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The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are intended to be used in combination with compatible endoscopes to maintain the field of view during endscopic procedures such as mucosal resection.

The FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR are comprised of three main sections: an attaching portion, a distal portion, and a drain portion. The attaching portion is a wider diameter opening which is used to connect the hood to an applicable endoscope; a distal portion is the ending portion of the hood which tapers into narrower diameter opening, the drain slits on the distal portion form drain portion which prevent the fluids lodging on the surface of the endoscope.

The subject devices are used in combination with their respective applicable Fujifilm's endoscopes as shown in the table 7.1. All the applicable endoscopes marketed in USA are cleared under respective 510(k) notices.

The provided document is a 510(k) premarket notification for FUJIFILM Hood Models DH-28GR, DH-29CR, and DH-30CR. It primarily focuses on demonstrating substantial equivalence to a predicate device, FUJIFILM Hood Model DH-17EN (K143556), rather than outlining specific acceptance criteria in the context of device performance metrics and a detailed study proving performance against those metrics in the way one might typically see for AI/ML devices.

Instead, the document details performance data that supports the substantial equivalence, particularly concerning changes in dimensions, material, and sterility status compared to the predicate device.

Here's an analysis based on the information provided, framed to address your requested points where applicable, and highlighting what is not present (which is most of the detailed information expected for an AI/ML device performance study):

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" is not used in the document for specific performance thresholds. Instead, the document discusses meeting "performance specifications" or demonstrating "substantially equivalent performance" to the predicate device. The performance data presented focuses on verifying that changes to the device (dimensions, material, sterility) do not negatively impact its safety and effectiveness compared to the predicate.

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

This information is not provided in the document. The testing described appears to be bench testing or in vitro assessments of device properties rather than a clinical study with patient data.

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

This information is not applicable and not provided as this is not a study involving expert review for ground truth establishment. The performance data relates to physical and material properties and compliance with engineering and sterilization standards.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a test set requiring adjudication by experts.

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

This information is not applicable and not provided. This device is an accessory for endoscopes, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

This information is not applicable and not provided. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as it applies to AI/ML device performance (e.g., expert consensus, pathology, outcomes data) is not relevant to this 510(k) submission. The "ground truth" in this context would be the established engineering specifications, material properties, and regulatory standards.

8. Sample Size for the Training Set

This information is not applicable and not provided. This is not an AI/ML device requiring a training set.

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

This information is not applicable and not provided.

Summary of the Study (as described in the document):

The "study" described in the 510(k) submission is a series of bench tests and evaluations aimed at demonstrating that the new FUJIFILM Hood Models DH-28GR, DH-29CR, and DH-30CR are substantially equivalent to the predicate device, FUJIFILM Hood Model DH-17EN. The focus is on showing that changes in dimensions, material composition, and the introduction of a sterile presentation do not introduce new questions of safety or effectiveness.

The performance data included:

• Biocompatibility testing according to ISO 10993 standards.
• Sterilization validation according to ISO 11135 and ASTM F1980.
• Endoscope-specific testing according to ISO 8600 standards.
• Verification of specific dimensions (outer diameter, max diameter of attaching endoscope, inner diameter of distal end, inner diameter of attaching portion, distance from the tip) against performance specifications.

The document concludes that these tests demonstrated substantially equivalent performance to the predicate device, supporting the claim that the new device models are as safe and effective as the previously cleared device.

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