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510(k) Data Aggregation
(78 days)
MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
THE MINOP® DISPOSABLE INTRODUCER IS INDICATED TO OBTAIN AND MAINTAIN A TEMPORARY PATHWAY INTO THE VENTRICULAR SYSTEM OF THE BRAIN.
The MINOP® Disposable Introducer is a single used to obtain ventricular access and facilitate endoscope insertion. The MINOP® Disposable Introducer consists of an introducer sheath and a ventricular obturator.
The document provided is a 510(k) premarket notification for the MINOP® Disposable Introducer. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with detailed acceptance criteria and standalone performance metrics typically associated with AI/ML device evaluations.
Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, training set details, expert qualifications for ground truth, etc.) are not applicable to this submission.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria in a quantitative table for multiple performance metrics. Instead, it refers to equivalence to a predicate device and internal standards for peel force.
| Feature/Test | Acceptance Criteria (or Comparison) | Reported Device Performance |
|---|---|---|
| Peel Force | Meets requirements defined in Medcomp's internal standards for force at break (of the sheath). | "Results of the peel force testing meet the requirements defined in Medcomp's internal standards for force at break." (The document states the MINOP® Disposable Introducer's sheath design (with ink depth markings) and obturator tip rounding do not affect the peel force relative to the predicate.) |
| Material | Substantially equivalent to Medcomp Vascu-Sheath® Introducer Set. | The document states "sheath are identical to the legally marketed Medcomp device." |
| Design | Substantially equivalent to Medcomp Vascu-Sheath® Introducer Set. | Minor differences: obturator has a rounded tip, sheath has ink depth markings. These were deemed not to affect peel force. |
| Sterilization | Substantially equivalent to Medcomp Vascu-Sheath® Introducer Set. | Not explicitly detailed, but implied by the claim of substantial equivalence. |
| Indications for Use | Equivalent to Medtronic PS Medical Endoscope Introducer. | "The MINOP® Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system of the brain." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the document. The performance data section vaguely refers to "Performance testing" and "Results of the peel force testing" without giving specific numbers of units tested.
- Data Provenance: The testing was "in-vitro" and relates to the physical properties of the device components. There is no information regarding country of origin or whether it was retrospective or prospective, as it's not a clinical study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. This is an invivo mechanical/material performance test, not a study requiring expert readers to establish ground truth. The "ground truth" here is the physical measurement of peel force against defined internal standards.
4. Adjudication Method for the Test Set
Not Applicable. There's no "adjudication" in the sense of reconciling divergent expert opinions, as this is a physical performance test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study was not done. The submission relies on substantial equivalence to predicate devices, supported by in-vitro mechanical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not Applicable. This is a physical medical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used
The ground truth used for the peel force analysis was "Medcomp's internal standards for force at break." This refers to a predefined, objective standard for mechanical performance.
8. The Sample Size for the Training Set
Not Applicable. This device did not involve machine learning; therefore, there was no training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there was no training set, this question is not relevant.
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