Search Results

RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

• Medial unicondylar
• Lateral unicondylar
• · Patellofemoral
• · Medial bi-compartmental (medial unicondylar and patellofemoral)

RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (RESTORIS™ MCK Uni) and a patellofemoral implant system (RESTORISTM MCK PF).

• RESTORIS™ MCK Uni: ●
  • o Unicompartmental femoral condyle components
  • Unicompartmental tibial onlay components (tibial baseplate and tibial o onlay insert)
  • Unicompartmental tibial inlay components o
• RESTORISTM MCK PF: o
  • o Patellofemoral trochlear components
  • o Patella components

The RESTORIS™ MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In RESTORIS™ MCK combinations where multicompartmental areas are being treated, the RESTORIS™ MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.

The provided document describes the RESTORIS™ Multicompartmental Knee (MCK) System, but it is a 510(k) summary for a medical device modification, not a study evaluating an AI algorithm's performance. Therefore, the acceptance criteria and study detailed in the document are for the mechanical performance and safety of the knee implant device itself, not for an AI device.

Many of the requested points, such as "Sample size used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details," are specific to the evaluation of AI algorithms. This document does not contain information relevant to those points because it is about a physical medical implant.

However, I can extract the information related to the performance data and conclusions for the RESTORIS™ Multicompartmental Knee (MCK) System as described in the 510(k) submission.

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding reported performance values for each test. Instead, it lists the types of nonclinical performance tests conducted and states a general conclusion that the device performed "within the intended use" and "did not raise any new safety and efficacy issues."

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

This information is not provided in the 510(k) summary. Nonclinical performance testing for medical implants typically involves a certain number of test samples (e.g., several implants for fatigue testing, a few for micromotion), but the exact sample sizes are not detailed here. "Data provenance" such as country of origin or retrospective/prospective is not applicable in the context of mechanical device testing described.

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 the mechanical testing of a knee implant and is not provided in the document. Ground truth as typically understood for AI algorithms (e.g., expert labels on images) is not relevant to this type of device submission.

4. Adjudication method for the test set:

Not applicable. Adjudication methods are typically used for establishing ground truth in expert-dependent evaluations, especially for AI or diagnostic devices. This document describes physical device testing.

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 not an AI device, and therefore no MRMC study was performed. The device, the RESTORIS™ Multicompartmental Knee (MCK) System, is referred to as being used "in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System," but the 510(k) is for the implant itself, and it doesn't describe an AI algorithm that assists human readers.

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

Not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used:

For mechanical performance testing of an implant, "ground truth" would be the engineering specifications, industry standards, and established biomechanical principles against which the device's performance is measured. The document implies compliance with these standards through its statement of "satisfactory results" and "performance characteristics adequate to withstand anticipated physiological loading."

8. The sample size for the training set:

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

Ask a specific question about this device

RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multicompartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

• Medial unicondylar
• · Lateral unicondylar
• · Patellofemoral
• · Medial bi-compartmental (medial unicondylar and patellofemoral)

RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (RESTORIS™ MCK Uni) and a patellofemoral implant system (RESTORISTM MCK PF).

• RESTORIS™ MCK Uni: .
  • Unicompartmental femoral condyle components o
  • Unicompartmental tibial onlay components (tibial baseplate and tibial onlay o insert)
  • Unicompartmental tibial inlay components 0
• RESTORIS™ MCK PF: .
  • Patellofemoral trochlear components o
  • Patella components o

The RESTORIS™ MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In RESTORIS™ MCK combinations where multi-compartmental areas are being treated, the RESTORIS™ MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.

The provided document, a 510(k) summary for the RESTORIS™ Multicompartmental Knee (MCK) System, describes the device and its intended use, but it does not contain information related to acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document states that the device has been evaluated through "non-clinical performance testing" for various aspects, and concludes that "The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices." However, it does not specify what these performance criteria were, what the acceptance thresholds for these criteria were, or the detailed results demonstrating that these criteria were met.

Therefore, I cannot populate the table or answer the specific questions posed, as the information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices rather than presenting detailed clinical or performance study results against predefined acceptance criteria.

Key takeaway: This document does not pertain to an AI/ML powered device, so acceptance criteria and study design as outlined in the prompt are not applicable to the information provided.

