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The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.

The SonoTip II Endoscopic Ultrasound Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only. A feature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This feature provides the user with the ability to precisely adjust the working length of the instrument relative to the endoscope being used.

The provided text is a 510(k) summary for the Medi-Globe SonoTip II Ultrasound Needle System, a medical device for fine needle aspiration. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting data for a novel artificial intelligence (AI) or software-based medical device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (especially those related to AI/software, ground truth, expert involvement, and statistical measures like sample sizes for training/test sets) are not applicable to this submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the format of a table with specific, quantifiable acceptance criteria and corresponding performance metrics for the SonoTip II. The submission relies on "design verification data" demonstrating general equivalence.

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

• Sample Size: Not specified. The document refers to "design verification data" but does not detail the size or nature of any test set used.
• Data Provenance: Not specified. It's customary for such mechanical device design verification to involve in-house testing rather than external clinical data in the same way an AI device would.

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

• Number of Experts: Not applicable. This type of submission for a physical device does not typically involve expert readers for "ground truth" establishment in the sense of image interpretation or diagnostic accuracy.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "design verification data" for a needle system would likely involve engineering and functional tests (e.g., tip sharpness, flexibility, aspiration effectiveness, compatibility with endoscopes) rather than diagnostic adjudication.

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

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to a physical medical device like a biopsy needle.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical instrument, not an algorithm. Its function inherently involves a human operator (clinician) manipulating it.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not specifically mentioned as "ground truth" in the context of clinical outcomes or pathology. For a device like this, "ground truth" for design verification would relate to engineering specifications and functional performance (e.g., material strength, needle penetration force, fluid aspiration volume, ease of deployment/retraction, compatibility with predicate endoscopes).

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable.

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The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.

The SonoTip 11 Ultrasound Needle System is complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single 101 I mo Noode Aspirature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This provides adjusted has been miss to precisely adjust the working length of the instrument to that of the specific ultrasound endoscope scope being used.

The provided text describes the SonoTip II Ultrasound Needle System and its 510(k) clearance. However, it does not contain detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or details about the studies (e.g., standalone, MRMC, or training set specifics) that would allow for a comprehensive breakdown as requested.

The document states:

• "Design verification data has demonstrated that the SonoTip II Ultrasonic Needle System meets design requirements and is as safe and effective as the predicate device."
• "The SonoTip II Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical characteristics and general range of descriptive features as the predicate Medi-Globe Ultrasound Needle System (K990220)."

This indicates that the clearance was based on substantial equivalence to a predicate device (GIP/Medi-Globe GI Ultrasound Needle System (K990220)) rather than a detailed clinical performance study with specific acceptance criteria and metrics. The "Performance Data" section primarily asserts equivalence.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

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.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document refers to "Design verification data" but does not detail its source or nature.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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

• No; an MRMC study was not done. This device is a manual medical instrument (a needle system), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. This is a physical medical device (needle system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not specified. Given the nature of the device (FNA needle), a typical "ground truth" for its performance might involve mechanical testing (e.g., needle sharpness, bend resistance, fluid aspiration efficiency) and biocompatibility, as well as a comparison of histological samples obtained with the device vs. the predicate, but these details are not provided.

8. The sample size for the training set

• Not applicable. This device is a physical instrument, not an AI model, so there is no "training set."

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

• Not applicable. As above, no training set.

Summary of available information:

The 510(k) clearance for the SonoTip II Ultrasound Needle System was based on demonstrating substantial equivalence to a legally marketed predicate device (Medi-Globe Ultrasound Needle System, K990220). The documentation does not provide specific performance metrics, detailed study designs, sample sizes, or information about expert involvement typically associated with a human-AI performance study. Instead, it relies on "design verification data" to assert that the device meets design requirements and is as safe and effective as the predicate.

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