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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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The intended use of the Perineologic PrecisionPoint™ Biopsy Needle Guide when used in conjunction with a BK ProFocus 2202 ultrasound system and attached to the ultrasound system's transducer, is to facilitate proper needle placement to access anatomical structures.

The PrecisionPoint Biopsy Needle Guide is a sterile, single use, disposable, polymeric needle guide containing 2 pieces of molded plastic (carriage and rail/clamp). The PrecisionPoint Biopsy Needle Guide is pressed / placed onto the region overlying the area to be biopsied. The PrecisionPoint Biopsy Needle Guide holds both the ultrasound probe and the needle guide in place relative to each other while the ultrasound-guided biopsy is being preformed. The PrecisionPoint Biopsy Needle Guide is an assembly of 3 unique polymeric components: carriage, rail, and clamp. The carriage component slides onto the rails to create an assembly that can hold and maintain the relative position of an ultrasound probe and a needle guide at the same time.

The clamp component is a ring shaped structure with 2 opposing rectangular handles at the bottom of the ring that contain a male flange that is designed to mate with the opposing female cavern. The male flange has ridges on the bottom of the flange while the female cavern has ridges on the top of the cavern, creating an adjustable locking mechanism in which the next row of ridges align and lock as the male flange advances. The advancement of the male flange into the opposing female cavern creates a ring with decreased and smaller circumference that imposes increased pressure on a cylindrical ultrasound probe positioned within the ring of the clamp component. The clamp component is designed to accommodate a cylindrical style transrectal ultrasound transducer (0.7' to .85" diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system cleared under K043524.

The carriage component has 5 equal holes to accommodate a 14 gauge needle and may contain holes of equal or various diameters from 14 gauge to 20 gauge. The 5 needle holes are equally spaced approximately 5cm apart and may be spaced closer or farther apart depending on the diameter of the holes. The number of needle holes may vary from as few as 1 to as many as 8. The dimensions of the fully assembled PrecisionPoint Biopsy Needle Guide are approximately 5.5cm long, 7cm tall, and 4.5cm wide.

This document describes a 510(k) premarket notification for the "PrecisionPoint Biopsy Needle Guide." A 510(k) submission typically demonstrates substantial equivalence to a predicate device, rather than proving that a device meets specific clinical performance acceptance criteria through the kind of study described in the prompt. Therefore, many of the requested elements for a study proving device acceptance criteria are not applicable in this context.

Here's a breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document describes performance testing against standards for sterilization, biological evaluation, and packaging, rather than clinical performance criteria with numerical targets. The acceptance criteria are implicit in meeting these recognized standards.

Regarding clinical performance acceptance criteria and a study to prove them:

The document describes performance testing related to basic medical device standards (sterilization, biocompatibility, packaging). It does not present a clinical study with an acceptance criterion for device effectiveness or accuracy (e.g., biopsy success rate, targeting accuracy). The primary "proof" for this 510(k) submission is showing substantial equivalence to a legally marketed predicate device.

Given that this is a 510(k) submission for a needle guide and relies on substantial equivalence to a predicate, the following requested information is not provided in this document:

2. Sample size used for the test set and the data provenance: Not applicable for this type of submission. There is no clinical "test set" described for performance evaluation of the needle guide's clinical efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or ground truth establishment by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. 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. This device is a physical needle guide, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. There is no clinical "ground truth" described for the device's performance. The "ground truth" in this submission relates to adherence to manufacturing and safety standards, and demonstrating design and intended use equivalence to the predicate.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of this device and submission type.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does indicate:

The device is a PrecisionPoint Biopsy Needle Guide, intended to facilitate proper needle placement during ultrasound-guided biopsies when used with a BK ProFocus 2202 ultrasound system. Its acceptance by the FDA (via 510(k) clearance) is based on:

• Meeting recognized standards for sterilization (ISO 11135-1), biological evaluation (ISO 10993-1), and packaging (ANSI/AAMI/ISO 11607-1, ANSI/AAMI/ISO 11607-2).
• Demonstrating substantial equivalence in indications for use, design, and materials to a predicate device: the Sonosite iLook 25 Needle Guide Attachment and Bracket Assembly (K030064). The document explicitly states the substantial equivalence in these areas.

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