatoid arthritis.
2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   The Genesis II Constrained System is 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 Genesis II Constrained System is indicated for use with cement and is a single use device.

The Genesis II Constrained System consists of a femoral component and a tibial insert. The femoral component is manufactured from cobalt-chromium-molybdenum and the tibial insert is manufactured from ultra-high-molecular-weight polyethylene. The femoral component has a boxlike design that mates with a post on the tibial insert to constrain motion.

This document, K962137, "Summary of Safety and Effectiveness Smith & Nephew Richards Inc. Genesis II Constrained System," is a 510(k) premarket notification for a medical device. It does not describe a study related to AI or a software algorithm, but rather a traditional mechanical medical device (a knee replacement system).

Therefore, I cannot provide information for most of your requested points, as they are specific to AI/software device evaluation studies.

Here's what can be extracted and addressed based on the provided text:

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

Explanation: The document states that "Mechanical testing was performed according to the requirements in the knee draft guidance document." The reported performance is a general statement that the device meets the criteria. Specific numerical values for the acceptance criteria and the test results are not provided in this summary document.

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

This question is not applicable as the document describes a mechanical medical device (a knee replacement system), not an algorithm or AI system.

The remaining requested information cannot be provided from the input document as it pertains to AI/software performance studies:

• 2. Sample sized used for the test set and the data provenance: Not applicable.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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