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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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The Dornier GENESIS II is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Genesis II is an Image Intensified Fluoroscopic X-ray System. It is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Genesis II consists of the following components: an x-ray generator and tube housing, image intensifier detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics and electronics for the imaging chain.

The Genesis II is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted over the table on a fixed arm. An image intensifier is mounted underneath the patient table. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position.

The provided text describes the 510(k) premarket notification for the Dornier MedTech America, Inc. Genesis II device, an Image Intensified Fluoroscopic X-ray System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific quantitative acceptance criteria.

However, based on the information provided, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states, "a board certified radiologist evaluated a number of sample images obtained using the Genesis II." A specific numerical sample size is not provided.
• Data Provenance: The origin of the sample images (e.g., country of origin) and whether the data was retrospective or prospective is not specified.

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

• Number of Experts: "a board certified radiologist" — this suggests one expert.
• Qualifications of Experts: The expert was a "board certified radiologist." No further detail (e.g., years of experience) is provided.

4. Adjudication method for the test set

• "a board certified radiologist evaluated... and determined..." This indicates that the evaluation was performed by a single expert. There is no mention of an adjudication method involving multiple experts to establish ground truth or resolve discrepancies, as only one expert is noted.

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. The document describes the evaluation of image quality of the device itself, not the performance of human readers with or without AI assistance. This device is an imaging system, not an AI-based diagnostic tool for interpretation.

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

• This question is not applicable as the Genesis II is an X-ray imaging system, not an algorithm or AI device that performs diagnoses independently. The evaluation described is for the diagnostic quality of the images produced by the hardware, which would then be interpreted by a human.

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

• The ground truth for the image quality assessment was established through expert opinion/evaluation by a single board-certified radiologist, who determined if the images were of "acceptable diagnostic quality." There is no mention of an objective reference standard like pathology or outcomes data.

8. The sample size for the training set

• The document implies that the device (Genesis II) itself was designed and verified against established engineering and safety standards, and its image intensifier technology is based on previously cleared devices. It does not describe a "training set" in the context of an algorithm or AI model. Therefore, this question is not applicable for this type of device submission.

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

• As the concept of a "training set" for an algorithm is not applicable to this device, the establishment of its ground truth is not relevant in this context. The device's "training" in a functional sense would be its design, manufacturing processes, and adherence to established technical standards, as well as the prior clearance of its component technologies.

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The Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are indicated for:

• Rheumatoid arthritis. 1.

Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 2.

Failed osteotomies, unicompartmental replacement, or total knee replacement. 3.

Posterior stabilized knee systems are designed for use in patients in primary and revision 4. · surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

The Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components are indicated for use only with cement and are single use devices.

Genesis II PS Non-modular and CR Non-modular with cement pocket femoral components are line extension of the Genesis II Total Knee System. It provides a non-modular option of the PS knee which is similar to the nonmodular CR knee in design concept. It is available from size 1-8 and in left and right configuration. The Nonmodular PS/CR femoral components are available with or without the feature of cement pocket. The material is cobalt chromium alloy (ASTM F75-07). The femoral component is a single use device and supplied sterile (Gamma sterilization). The Genesis II PS Non-modular with cement pocket femoral components can be implanted using the standard Genesis II Instrumentation or the Genesis II ECO Instrumentation.

The provided text from the 510(k) summary for the Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components does not contain information about acceptance criteria or a study proving that the device meets such criteria in the way typically expected for a software or AI/ML device.

This document describes a medical device, specifically knee joint prostheses, which are physical implants. The regulatory pathway for such devices, especially line extensions of existing devices, often relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than clinical trials or AI performance evaluations.