Ask a specific question about this device

The ConforMIS iDuo Bicompartmental Knee Repair System (iDuo KRS) 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 unicondylar or patellofemoral prosthesis. The indications for use including 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, hemiarthroplasties and unicondylar implants
  The iDuo KRS may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of these conditions. The iDuo KRS is intended for cemented use only.

The iDuo KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component (patellar component packaged separately). The product design 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 or effectively addressed using a device that treats only a single knee compartment (i.e. a unicompartmental or patellofemoral prosthesis) when the medial or lateral condyle and the patellofemoral regions are affected. Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The device is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. Two tibial components are offered: a single-piece all polyethylene tibial component manufactured from ultra-high molecular weight polyethylene ("UHMWPE") or a two-piece metal-backed tibial component which includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert manufactured from UHMWPE. The patellar component is manufactured from UHMWPE.

The provided text describes a 510(k) summary for a medical device, the ConforMIS® iDuo® Bicompartmental Knee Repair System (iDuo® KRS). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria through device performance.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document.

Here's a breakdown of the information that can be extracted and what is missing:

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

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

• Sample Size for Test Set: Not applicable. No clinical or standalone performance test set is described. The submission focuses on non-clinical laboratory testing for substantial equivalence.
• Data Provenance: Not applicable. The "nonclinical laboratory testing" details are not 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 with human-established ground truth is described.

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

• Not applicable. No clinical test set 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 repair system (implant), not an AI diagnostic tool. No MRMC study or AI component is mentioned.

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

• Not applicable. This is an implantable medical device, not a standalone algorithm. The submission mentions "patient imaging (either CT or MR scans)" being used to design the patient-specific implant, but this is part of the manufacturing process, not an algorithm's standalone performance evaluation in the context of diagnostic accuracy.

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

• Not applicable. No ground truth for device performance in a clinical or diagnostic context is detailed in this 510(k) summary. The basis for substantial equivalence was "a detailed device description" and "nonclinical laboratory testing."

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" in the context of machine learning or AI for this device. The device itself is patient-specific, designed using patient imaging, but this is a design input, not a "training set" for an algorithm being evaluated.

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

• Not applicable. As above, no training set is described in the context of this device's submission.

Ask a specific question about this device

The Smith & Nephew, Inc. Journey Select Knee System is intended to be used for those patients whereby conditions exist that may not be solely addressed by a device that treats a single compartment. The Journey Select Knee System is intended to replace the patellofemoral and either the medial or lateral condyle of the knee joint in patients where there is evidence of sufficient sound bone to seat and support the components. Indications include:

1. Post-traumatic arthritis;
2. Degenerative arthritis; and
3. Failed osteotomies and unicompartmental replacement.
   These indications will be used for the Journey Select Knee System, whereby a single condyle and patellofemoral regions of the knee have been affected by one or more of these conditions. The implant devices of the Smith & Nephew, Inc. Journey Select Knee System are single use only and are intended for implantation only with bone cement.

The Smith & Nephew, Inc. Journey Select Knee System is composed of existing unicompartmental femoral components, patellofemoral implant components, and unicompartmental tibial components previously cleared by FDA. These components may be used in various combinations to create a bicompartmental knee replacement prosthesis and allow the physician to choose the most appropriate option to treat the patient.

This document is a 510(k) premarket notification for the "Smith & Nephew, Inc. JOURNEY Select Knee System." It is a submission for a medical device that aims to demonstrate substantial equivalence to previously cleared devices, rather than establishing acceptance criteria and proving performance through a study in the same way one would for a novel device with a new intended use.

Here's an analysis based on the provided text, addressing your questions to the best of my ability given the nature of a 510(k) summary:

The core of this document is a claim of "Substantial Equivalence," not a study proving the device meets specific performance acceptance criteria via a clinical trial or algorithm performance study. The device is a combination of existing components already cleared by the FDA.

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and the results of a performance study proving adherence to them are not explicitly detailed in the provided text in the manner you might expect for a novel device. Instead, the "performance" is demonstrated through substantial equivalence to predicate devices and mechanical testing.

