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The KeYi Total Knee System indications for use are:

· Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis) or rheumatoid arthritis.

• · Correction of functional deformities.
• · Post-traumatic loss of knee joint configuration and function.
• · Moderate valgus, varus, or flexion deformity.
• · Knee fractures untreatable by other methods.

The KeYi Total Knee System is indicated for cemented use only.

The KeYi Total Knee System is a fixed-bearing, posterior stabilized (PS) arthroplasty device. It is a patellofemorotibial, polymer, semi-constrained, cemented knee prosthesis that consists of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, ultra-highmolecular-weight polyethylene (UHMWPE) tibial insert, titanium (Ti) alloy tibial baseplate and UHMWPE patellar component. The device has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component.

The provided text describes the 510(k) summary for the KeYi Total Knee System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data from mechanical and material testing, rather than clinical study data from an AI/imaging device.

Therefore, the requested information regarding acceptance criteria and a study proving device performance for an AI/imaging device (which would involve concepts like sensitivity, specificity, expert readers, ground truth, etc.) is not applicable to this document.

The document discusses mechanical and material performance data for the knee implant, which are proven through engineering tests against established ASTM and ISO standards for orthopedic implants.

Here's a breakdown of what is present in the document related to "acceptance criteria" and "proof of meeting criteria," reinterpreted for a physical medical device:

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

The document doesn't present a table in the exact format requested for AI, but it lists the types of mechanical tests performed, implying that the device met the corresponding acceptance criteria defined by the relevant ASTM and ISO standards.

The following points (2-9) are not applicable in the context of this device submission (a knee implant) and its associated performance testing (mechanical). They are relevant for AI/imaging device studies.

2. Sample size used for the test set and the data provenance: Not applicable. For mechanical tests, the "sample size" refers to the number of physical samples of the implant components tested. The provenance is internal lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical properties is established by engineering specifications and physical measurements, not human expert consensus.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth is derived from engineering design specifications and established material/mechanical properties standards.

8. The sample size for the training set: Not applicable. This concept mainly applies to machine learning models.

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

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The NEO™ PS Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with excised posterior cruciate ligament, undergoing surgery for total knee replacement due to:
. Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
. Failed osteotomies, partial knee replacement, or failed prior total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
. Moderate valgus, varus, or flexion deformities.
NEO™ PS Total Knee System components are indicated for use only with cement and are single use devices.

The NEO PS Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation:
The Neo PS Knee System femoral component, when used with the Neo PS articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The provided text describes a medical device, the NEO PS Knee System, and its clearance process through the FDA's 510(k) pathway. This pathway establishes substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials with defined acceptance criteria. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of diagnostic accuracy or performance, is not directly applicable to this submission.

However, based on the provided document, we can infer the "acceptance criteria" and "study" in the context of a 510(k) submission as demonstrating substantial equivalence to predicate devices through various performance tests.

Here's an analysis of the information that can be extracted or reasonably inferred from the document:

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

Since this is a 510(k) submission for a knee implant, the "acceptance criteria" are not reported as specific statistical thresholds for diagnostic accuracy (e.g., sensitivity, specificity). Instead, they are implied to be achieving comparable or acceptable performance in mechanical and functional tests as benchmarked against predicate devices and relevant industry standards.

• Tibial tray fatigue strength
• Insert locking mechanism strength
• PS post strength |
  | Functional Range of Motion (comparable to predicate devices and patient needs) | Evaluated for:
• Femorotibial range of motion
• Femorotibial range of constraint
• Patellofemoral range of constraint |
  | Contact Mechanics (comparable to predicate devices to minimize wear and stress) | Evaluated for:
• Femorotibial contact areas/contact stress
• Patellofemoral contact area and contact stress |
  | Material Compliance (meeting established biomedical standards) | "The metals and standard UHMWPE material from which the components are manufactured are the same materials used in the predicate knee systems and comply with applicable implantable materials standards." |
  | Overall Substantial Equivalence | "All evaluations determined that the NEO PS Knee System is substantially equivalent to the predicate devices." |

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

• Sample Size for Test Set: Not applicable in the context of a clinical test set for diagnostic performance. The "test set" here refers to the physical devices undergoing various mechanical and material tests. The specific number of physical samples tested for each mechanical test is not disclosed in this summary.
• Data Provenance: The tests are likely conducted in a controlled laboratory environment by the manufacturer (Pipeline Orthopedics) or a contract testing laboratory. The country of origin for these tests is not specified but is presumably the US, where the company is based. The data would be considered prospective in the sense that the tests are designed and performed to evaluate the new device's characteristics.