Here's an analysis of why the requested information is not present and what is provided:

1. Acceptance Criteria and Reported Device Performance:

   • Table: A table of acceptance criteria and reported device performance is not present.
   • Text: The document states: "Design verification has been performed based on 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. Technical report and justifications provided in the submission demonstrated that the Genesis II PS Non-modular and CR Non-modular with cement pocket Femoral Components met performance requirements and are as safe and effective as the predicate devices."
   • This indicates that performance requirements were met, but the specific numeric acceptance criteria (e.g., tensile strength, fatigue life, wear rates) and the actual measured performance are not detailed in this public summary. These are typically covered in technical reports submitted to the FDA, not always in the public 510(k) summary.

2. Sample size for the test set and data provenance: Not applicable. This is a physical device, and testing would involve materials testing, mechanical characterization, etc., which have different "sample" considerations than AI/ML algorithms. The summary does not provide details on the number of components tested for design verification. It specifies "Clinical data was not needed to support the safety and effectiveness of the subject devices."

3. Number of experts and their qualifications for ground truth: Not applicable. Ground truth, in the context of expert consensus, is mostly relevant for diagnostic or AI/ML-driven devices where an "expert diagnosis" is the target. For a physical implant, "ground truth" refers to its physical and mechanical properties being within specifications, typically verified by engineers and testing labs.

4. Adjudication method: Not applicable for a physical implant's design verification.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. MRMC studies are used to evaluate human reader performance, usually when making diagnostic decisions, and are particularly relevant for AI-assisted diagnostic tools. This device is an implant.

6. Standalone performance (algorithm only without human-in-the-loop): Not applicable. This is not an algorithm or software.

7. Type of ground truth used: For a physical device, the "ground truth" is typically engineering specifications, material standards (e.g., ASTM F75-07 for cobalt chromium alloy), and performance benchmarks established by regulatory guidance and predicate device performance. The performance requirements (referred to in the text) would be the "ground truth" against which the device's design verification results are compared.

8. Sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided 510(k) document is for a physical medical implant (a knee prosthesis). The "study" proving it meets acceptance criteria is a "Design verification" against "performance requirements" based on FDA guidance and comparison to a "predicate device." This is a different type of evidence than typically presented for software or AI/ML devices, and therefore much of the information requested is not relevant or not present in this document.

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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or 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 absent or incompetent. Total knee components are single use devices and may be used in cemented or uncemented applications.

The Smith & Nephew, Inc. Gender Knee Systems are the existing Smith & Nephew, Inc. Genesis II, Legion, and Journey BCS Knee Systems. This premarket notification seeks only to add gender-related claims for these existing total knee systems previously cleared by FDA marketed by Smith & Nephew. No new total knee components being introduced as a result of this premarket notification.

This document is a 510(k) Pre-market Notification for the Smith & Nephew, Inc. Gender Knee Systems. It is a regulatory submission to the FDA seeking to add gender-related claims to existing total knee replacement systems.

Based on the provided text, the device is being cleared based on substantial equivalence to previously marketed predicate devices, not on a new study demonstrating its efficacy or performance against specific acceptance criteria. This type of submission (510(k)) does not typically involve the rigorous clinical trial evidence that would include specific acceptance criteria and a detailed study report as requested in your prompt.

Therefore, many of the requested elements are not present in this type of regulatory document.

Here's a breakdown of what can be extracted and what cannot:

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

• Cannot be provided. This document does not describe specific performance-based acceptance criteria for the "Gender Knee Systems" or report performance results against such criteria. The submission is for "gender-related claims" for existing devices, relying on substantial equivalence to predicates.

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

• Cannot be provided. No new clinical testing or "test set" is described for this 510(k) submission. The clearance is based on substantial equivalence.

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)

• Cannot be provided. No "test set" requiring ground truth establishment by experts is described in this regulatory submission.

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

• Cannot be provided. No "test set" and thus no adjudication method is described.

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

• Cannot be provided. This document is about a knee implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable or mentioned.

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

• Cannot be provided. This document is about a knee implant, not an algorithm, so this concept is not applicable.

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

• Cannot be provided. As there's no new study or "test set" described, there's no mention of ground truth types.

8. The sample size for the training set

• Cannot be provided. This is not a machine learning/AI device, and no "training set" is relevant or mentioned.

