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Device is intended to be used for instrument placement to access anatomical structures under transrectal ultrasound guidance.

• . Prostate - Biopsy and minimally invasive puncture
• . Surgical (Prostate) - Biopsy and minimally invasive puncture

The TP Pivot Pro™ needle guide is a tool for performing freehanded transperineal prostate biopsies, taking advantage of the transperineal path to sample regions of the prostate including the difficult to reach anterior zone. Used in conjunction with an ultrasound probe, users visualize suspect target areas of the prostate, plan and position an access site, and obtain specimens from a precise point in the prostate.

The FDA Summary for the TP Pivot Pro™ Needle Guide (K233109) does not include specific acceptance criteria or detailed study results in the format typically used for performance claims of diagnostic or AI-powered devices. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data like clinical trials.

The information provided describes non-clinical tests to ensure design functionality and biocompatibility. Here's a breakdown based on your request, with missing information noted:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The acceptance criteria for the design specification tests are not quantified in this summary, but are described in terms of meeting established requirements for adequate function and integrity.)

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. The document mentions "Simulated use evaluations were performed by customers," but the number of customers/evaluations is not specified.
• Data Provenance: The biocompatibility tests are conducted in accordance with ISO standards, implying laboratory testing. The design specification tests and simulated usability testing are described as "tested internally" or "performed by customers," suggesting in-house and potentially external user tests, respectively. No information on country of origin for test data or whether it was retrospective/prospective is provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not applicable / Not provided. The document describes non-clinical engineering and usability tests. There is no mention of "ground truth" in the clinical sense (e.g., disease diagnosis) or involvement of experts for establishing clinical ground truth for the performance evaluations described. The "customers" in simulated usability testing are users, not necessarily experts establishing ground truth for a diagnostic outcome.

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Since there is no clinical "ground truth" determination described, no adjudication method like 2+1 or 3+1 is relevant for the reported tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This device is a mechanical needle guide, not an AI-powered diagnostic system or imaging device, so such a study comparing human reader performance with and without AI assistance is not relevant or described.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This device is a mechanical needle guide, not an algorithm or AI system.

7. Type of Ground Truth Used

• Not a clinical ground truth. For the biocompatibility tests, ground truth is based on established ISO standards. For the design specification tests, ground truth refers to the engineering requirements and functional specifications (e.g., "adequately attaches," "not damaged," "meets established requirements"). For simulated usability testing, ground truth is conformity to user needs.

8. Sample Size for the Training Set

• Not applicable / Not provided. This device is a mechanical device, not an AI or machine learning model, so there is no concept of a "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

• Not applicable / Not provided. As there is no training set for an algorithm, there is no ground truth establishment for a training set.

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Synthetic polyisoprene probe covers are indicated for use during diagnostic ultrasound procedures in cases where patient sensitivity to natural rubber latex is speculative.

The Sheathing Technologies, Inc CIS-Isoprene Ultrasound Transducer Cover provides a thin, conformal covering to fit various and specific ultrasound transducer shapes. The cover is made by dipping to form a general cylindrical shape. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer. This device is an accessory used on diagnostic probes to help minimize cross contamination. The cover material is a Cis-1,4-polyisoprene, a synthetic version of natural rubber latex made without using natural rubber latex in the formulation. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations. Product categories/models include General Purpose SheathesISO Ultrasound Transducer Covers (sterile and non-sterile). Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities, as well as in "procedure kit" form for single patient/procedure, disposable use. The "procedure kit" may include elastic fasteners, with or without coupling gel packets. Transducer covers are also combined with disposable needle guide devices into kits.

This document is a 510(k) premarket notification for a Synthetic Polyisoprene Ultrasound Transducer Cover. The information provided does not describe a study involving AI or complex statistical analysis for diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments. Therefore, many of the requested categories related to AI performance, expert ground truth, and comparative effectiveness studies are not applicable.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

The document describes the device's characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness relative to predicate devices. The "acceptance criteria" here are implied by successful completion of these tests in comparison to established standards and the predicate device's performance.

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