Regarding Questions 2-7, 8, 9, these types of studies and details are generally not part of a 510(k) submission for substantial equivalence based on mechanical testing and existing components.

• No clinical study to establish these points was conducted for this 510(k) submission. The entire premise of a 510(k) is to demonstrate that a new device is as safe and effective as an already legally marketed device (the predicate).

Specifically:

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 for this type of 510(k) submission, as it relies on mechanical testing of components and equivalence to existing devices, not a clinical "test set" of patient data.

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 as typically defined for diagnostic or prognostic devices (e.g., expert interpretation of images) is not relevant here. The ground truth for this device's safety and effectiveness is established by the prior FDA clearances of its individual components and the predicate devices.

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

• Not applicable. No clinical test set with adjudicated outcomes or diagnoses was 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 prosthesis system, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a knee prosthesis system, not an algorithm.

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

• The "ground truth" in the context of this 510(k) is effectively the prior FDA clearance and established safety/effectiveness profiles of the individual components and the predicate devices. Mechanical testing also serves as an engineering "ground truth" for the device's physical capabilities.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this 510(k) for a knee prosthesis system.

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

• Not applicable.

In summary: The provided document is a 510(k) premarket notification for a new combination of existing, cleared components for a knee prosthesis system. The "proof" it meets acceptance criteria (primarily safety and effectiveness) is primarily through demonstrating substantial equivalence to predicate devices that are already legally marketed and through mechanical testing showing the integrated system can withstand expected in-vivo loads. It does not involve a clinical efficacy study with patient data, expert ground truth, or AI performance metrics as would be seen for a diagnostic or prognostic device or a novel therapeutic with new mechanism of action.

Ask a specific question about this device

RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

• Medial unicondylar
• Lateral unicondylar
• Patellofemoral
• Medial bi-compartmental (medial unicondylar and patellofemoral)
  RESTORIS MCK is for single use only and is intended for implantation with bone cement.

The Restoris MCK is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). Restoris MCK Uni and Restoris MCK PF may be used in various combinations to create: a single unicompartmental femorotibial replacement for the medial or lateral side of the knee; a patellofemoral replacement; or a bicompartmental patellofemorotibial replacement for the medial side of the knee. Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The provided document is a 510(k) summary for the MAKO Surgical Corp. Restoris MultiCompartmental Knee System (Restoris MCK). This document describes the device, its components, materials, and intended use, and states its substantial equivalence to a predicate device.

However, it does not contain any information regarding specific acceptance criteria, performance data, or detailed study methodology (like sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, or MRMC studies) related to the device's clinical or algorithmic performance.

The document is a regulatory submission demonstrating substantial equivalence to a previously cleared device, not a report of performance testing against predefined acceptance criteria from a study.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on the text provided. The 510(k) summary focuses on the device description and its substantial equivalence to a predicate device, as opposed to a detailed performance study with specific metrics and acceptance criteria.

Ask a specific question about this device

The DePuy Graduated Compartmental Knee (GCK) is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

The GCK is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All GCK components are intended for CEMENTED USE ONLY.

The DePuy GCK is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create: a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee; two unicompartmental femorotibial replacements for both the medial and lateral sides of the knee; a patellofemoral replacement; a bicompartmental patellofemorotibial replacement for the medial or lateral side of the knee; or a tricompartmental patellofemorotibial replacement for the medial and lateral sides of the knee.

The GCK unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).

This submission describes design modifications to the previously cleared GCK unicompartmental femoral components and all polyethylene unicompartmental tibial components.

This document describes the 510(k) summary for the DePuy GCK Femoral and Tibial Components, focusing on design modifications to previously cleared components.

Table of Acceptance Criteria and Reported Device Performance

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not applicable. This submission relies on non-clinical testing (Finite Element Analysis) for substantial equivalence, not a clinical test set with patient data.
   • Data Provenance: Not applicable for a clinical test set. The Finite Element Analysis would be computational data generated based on design specifications and material properties.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Not applicable. As no clinical test set was used, no experts were involved in establishing ground truth for such a set. Substantial equivalence was primarily based on engineering analysis and comparison to predicate devices, which would have been reviewed by the FDA.

3. Adjudication Method for the Test Set:

   • Not applicable, as no clinical test set was evaluated.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done. Clinical testing was explicitly stated as "not necessary to determine substantial equivalence."

