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Found 44 results
510(k) Data Aggregation
(111 days)
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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(28 days)
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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(56 days)
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 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.
iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) is a patient-specific tri-compartmental faceted knee replacement system. It is a posterior cruciate ligament retaining knee replacement system. It is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components. An optional Cruciate Sacrificing insert may be utilized when additional anterior-posterior constraint is desired.
Using patient imaging (CT scans) 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 cap manufactured from polyethylene (UHMWPE) and either one or two polyethylene inserts. The CS insert is a one-piece insert. The polyethylene inserts may be manufactured from either iPoly® (UHMWPE) 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 iPoly® 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 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 the iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS), specifically focusing on the new Cruciate Sacrificing (CS) tibial insert. This document asserts substantial equivalence to existing predicate devices, rather than presenting a study proving that an AI/ML powered device meets acceptance criteria.
The information requested in the prompt (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are typically found in submissions for AI/ML-powered medical devices that perform tasks like image interpretation or diagnosis. This document, however, describes a mechanical medical device (a knee implant) and its component. The "performance data" section refers to engineering and biomechanical testing, not clinical performance or AI/ML model performance.
Therefore, I cannot extract the requested information from the provided text as it does not pertain to an AI/ML medical device. The document details the device's design, materials, sterilization, and basic performance testing for a physical implant, not an AI/ML algorithm.
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(24 days)
The Cordera™ Hip System may be used with iligs® designed from a patient's pre-operative CT scan, which must include certain necessary anatomic landmarks that are clearly identifiable. The Cordera™ 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 Cordera™ Hip System includes standard hip replacement components, and if selected, may use patient-specific single use instrumentation.
The Conformis Cordera Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.
The Cordera Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. The system can be used with or without a pre-operative CT scan that is used to design patient-specific instruments. All components are provided sterile.
The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is 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 femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta).
The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating 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 liner is provided with an impactor made of a biocompatible nylon material.
The purpose of this submission is to add patient specific instruments (iJigs) and surgical plans (iViews) to the Cordera Hip System.
I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets those criteria, specifically concerning an AI/ML powered medical device.
The document is an FDA 510(k) clearance letter for the Cordera Hip System, which is a traditional medical device (hip replacement system), not an AI/ML enabled one.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document discusses the substantial equivalence of the Cordera Hip System to predicate devices based on its intended use, technological characteristics, materials, and manufacturing processes. It briefly mentions "patient specific iJigs" (instrumentation) which use CT scans for design, but this is a design specificity for a physical instrument, not an AI/ML algorithm that interprets or diagnoses from images.
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(57 days)
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:
· 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 anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
Conformis knee replacement systems are patient-specific 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 patient-specific implant is designed 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, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity Posterior Stabilized Knee Replacement System 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 document is a 510(k) summary for a medical device called the "iTotal Identity Posterior Stabilized Knee Replacement System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.
However, the document does not contain the kind of information typically found in a study proving a device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy. This is a notification of intent to market, and its primary purpose is to demonstrate "substantial equivalence" to existing cleared devices, not to present a de novo clinical or algorithm performance study.
Therefore, for the information requested in your prompt, I can only provide what is explicitly stated or can be reasonably inferred from the document. Many of your requested points, especially those related to AI/algorithm performance studies, ground truth establishment, expert adjudication, and detailed statistical metrics, are not present in this type of FDA submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria in the typical sense of numerical performance targets (e.g., sensitivity > X%, specificity > Y%). Instead, the "performance" is assessed through non-clinical confirmatory testing to ensure safety and functionality.
| Acceptance Criteria (Implied by testing standards) | Reported Device Performance (Conclusion) |
|---|---|
| Meets ASTM F1814 and ASTM F2083 for insert interlock/modularity | Confirmatory testing was performed. Conclusion: Device is substantially equivalent to predicates. Implies compliance with these standards. |
| Meets ASTM F1800 and ASTM F2083 for tibial tray fatigue | Confirmatory testing was performed. Conclusion: Device is substantially equivalent to predicates. Implies compliance with these standards. |
| Meets criteria for simulated use | Confirmatory testing was performed. Conclusion: Device is substantially equivalent to predicates. Implies satisfactory performance. |
| Meets ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, and ASTM F2119-07 for MR Compatibility | Confirmatory testing was performed. Conclusion: Device is substantially equivalent to predicates. Implies compliance with these standards. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified. The document refers to "confirmatory testing" but does not detail the number of units or conditions tested for each non-clinical performance evaluation.
- Data provenance: Not applicable in the sense of patient data. The testing mentioned is non-clinical/bench testing of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not present in the document. The "ground truth" for non-clinical testing typically involves engineering specifications and compliance with standardized test methods, not expert clinical interpretation.
