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The Identity Imprint Porous Cruciate Retaining Total Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

• · Painful joint disease due to osteoarthritis, traumatoid arthritis or osteonecrosis of the knee.
• · Post traumatic loss of joint function.
• · Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
• · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
• · Revision procedures, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Identity Imprint Porous Cruciate Retaining Total Knee Replacement System is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.

The subject device, Identity Imprint Porous Total Knee Replacement System (including Identity Imprint Porous Cruciate Retaining Total Knee Replacement System) is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with other Conformis Knee Replacement Systems (KRS), the Identity Imprint Porous Knee Replacement System (KRS) is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. The device is intended for cementless fixation however the surgeon may also use cement.

Using patient imaging (CT scans), an Identity Imprint set of implants is selected. The femoral component is manufactured from a cobalt chromium molybdenum (CoCrMo) alloy with a porous Commercially Pure titanium (CP Ti) scaffold on the interior surface. The tibial tray is manufactured from alloy (Ti6Al4V-ELI), with a CP Ti porous scaffold on the interior surface. The tibial insert component is manufactured from highly cross-linked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly) with a solid titanium alloy (Ti6Al4V-EL) and CPTi porous metal backing. The layer of CPTi scaffolding bonded to the femoral, tibial, and patellar implants provides a surface for porous ingrowth, promoting biological fixation and obviating the need for bone cement to achieve fixation. Porous tibial, femoral, and patellar implants are designed for use without cement, but may be used with a cemented technique if necessary.

For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding of bone. These guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. The ilig instrument set is designed for single-use, and manufactured from biocompatible nylon material and supplied sterile along with the implants. In addition, reusable orthopedic manual surgical instruments are provided separately.

The device is intended to be used in a sterile field by trained orthopedic surgeons (Use Environment).

The Imprint Porous Knee Replacement System is compatible with cemented Identity Imprint CR KRS implants. Cemented and uncemented implants may be used together for a hybrid technique.

Unfortunately, the provided text does not contain the information needed to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device (Identity Imprint Porous Total Knee Replacement System). While it discusses non-clinical performance evaluation, it outlines the types of testing performed for substantial equivalence to a predicate device, rather than specifying:

• Quantitative acceptance criteria for each test (e.g., "Fatigue life shall be X cycles without failure").
• Reported device performance against those specific criteria.
• Details on a human-in-the-loop study (MRMC) or a standalone algorithm performance study, as these typically relate to AI/software device performance, which is not the primary focus of this submission for a knee replacement system that involves physical implants and surgical instruments.
• Information regarding sample sizes for training/test sets for AI models, expert qualifications, adjudication methods, or ground truth establishment in the context of an AI/software device. These are generally not applicable to the clearance of a mechanical orthopedic implant system.

The "Non-Clinical Performance Evaluation" section mentions:

• Femoral and Tibial Fatigue testing
• Patella Shear Testing
• Patella Tensile Testing
• Porous Bond Shear and Tensile Strength
• Tibial Micromotion
• Patella Durability/Wear Thru Testing
• MRI Compatibility Testing
• Cadaveric Testing

However, it does not provide the specific acceptance criteria or the numerical results of these tests, which would be found in the full 510(k) submission, not typically in the publicly available summary letter.

Therefore, I cannot fulfill the request based on the provided text.

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The Identity Imprint CR Total Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.

• · Post traumatic loss of joint function.
  · Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

• · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
  • Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans

This implant is intended for cemented use only. The CS insert option should be utilized when additional anterior-posterior constraint is desired.

The subject device, Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.

Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.

For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

This submission also seeks clearance of Cruciate Sacrificing (CS) Insert to be used with the cleared (secondary predicate) Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS).

The provided text describes the Conformis Inc. Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert. However, it does not contain the level of detail requested for acceptance criteria and the study proving a device meets those criteria, particularly for a software-driven device or AI model.