5. Standalone (Algorithm Only) Performance Study:

   • Not applicable. This device is a physical knee implant, not an algorithm or AI system. Its performance is assessed through engineering analysis (FEA) and equivalence to established predicate devices.

6. Type of Ground Truth Used:

   • Engineering-based equivalence: The "ground truth" for this submission is established through demonstrating that the modified components are substantially equivalent to previously cleared and clinically successful predicate devices, based on their design, materials, intended use, and simulated mechanical performance (Finite Element Analysis). There is no "ground truth" in the sense of clinical outcomes or pathology for this specific submission, as clinical testing was not conducted.

7. Sample Size for the Training Set:

   • Not applicable, as this is a physical medical device and not an AI or algorithm that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable.

Ask a specific question about this device

The DePuy Graduated Compartmental Knee (GCK) is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

The GCK is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All GCK components are intended for CEMENTED USE ONLY.

The DePuy GCK is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create a single or multicompartmental knee replacement prosthesis.

The GCK Unicompartmental Femoral Components are a modification of the Preservation® Unicondylar Femoral Components. They are manufactured from Co-Cr-Mo and are available in sizes 1-6 in left medial / right lateral and right medial / left lateral versions. The fixation surface is available with or without a beaded porous coating.

The GCK Patellofemoral Trochlear Components are a modification of the PFC Sigma® Femoral Components. They are manufactured from Co-Cr-Mo and are available in sizes 1-5 in left and right versions. The fixation surface is available with or without a beaded porous coating.

The GCK All Polyethylene Unicompartmental Tibial Components are a modification of the Preservation All Polyethylene Unicondylar Tibial Components. They are manufactured from XLK cross-linked polyethylene and are available in sizes 1-6, 5 thicknesses (8-12mm) and in left medial / right lateral and right medial / left lateral versions.

The patella components used with the GCK are the PFC Sigma Inset, Oval and Round Dome Patellae. These patellar components have been previously cleared for use in total knee arthroplasty.

I am sorry, but this document does not contain the information you are looking for. This is a 510(k) premarket notification for a medical device (DePuy Graduated Compartmental Knee), which establishes substantial equivalence to predicate devices. It does not describe an AI/ML device or a study evaluating its performance with acceptance criteria.

The document discusses:

• The device description (components, materials, modifications from existing products).
• Indications for use (for knee replacement in individuals with osteoarthritis, post-traumatic arthritis, or gout/pseudogout).
• Substantial equivalence to other legally marketed predicate devices.
• The FDA's decision to allow the device to be marketed.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, ground truth, study design, or expert involvement as these details pertain to the evaluation of an AI/ML medical device, which is not the subject of this 510(k) summary.

Ask a specific question about this device

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

Indications include:

• Post-traumatic arthritis;
• Degenerative arthritis; and
• Failed osteotomies, hemiarthroplasties; and unicompartmental replacement

These indications will be used for the Competitor Deuce femoral components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Competitor Deuce femoral components are single use only and are intended for implantation only with bone cement.

The components are used to replace the medial condyle and patellofemoral regions of a femoral knee joint. The Competitor Deuce femoral components will initially be available in both cobalt chrome and Oxinium. The overall design of the Competitor Deuce femoral components is based upon the existing Hybrid Knee femoral components and Competitor Duo femoral components subject of K042896 and K052265, respectively.

The provided document is a 510(k) summary for the Smith & Nephew Competitor Deuce Femoral Components. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth types) that would be typically associated with proving a device meets acceptance criteria in the context of an AI/software-as-a-medical-device (SaMD) study.

Instead, this document focuses on demonstrating substantial equivalence for a physical implantable device (a knee prosthesis component), primarily through mechanical and clinical data review, and comparison to predicate devices. It states: "A review of the mechanical and clinical data indicated that the Competitor Deuce femoral components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."

Therefore, I cannot populate the requested table and answer the questions related to acceptance criteria and study details for an AI/SaMD device, as this information is not present in the provided text.