4. Adjudication method for the test set
- Not applicable and not present. Adjudication methods (like 2+1, 3+1) are common in clinical studies where human interpretation or consensus is needed for a "ground truth." This document describes non-clinical engineering tests.
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 comparative effectiveness study was not done. This document describes a new knee replacement system, which is a physical implant, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a knee implant, not an algorithm. While its design involves "patient-specific implant [design] that best meets the geometric and anatomic requirements of the specific patient" using "patient imaging (either CT or MR scans)", the document focuses on the implant and its physical performance, not on the performance of a standalone algorithm for diagnosis or image interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance evaluations, the "ground truth" is established by the engineering specifications and the requirements of the ASTM (American Society for Testing and Materials) standards referenced (e.g., F1814, F2083, F1800, F2052-14). These standards define acceptable performance metrics for various aspects of orthopaedic implants.
8. The sample size for the training set
- Not applicable/not specified. Since this is a physical medical device (knee implant) and not an AI algorithm being "trained," there is no concept of a training set in the context of device performance as requested in your prompt. The patient imaging data mentioned is used for individual patient-specific design rather than training a general algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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(126 days)
The ConforMiS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface with evidence of adequate healthy bone sufficient for support of the implanted components. Candidates for unicondylar knee replacement include those with: · Joint impairment due to osteoarthritis or traumatic arthritis of the knee · Previous femoral condyle or tibial plateau fracture, creating loss of function · Valgus or varus deformity of the knee · 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 ConforMlS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solelyaddressed by the use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to: · Painful joint disease due to osteoarthritis · Traumatic arthritis of the knee Post traumatic loss of joint function · Failed osteotomies, hemiarthroplasties and unicondylar implants The Duo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of the above noted conditions. The iDuo implant is intended for cemented use only.
The iTotal Posterior Stabilized {PS) 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 knee 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 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 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, theumatoid 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.
ConforMIS knee replacement systems are patient-specific 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 ortrauma. Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo and polyethylene inserts manufactured from UHMWPE or an all polyethylene tibial component. The patellar components are manufactured from UHMWPE.
This document is a 510(k) premarket notification for knee replacement systems. It does not present a study or acceptance criteria for a device that relies on an algorithm or AI. Instead, it describes a non-clinical performance evaluation for sterilization validation of existing knee replacement systems.
Therefore, most of the requested information regarding acceptance criteria and studies for an AI/algorithm-based device simply do not apply to this document.
However, I can extract the information relevant to the non-clinical performance evaluation described:
-
A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Sterilization Validation to establish a SAL of 1x10^-6 for Vaporized Hydrogen Peroxide (VHP) sterilization. Device components are effectively sterilized using Vaporized Hydrogen Peroxide, achieving a SAL of 1x10^-6. VHP residual testing (Implicitly met, as effective sterilization was confirmed) Product and packaging compatibility with VHP sterilization (Implicitly met, as effective sterilization was confirmed) -
Sample size used for the test set and the data provenance: Not applicable. This is a non-clinical sterilization validation, not a study involving patient data or a test set in the context of an algorithm.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a non-clinical sterilization validation, not an analysis requiring expert ground truth for an algorithm.
-
Adjudication method for the test set: Not applicable.
-
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 document does not describe an AI device or an MRMC study.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not describe an algorithm or AI device.
-
The type of ground truth used: For the sterilization validation, the "ground truth" would be the scientifically established standard for sterility (SAL of 1x10^-6) as defined by regulatory bodies and testing protocols.
-
The sample size for the training set: Not applicable. This document does not describe a machine learning model.
-
How the ground truth for the training set was established: Not applicable.
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(85 days)
The Conformis Hip System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the Conformis 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, traumatic arthritis, rheumatoid 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 Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
The Conformis Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.
The Conformis Hip System is a semi-constrained, cementless artificial hip replacement system. Patient imaging (CT scans) and a combination of proprietary and off the shelf software are used to design a patient specific hip replacement system.
The Conformis Hip System consists of the following components:
a) Femoral Component:
- The femoral stem, with an integrated patient specific neck, is manufactured from titanium alloy and has a plasma sprayed hydroxyapatite (HA) coating. The femoral stem is available in various sizes.
- Both metal (Cobalt Chromium alloy) and Ceramic femoral heads are available for use with the Conformis Hip System. The femoral heads are available in various sizes and offsets.
b) Acetabular Component:
- The acetabular cup is manufactured from titanium alloy.
- The acetabular cup features a plasma sprayed outer surface. The acetabular cups are available in various sizes.
- The acetabular liner is manufactured from highly cross-linked Vitamin E infused ultra-high molecular weight polyethylene (iPoly XE™). The liners are available in a range of sizes with varying internal diameters and offsets.
