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The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).

Olympus NA-10J-1 Aspiration Needle

This is a 510(k) premarket notification for a medical device (Olympus NA-10J-1 Aspiration Needle) and does not contain information about acceptance criteria or a study proving device performance in the context of AI/algorithm-based diagnostic devices.

The provided document is a regulatory submission for a physical medical device (an aspiration needle) and focuses on establishing substantial equivalence to a predicate device for market clearance. It primarily covers:

• Device Name and Intended Use: Specifies the Olympus NA-10J-1 Aspiration Needle for ultrasonically guided fine needle aspiration (FNA) of lesions.
• Regulatory Classification: Identifies the classification name (Gastroenterology-Urology Biopsy Instruments) and product code (78 FOG).
• Predicate Device: States the Olympus NA-1C Aspiration Needle (K904667) as the predicate.
• FDA Clearance Letter: Confirms the FDA's review and determination of substantial equivalence, allowing the device to be marketed.

Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/algorithm-based device is not present in this document. This document describes a traditional medical device, not an AI/ML diagnostic system.

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The device indicated for patients who need to be placed in an oxygen enriched environment.

Disposable Infant hood with drape

This medical device submission is for a Burlew Infant Hood, which is an infant oxygen hood. The document does not describe a study involving acceptance criteria and device performance in the way typically found for diagnostic or AI-driven devices (e.g., sensitivity, specificity, accuracy). Instead, it focuses on comparing the Burlew Infant Hood to predicate devices based on various attributes.

Here's an analysis based on the provided text, recognizing its limitations regarding the specific type of "study" requested in the prompt:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present explicit "acceptance criteria" with numerical performance metrics like a diagnostic device. Instead, the "Performance Testing" attribute is listed as "Yes" for the Burlew device and its predicates, implying that such testing was done, but the details (criteria and results) are not provided in this summary.

The comparison table below highlights attributes where the Burlew Infant Hood matches or improves upon predicate devices. These can be considered the "performance metrics" being assessed for this type of device, related to its design and functional capabilities rather than diagnostic accuracy.

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

This document does not describe a "test set" in the context of diagnostic performance. There's no mention of patient data, images, or clinical studies with specific sample sizes. The "Performance Testing" mentioned is likely related to engineering or functional checks of the device itself (e.g., oxygen delivery rates, material strength, leakage) rather than a clinical trial with a "test set" of patients.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document does not describe a study involving expert review for establishing ground truth for a diagnostic output.

4. Adjudication Method

Not applicable. There is no diagnostic output requiring adjudication.

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

Not applicable. This device is an infant oxygen hood, not an AI or diagnostic tool where MRMC studies are typically performed.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

Not applicable in the context of a diagnostic or AI study. The "ground truth" for this device would be its demonstrated functional capability to provide an oxygen-enriched environment safely and effectively, and its material properties meeting specifications. The comparison table essentially acts as a "ground truth" for its features compared to predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is not an AI model, so there is no training set.

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

Not applicable.

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