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510(k) Data Aggregation
(253 days)
TrabEx Pro
The TrabEx Pro Handpiece is a manual ophthalmic surgical instrument with irrigation and aspiration functions.
The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration while the procedure is being performed. TrabEx PRO has an incision sealing sleeve.
The MicroSurgical Technology TrabEx Pro is a manual ophthalmic knife with irrigation and aspiration functions. The device was compared to the Trabectome (K040584) to demonstrate substantial equivalence, specifically for its irrigation and aspiration performance.
Here's an analysis of the acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate: Trabectome K040584) | Reported Device Performance (TrabEx Pro) |
|---|---|
| Irrigation Rate: Minimum 3 ml/min at 40 cm bottle height (0.59 psi) | Irrigation Rate: Minimum 3 ml/min at 40 cm bottle height (0.59 psi) |
| Aspiration Rate: 4 ml/min at no more than 250 mmHg (4.8 psi) | Aspiration Rate: 4 ml/min at no more than 250 mmHg (4.8 psi) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing of the TrabEx Pro (bench testing). It mentions that "The TrabEx Pro and the Trabectome were tested using the same test methods," implying a comparative bench test.
The data provenance is from bench testing conducted by MicroSurgical Technology, Inc. It does not involve human subjects or clinical data, thus there is no information on country of origin or retrospective/prospective nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device's performance (irrigation and aspiration rates) was established through objective physical measurements in a lab setting, not through expert opinions or clinical evaluation. The performance was directly measured against the specified rates of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. Since the "ground truth" was based on objective physical measurements of flow rates, there was no need for adjudication involving human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This device is a surgical instrument whose performance was evaluated based on physical operating parameters (irrigation and aspiration rates) in a bench test, not on an imaging-based diagnosis or interpretation that would typically involve a multi-reader study.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, in essence. The performance evaluation of the TrabEx Pro for irrigation and aspiration was a standalone assessment of the device's physical capabilities in a controlled bench test environment, without human surgical interaction being part of the primary performance measurement for regulatory submission.
7. The Type of Ground Truth Used
The ground truth used for establishing substantial equivalence was based on objective, quantitative physical measurements of irrigation and aspiration rates, mimicking the performance parameters of the legally marketed predicate device (Trabectome).
8. The Sample Size for the Training Set
Not applicable. This device is a manual surgical instrument, not an AI or machine learning algorithm. 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 for the same reason as point 8.
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