The document is a 510(k) Premarket Notification summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "Non-Clinical Performance Evaluation" section for this orthopedic implant lists only:

• Virtual Range of Motion (ASTM F2083)
• Verification/Validation Bioskills Lab

These are typical performance tests for a physical implant, not a software or AI device. The document does not provide information on:

• Specific acceptance criteria metrics (e.g., sensitivity, specificity, accuracy, error rates)
• Reported device performance against such metrics
• Sample sizes for test sets (beyond general "patient imaging (either CT or MR scans)" for design selection)
• Data provenance (country of origin, retrospective/prospective)
• Number and qualifications of experts for ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth used (beyond design rules based on patient imaging and anatomical requirements)
• Training set sample size
• How ground truth was established for the training set

Therefore, I cannot populate the requested table and answer the detailed questions based on the provided text, as this information is not present for this particular medical device submission. The device described is a physical knee replacement system, not an AI/software device that would typically have the acceptance criteria and study details requested.

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Total hip replacement using the Actera™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to:

· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia.

· Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.

· Revision procedures for failed previous hip surgery (excluding situations where hardware is present).

The Actera™ hip system implants are intended for cementless fixation using an anterior, lateral or surgical technique.

The Actera™ hip system is an uncemented, total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. X-ray templates, acetate or digital, are provided for determining implant sizes and component placement. Non-sterile reusable instruments are provided. The subject Actera™ hip system is comprised of the subject Actera™ femoral stem and the previously cleared compatible femoral head, Cordera acetabular cup, Cordera cup liner and Cordera screws (predicate K202484).

The subject, Actera™ femoral stem, is a re-designed stem. The stem is a proximally filling, triple-tapered design that is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581).

The femoral stem has an integrated neck with neck angle of 132° and neck length that progressively increases with stem size. Each size has two neck options: a standard neck, and a high offset neck that is shifted medially to provide additional femoral offset with the same leg length. The trunnion is a Conformis standard 12/14 taper, possessing a 12.7 mm diameter along with 5° 42′ 30″ angle with an asmachined geometry to form a taper lock with a mating femoral head implant. The trunnion is identical to that of the predicate Conformis Cordera femoral stem. The trunnion is designed to mate with existing standard 12/14 femoral heads. The stem body has a smooth tapered geometry in three planes. The proximal neck surface of the stem is highly polished; its geometry is intended to maximize range of motion. The femoral stems are designed to maximize contact between the stem and cancellous bone of the intramedullary canal and utilize press-fit fixation. The stem body is fully coated with hydroxyatite (HA) coating in conformance to ASTM F1185 on top of a proximal coating of commercially pure titanium (CPTi) conforming to ASTM F1580.

The femoral heads are unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (BIOLOX® delta). The femoral heads are designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem.

The acetabular component is unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). It consists of a standard size shell in 1mm increments with standard screw hole placement, a mating vitamin E polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fit through the acetabular shell screw holes and are driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation.

The purpose of this submission is to seek clearance of the subject Actera™ femoral stem which is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581). The subject Actera femoral stem is compatible with the previously cleared femoral head, Cordera acetabular cup and liner, Cordera screws and reusable instruments (class I) as described in the predicate K210581. . This submission also seeks clearance for new class II reusable instruments. New class I 510Kexempt reusable instruments and x-ray templates are also described.

The provided text describes a 510(k) premarket notification for a hip replacement system (Actera™ hip system). This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials as seen with PMAs or de novo devices.

Therefore, the information you're asking for, such as acceptance criteria based on metrics like sensitivity, specificity, or ROC AUC, sample sizes for test/training sets for AI, expert numbers for ground truth, MRMC studies, or standalone algorithm performance, is not applicable to this type of device submission and its accompanying documentation.

The document primarily focuses on:

• Device Description: What the device is and its components.
• Indications for Use: What conditions the device is intended to treat.
• Technological Characteristics Comparison: How the new device (specifically the Actera™ femoral stem) is similar to a predicate device in terms of materials, design principles, manufacturing, etc.
• Non-Clinical Performance Evaluation: This section details bench testing (in vitro/mechanical testing) performed on the device to ensure it meets established standards and performs comparably to the predicate. This is crucial for demonstrating substantial equivalence for orthopedic implants.

