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This device is to be used by a physician for viewing an interior cavity of the human body through either a natural opening or an incision.

Like the predicate devices, the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source consist of a semi-rigid fiberscope with a separate irrigating outer sheath or introducer to view and assess/biopsy soft tissue.

The provided text is a 510(k) summary for a microendoscope device and does not describe a clinical study or detailed acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, I cannot generate the requested table and information about acceptance criteria and a study proving those criteria are met.

Here's why and what information is available:

• No Acceptance Criteria or Performance Data: The document explicitly states: "All necessary testing was or will be performed on the C-Link Microendoscope Model S-0001 Single Light Source and D-0001 Dual Light Source to ensure that the product is substantially equivalent to the predicate devices and to ensure that the new device does not have a significant effect on safety and effectiveness." This indicates that the specific test results and acceptance criteria were likely part of the internal design control and testing, but are not included in this public 510(k) summary. The submission relies on substantial equivalence rather than a detailed performance study with explicit acceptance criteria.
• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is by showing "substantial equivalence" to a legally marketed predicate device (Acueity ViaDuct Microendoscope, K011189). This means the new device is similar in intended use, principles of operation, anatomical site, safety characteristics, and physical characteristics.

Therefore, I cannot populate the table or answer most of your specific questions as the information is not present in the provided text.

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The MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose or throat procedures.

The MicroEndoscope is a semi-rigid fiberscope that allows for visualization of the ear, nose, and throat. The device is labeled non-sterile and must be sterilized prior to use. The MicroEndoscope is accompanied by a camera coupler, which allows the MicroEndoscope to connect to a standard endoscopic camera.

The provided document for the Acclarent MicroEndoscope is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, the document explicitly states: "The MicroEndoscope met all performance testing acceptance criteria." However, it does not provide the specific acceptance criteria, the detailed results, or the methodology of the study.

Based on the provided information, I cannot complete the requested tables and sections with the specific details about acceptance criteria, detailed device performance, sample sizes, ground truth establishment, or multi-reader studies. The document only offers a general statement of compliance.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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 for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified. The document does not detail any human expert review or ground truth establishment relevant to a clinical performance study. The performance testing is likely related to engineering and functional specifications of the endoscope itself (e.g., image quality, illumination, durability, sterilization effectiveness).

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

• Not applicable/Not specified. Given the nature of a medical device submission focused on physical and functional performance rather than diagnostic accuracy, adjudication methods as typically understood in AI/imaging studies are not relevant here.

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 is a physical medical device (MicroEndoscope) for visualization, not an AI or diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not applicable. This device is a direct visualization tool; there is no "algorithm only" performance. Its primary function is to provide an image for a human user.

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

• Not specified. For this type of device, "ground truth" would likely relate to objective measurements of image quality, illumination, structural integrity, and successful sterilization, rather than clinical diagnostic outcomes or pathology.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

• Not applicable. (See #8)

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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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The Microendoscope system is used to apply and maintain pneumoperitoneum for laparoscopic procedures and to provide access and visualization for diagnostic and therapeutic purposes for laparoscopic and hysteroscopic procedures.

Cannula and tubes are made of medical grade stainless steel and chrome plated brass.

Telescopes are made of medical grade stainless steel (sleeve), glass-lenses, glass-fibers, brass chrome plated (housing), and plastic (eyepiece).

As the intended use describes, the set is miniaturized in diameter and length for minimally invasive laparoscopy. The veress cannula and the tubes are larger in diameter and longer in working length. The telescopes are shorter in length and smaller in diameter.

The provided text is a 510(k) summary for the Richard Wolf Mini Laparoscopes and Microendoscope System. It details the device's description, intended use, and claims of substantial equivalence to existing devices. However, the document explicitly states that "No clinical tests performed" and does not provide any acceptance criteria or performance data from a study to prove these criteria were met.

Therefore, I cannot populate the requested table or sections with information that is not present in the provided text.

Here's a summary of what is available regarding testing and performance, based on the input:

Further details from the document:

• Study (or lack thereof): The document explicitly states in section 6.0, "Clinical Tests: No clinical tests performed."
• Performance Data: Section 5.0, "Performance Data," states: "Instruments have been tested to assure the function of the spring loaded cannula and the possibility of steam autoclaving." This indicates engineering/functional testing was done, but no clinical performance data is provided or referenced, nor are specific acceptance criteria for these functional tests detailed.
• Conclusion: The conclusion drawn (Section 7.0) is that the devices are "substantially equivalent to existing devices on the market" and "They have been tested to allow safe usage with no significant changes during the standard lifetime when used according to instructions." This reinforces the focus on functional testing and substantial equivalence rather than a clinical performance study against specific acceptance criteria.

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