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The Identity™ Imprint™ Porous Cruciate Retaining (CR) Total Knee Replacement System with Cruciate Sacrificing (CS) Insert 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

The Ildentity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.

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

The subject device, Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, is proposed to be a modification from Identity™ Imprint™ Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (K223316) to be compatible with the Identity™ Imprint™ Cruciate Sacrificing (CS) Tibial Insert cleared in K230844. This submission also seeks the inclusion of the cleared AIM2Surf software (K230846) for use with the subject device. This software is used by CAD to do preliminary surface planning. No software version change is required as the surface planning is unchanged between the predicate and subject devices. The Porous Ancillary Reusable instrument tray was modified and clearance of the modification is also sought.

The subject device, Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrficing (CS) Insert, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. It 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 (CT scan), an Identity Imprint Porous implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from a cobalt chromium molybdenum (CoCrMo) alloy with a porous Commercially Pure titanium (CPTi) scaffold on the interior surface. The tibial tray is manufactured from a titanium alloy (Ti6Al4V-EL), with a CPTi 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 (Ti6A4V-ELI) and CPTi porous metal backing. Porous tibial, femoral, and patellar implants are designed for use without cement, but may be used with a cemented technique if necessary. The ldentity™ 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. The subject CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.

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 Cruciate Sacrificing tibial insert of iPoly™ XE is offered in thicknesses of 6mm to 18mm and is the same insert as cleared with Identity™ Imprint™ Cruciate Retaining (CR) Knee Replacement System (KRS) with CS insert (K230844).

This document is a 510(k) premarket notification for a knee replacement system, which focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about an AI/ML-based medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as these concepts are typically applied to the validation of AI/ML algorithms, not mechanical medical devices like knee implants.

The document discusses:

• Device Name: Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
• Purpose of Submission: To demonstrate compatibility of a previously cleared Cruciate Sacrificing (CS) tibial insert with an existing porous knee replacement system and to include an existing software (AIM2Surf) for preliminary bone surface planning.
• Testing Performed: Only "Tibial Micromotion Testing" is mentioned to confirm the CS insert's intended function. This is a biomechanical test, not an AI/ML performance study.
• Conclusion: The device is substantially equivalent to predicate devices based on intended use, technological characteristics, and confirmatory testing.

Since no AI/ML software performance study is described, the requested information elements (acceptance criteria for AI, sample sizes for AI test sets, AI ground truth, MRMC studies, etc.) are not present in this document.

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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 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, 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.

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, traumatic arthritis, rheumatoid arthritis, 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 Conformis Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS hereafter referred as Identity Imprint KRS Knee Replacement System (KRS) represents a family of standardized Posterior Stabilized (PS) knee implants, Cruciate Retaining (CR) knee implants, and compatible system component product offerings based on the Identity Imprint PS and CR knee replacement systems. The total knee replacement system for each size includes a femoral implant, tibial tray, polyethylene inserts, patientspecific and standardized iligs, as well as surgical instrumentation. The system also includes an iView, generated utilizing Conformis' 'Best Fit' planning software. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.

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.

I am sorry, but the provided text (K231233 510(k) Premarket Notification) does not contain information about an AI/ML-based medical device. This document is for a Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis (a physical knee implant), not a software or AI-driven diagnostic/therapeutic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, human reader performance, ground truth establishment, or training set specifics, as these concepts are not applicable to the type of device described in the document.

The document primarily focuses on:

• The device name and classification.
• Indications for Use.
• Device description (materials, components).
• Comparison to predicate devices.
• Non-clinical performance evaluation for changes like sterilization methods and shelf life extension.

There is no mention of an algorithm, image analysis, AI assistance, or any study involving human readers or ground truth for diagnostic accuracy.

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The ACTERA™ hip system may be designed from a patient's preoperative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. 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 osteoarthrits, 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 posterior surgical technique.

The ACTERA™ hip system is an uncemented, primary total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. Optional Surgical plans (iViews) and iJgs/ancillary instruments are also available. Non-sterile reusable instruments are provided.
The subject ACTERA™ is comprised of the subject Actera™ femoral stem (cleared in K221104) with additional sizes (0, 1 and 10, 11, 12) added to the size portfolio. Additionally, the subject ACTERA™ will offer a patient specific neck option. This option has the same stem body (K221104) with a patient specific neck (K192198). The patient specific neck has the same neck version angle, and similar neck length as that cleared in the secondary predicate Conformis Hip System (K192198). The subject hip stems with patient specific necks are compatible with the same femoral heads and acetabular components as the patient specific necks cleared in the Conformis Hip System (K192198). The ACTERA™ with the patient-specific neck option will be ordered as 'ACTERA™ HipRx'.
This submission also seeks clearance of iJigs®/Ancillary Instruments to assist in the positioning of the ACTERA™ implants. The iligs® are sterile, single-use disposable instruments of nylon material. These instruments may be standardized or patient specific. These instruments are the iJig instrumentation described in the secondary predicate K192198 (and K202484). These instruments were not offered with the initial release of the ACTERA™ device, primary predicate Actera™ K221104. Additionally, Surgical Plans, called iViews, are also part of this submission. The iligs and iViews are provided based on ordered options.
The stem taper is identical to the predicates. The subject device, ACTERA™ is compatible with the previously cleared femoral heads (Ceramic or CoCrMo) and acetabular components. The femoral head is unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). The Cordera acetabular cup, Cordera cup liner and Cordera screws are unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). There are no changes with this these components and are not the subject of this submission.

The provided text is a summary for a 510(k) premarket notification of the ACTERA™ hip system. It does not describe a study involving an AI medical device or digital health software, nor does it present specific acceptance criteria with quantifiable performance metrics.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document focuses on the substantial equivalence of new components (extended sizes for the femoral stem, patient-specific neck option, iJigs, and surgical plans) to previously cleared predicate devices, supported by non-clinical performance evaluations like fatigue testing of the physical implants.

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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.

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