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The EchoTip® Ultra Endoscopic Ultrasound Needle is used with an ultrasound endoscope for fine needle aspiration (FNA) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

The EchoTip ProCore® HD Ultrasound Biopsy Needle is used with an ultrasound endoscope for fine needle biopsy (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Echotip® Ultra Endobronchial High Definition Ultrasound Needle for Olympus scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).

Echotip® Ultra Endobronchial High Definition Ultrasound Needle for Pentax scopes: This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).

Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for Olympus scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract.

Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for Pentax scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree.

EchoTip Ultra Endoscopic Ultrasound Needle: This Needle is used in conjunction with an ultrasound endoscope and is available in needle gauge sizes of 19, 22 and 25 Ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The purpose of the needle cannula is for puncturing of the target site. The preloaded nitinol stylet is withdrawn from the needle when obtaining sample from the target site. The sheath covers the needle when it is not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in sample aspiration. The device is supplied sterile and is intended for single use. The device is for Rx use only.

EchoTip ProCore HD Ultrasound Biopsy Needle: This Needle is used in conjunction with an ultrasound endoscope and is available in needle gauge sizes of 19, 20, 22 and 25 ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and a notch. The purpose of the needle cannula is for puncturing/biopsy of the target site. The preloaded nitinol stylet is withdrawn from the needle for biopsy. Some variants have a stylet that coils when not in the needle. The sheath covers the needle when it is not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in tissue aspiration. The device is supplied sterile and is intended for single use. The device is for Rx use only.

EchoTip Ultra / ProCore Endobronchial High Definition Ultrasound Needle: These Needles are used in conjunction with an endobronchial ultrasound endoscope and is available with needle gauge sizes of 22 and 25 Ga. The device is composed of a needle assembly and a syringe. An adapter can also be supplied for use with endobronchial ultrasound endoscopes with metal non-Luer hubs. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and comes either with or without a notch. The purpose of the needle cannula is for puncturing/sampling of the target site. The needle is provided with a preloaded stylet which remains in place during advancement of the needle. The sheath covers the needle when the needle is retracted and not in use. The device handle allows for needle and sheath length adjustment. The stylet/syringe can aid in specimen retrieval. The device is supplied sterile and intended for single use only. The device is for Rx use only.

The provided text is a 510(k) Summary for medical devices, specifically various EchoTip ultrasound needles. It describes the devices, their indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence.

However, it does not contain acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a device based on clinical or diagnostic outcomes, nor does it describe a study that uses such acceptance criteria to demonstrate the device meets them. This document is a regulatory submission focused on proving equivalence to previously cleared devices through non-clinical performance testing and technological comparison.

Therefore, I cannot extract the requested information in the format provided. The document outlines performance testing as part of Cook Ireland's design control system, but these are engineering/material tests, not studies against clinical acceptance criteria.

To elaborate on what is present in relation to performance, albeit not in the requested format:

Performance Data (Non-Clinical):
The document states that performance testing was conducted as per Cook Ireland's design control system. These tests include:

• Tensile testing
• Crumple testing
• Joint strength testing
• Finite element analysis
• Simulated use and drop testing

Purpose of these tests:
To support the safety of the modified devices and demonstrate that they should perform as intended, thereby supporting substantial equivalence to the predicate devices. These are engineering and material science tests, not clinical performance studies for diagnostic accuracy.

Missing Information (as per your request):
The document does not provide:

1. A table of acceptance criteria and reported device performance related to diagnostic outcomes.
2. Sample size used for a clinical test set, nor data provenance (country, retrospective/prospective).
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a clinical test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect size regarding human readers improving with/without AI assistance.
6. Information about standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcome data) in a clinical context.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This is expected as the submission is for needle devices, which are instruments used by clinicians, not AI/diagnostic algorithms with specific diagnostic performance metrics. The criteria for these devices are typically related to mechanical integrity, biocompatibility, and functional equivalence to similar devices already on the market.

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This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

The EchoTip Procore® HD Ultrasound Biopsy Needle is used in conjunction with an ultrasound endoscope and is available with needle gauge sizes of 19, 20, 22 and 25 ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and a notch. The purpose of the needle cannula is for puncturing/biopsy of the target site. The preloaded nitinol stylet is withdrawn from the needle for biopsy. Some variants have a stylet that coils when not in the needle. The sheath covers the needle when it's not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in tissue aspiration. The device is supplied sterile and is intended for single use. The device is for Rx used only.

This document is a 510(k) premarket notification for a medical device called the EchoTip Procore® HD Ultrasound Biopsy Needle. It is not an academic study or research paper, but rather a regulatory submission to the FDA. Therefore, it does not contain the detailed information typically found in study reports regarding acceptance criteria and performance data for an AI/ML device.

Specifically, the document pertains to a physical medical device (a biopsy needle), not a diagnostic algorithm or AI/ML-driven device. As such, the typical metrics for evaluating AI performance (such as sensitivity, specificity, AUC, MRMC studies, standalone performance, etc.) are irrelevant to this submission.

Here's a breakdown of why the requested information cannot be provided from this document:

1. Acceptance criteria and reported device performance (for AI/ML): This document deals with a physical biopsy needle. Its performance is evaluated through metrics like biocompatibility, visual inspection, dimensional inspection, simulated use, stylet removal force, and joint strength. These are mechanical and material property tests to ensure the physical device functions as intended and is safe for use, not metrics for algorithm accuracy.

   • Table of acceptance criteria and reported device performance: Not applicable for AI/ML. The document states "Performance testing such as visual inspection, dimensional inspection, simulated use, stylet removal force testing and joint strength testing were performed as per Cook Ireland's design control system." Specific numerical acceptance criteria or performance results for these physical tests are not provided in this summary.

2. Sample size for test set and data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated. The 'tests' performed are on the physical device itself (e.g., individual needles).

3. Number of experts used to establish ground truth & qualifications: Not applicable. There is no ground truth, as understood in AI/ML validation, for a physical biopsy needle. Its performance is based on physical and biological characteristics.

4. Adjudication method: Not applicable.

5. MRMC comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks.

6. Standalone performance (algorithm only): Not applicable. There is no algorithm.

7. Type of ground truth used: Not applicable.

8. Sample size for training set: Not applicable. There is no AI model requiring a training set.

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

Summary relevant to the provided document for a physical device:

• Acceptance Criteria: The document mentions that performance testing was conducted "as per Cook Ireland's design control system" and refers to ISO 10993-1:2009 for biocompatibility and FDA's G95-1 guidance. This implies internal, pre-defined acceptance criteria for physical, mechanical, and biological properties, but the specific numerical criteria are not detailed in this public summary.
• Reported Device Performance: The summary only states that "Non-clinical testing carried out on the device supports the substantial equivalence... and provides a reasonable assurance of safety and effectiveness." No specific performance data (e.g., exact force values, dimensional tolerances met, cytotoxicity scores) are provided.
• Study Types:
  • Biocompatibility evaluation: Conducted according to ISO 10993-1:2009 and FDA's G95-1 guidance. Tests performed were Cytotoxicity, Sensitization, and Intracutaneous reactivity.
  • Performance testing (physical/mechanical): Visual inspection, dimensional inspection, simulated use, stylet removal force testing, and joint strength testing.
• Purpose of the "study": To demonstrate substantial equivalence to predicate devices (Cook Endoscopic Ultrasound Needle, K083330, and Biopsy Sciences, LLC Maxi-Cell Biopsy Needle, K021847) for regulatory clearance, not to evaluate an AI algorithm.

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