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

• Cannot be provided. As above, a training set and its ground truth establishment are not applicable to this device or its regulatory pathway.

Summary of what is known based on the provided text:

• Device Name: Smith & Nephew, Inc. Gender Knee Systems (based on existing Genesis II, Legion, and Journey BCS Knee Systems)
• Regulatory Pathway: 510(k) Premarket Notification
• Purpose of Submission: To add "gender-related claims" to existing, previously cleared total knee systems.
• Basis for Clearance: Substantial Equivalence to predicate devices, specifically:
  • Zimmer NexGen Knee Gender Solutions Female (GSF) Femoral Components (K060370)
  • Zimmer Gender Solutions Natural-Knee Flex System (K070214)
  • Stryker Triathlon Total Knee System (K053514)
• Intended Use: Standard total knee replacement indications for rheumatoid arthritis, post-traumatic arthritis, degenerative arthritis, and failed previous surgeries, tailored to posterior stabilized or constrained knee systems, in cemented or uncemented applications.

In essence, this document demonstrates that the FDA reviewed the application and determined that the "Gender Knee Systems" with the added gender-related claims are substantially equivalent to other legally marketed predicate devices, meaning no new performance acceptance criteria or detailed study results are included within this specific 510(k) summary.

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The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System.

The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; 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 absent or incompetent and the collateral ligaments remain intact.

The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.

The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee System cleared via K030612. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.

The Genesis II Deep Flexion Cruciate Retaining Articular Inserts are UHMWPE tibial components which provide the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. The insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibial tray components cleared in K030612.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert:

Acceptance Criteria and Device Performance

This 510(k) submission primarily relies on substantial equivalence to predicate devices. As such, the "acceptance criteria" are not explicitly defined as numerical thresholds for specific performance metrics in the same way they might be for a novel device or a detailed clinical trial. Instead, the acceptance criteria are implicitly that the new device performs equivalently to the predicate devices in terms of its mechanical properties and intended use.

The study presented is a mechanical test data review rather than a human-involved clinical study.

Study Details

Given the nature of this 510(k) summary, which focuses on substantial equivalence based primarily on mechanical testing, many of the typical clinical study parameters are not applicable.

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

   • Sample Size: Not explicitly stated as a number of devices. The study refers to "mechanical test data" for the device, implying a set of prototypes or manufactured units were subjected to various tests.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective, though mechanical testing typically occurs in a lab setting.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing, the "ground truth" is typically established by engineering standards and validated testing protocols, not human expert consensus.

3. Adjudication method for the test set: Not applicable. Mechanical testing outcomes are typically objectively measured against established engineering specifications, not adjudicated by human experts.

4. 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 device is a knee implant component, and this type of study is irrelevant to its evaluation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the mechanical testing would be the established engineering requirements, material properties, and performance benchmarks derived from predicate devices, demonstrated through validated mechanical and material testing.

7. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI or algorithm-based device.

8. How the ground truth for the training set was established: Not applicable.

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The Genesis II Total Knee System is 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 Genesis II Total Knee System includes porous and porous plus HA coated devices which are indicated for use with or without bone cement, and are single use devices.

Genesis II Porous Plus HA Knee System Components contain an HA coating on the porous coated areas of the devices. These porous plus HA components are designed for use with existing knee components contained within the Genesis II Total Knee System.

The provided text is a 510(k) summary for the Smith & Nephew Genesis II Knee System, specifically the Porous Plus HA Knee System Components. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance levels in the way a clinical trial for a new drug or an AI-powered diagnostic device might.

Therefore, many of the details requested in your prompt (e.g., sample sizes for test sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, training set details) are not applicable to this type of regulatory submission for a medical device that demonstrates substantial equivalence based on material and design similarity, and existing predicate devices.

Here's a breakdown based on the information available in the provided text:

1. Table of acceptance criteria and reported device performance:

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

• Not Applicable. This submission is for establishing substantial equivalence based on material and design comparisons to predicate devices, not a clinical study with a test set of patient data. The "test set" in this context would refer to material and mechanical testing data, which is not detailed in the provided 510(k) summary.

