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The Indications for this device use is for medical practitioner needing visualization of soft tissue, either through a natural orifice or incision.

'Use for visualization inside the human body to view surgical procedure(s), by physician. '

The design of SOLOS ENDOSCOPY made/marketed endoscope K983538 is identical in every way as the scope approved for intended uses that are listed in this document. The physical characteristics, except for miniaturization, are identical as the approved device and this predicate device has been accepted with respect to: performance specifications, composition, intended use, technology employed, biocompatibility, manufacturing, QC, physical testing, etc.

The provided text is related to a 510(k) premarket notification for a medical device, the Miniature Endo/Laparoscope, submitted by DOFI Communications. The core of this submission is to establish Substantial Equivalence to an already legally marketed predicate device (Solos Endoscopy's K983538).

Crucially, a 510(k) submission for substantial equivalence does not typically involve a new clinical study to prove the device meets specific acceptance criteria in the same way a novel device might via a de novo or PMA pathway. Instead, it demonstrates that the new device is as safe and effective as a predicate device. Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics (like sensitivity, specificity, etc.), sample sizes, ground truth, and human-in-the-loop studies is not present in this document because it's not relevant to a substantial equivalence claim based on identicality.

The document explicitly states that the DOFI Communications device is "IDENTICAL in every way" to the Solos Endoscopy device (K983538). This means it is assumed to share the same performance characteristics, safety profile, and efficacy as the predicate device.

However, I can extract the information relevant to how the substantial equivalence was claimed, which acts as the "proof" in this context.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence due to the nature of the 510(k) claim:

Acceptance Criteria and Study Proving Device Meets Criteria

The fundamental "acceptance criterion" for this 510(k) submission is demonstrating Substantial Equivalence to a legally marketed predicate device. The "study" proving this is the comparison report provided by DOFI Communications, asserting the device's identicality to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the claim of "identicality" to a predicate device, specific performance metrics for the DOFI device are not reported independently. The "acceptance criteria" are not quantitative performance thresholds for a novel study, but rather a qualitative assessment of identicality/similarity to the predicate.

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

• Not applicable. This submission is based on a claim of identicality to a predicate device, not on a new clinical study with a test set of data. The "test set" here is the design and specifications of the DOFI device being compared to the existing specifications of the predicate device (Solos Endoscopy K983538).
• The provenance of underlying data for the predicate device's approval (K983538) is not detailed in this document.

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

• Not applicable. No new "ground truth" establishment for a test set was required for this substantial equivalence claim. The "ground truth" is effectively the established safety and efficacy of the predicate device as determined by its original approval.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication was used. The substantial equivalence was assessed by the FDA against the provided documentation from DOFI Communications confirming the identicality to the predicate.

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

• No. An MRMC study was not conducted as this is a substantial equivalence claim based on physical and functional identicality, not a new assessment of AI or reader performance.

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

• No. This is not an AI device, and no standalone performance study in this context was performed or required.

7. The Type of Ground Truth Used

• Implicitly, the ground truth is the established safety and effectiveness profile of the predicate device (Solos Endoscopy K983538) and other similar legally marketed endoscopes. The DOFI device is deemed safe and effective because it is "identical" to these already-approved devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device; therefore, there is no "training set" in the context of an algorithm.

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

• Not applicable. As above, there is no training set for an algorithm in this context.

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