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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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