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The OrthoGlide Lateral Knee Implant is intended for use in the osteoarthritic knee, where substantial amounts of cartilage have been lost as a result of the disease. The device is indicated for uncemented use in the treatment of moderate degeneration of the lateral compartment of the knee (grade II-IV chondromalacia) with no more than minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the medial and patellofemoral compartments in patients with osteoarthritis.

The OrthoGlide Lateral Knee Implant is placed in the lateral compartment of the knee between the tibial plateau and femoral condyle by means of minimally invasive surgery. The instruments are intended to aid in the surgical preparation of the implant site and implant placement. The OrthoGlide is made of a Cobalt-Chrome-Molybdenum Alloy. Device geometry and ligament tension combine to keep the implant in place. The implant covers the lateral tibial plateau. The device is designed to improve the alignment of the knee, returning the joint to a less valgus position. Realignment of the knee distributes the weight-bearing forces across the joint and helps restore the normal relationships of the articular surfaces and the surrounding capsular, ligamentous and muscular structures. The device is designed to help relieve pain by providing an articulating surface with a low coefficient of friction and high durability. Device geometry improves knee alignment and joint spacing. The device surface is smooth and when wet, is intended to mimic the lubricious surface previously provided by the articular cartilage.

The advanced Bio-Surfaces, Inc. OrthoGlide® Lateral Knee Implant did not undergo clinical studies with acceptance criteria and measured performance in the traditional sense as this was a 510(k) premarket notification for a Class II medical device. The device was found substantially equivalent to predicate devices based on non-clinical testing.

Here's a breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this was a 510(k) submission based on substantial equivalence to predicate devices, there isn't a direct "acceptance criteria" table with measured performance like in a clinical trial. Instead, the "acceptance criteria" revolved around demonstrating that the device performed similarly to the predicates and met established standards through bench and cadaver testing.

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

• Sample Size for Test Set:
  • Bench Testing: Not specified in terms of number of samples, but implied to be sufficient to demonstrate the listed physical attributes and durability.
  • Cadaver Testing: Not specified in terms of the number of cadavers used.
• Data Provenance: The data is from non-clinical testing (bench and cadaver studies) conducted by Advanced Bio-Surfaces, Inc. The document does not specify the country of origin for the cadavers or the exact location of the bench testing facilities, but the manufacturer is based in Minnetonka, MN, USA. The studies are by nature prospective for the device's design verification and validation.

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

This type of information is generally not applicable to non-clinical bench and cadaver testing for medical devices, particularly for a 510(k) submission not involving clinical data. The "ground truth" for bench testing would be defined by the specifications and standards (e.g., ISO, EN) the device is tested against. For cadaver testing, the "ground truth" would be the successful execution of the surgical technique and observation of desired physiological effects by medical professionals/surgeons involved in the cadaver labs.

The document does not mention the number or qualifications of experts involved in the cadaver evaluations.

4. Adjudication Method for the Test Set

Not applicable, as this was not a clinical study requiring adjudication of expert opinions on patient outcomes. The evaluation of bench and cadaver tests would be based on objective measurements and observations against pre-defined criteria.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not used to determine substantial equivalence." and "The OrthoGlide as well as the predicates are submitted without clinical information."
• Effect Size: Not applicable, as no MRMC study was conducted.

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

Not applicable. The OrthoGlide® Lateral Knee Implant is a physical implant, not an AI algorithm. Therefore, "standalone" performance in the context of AI is not relevant. The performance of the implant itself is assessed through the bench and cadaver testing described.

7. Type of Ground Truth Used

• Bench Testing: Engineering specifications, material standards (e.g., tensile strength, fatigue limits), and international voluntary standards (e.g., ISO 10993 for biocompatibility, EN550 for sterility).
• Cadaver Testing: Direct observation and measurement of surgical technique execution, instrument fit, knee stability, and range of motion on cadaveric specimens, likely by surgical experts or engineers.

8. Sample Size for the Training Set

Not applicable. As a physical implant, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering development and testing.

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

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

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The ConforMIS, Inc., BiCompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only a single knee compartment, such as a unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to:

• painful joint disease due to osteoarthritis, traumatic arthritis or . rheumatoid arthritis of the knee
• post traumatic loss of joint function .
• . failed osteotomies, hemiarhtoplasties and unicondylar implants.
  The BiCompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofcmoral areas have been affected by one or more of these conditions.
  The ConforMIS, Inc., BiCompartmental Knee Repair System is intended only for use with bone cement.

The ConforMIS, Inc., BiCompartmental Knee Repair System is a femorotibial semi-constrained total knee implant. The design of the product incorporates a bone preserving approach, with minimal bone resection, for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. It is intended for use in those patients whose condition cannot be appropriately and effectively addressed using a device that treats only a single knee compartment (i.e. a unicondylar or patellofemoral prosthesis), when the medial or lateral condyle and the patellofemoral regions are affected. Using patient imaging (either CT or MRI scans), a patient specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. The device is manufactured from cobalt chromium molybdenum alloy (ASTM-F-1537) from data obtained from images of the patient's individual geometry obtained using either CT or MRI scans. The tibial and patellar components are manufactured from Ulta-High Molecular Weight Polyethylene ("UHMWP" ASTM-F-648) The ConforMIS, Inc., Implant Software is used to remove surface defects to produce a working design image of a smooth surface. Off the Shelf (OTS) software is utilized to produce the surface Subsequently, Solid Works OTS software is used to create the design. ConforMIS, Inc., Implant Engineering Drawing. The BiCompartmental Knee Repair System is intended for use in conjunction with the tibial components of the ConforMIS Unicondylar Knee Replacement System and the patellofemoral components of the ConforMIS Total Knee Repair System.

