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The Z™ - Series Modular Total Hip System Plasma Coated is indicated for use in total or partial hip replacements in patients suffering severe pain and disability due to structural hip problems such as rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated in patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and failed previous fusion, where bone stock is inadequate for other reconstruction techniques. CP Titanium Plasma Coated Implants are intended for Cement or Press Fit Applications.

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The provided document is a 510(k) clearance letter for a medical device (Z-Series Modular Total Hip System Plasma Coated) and does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, I cannot extract the requested information from this text.

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OTI Alumina Ceramic Femoral Head System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, post traumatic arthritis, collagen disorders, avascular necrosis, traumatic arthritis, congenital hip dysplasia, protrusio acetabuli, slipped Capital Femoral Epiphysis, failed previous fusion, where acetabular reconstruction is not possible, and revision of previously failed hip arthroplasty.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device conformance to such criteria, or any details regarding a medical imaging AI device. The document is a 510(k) clearance letter from the FDA for a non-AI medical device: OTI Alumina Ceramic Femoral Head System – Line Extension, which is a hip joint prosthesis.

Therefore, I cannot provide the requested information as it is not present in the given input.

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OTI Alumina Ceramic Femoral Head System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

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This is a 510(k) premarket notification letter for a medical device (OTI Alumina Ceramic Femoral Head System), not a study report. Therefore, it does not contain information about acceptance criteria, device performance from a study, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This determination is based on a comparison to existing devices rather than a new study detailing specific performance metrics against acceptance criteria.

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The Z™ - Series Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

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This document is a 510(k) premarket notification from the FDA, specifically an approval letter for a medical device. It does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The document states that the FDA has reviewed the 510(k) premarket notification for the "Z™-Series Modular Total Hip System" and found it to be substantially equivalent to legally marketed predicate devices. This is a regulatory determination, not a statement about performance against specific acceptance criteria from a study.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The OTI Bone Cement Plug is intended to allow bone cement pressurization in the intramedullary canal and preventing cement seepage distally. The Bone Plug is placed into the intramedullary canal of the femur at a set distance from the proximal end prior to placement of bone cement and Femoral Prosthesis.

OTI Bone Cement Plug - Line extension

The provided text is a 510(k) premarket notification letter from the FDA regarding the "OTI Bone Cement Plug." It does not contain any information about acceptance criteria, device performance data from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

The document primarily focuses on:

• Device Identification: OTI Bone Cement Plug
• Regulatory Classification: Class II, Product Code JDK (Surgical mesh)
• Substantial Equivalence Determination: FDA has determined the device is substantially equivalent to legally marketed predicate devices.
• Limitations: A crucial warning is mandated: "WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED."
• Indications For Use: To allow bone cement pressurization in the intramedullary canal, preventing cement seepage distally, when placed at a set distance from the proximal end of the femur prior to bone cement and femoral prosthesis placement.
• General Controls: Mentions requirements for annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Therefore, I cannot fulfill your request for details on acceptance criteria and study information as these are not present in the provided text. This document is a regulatory clearance letter, not a study report or clinical trial summary.

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The OTI Unicondular Interpositional Spacer is intended for use in the Osteoarthritic knee, where substantial amounts of articular cartlige have been lost as a result of the disease.

The prostheses will be used in indications for uncemented treatment of the Tibia articulating surfaces (Medial and Lateral) of the following:

Moderate degeneration of the Medial and/or Lateral compartment of the knee (grade II-IV chondromalicia ) and minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the patellofemoral components.

OTI Unicondular Interpositional Spacer System

This is an FDA Premarket Notification (510(k)) letter for a medical device called the "OTI Unicondular Interpositional Spacer System." This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and grants permission to market the device.

This document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.

510(k) clearances typically do not include:

• A table of acceptance criteria and reported device performance from a specific study. The substantial equivalence determination is often based on design similarities, material properties, and sometimes limited bench or preclinical testing, rather than extensive clinical efficacy studies with predefined acceptance criteria as might be seen for a PMA (Premarket Approval) or De Novo pathway.
• Details about sample size, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance. These are more relevant to AI/ML-driven device evaluations or devices requiring clinical trials to demonstrate efficacy.
• Specifics on how ground truth was established for training or testing sets.

To reiterate, the provided text does not contain the information requested in your prompt. It solely outlines the FDA's decision to clear the device for marketing based on substantial equivalence.

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The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Total Hip System is intended for use with and without bone cement.

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The provided text is an FDA 510(k) clearance letter for a medical device (R120™ Modular Total Hip System - Line Extension). It does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory classification and general controls applicable to the device.
• Stating the intended indications for use.

Therefore, I cannot provide the requested information based on the input text. The text does not detail any performance studies, test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

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The MJS Posterior Stabilized Knee System is indicated for use in total knee replacement procedures for patients suffering from:

• Rheumatoid arthritis. ●
• Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose . age, weight, and activity level are compatible with an adequate long-term result.
• Failed osteotomies, unicompartmental replacement, or total knee replacement. .

The Posterior stabilized system is intended for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact and extra joint stability is required.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the MJS Posterior Stabilized Knee System. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the acceptance of an AI/ML-enabled medical device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates the approval is based on substantial equivalence to existing devices, not on a new study demonstrating performance against specific acceptance criteria in the context of an AI/ML system.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

• The device is a knee implant system, not an AI/ML-enabled medical device. The questions you've asked are specific to the evaluation and acceptance of AI/ML systems (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance).
• The document is an FDA 510(k) clearance letter. This type of document confirms substantial equivalence to a predicate device, which is a regulatory pathway that typically does not involve the detailed performance studies or AI-specific evaluation methodologies implicit in your questions.
• No performance data, acceptance criteria, or study details are present. The letter confirms the device can be legally marketed but does not provide any technical specifications, study methodologies, or results that align with your request.

To answer your questions accurately, I would need a document detailing the clinical or technical performance study of an AI/ML-enabled medical device, including its acceptance criteria and results.

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The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement The X120 - Northering sovere pain and disability due to structural damage in the hip joint from rheumatoid atthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other opplysis, that encation a. The Total Hip System is intended for use with and without bone cement.

Not Found

I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) approval letter from the FDA for a total hip system, not a study report or technical specification document that would contain the detailed information you are asking for regarding acceptance criteria and device performance studies. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not provide details about the specific studies conducted or their results.

Ask a specific question about this device

Ask a specific question about this device