Here's a breakdown of the provided information in relation to your request, highlighting what's present and what's absent (due to the nature of a 510(k) for an orthopedic implant):

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

For this type of orthopedic implant, acceptance criteria are typically defined by engineering and mechanical performance standards, not statistical metrics for AI performance. The document lists the types of tests performed:

Note: The document states, "The results of the testing support that the subject device is safe, effective and performs as well as or better than the predicate device. No new issues of safety or efficacy were raised." Specific numerical performance data (e.g., fatigue strength in MPa) are typically found in the full 510(k) submission, but usually not summarized in the publicly available summary letter.

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

• Sample Size: Not applicable. For mechanical testing, "samples" refer to physical test specimens (e.g., a certain number of stems subjected to fatigue testing), not patient data for an AI algorithm. The document does not specify the number of physical specimens tested for each type of bench test.
• Data Provenance: Not applicable. This is not a study involving patient data (retrospective or prospective) from specific countries, but rather laboratory bench testing.

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

• Not applicable: This device does not involve AI or image analysis where human expert ground truth is established. The "ground truth" for mechanical testing is adherence to international standards (ISO, ASTM) and predefined engineering specifications.

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

• Not applicable: No human adjudication is involved for bench testing of an orthopedic implant.

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 an orthopedic implant, not an AI-powered diagnostic device.

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

• Not applicable: This is an orthopedic implant, not an AI algorithm.

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

• Not applicable: The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards (e.g., ISO, ASTM).

8. The sample size for the training set

• Not applicable: This is an orthopedic implant, not an AI device that requires training data.

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

• Not applicable: This is an orthopedic implant, not an AI device.

In summary, the provided document aligns with the typical process for 510(k) clearance of a Class II orthopedic implant. The "study" that proves the device meets acceptance criteria is a series of non-clinical (bench) tests designed to demonstrate that the device performs equivalently to the predicate and meets relevant industry standards for mechanical properties and biocompatibility.

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Identity Imprint CR KRS

The Identity Imprint CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatoid arthritis or osteonecrosis of the knee.

• Post traumatic loss of joint function
  · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants

· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

Identity Imprint PS KRS

The Identity Imprint PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.

· Post traumatic loss of joint function

• · Moderate varus, valgus or flexion deformity
  · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartental implants

· Revision procedures provided that the anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

The subject device, Identity Imprint Knee Replacement System, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.

Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.

For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device: the Identity Imprint Knee Replacement System. This type of document is a submission for regulatory clearance, not a clinical study report. Therefore, it does not contain the detailed acceptance criteria for an AI/software device, nor does it describe a study that explicitly proves the device meets such criteria in the way an AI/ML device would be evaluated (e.g., involving AI performance metrics like sensitivity, specificity, or AUC).

The document states that the "focus of this submission is on additional manufacturing software enhancements aimed at adding an option to enhanced automated processes in lieu of the previously cleared manual and automated processes in order to improve manufacturing efficiencies." It further mentions "Software Verification and Validation" as a confirmatory test. This suggests the software in question is primarily for manufacturing process enhancement, not for diagnostic or therapeutic AI assistance to clinicians.

Therefore, many of the requested details about acceptance criteria and study design for an AI/ML-based device cannot be extracted from this document, as it doesn't describe such a device or study.

Here's what can be inferred or directly stated from the document, acknowledging the limitations regarding AI/ML-specific evaluations:

Based on the provided document, the Identity Imprint Knee Replacement System is primarily a hardware device with associated manufacturing software enhancements, not an AI/ML diagnostic or therapeutic device. As such, the document does not describe the types of acceptance criteria or performance studies typically associated with AI/ML products (e.g., sensitivity, specificity, MRMC studies).

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, largely through manufacturing process updates and software enhancements related to those processes.

