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The Perineologic Access Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue and tumors of such organs as liver, kidney, spleen, lymph nodes, prostate, lung and various soft tissue lesions.

The Perineologic Access Needle is a sterile, single use, disposable, hollowed/tubular, stainless steel needle that is sharpened at one end and blunt on the opposing end while containing a polymeric hub with a female luer-lock style fitting to accept a male luer lock syringe. The polymeric hub contains a female luer fitting on the proximal end, a protruding, elongated rectangle for gripping, and a distal circumferential tubular lip that protrudes approximately 1 cm along the axis of the stainless steel needle. The protruding rectangle in the middle of the polymeric hub has 2 opposing and equal sides in the shape of a tapered rectangle containing ribs for gripping. The remaining 2 sides of the tapered rectangle are hollowed.

The Perineologic Access Needle is provided in various lengths and diameters as required for particular biopsy procedures. The Perineologic Access Needle is provided in lengths ranging from 7cm to 20cm and inner diameters ranging from 14 gauge to 20 gauge.

This document describes a 510(k) premarket notification for the Perineologic Access Needle, a device intended for use as a guiding needle in obtaining core biopsy samples.

Unfortunately, the provided text does not contain information about acceptance criteria or a specific study that proves the device meets those criteria in terms of clinical performance. The document focuses on demonstrating substantial equivalence to existing predicate devices based on design characteristics, materials, and intended use, rather than presenting novel performance data against pre-defined clinical acceptance criteria.

The "Performance Testing" section (page 4) lists general standards related to sterilization, biological evaluation, and packaging, which are crucial for device safety and regulatory compliance but are not, strictly speaking, clinical performance acceptance criteria.

Therefore, I cannot provide a detailed answer to your request as the information is not present in the provided text. To answer your questions, I would need a section describing clinical performance studies with specific statistical outcomes and acceptance criteria.

However, based on the provided text, I can infer some general information about the device and its regulatory submission:

• Device Name: Perineologic Access Needle
• Intended Use: Guiding needle in obtaining core biopsy samples from soft tissue and tumors of organs like liver, kidney, spleen, lymph nodes, prostate, lung, and various soft tissue lesions.
• Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
• Predicate Devices:
  • Bard TrueGuide™ Coaxial Biopsy Needle Guide (K936194)
  • PFM Medical Biopsy Needle System (K140137)

Missing Information (based on your request):

1. Table of Acceptance Criteria and Reported Device Performance: Not available. The document does not define specific clinical acceptance criteria (e.g., success rate, accuracy) for the device's function as a guiding needle, nor does it report performance against such criteria.
2. Sample Size and Data Provenance for Test Set: Not available. No clinical test set data is provided.
3. Number and Qualifications of Experts for Ground Truth: Not applicable, as no clinical performance data requiring expert-established ground truth is presented.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not mentioned or conducted. The submission is for a medical device (a needle), not an AI algorithm.
6. Standalone Performance Study: Not clearly detailed in terms of clinical performance. The focus is on equivalence.
7. Type of Ground Truth Used: Not applicable, as no clinical performance data is presented.
8. Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
9. How Ground Truth for Training Set was Established: Not applicable.

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