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The injeTak™ Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile and single use only.

The injeTAK'" Adjustable Tip Needle consists of a metal needle cannula and an outer movable sheath with an attached adjusting mechanism. The needle sheath diameter is 6Fr with 35-50cm in length, The stainless steel needle is 25gauge Needle tip length adjusting mechanism is used to adjust & set the relative distance between the distal needle point to the distal end tip of needle sheath in a range of 0-5 millimeter (mm). Numbers (0, 2, 3, 5) printed on handle of the adjusting mechanism are used to indicate the individual needle tip (penetration) lengths in millimeter (mm) unit.

The provided text is a 510(k) summary for the injeTAK™ Adjustable Tip Needles. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, performance studies, or details relevant to artificial intelligence (AI) or machine learning (ML) models. Such information is typically found in sections detailing validation studies, clinical trials, or software performance reports, which are absent in this document.

Therefore, I cannot provide the requested information based on the input text. The questions posed are related to the evaluation and validation of AI/ML-driven medical devices, which this document does not cover.

To answer your questions, I would need a document that describes:

1. Specific performance metrics and thresholds (acceptance criteria).
2. Details of a study (clinical or analytical) conducted to evaluate the device's performance against those criteria.
3. Information on the dataset used (sample size, provenance, ground truth establishment, expert qualifications, adjudication).
4. If applicable, details of MRMC studies or standalone algorithm performance.

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The Laborie UROSTYM™ is intended to be used in treating urinary incontinence (stress incontinence (hypermobility) and bladder instability) by way of perineal reeducation. Using the available accessories, the system can be used for performing biofeedback and electro-stimulation therapy as treatment modalities for urinary incontinence.

UROSTYM™ Biofeedback and Stimulation Device

This document is a 510(k) clearance letter from the FDA for the UROSTYM™ Biofeedback and Stimulation Device. It does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory information for marketing the device.

Therefore, I cannot provide the requested information from this document.

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Ask a specific question about this device

Ask a specific question about this device