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, or F1-score as would be seen for an AI/ML diagnostic device. The acceptance criterion is "substantial equivalence" to the predicate device, K221059, demonstrated through "Software Verification and Validation."
• Reported Device Performance: The document states: "The software verification and validation data provided in this submission supports that the subject device is safe, effective, and performs as well as or better than the predicate device. No new issues of safety or efficacy were raised." No specific metrics are provided.

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

• Sample Size: Not specified. The "Software Verification and Validation" would typically involve testing of the software itself, potentially using simulated or real manufacturing data, but the sample size of such data is not detailed.
• Data Provenance: Not specified. Given it's a manufacturing software enhancement, the data would likely be related to manufacturing inputs, outputs, and quality control, potentially from the manufacturer's own internal processes. The document doesn't indicate if it's retrospective or prospective data from a clinical context.

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

• Not applicable as described. This document pertains to regulatory clearance of a physical medical device and its manufacturing software, not to an AI diagnostic tool requiring expert ground truth for clinical image analysis. "Ground truth" for manufacturing software validation would likely relate to the correctness of the enhanced automated processes, validated against established engineering or quality control standards, rather than expert clinical consensus.

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

• Not applicable. Adjudication methods like 2+1 are typically used in clinical studies for AI diagnostic devices where there's a need to reconcile divergent expert opinions on medical images. This document describes software verification and validation for a manufacturing process.

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

• No. An MRMC study is not mentioned or implied. This type of study is specifically designed to assess the impact of an AI system on human diagnosticians' performance.

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

• Not directly applicable in the context of an AI diagnostic algorithm. "Software Verification and Validation" was performed, which assesses the software's functionality and performance independently, but this is for manufacturing processes, not for a clinical diagnostic algorithm.

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

• Not explicitly stated. For "Software Verification and Validation" in a manufacturing context, ground truth would likely be defined by engineering specifications, validated process outputs, and quality control measurements rather than clinical ground truth types like pathology or outcomes data.

8. The sample size for the training set

• Not applicable. This document describes the clearance of a device with manufacturing software enhancements. It does not mention machine learning model training.

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

• Not applicable. See point 8.

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Identity Imprint CR KRS

The Identity Imprint CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatoid arthritis or osteonecrosis of the knee.

• Post traumatic loss of joint function
  · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants

· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

Identity Imprint PS KRS

The Identity Imprint PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.

· Post traumatic loss of joint function

• · Moderate varus, valgus or flexion deformity
  · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartental implants

· Revision procedures provided that the anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

The subject device. Identity Imprint Knee Replacement System, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.

Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.

For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

The provided text is a 510(k) summary for a knee replacement system. It details the device description, indications for use, and a comparison to predicate devices, focusing on a change in packaging configuration. It does not contain information about the performance of an AI/ML device, nor does it provide acceptance criteria or a study proving that a device meets such criteria in terms of analytical or clinical performance.

Therefore, I cannot extract the information required to populate the table of acceptance criteria and reported device performance, or to answer the subsequent questions regarding sample sizes, expert involvement, ground truth, or MRMC studies.

The document discusses the substantial equivalence of the "Identity Imprint Knee Replacement System" based on its technological characteristics and intended use being identical to a predicate device, with the specific modification being an alternate packaging configuration. The "Non-Clinical Performance Evaluation" section explicitly states:

"The proposed packaging configuration has been previously verified/validated and cleared for use with the Conformis iTotal Hip Replacement System (K192198). A rationale (TD-05001) for the proposed packaging configuration for use with the Identity Imprint Inserts summarizes packaging testing, sterilization adoption justification, bioburden test results, and EO residual test results. This rationale supports that the proposed packaging configuration for use with the subject device are as safe, effective, and perform as well or better than the predicate device(s) packaging configuration. No new issues of safety or efficacy were raised."

This content relates to packaging and sterilization validation, not AI/ML model performance or clinical outcomes related to diagnostic accuracy or effectiveness which would typically involve the requested criteria.