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

• Not Applicable. This type of information is generally relevant for AI/ML device submissions where expert annotation is used to create a ground truth for diagnostic accuracy. Given this is a knee implant, the "ground truth" would relate to material properties, mechanical performance, and biocompatibility, typically evaluated through engineering tests, not expert clinical interpretation of data.

4. Adjudication method for the test set:

• Not Applicable. As per the above, there isn't a traditional "test set" requiring clinical adjudication.

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. MRMC studies are specific to diagnostic devices, especially those involving human interpretation of medical images, and are not relevant for a knee implant 510(k) submission.

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

• Not Applicable. This is a hardware device (a knee implant), not an algorithm or software device.

7. The type of ground truth used:

• For this type of device, the "ground truth" for demonstrating substantial equivalence would primarily be objective engineering performance data (e.g., mechanical strength, wear characteristics, biocompatibility of materials, fixation properties) as tested against recognized standards and compared to the predicate devices, along with clinical history and performance of the predicate devices. The provided text mentions "summary report results" indicating compliance with FDA guidance, which would encompass such engineering data.

8. The sample size for the training set:

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

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

• Not Applicable. No training set exists for this type of device.

In summary: The K032683 submission for the Genesis II Porous Plus HA Knee System components relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This is achieved by showing that the new device has the same intended use, similar technological characteristics (design, materials, HA coating on porous areas), and meets applicable FDA guidance documents, implying that relevant engineering and biocompatibility tests were performed and their results deemed acceptable by the FDA in relation to the predicate devices. The document does not describe a clinical study in the typical sense with patient sample sizes, expert-adjudicated ground truth, or AI performance metrics.

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The Genesis II Posterior Stabilized High Flexion Articular Insert 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.
4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact.

The Genesis II Posterior Stabilized High Flexion Articular Insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274. The Genesis II Posterior Stabilized High Flexion Articular Insert is for single use only.

The Genesis II Posterior Stabilized High Flexion Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee System cleared via K030612. The Genesis II Posterior Stabilized High Flexion Articular Insert is for single use only.

The Genesis II Posterior Stabilized High Flexion Articular Inserts are URMWPE tibial components which provide the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. The insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibial tray components cleared in K030612.

This document describes the Genesis II Posterior Stabilized High Flexion Articular Insert, a knee implant component.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document refers to "mechanical test data," but it does not specify the sample size used for these tests.
The provenance of the data (country of origin, retrospective/prospective) is not mentioned.

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

The document does not mention any experts being used to establish a "ground truth" for the mechanical test data. The determination appears to be based on direct mechanical evaluation and comparison to existing devices.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method as this type of study is not applicable to the mechanical testing described.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable for this type of medical device (knee implant component). The focus is on mechanical and design equivalence, not interpretative tasks.

6. Standalone (Algorithm Only) Performance

A standalone performance study was not done, nor is it applicable as this is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria appears to be:

• Mechanical performance standards/benchmarks: The device's mechanical test data was compared against "expected in vivo loading" and demonstrated equivalence to "devices currently used clinically."
• Predicate device characteristics: Substantial equivalence relies on comparisons in "indications for use, design features, operational principles, and material composition" to existing legally marketed devices.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical knee implant component, not an AI or machine learning model that would require a training set.

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

This information is not applicable for the same reason as point 8.

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The porous components of the Genesis II Total Knee System are single use devices for use without cement. The devices 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 porous coated components of the Genesis II Total Knee System are designed for use with existing tibial and patellar components and accessories of the Genesis II Total Knee Systems cleared via K951987 and K953274. The subject components are porous coated metal alloy devices.

The provided document is a 510(k) premarket notification for the Smith & Nephew, Inc. Genesis II Total Knee System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data with predefined acceptance criteria for device performance.

Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in this document.