Here's a breakdown of what is available and why the requested information isn't:

Information Available:

• Device Name: Competitor Deuce Femoral Components
• Manufacturer: Smith & Nephew, Inc. Orthopaedic Division
• Device Description: Components used to replace the medial condyle and patellofemoral regions of a femoral knee joint. Available in cobalt chrome and Oxinium. Design based on existing Hybrid Knee femoral components and Competitor Duo femoral components.
• Intended Use/Indications: For patients with conditions that cannot be solely addressed by single-compartment devices, including post-traumatic arthritis, degenerative arthritis, and failed osteotomies, hemiarthroplasties, and unicompartmental replacements, affecting the medial condyle and patellofemoral regions. Single-use only, for implantation with bone cement.
• Classification: Class II, under 21 CFR 888.3560 (Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis).
• Substantial Equivalence: Claimed to be substantially equivalent to Smith & Nephew Hybrid Knee Femoral (K042896) and Competitor Duo Knee Femoral Component (K052265).
• Proof of Equivalence: A review of "mechanical and clinical data indicated that the Competitor Deuce femoral components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure."

Why the Requested Information (for AI/SaMD) is Not Applicable/Present:

The request asks for details typically found in validation studies for AI/Machine Learning algorithms or SaMDs. These studies involve quantifying performance metrics (e.g., sensitivity, specificity, AUC) against a ground truth established by experts, using specific datasets, and statistically proving performance against predefined acceptance criteria.

This document describes a physical medical device (a knee implant component). The "study" mentioned is a "review of mechanical and clinical data" to establish substantial equivalence based on existing predicate devices. This type of submission relies on:

• Design Similarity: How the new device is similar to predicate devices.
• Material Equivalence: Using materials known to be safe and effective.
• Biocompatibility Testing: (Though not explicitly detailed here, standard for implants).
• Mechanical Testing: Bench testing to demonstrate the device can withstand expected in vivo forces (e.g., fatigue testing, static strength testing). This is what the phrase "capable of withstanding expected in vivo loading without failure" refers to.
• Clinical Data Review: Often refers to reviewing literature, existing clinical experience with similar devices, or non-clinical data supporting the safety and effectiveness.

Since this is not an AI/SaMD, the concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC studies," or "standalone algorithm performance" are not relevant or discussed in this 510(k) summary.

Ask a specific question about this device

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.

Ask a specific question about this device

The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or The only ar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different companents of the Stryker Compartmental Knee System include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the following conditions:

• Degenerative arthritis in the distal femur and patella, .
• Patients with a history of patellar dislocation or patella fracture, .
• Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where ● pain, deformity or dysfunction persists,
• Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic . arthritis,
• Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous . use of an unicompartmental knee prosthesis,
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, or .
• Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated . by deficiencies of the femoral condyle/tibial plateau.
  These components are single use only and are intended for implantation with bone cement.

The Stryker® Compartmental Knee System consists of sterile, single-use components intended for r ne our new - Companiside of the patellofemoral joint and/or the condyle region(s) of the femoral rophoominent of the system includes patellofemoral, femoral, and tibial components from currently marketed Howmedica Osteonics' knee systems for patellofemoral and unicondylar arthroplasty. The system allows the physician to choose the most appropriate option to treat the patient with patellofemoral arthroplasty and/or unicondylar arthroplasty as needed.

This 510(k) summary describes a new medical device, the Stryker® Compartmental Knee System, and demonstrates its substantial equivalence to previously marketed devices. However, it does not contain information regarding pre-established acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The document focuses on:

• Device Identification and Description: Detailing the components and intended use of the Stryker® Compartmental Knee System (sterile, single-use components for knee arthroplasty).
• Indications for Use: Listing the specific conditions for which the device is intended (e.g., degenerative arthritis, failed previous surgeries).
• Substantial Equivalence: Asserting that the device is substantially equivalent to existing predicate devices based on indications for use, materials, and operational principles. The document explicitly states: "The analyses armonstrate that the components from these systems are compatible when used for patellofemoral and/or femorotibial replacement."
• FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) premarket notification and found the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study proving the device meets those criteria because this information is not present in the provided text.

The document is a regulatory submission for premarket clearance based on substantial equivalence to existing devices, not a performance study against specific acceptance criteria. This type of submission relies on the safety and effectiveness of the predicate devices.

Ask a specific question about this device