Search Results
Found 1 results
510(k) Data Aggregation
(292 days)
MPORT FOLDABLE LENS PLACEMENT SYSTEM
The Mport™ Foldable Lens Placement System is a Class I device indicated for compressing and inserting a Soflex™ (formerly Chiroflex II) series multi-piece intraocular lens into the eye during small incision cataract surgery.
The Mport™ Foldable Lens Placement System is a device designed to compress and insert a Soflex™ multipiece foldable intraocular lens into the eye during normal small incision cataract surgery. The Mport™ is a single use only disposable device. The Mport™ materials the same as those materials used in the lens/patient contacting cartridge of the predicate device (polypropylene).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Mport™ Foldable Lens Placement System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No negative impact on lens diopter | Optical specifications measured before and after lens delivery showed no negative impact to the lens. |
| No negative impact on lens resolution | Optical specifications measured before and after lens delivery showed no negative impact to the lens. |
| No negative impact on cosmetic appearance of the lens | Optical specifications measured before and after lens delivery showed no negative impact to the lens. |
| Biocompatibility | Biocompatibility testing supported that technological changes do not raise new safety issues. |
| Sterilization effectiveness | Sterilization studies supported that technological changes do not raise new safety or effectiveness issues. |
| Acceptable for delivery of Soflex™ multi-piece lenses | The Mport™ Foldable Lens Placement System was found to be acceptable for delivery of Chiron's Soflex™ multi-piece lenses. |
| No new issues of safety or effectiveness | Biocompatibility testing and sterilization studies support the fact that the technological changes in the Mport™ system do not raise any new issues of safety, effectiveness or performance of the product. |
| Proper functioning in accordance with Directions for Use | Performance was evaluated "when used in accordance with the directions for use." |
Explanation of "Implied" Criteria: The document does not explicitly list "acceptance criteria" with numerical thresholds. Instead, it states that various tests "showed no negative impact" or "supported the fact that technological changes do not raise any new issues," which serves as the de-facto acceptance standard for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size for the studies mentioned. The testing summarized appears to be a series of non-clinical, bench-top tests rather than human subject trials with a defined test set.
- Data Provenance: Not explicitly stated. Given the nature of the device (a lens insertion system) and the tests performed (optical specifications, biocompatibility, sterilization), the data is most likely from laboratory and bench testing, rather than human clinical data. The country of origin is not mentioned, but the submitting company is Chiron Vision Corporation in Claremont, California, USA, suggesting the testing was likely conducted in the US or under US regulatory guidance. The studies are retrospective in the sense that they were conducted before the 510(k) submission to demonstrate the device's characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for the non-clinical tests described would be derived from objective measurements and scientific principles (e.g., optical measurement standards, biocompatibility guidelines, sterilization efficacy standards), not human expert consensus on a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a human-adjudicated test set in this non-clinical evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The Mport™ is a surgical tool for inserting an intraocular lens.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable in the context of an AI algorithm. The device itself is a mechanical-surgical tool. The "standalone" performance here refers to the device's ability to compress and insert the lens without causing damage or issues, which was evaluated through the non-clinical tests.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on:
- Objective Measurements/Standards: For optical specifications (diopter, resolution, cosmetic appearance), it would be against predefined optical engineering standards and specifications for the lens.
- Biocompatibility Standards: Adherence to established ISO or ASTM standards for materials in contact with the body.
- Sterilization Efficacy Standards: Adherence to established standards for ethylene oxide (EO) sterilization.
- Functional Adequacy: The ability to successfully deliver the lens without damage, as per the device's intended function.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical tool, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1