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

This information is not applicable to this type of submission. "Ground truth" in the context of a 510(k) for a medical implant refers to established engineering principles, material standards, and the performance characteristics of legally marketed predicate devices. The "experts" involved are likely biomechanical engineers, material scientists, and regulatory experts who interpret test results against these standards and predicate device data. The document does not specify the number or detailed qualifications of such experts involved in the testing or the substantial equivalence determination beyond the general regulatory process.

4. Adjudication method for the test set:

This concept is not applicable here. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations of medical data (e.g., image readings). For a medical implant's mechanical testing, the "adjudication" is inherent in the test protocols themselves, the calculation of results, and the comparison against predefined acceptance criteria or predicate device performance. Any discrepancies would relate to test execution or interpretation which would be resolved through standard engineering and quality control procedures.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. An MRMC study is relevant for diagnostic devices (e.g., imaging software) where human interpretation is involved and improved with AI assistance. The NEO PS Knee System is a joint implant, not a diagnostic tool.

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

This is not applicable. This question pertains to AI/algorithm performance. The NEO PS Knee System is a physical knee implant.

7. The type of ground truth used:

The "ground truth" for this 510(k) submission is primarily established through:

• Predicate Device Performance: Benchmarking against the mechanical and functional characteristics of the legally marketed predicate devices (NEO CR Knee System, NexGen® LPS-Flex Knee System, Triathlon PS Knee System).
• Industry Standards: Compliance with "applicable implantable materials standards" (e.g., ASTM, ISO standards for biocompatibility, mechanical properties, etc., though not explicitly named).
• Engineering Principles: The tests conducted (fatigue, strength, ROM, contact stress) are based on established biomechanical and engineering principles to ensure the device can withstand anticipated physiological conditions.

8. The sample size for the training set:

This is not applicable. A "training set" refers to data used to train an AI algorithm. The NEO PS Knee System is a physical implant.

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

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

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The Balanced Knee® System High Flex PS is intended for use in cemented total knee arthroplasty procedures.

Total knee arthroplasty is indicated for the following conditions:

1. Loss of knee joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The Balanced Knee System High Flex PS (High Flex PS) is designed to accommodate increased range of motion up to 150° of flexion. The High Flex PS includes a highly polished Co-Cr-Mo PS femoral component and a compression molded UHMWPE PS tibial insert component. The High Flex PS femoral and insert components may be used in conjunction with the Balanced Knee System (BKS) standard and modular tibial trays, tibial augments, stems, and patellae to complete the semi-constrained modular knee prosthesis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Balanced Knee System High Flex PS, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a 510(k) premarket notification for a medical device (a knee replacement prosthesis). The "Performance Data" section primarily focuses on mechanical testing results rather than clinical study data from a "test set" of patients.

• Test Set Sample Size: Not applicable in the context of clinical patient data. The sample sizes for the mechanical tests (e.g., number of components tested for fatigue) are not specified in the provided summary.
• Data Provenance: Not applicable for patient data. The "Performance Data" describes laboratory mechanical testing of the device components.

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

Not applicable. As described above, this document refers to mechanical testing for device performance, not clinical studies requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or expert consensus for adjudication.

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

No. This document does not mention or describe a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the mechanical equivalence of a knee prosthesis to predicate devices.

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

Not applicable. This is a physical medical device (knee prosthesis), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering and biomechanical principles, and the performance characteristics of predicate devices. The device's performance is compared against:

• Mechanical benchmarks: Sufficient strength for in-vivo loading for fatigue tests.
• Predicate device characteristics: Similarity in range of motion, constraint, and contact areas to the Balanced Knee System (BKS) and LPS-Flex predicate devices.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device and its mechanical testing, not a machine learning model requiring a training set.

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

Not applicable. As this is not a machine learning context, there is no "ground truth for the training set." The performance
evaluation relies on mechanical testing against defined standards and comparison with predicate device characteristics.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  This device is intended for cemented use only.

The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.

This document describes the non-clinical performance testing for the Zimmer® Persona™ Personalized Knee System, a semi-constrained modular knee prosthesis. Since this is a medical device (knee implant) rather than an AI/software device, many of the requested fields (multi-reader multi-case study, ground truth establishment, training set details) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly demonstrating "sufficient" or "adequate" strength/wear/constraint, or being "comparable" to predicate devices. The "Test Results" column describes how the device performance met these implicit criteria.

