(122 days)
Used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses into the eye.
The One Series™ Ultra cartridge is used to fold and assist in the insertion of a TECNIS® 1-Piece soft acrylic intraocular lens (IOL) into the eye following cataract extraction. The cartridge, Model 1VIPR30 is a single-use component composed of polypropylene which is injection molded and coated with a lubricious coating. The cartridge is provided sterile. The IOL is loaded into the proximal portion of the cartridge using forceps. The cartridge is then placed in a reusable titanium handpiece, which advances the IOL through the tube section of the cartridge and delivers it into the eye.
The provided text is related to a 510(k) premarket notification for a medical device called the "ONE SERIES™ Ultra Cartridges" (later renamed ONE SERIESTM Ultra Cartridges). This document primarily serves as an FDA clearance letter and a 510(k) summary, establishing substantial equivalence to predicate devices rather than detailing a specific clinical study with granular acceptance criteria and performance metrics.
Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment, as typically found in detailed study reports, is not present in these documents. The document focuses on demonstrating equivalence through bench testing and biocompatibility.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics in a tabular format as would be found in a detailed study report. It broadly states that the device was found equivalent to predicate devices based on "material and performance characteristics."
| Acceptance Criteria (Inferred/General) | Reported Device Performance (General) |
|---|---|
| Material equivalence to predicate devices | Found equivalent |
| Sterilization method equivalence | Found equivalent |
| Intended use equivalence | Found equivalent |
| Mode of operation equivalence | Found equivalent |
| Performance: Folding of IOL | Verified to be equivalent to predicate devices |
| Performance: Delivery of IOL | Verified to be equivalent to predicate devices |
| Performance: Retention of IOL | Verified to be equivalent to predicate devices |
| Performance: Cosmetic properties of IOL | Verified to be equivalent to predicate devices (implying no negative impact on cosmetic properties) |
| Performance: Dimensional properties of IOL | Verified to be equivalent to predicate devices (implying no negative impact on dimensional properties) |
| Performance: Optical properties of IOL | Verified to be equivalent to predicate devices (implying no negative impact on optical properties) |
| Biocompatibility | Conducted and verified |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "Bench testing and biocompatibility testing," but does not provide details on the number of cartridges or IOLs tested.
- Data Provenance: Not specified. It's likely the testing was conducted in a laboratory setting by the manufacturer (Advanced Medical Optics, Inc.) in the USA, as indicated by their address. The testing is non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable for this type of submission. The performance testing described (folding, delivery, retention, cosmetic, dimensional, optical properties) would likely be assessed against engineering specifications and predicate device performance, not by expert human interpretation in the way an AI diagnostic device would be.
4. Adjudication Method for the Test Set
- Not applicable as the testing involves objective measurements against specifications rather than expert consensus on subjective interpretations.
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
- No. This is not an AI-assisted diagnostic device, but rather a physical medical device (intraocular lens cartridge). Therefore, MRMC studies and AI-related effectiveness metrics are not relevant or present in this document.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This device is an intraocular lens cartridge, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance would be engineering specifications, material standards, and benchmark performance of the predicate devices. For example, successful folding and delivery without damage to the IOL would be objectively verifiable against defined criteria. Biocompatibility would be assessed against established standards for medical devices.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The "training" for such a device involves product development, engineering, and manufacturing processes to meet design specifications, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See 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.