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Identity Imprint CR KRS

The Identity Imprint CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatoid arthritis or osteonecrosis of the knee.

• · Post traumatic loss of joint function
• · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.

· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants

· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

Identity Imprint PS KRS

The Identity Imprint PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.

· Post traumatic loss of joint function

· Moderate varus, valgus or flexion deformity

· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartental implants

· Revision procedures provided that the anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

The subject device. Identity Imprint Knee Replacement System, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.

Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.

For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

The provided text is a 510(k) summary for a medical device (Identity Imprint Knee Replacement System). It does not describe an AI/ML powered device, nor does it contain information about clinical studies with acceptance criteria for device performance, ground truth establishment, or expert evaluations.

Therefore, I cannot extract any of the requested information regarding AI/ML device performance or clinical study details. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance evaluation of packaging configurations.

Ask a specific question about this device

The Identity Imprint Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.

• · Post traumatic loss of joint function.
• · Moderate varus, valgus of flexion deformity.
• · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
• · Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

The subject device, Identity Imprint Knee Replacement System, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS), the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.

Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.

For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

The provided text describes the Conformis Inc. Identity Imprint Knee Replacement System. However, it does not contain information about acceptance criteria or a study proving the device meets said criteria. The document focuses on the FDA 510(k) clearance process, detailing the device description, indications for use, and a statement about software verification and validation. It explicitly states the submission's focus is on "manufacturing software enhancements aimed at adding an option to use an automated process in lieu of the previously cleared manual processes in order to improve manufacturing efficiencies."

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.

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The Identity Imprint Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

· Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.

• · Post traumatic loss of joint function.
• · Moderate varus, valgus of flexion deformity.
• · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.

· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is intended for cemented use only.

The subject device, Identity Imprint Knee Replacement System, is a new device offering of a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS). the Identity Imprint Knee Replacement System is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.

Using patient imaging (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.

For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

This FDA 510(k) K210191 document describes the Identity Imprint Knee Replacement System. However, the provided document does not contain any information about acceptance criteria, device performance, a specific study proving the device meets acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

The document is a premarket notification for a medical device and primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It lists indications for use, technological characteristics, and mentions some non-clinical performance evaluations (cadaver/bioskills lab, femoral implant fatigue test, implant range of motion evaluation).

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and a study proving device performance as requested, as this information is not present in the provided text.

The document states:

• Non-Clinical Performance Evaluation: "The following confirmatory testing was performed: Cadaver/bioskills lab, Femoral implant fatigue test, implant range of motion evaluation."
• Conclusion: "Based on a comparison of the intended use and technological characteristics to the predicate devices and on the results of confirmatory testing it is concluded that the proposed Identity Imprint KRS is substantially equivalent."

This indicates that some testing was performed to support the substantial equivalence claim, but the details of acceptance criteria, specific performance metrics, sample sizes, ground truth, or study methodology are not disclosed in this summary document.

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The Triathlon AS-1 patient specific cutting guides are disposable, single-use surgical instruments intended to assist orthopedic surgeons in the positioning of femoral and tibial total knee arthroplasty components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. They are intended for use with the Cruciate Retaining (CR), Condylar Stabilizing (CS), Posterior Stabilized (PS) and Tritanium® components of the Triathlon® Total Knee System and the Total Stabilizer (TS) and Posterior Stabilized Rotation (PSR) Triathlon® tibial inserts.

The subject device, Triathlon AS-1, is a new Conformis Inc. device offering. The Triathlon AS-1 is comprised of patient matched single-use disposable cutting guides (also referred to as instruments or jigs) with corresponding surgical documentation which includes the Instructions for Use, Surgical Protocol and Surgical Plan. The single-use patient-matched instruments (including documentation) are similar to those of the legally marketed predicate device Knee Replacement Systems by Conformis Inc. (predicate devices K180906, K201023).

