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The Acquire™ Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

The Acquire™ device is comprised of the following:

• One (1) Acquire™ needle
• One (1) Syringe
• One (1) Stopcock

The Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is a sterile singleuse device. It is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire aspiration samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction.

Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.

This document is a 510(k) premarket notification for a medical device called the Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device. It describes the device and claims substantial equivalence to a predicate device.

Based on the provided text, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "No performance testing is required to evaluate the new needle tip design. Verification activity has been performed on the proposed Acquire™ device, which demonstrates that the modified needle tip design met the pre-defined product specification: 'Franseen' Needle Grind Specification."

This indicates that a formal clinical "test set" with patient data was not used for the determination of substantial equivalence based on clinical performance. The testing focused on meeting specific engineering/design specifications of the new needle tip. Thus, there is no information about the sample size of a test set nor its provenance (country of origin, retrospective/prospective).

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

As direct clinical performance testing on a "test set" to establish ground truth about diagnostic accuracy or effectiveness was not conducted according to the document, this information is not applicable and therefore not provided. The verification focused on physical specifications.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set for diagnostic performance was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document states that "No performance testing is required to evaluate the new needle tip design." The focus was on engineering specifications and substantial equivalence to a predicate device based on similar intended use and technological characteristics, with the exception of the needle tip geometry.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This question is not applicable to this medical device. The Acquire™ device is a physical, sterile, single-use endoscopic ultrasound aspiration needle used by a human operator (a clinician) to acquire tissue samples. It is not an algorithm or an AI-powered device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the "Franseen" Needle Grind Specification. The performance verification ensured the manufactured device adhered to this engineering specification, rather than to a medical "ground truth" like pathology results.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical instrument, not an AI or algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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