Here's a breakdown based on the information provided and the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable in the context of this 510(k) submission. Mechanical testing was performed, but specific sample sizes and data provenance for these internal tests are not detailed. The submission relies on a comparison to existing devices, not a new clinical trial with a "test set" of patients.

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

Not applicable. Ground truth in a clinical sense (e.g., diagnosis, outcome) is not established within this 510(k) submission. The "ground truth" for the submission is the regulatory acceptance of existing predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication in this submission.

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

No. This document does not describe any MRMC comparative effectiveness study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for this 510(k) submission is the regulatory acceptance and established safety/effectiveness profile of predicate devices that were already legally marketed. The submission demonstrates that the new device is "substantially equivalent" to these predicates.

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not a machine learning model. There is no "training set" in this context.

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

Not applicable (as above).

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Components in the Genesis, Genesis II, and Profix Knee Systems are 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. 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. 5) The constrained knee system is designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligaments) are absent or incompetent. The devices that are the subject of this premarket notification are intended for cemented use only and are for single use only. The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the Genesis Knee System, the Genesis II Knee System, and the Profix Knee System (tibial articular inserts, all polyethylene tibial bases, patellae, and flex-lok pegs).

There have been no changes in indications for use, design, or material property changes to any Geness, Genesis II, or Profix Knee System UHMWPE components that will be sterilized using the VHP® process. The VHP sterilization process uses hydrogen peroxide (H2O2) vapor for sterilization Genesis Knee System, Genesis II Knee System, and Profix Knee System components (tibial articular inserts, all polyethylene tibial bases, patellar, and flex-lok pegs) manufactured from UHMWPE using the Century SL VHP® Sterilizer. Sterilization is achieved by a series of H2O2 gas injections at deep vacuum set points. Aeration of the medical devices after sterilization is conducted by a series of chamber evacuations.

Acceptance Criteria and Study for Smith & Nephew UHMWPE Components Sterilization

This document describes the acceptance criteria and the study that demonstrates the Smith & Nephew UHMWPE Components of the Genesis, Genesis II, and Profix Knee Systems meet these criteria after being sterilized with the VHP® Sterilization Process.

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the VHP® sterilization process is its ability to achieve a Sterility Assurance Level (SAL) of at least 10⁻⁶ for the UHMWPE components.

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for the "numerous tests" conducted. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set in the context of validating the sterilization process. The ground truth for sterilization is typically established through recognized microbiological methods and standards, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method

Not applicable. Adjudication methods are typically used in studies involving subjective assessment (e.g., medical image interpretation) where multiple readers might have differing opinions. For sterilization validation, the results are generally objective and based on established laboratory protocols.

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

Not applicable. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, not for validating a sterilization process.

6. Standalone Performance (Algorithm Only)

This study focuses on the standalone performance of the VHP® sterilization process itself, without human intervention during the sterilization cycle. The performance metrics reported directly reflect the capabilities of the process to achieve sterility. The statement, "Test results demonstrated that the VHP® sterilization process is capable of terminally sterilizing UHMWPE orthopaedic implants and verifies achievement of a SAL of 10," confirms its standalone capability.

7. Type of Ground Truth Used

The ground truth used for this study is based on microbiological efficacy testing and sterility assurance level (SAL) determination. This involves standardized methods to challenge the sterilization process with known microbial loads and evaluate its ability to eliminate them to a specified probability (10⁻⁶ in this case). This is an objective, science-based ground truth.

8. Sample Size for Training Set

Not applicable. This is not a study involving machine learning or AI where a "training set" would be used. The "training" for the VHP® sterilization process refers to the development and optimization of the sterilization cycle parameters, which is a process engineering activity rather than an AI training process.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no "training set" in the AI sense for this type of study. The development of the VHP® sterilization process and its parameters would have relied on iterative testing and validation using microbiological indicators and standard sterility testing protocols to ensure efficacy and reproducibility. These protocols establish the "ground truth" for effective sterilization parameters.

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