The provided text is a 510(k) Summary for the ConforMIS, Inc. BiCompartmental Knee Repair System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study that establishes acceptance criteria and proves the device meets those criteria through performance metrics.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to performance testing against specific acceptance criteria, which is not the primary purpose of a 510(k) substantial equivalence submission for this type of device.

Here's a breakdown of what can and cannot be derived from the provided text:

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

• Cannot be provided. The document states that the device is "substantially equivalent to FDA-approved predicate devices with regard to indications for use and technological characteristics." It does not present specific acceptance criteria (e.g., in terms of biomechanical performance, wear rates, etc.) or report detailed performance data against such criteria. The "performance" assessment is based on comparison to predicate devices, not on a standalone performance study with defined acceptance metrics.

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. This document does not describe a clinical or performance test set. It refers to patient imaging (CT or MRI scans) being used to design patient-specific implants, but this is part of the manufacturing process, not a test set for evaluating the device's overall performance against acceptance criteria.

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. There is no mention of a test set with ground truth established by experts.

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

• Cannot be provided. No test set or 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:

• Not applicable. This device is a knee implant, not an AI diagnostic tool that assists human readers.

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

• Not applicable. This device is a knee implant. While "ConforMIS, Inc., Implant Software is used to remove surface defects to produce a working design image of a smooth surface," this software is part of the design and manufacturing process, not a standalone diagnostic algorithm whose performance would be assessed in this manner.

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

• Cannot be provided. There is no mention of ground truth as part of a performance study.

8. The sample size for the training set:

• Cannot be provided. The document refers to "patient imaging (either CT or MRI scans)" being used to design the implant, suggesting individual patient data for custom manufacturing, not a "training set" in the context of an AI/ML algorithm development.

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

• Cannot be provided. No training set or ground truth establishment is described.

Summary of what can be extracted related to the device:

The ConforMIS, Inc. BiCompartmental Knee Repair System is a Class II medical device (NPJ) intended for use in patients with severe knee joint pain and disability due to conditions like osteoarthritis, traumatic arthritis, or rheumatoid arthritis, where a single-compartment prosthesis is insufficient. It is a patient-specific implant designed using CT or MRI scans of the patient's knee. The device is manufactured from cobalt chromium molybdenum alloy, with tibial and patellar components from Ultra-High Molecular Weight Polyethylene and is intended for use with bone cement.

The 510(k) submission demonstrates substantial equivalence to predicate devices (listed in the table in section {1}) in terms of "indications for use and technological characteristics." The document states:

• "The technological characteristics of the ConforMIS, Inc., BiCompartmental Knee Repair System are substantially equivalent to those of the cited predicate orthonedic devices."
• "The image analysis is identical to that used for the Imaging Therapeutics Interpositional Device (iPD) and the ConforMIS Unicondylar Implant."
• "This device is equivalent in terms of design process, materials, production process, and equipment."

The regulatory path chosen for this device (510(k) substantial equivalence) means that the testing and validation focus on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo performance data against a set of newly defined acceptance criteria. The FDA's letter (Section {4} and {5}) confirms the substantial equivalence determination, allowing the device to be marketed.

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The ConforMIS™ Unicondylar Knee System is intended for use in Patients with:

• joint impairment due to osteoarthritis or traumatic arthritis of the knee
• Previous tibial condyle or plateau fracture, creating loss of function
• valgus or varus deformity of the knee
  The ConforMIS™ Unicondylar Knee System is for use with cement.

The ConforMIS Unicondylar Knee System is a device developed from patient CT scans to replace one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and allows internal/external rotation between the femoral and tibial components. Movement is limited by the ligaments and other soft tissues surrounding the device. The device is designed to conform to the patient's anatomy as closely as possible based on the CT scans.

The provided document describes the ConforMIS™ Unicondylar Knee Repair System, a custom-designed knee implant. However, it does not contain specific acceptance criteria, performance data from a clinical study, or details about the methodology of such a study.

Here's an breakdown of the information that is available and what is missing based on your request:

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

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: Not reported in the document. The document states: "Performance Data: Non-clinical Performance and Conclusions: Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System found this device to be as safe and effective as the predicate devices, further confirming substantial equivalence. Clinical Performance: Clinical data and conclusions are not necessary to demonstrate substantial equivalence."

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

• Not Applicable. No clinical test set data is provided.

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. No clinical test set data is provided, and therefore no ground truth establishment based on expert review.

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

• Not Applicable. No clinical test set data is provided.

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 physical knee implant, not an AI/software device intended for diagnostic interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. No clinical study involving ground truth establishment is described.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. It is "developed from patient CT scans to replace one compartment of the knee condyles" and "designed to conform to the patient's anatomy as closely as possible based on the CT scans." While patient CT scans are used for designing the individualized implant, this is not a "training set" in the context of an AI algorithm, and no sample size for such a set is mentioned.

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

• Not Applicable. As above, there is no "training set" in the AI sense for which ground truth would be established. The "ground truth" for the device design is the individual patient's anatomy derived from their CT scans.

Summary of the Study (as described in the document):

The document explicitly states: "Clinical data and conclusions are not necessary to demonstrate substantial equivalence." Instead, the submission relies on:

• Non-clinical Performance and Conclusions: "Testing completed as part of the design verification procedure for the ConforMIS Unicondylar Knee System found this device to be as safe and effective as the predicate devices, further confirming substantial equivalence." This refers to non-clinical (e.g., bench, mechanical) testing, but no specific results or acceptance criteria for this testing are provided.
• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through a comparison to legally marketed predicate devices (K033242, K033363, K033769). The ConforMIS™ Unicondylar Knee System is deemed substantially equivalent in terms of technological characteristics (design, production process, materials) and intended use.

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