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

The document does not explicitly state the sample sizes for each mechanical test. These "tests" are non-clinical (laboratory-based mechanical and wear simulations) rather than using patient data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) is not applicable here as these are not studies involving human subjects or patient data.

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

Not applicable. This is a medical device, not an AI/software device that requires expert ground truth for its performance evaluation. The "ground truth" for these tests is based on established engineering principles, industry standards (e.g., ISO 14243), and comparison to predicate devices, not expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is non-clinical mechanical testing, not a clinical study requiring human 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. This is a physical medical device (knee implant), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are not relevant.

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

Not applicable. As this is not an AI/software device, the concept of a "standalone algorithm" is not relevant. The device itself (the knee implant) is the "standalone" item being tested in these non-clinical performance studies.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance tests is based on:

• Industry Standards: For instance, wear testing was conducted "Under Load and Motion Curves From the ISO 14243 Standard."
• Established Engineering Principles: Tests like fatigue, static shear strength, and contact mechanics rely on well-known engineering material and biomechanical principles.
• Predicate Device Performance: Many tests established comparability to existing, legally marketed predicate devices (e.g., NexGen articular surfaces, NexGen predicate devices). The performance of these predicate devices, which have a history of safe and effective use, serves as a benchmark or "ground truth" for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device (knee implant), not a machine learning or AI algorithm. There is no concept of a "training set" for the device itself.

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

Not applicable, as there is no training set for this type of device.

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This device is indicated for patients with severe knee pain and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities, the salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

This device is intended for cemented use only.

Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90prefix 17 or 20mm Prolong™ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

The NexGen Knee GSF Femoral Components include both LPS-Flex GSF and CR-Flex GSF versions and are part of the Zimmer Flex-series of semiconstrained, nonlinked, condylar knee prostheses that are designed to have a maximum active flexion of 155 degrees. The GSF designation indicates that the design of the femoral component has been modified slightly to address specific anatomic features of the distal femur that can be seen in both male and female patients, but are more typical of a female patient.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NexGen® Knee Gender Solutions Female (GSF) Femoral Components:

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: Not applicable. The submission explicitly states "Clinical data and conclusions were not needed for this device." The primary evaluation relied on non-clinical testing (mechanical testing and Finite Element Analysis) and comparison to predicate devices, rather than a clinical test set with human subjects.
• Data Provenance: Not applicable for a human subject test set. The data provenance for the non-clinical mechanical testing and Finite Element Analysis would be internal laboratory data generated by Zimmer, Inc.

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

• Not applicable. No human subject test set was used, and therefore no ground truth established by experts in this context.

4. Adjudication method for the test set

• Not applicable. No human subject test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a total knee prosthesis, not an AI-assisted diagnostic tool or imaging device that would involve human readers.

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

• Not applicable. This device is not an algorithm or software. The "standalone" performance here refers to the mechanical and analytical performance of the physical device components, which was assessed through non-clinical testing.

7. The type of ground truth used

• The implicit "ground truth" for the performance evaluation of this medical device is the established performance and safety characteristics of its predicate devices (NexGen LPS-Flex Knee and NexGen CR-Flex femoral component). The device is deemed safe and effective if it can demonstrate substantial equivalence to these legally marketed predicates through mechanical testing and component analysis.

8. The sample size for the training set

• Not applicable. This device is a physical implant, not an AI algorithm that requires a training set. The "training" in product development would refer to engineering design, CAD modeling, and material selection based on established bio-mechanical principles and previous device designs.

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

• Not applicable. As noted above, this isn't an AI device with a training set. The design was informed by the established anatomical features and performance of prior generations of knee prostheses, particularly those with modifications for "female" anatomical characteristics. The "ground truth" for its design would be anatomical data, biomechanical principles, and the performance history of existing devices.

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Total knee components are 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. Smith & Nephew, Inc. High Performance Knee components are indicated for use only with cement and are single use devices.

The High Performance Knee consists of femoral, tibial insert and patellar components to be used with existing Genesis II tibial trays. The High Performance Knee is a total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range.

The provided text describes a medical device, the "High Performance Knee," and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria for a study, a study that proves the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in such a study.

The document is a summary of safety and effectiveness, along with the FDA's 510(k) clearance letter. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document explicitly states:

"A review of the mechanical test data indicated that the High Performance Knee is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."

This statement implies that mechanical testing was performed, but it does not provide the specific "acceptance criteria" for that testing, the detailed "reported device performance" against those criteria, or any of the other study details requested. The focus is on demonstrating equivalence, not on a new performance study with independent acceptance criteria.

