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To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:

• Keeping the suitable depth of endoscope's view field
• Helping the endoscope with being inserted into the gastrointestinal tract

The Arc EndoCuff has a short tube like shape with flexible hairs and is attached to the distal end of the endoscope to facilitate endoscopic therapy.

The Arc EndoCuff is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following radiation sterilization and is single use only.

The provided 510(k) summary for the Arc EndoCuff does not describe quantitative acceptance criteria or a study designed to rigorously prove that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through qualitative comparisons and bench testing.

Here's an analysis of the provided information based on your requested categories:

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

No explicit quantitative acceptance criteria are provided in the document, nor are specific performance metrics reported against such criteria. The document states:

"The bench testing demonstrates that the Endocuff design combines some of the benefits of both being a slim cylindrical device (like the Olympus product) and being able to stabilise and view the mucosa effectively on a greater diameter (as does the Fujinon balloon) but within the one product."

And concludes:

"The performance data showed that the sterilisation method selected...has not introduced any additional risks and the patient contacting materials have been tested for biocompatibility with reports demonstrating no negatives in safety or effectiveness."

"The bench testing has demonstrated that the device does not introduce any additional risks when undertaking endoscopic therapy and meeting the intended use."

These statements are qualitative and comparative, focusing on the absence of additional risks and meeting intended use, rather than predefined measurable acceptance criteria.

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

The document describes "bench testing" but does not specify a "test set" in the context of clinical data, as it's not a clinical study. The testing appears to be primarily laboratory-based to assess material properties, sterilization effectiveness, and mechanical characteristics. Therefore, sample sizes for a patient test set are not applicable here.

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)

Not applicable, as this was not a clinical study involving diagnosis or interpretation where expert ground truth would be established. The evaluations described ("bench testing") would likely involve engineers and materials scientists ensuring the device's physical and functional properties meet design specifications and are comparable to predicates.

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

Not applicable, as this was not a clinical study requiring adjudication of expert interpretations.

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. This device is a mechanical accessory (EndoCuff) for an endoscope, not an AI or imaging interpretation device. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

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

Not applicable. This is not an algorithm or AI-based device.

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

The concept of "ground truth" as typically used in AI or diagnostic device evaluations (e.g., pathology, clinical outcomes) is not directly applicable. For "bench testing," the "truth" would be established by validated engineering specifications, material standards (e.g., USP Class VI for biocompatibility), and direct physical measurements or observations of device function and integrity under controlled conditions.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable.

Overall Conclusion on Acceptance Criteria and Study:

The Arc EndoCuff 510(k) summary primarily demonstrates substantial equivalence to existing legally marketed devices (Olympus Distal Attachment and Fujinon BS-2 balloon). The "study" referenced is bench testing, which compared the "design," "materials," and "size" of the EndoCuff to its predicates. The performance data focused on proving that:

• The device combines benefits of both predicate types (slim cylindrical + ability to stabilize/view mucosa effectively).
• The sterilization method does not introduce additional risks.
• Biocompatibility testing showed no negatives in safety or effectiveness for patient-contacting materials.
• The device does not introduce additional risks during endoscopic therapy and meets its intended use.

The acceptance criteria implicitly derive from the predicate devices' established safety and effectiveness. The "study" (bench testing) was deemed sufficient to show that the minor technological differences "do not raise different questions of safety and effectiveness" and that the device is "as safe and effective" as the predicates. No specific quantitative performance metrics or clinical study results against predefined acceptance criteria are provided because the regulatory pathway chosen emphasizes equivalence rather than novel performance claims.

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The sterile overtubes are intended to be used as accessories with the Fujinon Enteroscopes and Colonoscopes cleared for use with overtubes. The overtubes are used to assist with the movement of the scopes inside the upper or lower digestive tract.

The sterile overtubes are intended to be used as accessories with the Fujinon Double Balloon Enteroscopy system, which is used for the optical visualization of the gastrointestinal tract

The Fujinon double balloon enteroscopy system (K040048) and EC-450B15 (K090116) utilize specialized overtubes to ensure complete positioning of the enteroscope or colonoscope in the digestive tract and to ensure the tip of the scope can be smoothly inserted to reach the area of diagnosis.

The overtube (TS-12140) was included in the original 510(k) K040048 and the overtube (TS-13101) was included in 510(k) K090116 with the EC-450BI5.

This submission includes the following items:
TS-12140 Over Tube Originally included in the K040048 as non-sterile.
TS-13140 Over Tube
TS-13101 Over Tube Including in K090016.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Acceptance Criteria for Fujinon Sterile Overtubes",
    "headers": ["Acceptance Criteria (Performance Standard)", "Reported Device Performance"],
    "rows": [
      ["Biocompatibility requirements (per ISO standards)", "Passed"],
      ["Sterilization process validation (per ISO standards)", "Validated"],
      ["Same indications for use as predicate devices", "Met"],
      ["Same dimensions as predicate devices", "Met"],
      ["Same material composition as predicate devices", "Met"]
    ]
  },
  "study_details": {
    "sample_size_test_set": "Not applicable, as the submission describes a change to a sterile version of an existing device, not a new diagnostic algorithm using a test set.",
    "data_provenance": "Not applicable.",
    "number_of_experts_ground_truth_test_set": "Not applicable.",
    "qualifications_of_experts": "Not applicable.",
    "adjudication_method": "Not applicable.",
    "mrmc_comparative_effectiveness_study": false,
    "effect_size_human_readers_ai_vs_without_ai": "Not applicable.",
    "standalone_performance_study": false,
    "type_of_ground_truth_used": "Not applicable. The study focuses on demonstrating sterility and biocompatibility, not diagnostic accuracy requiring a ground truth.",
    "sample_size_training_set": "Not applicable.",
    "ground_truth_for_training_set_establishment": "Not applicable."
  },
  "additional_information": "This 510(k) submission ([K091773](https://510k.innolitics.com/search/K091773)) is for Fujinon Sterile Overtubes, which are a sterile version of previously cleared non-sterile overtubes ([K040048](https://510k.innolitics.com/search/K040048) and [K090116](https://510k.innolitics.com/search/K090116)). The submission aims to establish substantial equivalence by demonstrating that the sterile devices meet biocompatibility and sterilization standards, and maintain the same intended use, dimensions, and material composition as their non-sterile predicates. The document does not describe a study involving diagnostic performance, AI algorithms, or human readers, but rather focuses on the safety and effectiveness aspects related to the sterilization of the device."
}

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