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The device intended for use as a specialized manual surgical instrument. It is reusable and intended to provide access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical provides a selflocking type surgical retraction system with inflatable tissue protectors.

GEISTER Medizintechnik GmbH Self-retaining Retractors are reusable manual instruments made from stainless steel, PEEK or titanium. They are sold unsterile and can be re-processed according the instructions for use.

The provided document is a 510(k) premarket notification letter and summary for a medical device: "Geister® retractor for neuro - and spine surgery." This document is not about an AI/ML-based device, but rather a traditional surgical instrument.

Therefore, the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them (including aspects like sample size for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for AI/ML, etc.) is not applicable to this document.

The document discusses the device's substantial equivalence to predicate devices based on:

• Indications for Use: The device is a specialized manual surgical instrument intended for use in thoracic and lumbar spinal column access during minimally invasive and endoscopic surgical procedures.
• Material: Titanium, Stainless Steel, PEEK.
• Technology: Self-locking type surgical retraction system.
• Design: Various dimensions for retractors and blades, different systems (Microdiscectomy, SpineControl Cervical, Self-Retaining Retractors).
• Performance Specifications: Bench testing was performed.

The testing mentioned for this device consists of:

• Biocompatibility
• Re-processing and sterilization
• Performance testing (bench)

No information related to AI/ML acceptance criteria or studies can be extracted from this document.

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The Geister Valvulotomeare designed to incise the valve cusps of the graft in coronary artery bypass graft (CABG) procedures.

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This document is not about an AI/ML powered device, therefore, the requested information about acceptance criteria and study details for such a device is not present. The document is a 510(k) premarket notification approval letter for the "Geister Valvulotome", a mechanical surgical instrument.

Therefore I cannot provide the information requested in the format of acceptance criteria and study data for an AI/ML powered medical device.

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GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

GEISTER vessel dilators

This is a 510(k) premarket notification for a medical device (GEISTER Vessel Dilators), not a study report for an AI/ML device. Therefore, the document does not contain information on acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth types related to an AI/ML study.

The document is an FDA letter stating that the GEISTER Vessel Dilators are substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. It outlines the regulatory classification, product code, and indications for use of the device.

To directly answer your request based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This document does not contain information relevant to an AI/ML device study. It is a 510(k) clearance letter for a Class II surgical vessel dilator and discusses substantial equivalence to predicate devices, not performance against specific acceptance criteria in a study format typically associated with AI/ML.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: Not applicable for this type of document.
• Sample size used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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To temporarily occlude an artery or vein with correct tension to produce minimal trauma to vessels. The different sizes and models are designed according to the type and size of the blood vessels, anatomical sites, and surgical techniques. Bulldog clamps are self-closing and are used for small vessels. The closing pressure of the GLOVER clamps can be adjusted using a nut and spring.

Applying forceps are used to apply bulldog clamps in deep surgical wounds.

To secure vascular occlusion of small vessels during surgery and to secure vascular occlusion during pediatric surgery.

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The provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer for "Vascular Clamps." This type of document is an approval based on substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the performance of the device against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies is not present in this document.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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...".

Therefore, I cannot provide the requested information based on the provided text.

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