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The Semi-Automatic Biopsy Instrument and associated Co-Axial Introducer Needle are used to obtain samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, pancreas, and other masses.

The Semi-Automatic Biopsy Instrument is used to obtain soft tissue biopsies. It is composed of a spring-loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. The position of the needle may be visualized by x-ray, CT, or ultrasound. The needle has numerically ordered centimeter markings to facilitate precise depth placement. The adjustable instrument allows for a specimen notch size of 10mm or 20mm, providing clinical flexibility. The device has an adjustable co-axial adapter built into the device for either the 10mm or 20mm notch settings. The stylet travels up to 27mm from when the device is in a fully charged position (prepared for a collection with the 20 mm notch size) to when the stylet is fully extended. The needle has an echogenic tip. The semi-automatic biopsy instrument is available in several needle gauge sizes and lengths. The plunger is color coded according to the various gauge sizes, e.g., green=14-gauge, purple=16-gauge, pink=18-gauge, and yellow=20-gauge.

The provided document is a 510(k) summary for a medical device (Semi-Automatic Biopsy Instrument). It lacks the specific details required to answer your request about acceptance criteria and a study proving that an AI/ML-based device meets those criteria.

The document describes a traditional medical device (biopsy instrument) and its performance testing, which are primarily engineering and material tests, not clinical studies involving AI performance, human readers, or ground truth establishment relevant to AI.

Therefore, I cannot provide the requested information based on the provided text. The document does not contain:

1. A table of acceptance criteria and reported device performance related to AI/ML.
2. Sample sizes for test sets in an AI context.
3. Data provenance for AI/ML training/test sets.
4. Number of experts and their qualifications for ground truth in an AI context.
5. Adjudication method for AI test sets.
6. MRMC comparative effectiveness study details.
7. Standalone AI performance (algorithm only).
8. Type of ground truth (expert consensus, pathology, outcomes data) for AI/ML.
9. Sample size for training set for AI/ML.
10. How ground truth for the training set was established for AI/ML.

The "Performance Testing" section in the document refers to physical and material tests for the biopsy instrument itself (e.g., Dimensional, Peak Tensile Strength, Simulated Use, Radiopacity, Echogenicity, Corrosion Resistance). This is entirely different from the kind of performance testing relevant to AI/ML medical devices.

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