Missing Information:
All requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC studies, or standalone performance is not present in the provided text.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  The device is indicated for use when both cruciate ligaments have been excised.
  The device is intended for use as part of a cemented or uncemented knee prosthesis.

The NexGen LPS-Flex Prolong articular surfaces are part of the NexGen system of semiconstrained,

The provided document describes a 510(k) premarket notification for a medical device, specifically NexGen® Complete Knee Solution LPS-Flex Prolong™ Highly Crosslinked Polyethylene Articular Surfaces. The document focuses on demonstrating substantial equivalence to predicate devices rather than a de novo study with explicit acceptance criteria and performance data.

Therefore, many of the requested categories (2-9) are not directly applicable or explicitly stated in this type of submission which primarily relies on equivalence to devices already on the market.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a 510(k), which asserts substantial equivalence to predicate devices rather than establishing new performance acceptance criteria and showing performance against them in a de novo study. The "Performance Data" section explicitly states "Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

Therefore, a table of explicit acceptance criteria and reported device performance, as one would see in a de novo study, is not provided in this type of submission. The 'acceptance criterion' for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate. The 'performance' is therefore inherently linked to the performance of the predicate device.

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

Not applicable. No dedicated "test set" or clinical study with a prospectively collected sample size is described as clinical data was not needed. The non-clinical performance refers to design assurance testing, which would typically involve laboratory testing, not a clinical test set. The provenance of such non-clinical data would be internal lab reports.

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

Not applicable. As clinical data and a test set requiring ground truth establishment by experts were not needed or presented, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

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

Not applicable. No clinical study, let alone an MRMC study comparing human readers with or without AI assistance, was performed or presented for this 510(k) submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical knee prosthesis component, not an algorithm or AI. Therefore, a standalone performance study in the context of an algorithm's performance is not relevant.

7. Type of Ground Truth Used

Not applicable, as no external "ground truth" for a clinical assessment was required. The "truth" in this context is established through engineering and material science testing that demonstrates the physical properties and performance characteristics (e.g., wear, strength) of the device are equivalent to the predicate.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.

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This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also indicated for the revision of knee prosthesis. The HLS NOETOS cemented system with fixed tibial bearing is intended for cemented use only.

The HLS NOETOS System is intended for use as a total knee replacement system sacrificing the cruciate ligaments. The HLS NOETOS System provides the flexibility needed to adapt the therapentic solution to the patients need. All the type of implants have been designed with the same objectives: to restore the joint line both in flexion and in extension without altering the patellar height. to restore the articular morphology and to preserve bone stock. The design of the implant, particularly the tibial one, guarantees the antero-posterior stability, by a third femoral condyle that engages a tibial cam during flexion. The HLS NOETOS System consists of the association of three components: a femoral component, a tibial tray associated with a polyethylene bearing and a polyethylene patella can be preserved if it is in good state or resurfaced by the patellar implant.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

This document is a 510(k) premarket notification for a medical device (HLS NOETOS System). The primary purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its clinical effectiveness through detailed performance studies with acceptance criteria in the way you've outlined.

The key aspects of this document are:

• Device Description: What the HLS NOETOS System is, its components, and materials.
• Intended Use/Indications: The conditions for which the device is designed (e.g., total knee replacement for osteoarthritis).
• Comparison to Predicate Devices: This is the core of the 510(k). The document lists several predicate devices (ROTAGLIDE+, INSALL/BURSTEIN II, PFC Modular Total Knee System, NEX-GEN Complete Knee Solution LPS) and performs a side-by-side comparison of features like materials, fixation methods, indications for use, and compliance with standards. The "SE?" column likely stands for "Substantially Equivalent?".
• FDA Clearance: The letter from the FDA confirms that based on the submitted information, the HLS NOETOS System is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

While the document mentions compliance with ISO standards for materials (e.g., ISO 5832-4 for CoCr, ISO 5834-2 for UHMWPE), these are material specifications, not acceptance criteria for overall device performance in a clinical study.

Therefore, I cannot fill out your table or answer your specific questions about acceptance criteria, study details, sample sizes, expert ground truth, adjudication, or MRMC studies because this information is not present in the provided text. A 510(k) submission typically relies on a comparison to predicate devices, and often the clinical performance data (if any is required beyond equivalence) would be summarized in a much higher-level fashion or referenced rather than detailed in this specific type of public summary.

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