(53 days)
The UNFOLDER Vitan™ Inserter, Model DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.
The UNFOLDER Vitan™ Inserter, Model DK9000, is an autoclavable, reusable titanium intraocular lens (IOL) inserter or handpiece that is designed for use in combination with the SmartLOAD™ Delivery Technology (P980040/S095) to fold and assist in the insertion of a J&J Vision acrylic one-piece IOL into the eye following cataract extraction. The IOL is provided preloaded in the disposable polypropylene cartridge and is snapped into the inserter. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye. The SmartLOAD™ Delivery Technology cartidge is designed to eliminate the need for the IOL to be loaded into the cartridge to provide a sterile, controlled, and convenient method of efficiently delivering J&J Vision acrylic onepiece lenses into the eye during cataract surgery.
The provided document describes the UNFOLDER Vitan™ Inserter, Model DK9000, which is an intraocular lens (IOL) inserter. It is a Class I device used to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, in combination with the SmartLOAD™ Delivery Technology. The document does not describe an AI/ML device per se but a medical device in general. Therefore, some of the requested information, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and specifics about AI/ML algorithm training, are not applicable.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table detailing numerical acceptance criteria and reported device performance for specific metrics. Instead, it generally states that the device "complies with applicable standards" and "passed all acceptance criteria" during functional testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Reprocessing (Reusability/Durability) | Withstood 500 clinical reprocessing cycles (CRC) without losing functional properties. Devices remained intact and successfully delivered IOLs per Directions for Use (DFU), with no degradation of functional surfaces, mating surfaces, identification marks, thread forms, or functional capability. |
| Functional Delivery | All tested IOLs under simulated surgical manipulation passed all acceptance criteria for: |
- Post-delivery dioptric power
- Image quality
- Overall diameter
- Sagitta
- Surface and bulk homogeneity |
| Overall Safety and Effectiveness | Demonstrated substantial equivalence to predicate devices. Functional requirements and product specifications will be met prior to commercial release. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Reprocessing Study: The study involved processing a sufficient number of UNFOLDER Vitan™ Inserters to verify that they can withstand 500 clinical reprocessing cycles. The exact number of inserters tested is not specified but it states "the inserters" implying multiple units.
- Functional Delivery Testing: "All tested IOLs" were evaluated. The exact number of IOLs tested is not specified, but the phrase implies a representative sample.
- Data Provenance: The studies were non-clinical tests conducted by Johnson & Johnson Surgical Vision, Inc. There is no information about the country of origin of the data as it's not patient-specific data, but rather device performance data. The studies are described as verification and validation testing, which are typically prospective in nature to assess product performance against design specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and their Qualifications
This information is not applicable as the described tests are non-clinical device performance tests. Ground truth in the context of expert consensus is typically associated with clinical studies or AI/ML evaluations where human experts label or interpret data. For device performance testing, "ground truth" is typically defined by engineering specifications and objective measurements against those specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML evaluations when there's a need for consensus among multiple human readers/experts to establish a definitive "ground truth" for ambiguous cases. For device performance testing, results are typically determined by objective measurements and passing/failing predefined specification limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses the performance of human readers, often with and without AI assistance, which is not relevant for a standalone medical device like an IOL inserter that doesn't involve interpretation by human readers in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The device described is a physical instrument (IOL inserter), not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on:
- Engineering Specifications and Functional Requirements: For the reprocessing study, the ground truth was the device's ability to maintain its "functional properties," remain "intact," and "successfully deliver IOLs per the Directions for Use," ultimately meeting its predefined design and performance specifications.
- Established ISO Standards (ISO 11979-3: 2012): For functional delivery testing, the "ground truth" was defined by the acceptance criteria mentioned in Section 5 of ISO 11979-3: 2012, specifically for post-delivery dioptric power, image quality, overall diameter, sagitta, and surface and bulk homogeneity. These standards provide objective, measurable criteria for IOL delivery performance.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable (as explained in point 8).
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.