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EBA One Nailing System standard trochanteric nail is indicated for the treatment of stable intertrochanteric fractures, pertrochanteric fractures, non-unions, mal-unions.

EBA One Nailing System long trochanteric nail is indicated for the treatment of pertrochanteric fractures with extension of the fracture line to the diaphysis,pertrochanteric fractures associated with diaphyseal fractures (bifocal fractures), pathological fractures, non-unions, mal-unions.

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This document is an FDA 510(k) clearance letter for the EBA One Nailing System. It is not a study report for an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, or comparative effectiveness studies for an AI/ML device.

The information you are asking for typically comes from a clinical validation study or performance testing report, which would be part of a 510(k) submission for an AI/ML device, but isn't explicitly detailed in the FDA clearance letter itself unless specifically summarized.

This letter solely confirms that the EBA One Nailing System (an intramedullary fixation rod, a physical implant, not an AI/ML software) has been deemed substantially equivalent to legally marketed predicate devices.

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The Estremo Citieffe Nailing System is indicated for femoral fracture fixation, which may include the following:

• · diaphyseal femoral fractures;
• · supra-condylar femoral fractures:
• · corrective osteotomies;
• · pseudoarthrosis:
• non-unions and mal-unions.

The Estremo Citieffe Nailing System is indicated for tibial fracture fixation, which may include the following:

• · diaphyseal tibial fractures;
• · corrective osteotomies;
• · pseudoarthrosis;
• · non-unions and mal-unions.

The Estremo Citieffe Nailing System is indicated for tibiotalocalcaneal arthrodesis.

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This document is an FDA 510(k) clearance letter for the Estremo Citieffe Nailing System, which is an intramedullary fixation rod for fracture fixation. It is NOT an AI/ML medical device submission.

As such, the document does not contain the information required to answer the prompt. The prompt asks for details about a study that proves an AI/ML device meets acceptance criteria, including:

• A table of acceptance criteria and reported device performance (for an AI/ML device, this would typically involve metrics like sensitivity, specificity, AUC, etc.)
• Sample size for the test set and data provenance
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC study details and effect size
• Standalone AI performance
• Type of ground truth used
• Training set sample size and ground truth establishment

None of this information is present in the provided FDA 510(k) clearance letter for a physical medical implant (nailing system). The letter confirms the device's substantial equivalence to a predicate device based on its indications for use and general controls, but it does not describe an AI/ML algorithm's performance study.

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PL8 Wrist Reconstruction Plate is indicated for the treatment of intra-articular and extra-articular fractures and osteotomies of the distal radius.

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I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "PL8 Wrist Reconstruction Plate". This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or any other details related to the evaluation of a device's performance through a study.

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 marketed in interstate commerce prior to May 28, 1976...".

This means the device was cleared based on its substantial equivalence to a predicate device, not through a performance study that would typically involve acceptance criteria and data analysis as described in your request. Therefore, I cannot extract the requested information from this document.

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Dolphix® External Fixation System MR Conditional includes various elements designed to build a fixator construct. The system includes fixation bone screws, clamps and rods. Dolphix® External Fixation System MR Conditional is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for:

• Temporary stabilization of open or closed acute fractures with soft tissue injuries;
• Temporary stabilization of fractures in the context of polytrauma;
• Temporary stabilization of certain pelvic fractures or pelvic ring injuries;
• Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure:
• Temporary stabilization of non-unions;
• Intra-operative temporary stabilization tool to assist with indirect reduction.

Dolphix® External Fixation System MR Conditional is intended for use in a non-weight bearing patient.

Dolphix® External Fixation System MR Conditional includes various elements designed to build a fixator construct. The system includes fixation bone screws, clamps and rods.

I am sorry, but based on the provided document, I cannot extract any information about acceptance criteria or a study proving device performance as the document primarily concerns an FDA 510(k) clearance letter for the "Dolphix® External Fixation System MR Conditional."

The letter outlines the regulatory classification, product codes, and indications for use of the device. It states that the device has been found substantially equivalent to legally marketed predicate devices, but it does not detail any specific performance studies or acceptance criteria beyond stating its intended uses.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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Citieffe External Fixator ST.A.R 90 F4 ELBOW is intended for use in upper extremity treatment of bone and soft tissue conditions and other bone conditions amenable to treatment by use of the external treatment modality. Possible applications include:

• Fracture dislocation with ligaments instability;
• Comminuted intra-articular fractures;
• Post traumatic reconstruction for joint stiffness.
  Citieffe External Fixator ST.AR. 90 F4 KNEE is intended for use in the treatment of bone conditions leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

ST.A.R.90 F4 External Fixation Screws With Hydroxyapatite

I apologize, but the provided text from the FDA 510(k) summary for K150661 does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) or machine learning (ML) models such as sample sizes for test/training sets, expert qualifications, or comparative effectiveness studies.

The document is a standard FDA clearance letter for a medical device (external fixation screws) and focuses on regulatory compliance and substantial equivalence to predicate devices, not on the performance evaluation of a diagnostic AI system against specific clinical acceptance criteria.

Therefore, I cannot fulfill your request for that specific information based on the text provided.

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Dolphix® External Fixation System includes various elements designed to build a fixator construct. The system includes fixation bone screws. clamps and rods. Dolphix® External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for:

• Temporary stabilization of open or closed acute fractures with soft tissue injuries; -
• Temporary stabilization of fractures in the context of polytrauma: -
• Temporary stabilization of certain pelvic fractures or pelvic ring injuries; ...
• Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure;
• Temporary stabilization of non-unions; -
• Intra-operative temporary stabilization tool to assist with indirect reduction. -

Dolphix® External Fixation System is intended for use in a non-weight bearing patient.

Dolphix® External Fixation System includes various elements designed to build a fixator construct. The system includes fixation bone screws. clamps and rods.

The provided text is a 510(k) premarket notification letter from the FDA to CITIEFFE s.r.l for their Dolphix® External Fixation System. This document is a regulatory communication concerning the substantial equivalence of a medical device and does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, not on specific performance data or clinical study results.

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EBA2 Femoral Nailing System is intended for insertion into the medullary canal of femur for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: tractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets such criteria. The document is a letter from the FDA to Citieffe S.r.l. regarding the 510(k) premarket notification for the EBA2 Femoral Nailing System. It primarily discusses the substantial equivalence determination and regulatory requirements for marketing the device.

The letter does not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance for test or training sets.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• How ground truth for the training set was established.

Therefore, I cannot fulfill your request for this specific information using the provided document.

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