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The EZ-Mister is indicated for use in atomizing topical anesthetics to the oropharynx and upper airway regions.

The EZ-Mister consists of a plastic atomizer used to deliver topical anesthetic solutions. The device includes a receptacle intended to contain a single container of topical anesthetic; the atomizer housing has a plastic tube that extends into the anesthetic solution. The device uses oxygen flow to achieve atomization.

The E-Z Mister device is a topical anesthetic atomizer. The study performed to demonstrate its performance focused on particle size testing. However, the document does not include a table of acceptance criteria, the specific results of the particle size testing, or the other requested details regarding the study methodology.

Based on the provided information, I can answer some of the points:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided document. It's only mentioned that "Performance data provided in this submission consists of particle size testing." Without specific thresholds or target ranges for particle size, it's impossible to create this table.
• Reported Device Performance: Not explicitly provided in the document. The document only states that particle size testing was performed, but the results of this testing are not given.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for the particle size testing.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable as the study involved particle size testing, not a clinical assessment requiring expert-established ground truth.

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

• This question is not applicable as the study involved particle size testing, not a clinical assessment requiring adjudication.

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, a multi-reader multi-case comparative effectiveness study was not done. The study was focused on the physical characteristics (particle size) of the device.

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

• This question is not applicable as the device is a physical medical device, not an algorithm or AI system.

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

• This question is not applicable as the study involved particle size testing through laboratory measurements, not a clinical assessment requiring ground truth established by experts or pathology.

8. The sample size for the training set

• This question is not applicable as the device is a physical medical device, not an algorithm or AI system that requires a training set.

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

• This question is not applicable as the device is a physical medical device, not an algorithm or AI system that requires a training set.

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For use as an adapter for the introduction of tools and/or irrigation fluid through the endoscope working channel.

The N.M. Beale Co., Inc. Scope Introducer consists of a one-piece metal construct with a luer fitting on one end and a tubular opening at the other end. The luer connector of the introducer can be connected to an irrigation source; the tubular end is inserted into the endoscope working channel to facilitate the introduction of accessories and/or irrigation. The Scope Introducer can be reused and is intended to be sterilized between uses.

The N.M. Beale Co., Inc. Scope Introducer, as described in the provided documents, is a simple medical device intended as an adapter for introducing tools or irrigation fluid through an endoscope working channel. The "performance testing" mentioned in Section 5 of the 510(k) summary (page 0) refers only to "cleaning and sterilization validations." This device is a Class II device and was cleared via the 510(k) pathway by demonstrating substantial equivalence to a predicate device.

Given the nature of this device and the information provided, it does not involve Artificial Intelligence (AI) or any complex algorithms that would necessitate the extensive study and performance evaluation metrics typically associated with AI-driven medical devices. Therefore, a table of acceptance criteria and reported device performance related to diagnostic accuracy, sensitivity, specificity, or other AI-specific metrics is not applicable here.

The questions regarding sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set details are all relevant to the evaluation of AI models. Since this device is not an AI product, these questions cannot be answered based on the provided documents.

In summary:

• 1. A table of acceptance criteria and the reported device performance: Not applicable for an AI device. The submission mentions "cleaning and sterilization validations" as performance testing, which would have their own acceptance criteria, but these are not specified in the provided text.
• 2. Sample sized used for the test set and the data provenance: Not applicable as it is not an AI device.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it is not an AI device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as it is not an AI device.
• 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 as it is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it is not an AI device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as it is not an AI device.
• 8. The sample size for the training set: Not applicable as it is not an AI device.
• 9. How the ground truth for the training set was established: Not applicable as it is not an AI device.

The study referenced is the 510(k) premarket notification process for medical device clearance, which, in this case, primarily focused on demonstrating substantial equivalence to a predicate device and included "cleaning and sterilization validations" for reusability.

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For use in achieving simultaneous access to the stomach and duodenum to allow fluid sampling in procedures such as pancreatic exocrine function testing.

The PEF Tube consists of a soft, dual-lumen tube with a proximal Y-connector that allows separate access to each of the 2 lumens. One lumen opens distally in the stomach; the second lumen opens into the duodenum.

The N.M. Beale Company, Inc. PEF Tube is a gastrointestinal tube designed for simultaneous access to the stomach and duodenum for fluid sampling, particularly in pancreatic exocrine function testing. The performance testing for this device focused on demonstrating substantial equivalence to a predicate device and/or meeting pre-determined acceptance criteria for safety and effectiveness.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

Note: The provided document states that "tensile testing" was performed, but it does not specify the exact numerical acceptance criteria for this testing (e.g., minimum tensile strength in Newtons, or maximum elongation). It only indicates that the device "met pre-determined acceptance criteria."

Study Information

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

   • The document does not specify the sample size for the tensile testing or its
     provenance (e.g., country of origin, retrospective/prospective).

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

   • This is not applicable as the performance testing for the PEF Tube
     involved physical tensile testing, not interpretation of data requiring expert
     ground truth.

3. Adjudication method for the test set:

   • This is not applicable for tensile testing.

4. 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 MRMC or AI-related study was indicated for this medical device. The
     device is a physical gastrointestinal tube, not an AI or imaging device.

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

   • This is not applicable. The device is a physical gastrointestinal tube,
     not an algorithm.

6. The type of ground truth used:

   • For tensile testing, the "ground truth" would be established by
     engineering standards and specifications for the material and design of
     gastrointestinal tubes, verified through calibrated testing equipment. The
     document does not explicitly state the specific standards or
     specifications used but implies that predefined criteria were met.

7. The sample size for the training set:

   • This is not applicable. The device undergoes physical performance
     testing, not machine learning training.

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

   • This is not applicable.

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For Endoscopic Ultrasound Applications using the Balloon Method in the Upper or Lower Gastrointestinal Tract.

Endoscopic Ultrasound Balloon Device Name: Latex Free

The provided text describes a 510(k) clearance letter for the "Endoscopic Ultrasound Balloon" device. It outlines the FDA's determination of substantial equivalence to a predicate device for the stated indications for use.

Crucially, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a detailed study report within this document. While the manufacturer would have submitted testing data to the FDA to support their claim of substantial equivalence, those details are not present in the provided letter.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given input.

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