The subject device, Triathlon AS-1, does not include an implant or reusable instrumentation associated with knee replacement systems. The subject device, however, is designed to be compatible with selected legally marketed Triathlon Total Knee implants and reusable instrumentation from Stryker Orthopaedics. While no implant is part of this subject device, the subject device utilizes software to determine the size and position of the compatible implant for an individual patient and then design the subject device around the patient's anatomy to prepare for the identified implant.

For the subject device, the predicate Conformis design software, surgical plan, and single-use cutting guides (instrumentation) are being modified to accurately size, position, and prepare the bone for off-the-shelf Triathlon femoral and tibial implants. Using patient imaging (CT scans), a Triathlon Total Knee implant set is sized and positioned to best meet the unique anatomic requirements of the specific patient. The Triathlon AS-1 planning process allows for efficient 3D planning, providing optimized fit of an off-the-shelf Triathlon implant and providing the design of the patient-matched, single-use guides to prepare for the planned implant in the planned position.

Jigs are designed to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. The design of the instrumentation will be modified as needed to be compatible with the Stryker Orthopaedics Triathlon manual surgical instrumentation.

Each set of instruments is designed for single use, specifically for one patient. The disposable single-use instrument set is manufactured from biocompatible nylon material and supplied sterile.

Note: The provided text is a 510(k) summary for a medical device (surgical cutting guides). It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner of an AI/ML algorithm evaluation (e.g., performance metrics like sensitivity, specificity, or AUC).

Therefore, I cannot fully address all aspects of your request, particularly those related to the performance of an AI/ML device, such as sample sizes for test/training sets, ground truth establishment methods, expert adjudication, or MRMC studies. The document describes a traditional medical device (patient-specific cutting guides) whose "performance" would relate to its physical properties, manufacturing quality, and usability.

Based on the provided text, I will address what information is available and indicate where it is not provided.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

Overview: The provided document is a 510(k) summary for the Triathlon AS-1 patient-specific cutting guides. The "acceptance criteria" in this context are primarily related to demonstrating substantial equivalence to legally marketed predicate devices, ensuring the device is safe and effective, and performs as well as the predicate. The "study" described is a series of non-clinical tests and evaluations rather than a traditional clinical trial or AI/ML performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (surgical cutting guides) and the 510(k) submission, the "acceptance criteria" are not presented as quantitative performance metrics for an AI/ML model. Instead, the focus is on functional equivalence and safety.

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

• Test Set Sample Size: Not explicitly stated in the document. The testing involved "Cadaver testing" and "Implant sizing and positioning testing," but the number of cadavers or patient cases used for these tests is not provided.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data appears to be from non-clinical testing (cadavers, software validation).

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

• Number of Experts: Not specified. "Surgeon evaluation" is mentioned for cadaver testing, implying expert involvement, but the number or specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed. Given the device, these would likely be orthopedic surgeons.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC study was not stated to be done. This device is a surgical cutting guide, not an AI-assisted diagnostic or interpretation tool for human readers. Its evaluation would focus on the accuracy of the cuts, fit to anatomy, and ease of use in surgery, rather than improving human "reading" performance.

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

• Standalone Performance: The device itself (the physical cutting guides) is the output of a CAD design process that utilizes patient imaging (CT scans) and an algorithm for sizing and positioning. The "software verification and validation" would assess the standalone performance of this design algorithm in terms of accurately generating the guides for the planned implant position. However, specific metrics for this standalone performance (e.g., precision of cuts, deviation from plan) are not detailed in this summary.

7. The type of ground truth used

• Type of Ground Truth: For the "Implant sizing and positioning testing" and "Software verification and validation," the ground truth would likely be based on established anatomical landmarks, implant specifications, and potentially manual measurements or a "gold standard" 3D model derived from the patient's CT scan. For "Cadaver testing (surgeon evaluation and usability)," the ground truth would be based on surgical assessment of fit, alignment, and ease of use, likely against pre-defined surgical goals or standards.