- Acetabular screws and the apex hole plug are manufactured from titanium alloy.
c) Ancillary orthopedic manual surgical instruments
Ancillary orthopedic manual surgical instruments are provided with the Conformis Hip System to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total hip replacement components intra-operatively and in guiding the cutting/reaming of bone.
I am sorry, but the provided FDA 510(k) clearance letter for the Conformis Hip System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as you've outlined.
This document is primarily focused on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance. It confirms that the device has similar intended use, indications for use, operating principle, materials, coatings, sterilization, and packaging as its predicate.
While it mentions "Non-clinical laboratory testing was performed demonstrating that the device can be considered substantially equivalent to the predicate device for the intended use," and lists specific standards (ISO-7206-4, ISO 7206-6, ASTM F2996) for "Stem and neck fatigue testing," it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample size or data provenance for a test set.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method.
- Information on any multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI. (This product is a physical implant, not an AI/software diagnostic device, so this is not applicable).
- Information on standalone algorithm performance. (Again, not applicable).
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that a "Detailed software description and software verification and validation testing of proprietary software" was done, but does not provide any specifics about performance metrics or acceptance criteria for this software.
Therefore, I cannot fulfill your request based on the provided text.
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(142 days)
The ConforMIS BeneFIT 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, traumatic arthritis, 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, manageable by other techniques.
- Revision procedures for failed previous hip surgery (excluding situations where hardware is present). . The ConforMS BeneFIT Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.
The Conformis BeneFIT Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. All components are provided sterile. The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is 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 femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta). The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating 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 fits through the acetabular shell screw holes and is 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 liner is provided with an impactor made of a biocompatible nylon material.
The ConforMIS BeneFIT Hip System is a medical device and its acceptance criteria are established through non-clinical laboratory testing. This is a hip implant system, not a software or AI-driven device, so the typical AI/software performance metrics, ground truth establishment, and expert adjudication as described in your prompt are not applicable.
Here's an overview of the acceptance criteria and the study as described in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Femoral Stem Fatigue Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Femoral Neck Fatigue Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Femoral Taper-CoCr Head Junction Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Femoral Taper-Ceramic Head Junction Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Acetabular Liner-Cup Disassembly Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Acetabular Liner Impingement Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Wear Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Acetabular Bone Screw Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| HA Coating Microstructure Characterization | Demonstrated acceptable performance; substantially equivalent to predicates. |
| HA Coating Static Fatigue Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| HA Coating Shear Fatigue | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Range of Motion Testing | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Chemical and Mechanical Characterization of iPoly XE | Demonstrated acceptable performance; substantially equivalent to predicates. |
| Cadaveric Evaluation | Demonstrated acceptable performance; substantially equivalent to predicates. |
Note: The document states "Test results demonstrated that the device can be considered substantially equivalent to the predicate devices for the specified intended use." This implies that the device met pre-defined performance thresholds, typically based on industry standards and comparison to the predicate devices, for each of these tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes for each non-clinical test. Clinical trials (human test subjects) for hip implants involve sample sizes that depend on the study design (e.g., pilot studies, pivotal studies), but this document focuses on non-clinical testing for 510(k) clearance, which typically involves mechanical testing of device samples.
- Data Provenance: The data is generated from non-clinical laboratory testing conducted by ConforMIS, Inc. or its designated testing facilities. There is no information about country of origin of data in the sense of patient data, nor is it retrospective or prospective in a clinical study context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This is not applicable to the non-clinical laboratory testing described. The "ground truth" for the performance of a mechanical device like a hip implant is established by meeting predefined engineering specifications, adherence to ISO standards (e.g., for fatigue, wear), and demonstrating equivalence to predicate devices, rather than through expert consensus on interpreting patient data.
4. Adjudication Method for the Test Set
- Not applicable. As this is non-clinical mechanical testing, there is no "adjudication method" in the sense of reconciling human expert opinions on cases. Test results are typically evaluated against pre-defined engineering criteria and scientific principles.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- Not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms where human interpretation plays a role. This document concerns a physical implant and its mechanical properties.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device, in the context of non-clinical testing, is compliance with established engineering standards (e.g., ISO standards for orthopedic implants), predefined performance specifications, and demonstrated substantial equivalence to legally marketed predicate devices. This includes meeting specified thresholds for properties like fatigue strength, wear resistance, and component integrity.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a "training set." The design and manufacturing processes are refined through engineering, material science, and iterative testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated in point 8.
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(156 days)
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 knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
• Painful joint disease due to osteoarthritis, traumatoid 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 iTotal Identity® Cruciate Retaining Knee Replacement System (hereafter referred to as the "iTotal Identity CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal Identity CR KRS is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar 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 cap manufactured from polyethylene (UHMWPE), and either one or two polyethylene inserts. These inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked Vitamin E infused polyethylene). 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, and similar to the primary predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity CR 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 a 510(k) premarket notification for the "Conformis iTotal Identity Cruciate Retaining Knee Replacement System." It does not contain information about an AI/ML medical device. Therefore, I cannot provide the requested details regarding acceptance criteria, study design, ground truth establishment, or expert involvement for an AI/ML device.
