Search Results

BNX Fine Needle Aspiration System: The device is used to sample targeted sub-mucosal and extramural gastrontestinal lesions through the accessory channel of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle sticks. The 19Ga. and 22Ga. BNX™ ASPIRATION Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

Shark Core Fine Needle Biopsy System: The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adiacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shelding feature to aid in the prevention of needle sticks.

The BNX FNA / SharkCore FNB Systems are sterile, single patient use endoscopic ultrasound aspiration needles. The devices consists of the Beacon Endoscopic Ultrasound Delivery System and either the BNX Fine Needle Aspiration Needle or the SharkCore Fine Needle Biopsy Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The devices are offered with needle sizes of 19, 22 and 25 gauge. The BNX FNA / SharkCore FNB Systems have an integrated needle protection shield that automatically engages over the distal end of the needle during removal to cover the needle sharp. In this manner, the needle tip is covered to help protect against inadvertent needle sticks.

The provided document is a 510(k) summary for the BNX™ Fine Needle Aspiration System and the SharkCore™ Fine Needle Biopsy System. It describes the devices, their indications for use, and a summary of performance data. However, it does not contain the detailed information needed to construct a table of acceptance criteria and the study that proves the device meets those criteria, specifically regarding:

• Specific acceptance criteria values: The document only states that the devices "met the required specifications for completed design verifications tests." It does not provide the actual numerical or qualitative acceptance criteria for these tests (e.g., "unlocking forces must be > X N," or "sheath extension must be Y mm").
• Reported device performance values: Similarly, it states the devices "met the required specifications" but does not report the actual measured performance values (e.g., "unlocking forces measured Z N," or "sheath extension measured W mm").
• Sample sizes for test or training sets: It mentions "bench testing" but does not specify the number of units tested.
• Data provenance: No information on country of origin or retrospective/prospective nature.
• Details about experts or ground truth: Not applicable for bench testing.
• Adjudication method: Not applicable for bench testing.
• MRMC comparative effectiveness study: Not applicable, as this is bench testing, not a clinical study involving human readers.
• Standalone algorithm performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth, training set size, and how training ground truth was established: Not applicable for bench testing.

Therefore, I can only provide the information that is available in the document, which primarily concerns the types of tests performed and a general statement about meeting specifications.

1. Table of Acceptance Criteria and Reported Device Performance

                                                                                              |

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document only mentions "Bench testing has been performed."
• Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer, Covidien, LLC. This is prospective testing of manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The described testing involves bench testing of physical device attributes (forces, dimensions, durability), not human expert evaluation of data or images.

4. Adjudication method for the test set:

• Not applicable. The described testing involves bench testing of physical device attributes.

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 document pertains to the 510(k) clearance of physical aspiration/biopsy needles and does not involve AI or human image interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This document pertains to a physical medical device, not an algorithm.

7. The type of ground truth used:

• For this bench testing, the "ground truth" would be the engineering specifications and design requirements that the device's performance characteristics (e.g., unlocking force, dimensions) were measured against.

8. The sample size for the training set:

• Not applicable. This document describes verification testing for a physical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. No training set is involved in the context of this device's regulatory submission as described.

Ask a specific question about this device