8. The sample size for the training set

• Training Set Sample Size: Not applicable or not provided. This device involves a patient-specific design process initiated from a CT scan for each individual patient, rather than a machine learning model that is trained on a large dataset and then applied. The underlying CAD design software is a rule-based or algorithmic system that may have been developed and validated over time, but the concept of a distinct "training set" in the context of an AI/ML model is not directly applicable here.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no explicitly mentioned "training set" in the context of an AI/ML model. The "ground truth" for the design software would be established through engineering design principles, anatomical studies, and clinical experience informing the parameters and rules within the CAD system.

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The iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

• Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate finction and stability.
• Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
• Revision procedures provided that analy landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is for cemented use only.

The iTotal PS Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint I rie 1 olar 1 5 Kince Replacement be solely addressed by the use of a prosthetic device that treats only one or two of the three compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include:

• Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity.
• Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
• Revision procedures provided that and only landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

iTotal Identity® Cruciate Retaining (CR) Knee Replacement System (KRS) and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System (KRS) are patient specific tri-compartmental faceted knee replacements systems. The iTotal Identity CR KRS is a faceted posterior cruciate ligament retaining knee replacement system. It is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components. iTotal Identity® PS KRS is a semi-constrained, cemented knee implant consisting of femoral, tibial, patellar and articular tibial insert components.

Using patient imaging and a combination of proprietary and off-the-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel (stem) cap manufactured from polyethylene (UHMWPE) and either one or two polyethylene inserts (Two piece is available with the CR KRS only). The polyethylene inserts may be manufactured from either UHMWPE (iPoly®) or iPoly® XE (a highly cross-linked vitamin E stabilized UHMWPE). The patellar component is provided in either a round or oval dome shape and may be manufactured from either UHMWPE or iPoly® XE.

For user convenience, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity® CR KRS or iTotal Identity® PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.

This document describes the 510(k) clearance for the iTotal Identity® Cruciate Retaining (CR) Knee Replacement System and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System. This clearance specifically focuses on adding an additional sterilization process (Vaporized Hydrogen Peroxide Low-Temperature Sterilant-Vacuum (VHP LTS-V)) to the existing approved methods. No device modifications were made.

Therefore, the acceptance criteria and study proving the device meets these criteria relate to the sterilization process and its impact on the safety and effectiveness of the device, rather than the device's functional performance as a knee replacement system itself.

Here's the breakdown of the information requested, based on the provided text:

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

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

• Sample Size: The document does not specify the exact sample sizes used for sterilization validation (e.g., number of devices or sterilization cycles). Sterilization validation typically involves a statistically determined number of units.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that this is a 510(k) submission for a medical device, the testing would be conducted post-development and pre-market, implying prospective testing specific to the sterilization method change.

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

This type of information is not applicable to this submission. The "ground truth" here is objective scientific measurement (e.g., microbial load reduction for SAL, chemical residue levels for VHP residuals, biological response for biocompatibility). These are established through standardized testing protocols, not through expert consensus on images or clinical outcomes.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to a process where multiple human readers assess data (e.g., medical images) and their disagreements are resolved by an independent expert. This submission concerns engineering and material testing for sterilization, not human interpretation of clinical data.

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. This submission is for enabling an additional sterilization process for an existing knee replacement system. It does not involve AI, human readers, or image interpretation.

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

This is not applicable. This is not an algorithm or software submission; it's a submission for a physical medical device and its manufacturing/sterilization process.

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

The "ground truth" for this sterile medical device submission is based on scientific and engineering measurements from validated laboratory testing. This includes:

• Microbiological testing: To establish Sterility Assurance Level (SAL) (e.g., bioburden testing, overkill methods, half-cycle testing).
• Chemical analysis: To measure residual levels of the sterilant.
• Biological assays: For biocompatibility testing to ensure the sterilized material does not elicit an adverse biological response.

8. The sample size for the training set

This is not applicable. A "training set" refers to data used to train machine learning models. This submission is for a physical medical device and its sterilization process, not an AI/ML product.

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

This is not applicable for the same reason as above.

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