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The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee jount 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

This implant is intended for cemented use only.

The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.

The iTotal Identity Posterior Stabilized 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 compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

Pamful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, osteonerosis 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 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 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 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 Identity™ Imprint™ PS 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, polyarthritis, 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 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 iTotal Identity and Identity Imprint Knee Replacement Systems (KRS) are semi-constrained total knee prosthetic devices consisting of femoral, tibial, and patellar components. These devices are intended for treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.

Patient imaging (CT scans) can be used to design patient-specific implants (iTotal Identity) or to select standard sized implants (Identity Imprint), to meet 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, patient-specific surgical instruments 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) summary does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen with AI/ML-powered medical devices.

The document is a 510(k) premarket notification for knee replacement systems (surgical implants and instruments), not an AI/ML device. The mention of "software updates to improve manufacturing efficiencies" is the only reference to software, but it explicitly states that these updates do not raise "different questions of safety or effectiveness," suggesting they are likely minor software changes related to manufacturing processes rather than an AI/ML component affecting diagnostic or treatment decisions.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to predicate prosthetic devices based on the following:

• Identical Indications for Use: The devices are intended for total knee replacement under the same conditions as the predicate devices.
• Identical Technology: The implants and instruments remain "identical to the predicate devices in operating principle, fundamental technology, design and materials."
• Manufacturing Software Updates: Minor software updates are mentioned for manufacturing efficiency, but these are explicitly stated not to affect safety or effectiveness in a way that generates new questions.

This type of submission typically relies on existing standards for mechanical and material performance of implants, not on AI/ML performance metrics.

To answer your request based on the provided text, I can only state that the document does not contain the information you asked for regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/ML device.

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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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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.

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 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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