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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:

1. 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)

2. 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.

3. 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.

4. Adjudication method for the test set: Not applicable.

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 document does not describe an AI device or an MRMC study.

6. 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.

7. 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.

8. The sample size for the training set: Not applicable. This document does not describe a machine learning model.

9. How the ground truth for the training set was established: Not applicable.

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The iTotal Identity Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three 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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The iTotal® Hip Replacement 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 iTotal® Hip Replacement 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 iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation.
The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach.

The iTotal® Hip Replacement System is a patient specific hip replacement system which consists of femoral and acetabular components and patient specific instrumentation (iJigs). The femoral component consists of a standard femoral stem body with an integrated (non-modular) patient specific neck, which connects with a standard femoral head. The acetabular component consists of a metal acetabular cup with two screw holes and polyethylene liners in standard sizes. Standard bone screws and apex hole plug may also be provided with the iTotal® Hip Replacement System.
The iTotal® Hip Replacement System is intended to treat skeletally mature patients who are candidates for total hip replacement surgery.
Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific hip replacement system is designed. The iTotal® Hip Replacement 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 iTotal® Hip Replacement 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 are provided with the iTotal® Hip Replacement 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.

This is a 510(k) premarket notification for the iTotal® Hip Replacement System, a medical device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for AI/ML performance is not applicable.

The document discusses non-clinical testing performed to establish substantial equivalence to predicate devices, which is standard for medical devices. The relevant section regarding testing is on page 7, under "Substantial Equivalence".

Here's why the AI/ML specific questions cannot be answered from this document:

• No AI/ML Component: The device description and summary of technological characteristics (pages 5 & 6) do not mention any artificial intelligence or machine learning components. The design is based on a patient's pre-operative CT scan and proprietary/off-the-shelf software to create patient-specific components and instrumentation, but this is described as a design and manufacturing process, not an AI/ML diagnostic or assistive tool.
• Focus on Substantial Equivalence: The entire document is geared towards demonstrating substantial equivalence to previously cleared predicate devices through traditional non-clinical testing methods (e.g., fatigue testing, wear testing, material characterization, cadaveric evaluation, software verification/validation). There is no mention of algorithms, performance metrics for diagnostic accuracy, reader studies, or ground truth establishment in the context of AI.

Summary of available information regarding acceptance criteria and studies (as applicable to a non-AI/ML device):

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance: Not specified in the provided text. The document refers to "non-clinical testing" and implies laboratory-based or cadaveric evaluations, not patient data in the sense of AI/ML test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML diagnostic or assistive device that requires expert ground truth for interpretation. Cadaveric evaluations would involve expert surgeons, but their number and specific qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (implant and instruments), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical testing, ground truth would be based on established engineering and materials science standards, biomechanical principles, and potentially anatomical correctness assessed during cadaveric evaluations.

8. The sample size for the training set: Not applicable as this is not an AI/ML device in the context of the questions asked. The design process uses patient CT scans to design the specific components, but this is a design data set, not an AI training set for algorithm performance.

9. How the ground truth for the training set was established: Not applicable. The "training data" here would be the anatomical information from individual patient CT scans used for custom design, which by its nature is the patient's individual "ground truth" anatomy.

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