The provided text focuses on demonstrating substantial equivalence of a knee replacement system to legally marketed predicate devices through:
- Intended Use and Indications for Use: Comparing the new device's intended use and indications to those of predicate devices.
- Technological Characteristics: Analyzing the operating principle, design, materials, and sterilization methods.
- Non-clinical Testing: Listing various mechanical and material tests performed (e.g., cadaver testing, fatigue testing, biocompatibility, sterilization validation) to ensure the new device performs similarly and is safe.
There is no mention of a machine learning model, a test set for AI performance, expert labeling, or human-in-the-loop studies.
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(40 days)
The iTotal 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 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 iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient-specific, tricompartmental, faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained, cemented knee implant which consists of a femoral, tibial, and patellar component.
Using patient imaging and a combination of proprietary and offthe-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral implant is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked vitamin E infused polyethylene) The patellar component may also be manufactured from either UHMWPE or iPoly® XE.
For user convenience, and similar to the predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal CR 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.
The function and general design features of the patient-specific implants and ancillary instruments remain similar to those described in the predicate 510(k), K161366.
This document does not contain the detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML device.
The provided text is a 510(k) summary for the Conformis iTotal Cruciate Retaining (CR) Knee Replacement System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K161366) rather than establishing new performance metrics.
Here's a breakdown based on your requested information, highlighting what is and is not present in the provided text:
1. A table of acceptance criteria and the reported device performance
- Not present in this document. This document does not establish specific performance acceptance criteria (e.g., accuracy, precision) for a medical image analysis algorithm or AI component in the typical sense. Instead, it focuses on demonstrating that the updated software produces results comparable to the predicate software and that the overall device design and materials remain unchanged.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present in this document. There is no mention of a test set sample size or data provenance as this 510(k) is not presenting a clinical performance study. The "test set" in this context refers to the software verification and validation testing, but no details on the data used are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not present in this document. Ground truth for clinical performance is not discussed as there is no clinical performance study being presented. For software verification, ground truth would likely be based on engineering specifications or comparisons to output from the previous software version.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present in this document. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. This is not applicable to the type of submission described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not present in this document. This device is a knee replacement system, and the software components are for patient-specific implant design and surgical planning. It is not an AI-assisted diagnostic tool for human readers, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document states "Software verification and validation testing of proprietary software" was performed. This implies standalone testing of the algorithm (software modules) to ensure they function as intended and produce expected outputs for implant design and surgical planning. However, no specific details of this testing are provided. The software's output (implant design and surgical plan) is ultimately used by human surgeons during the procedure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "Software verification and validation testing," the ground truth would likely be based on:
- Engineering specifications: The software should produce designs that meet predefined geometric and functional requirements.
- Comparison to predicate software outputs: The updated software (iTotalWorks 6.0, iTotalFem CR 1.0, iTotalTib CR 5.0, iTotal CR iView 4.0) should produce designs and plans that are equivalent or demonstrate appropriate improvements compared to the predicate software (iTotalWorks 5.1, iTotal FemJigs 3.0, iTotalTib CR 4.3, iTotal CR iView 3.0). The purpose of the changes is to improve manufacturing efficiencies through automation, implying the output should remain consistent with the validated predicate.
- No clinical "ground truth" (pathology, outcomes data) is mentioned as it's not a diagnostic device.
8. The sample size for the training set
- Not applicable/Not present. This document discusses a change in software versions (i.e., v5.1 to v6.0 for iTotalWorks, etc.) for a workflow that custom designs existing implants. It is not describing a machine learning model that was specifically "trained" on a dataset in the way an AI diagnostic algorithm would be. The "proprietary and off-the-shelf software" uses patient imaging to design a patient-specific implant based on pre-defined algorithms and rules, not necessarily a training phase with a distinct training set.
9. How the ground truth for the training set was established
- Not applicable/Not present. As there's no explicitly defined "training set" in the context of an AI/ML model for this device, there's no discussion of how ground truth for such a set was established.
In summary:
This 510(k) pertains to a knee replacement system where the software is used for patient-specific implant design and surgical planning. The submission is a modification to an already cleared device and focuses on demonstrating that changes to the software modules for CAD manufacturing processes do not alter the substantial equivalence of the device to its predicate. The "study" mentioned is "Software verification and validation testing of proprietary software," which ensures the new software performs as intended and produces results consistent with the previously cleared versions. This is a technical (engineering) validation rather than a clinical performance study with human readers or AI diagnostic capabilities.
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