(84 days)
The Akreos Single Use Insertion Device should only be used to fold and deliver those IOL models that allow use of this injector in their approved labeling.
Akreos Single Use Insertion Device, Model AI-28, previously known as Hydroport SI, is validated for folding and delivering the Bausch & Lomb one-piece Akreos Advanced Optics Aspheric Intraocular Lens (IOL) into the eye during cataract surgery. Future IOL models may also by qualified with the Akreos Single Use Insertion Device following fold and recovery validation studies. The device provides a small tubular pathway in which the Akreos Advanced Optics Aspheric Lens can be placed into the eye with one continuous forward motion. The Akreos Single Use Insertion Device consists of two parts: a syringe shaped tube (includes lens loading deck and lens cap) with a plunger, and a transition cell. The Akreos Single Use Insertion Device is a sterile (EtO), disposable plastic device, designed for single use only.
Here's an analysis of the provided text regarding the Akreos Single Use Insertion Device, Model AI-28, addressing your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The subject device met the acceptance criteria for fold and recovery testing of the Akreos Aspheric Optic IOL using the same principle of operation as the predicate device. | The Akreos Single Use Insertion Device, Model AI-28, was "validated for folding and delivering the Bausch & Lomb one-piece Akreos Advanced Optics Aspheric Intraocular Lens (IOL) into the eye during cataract surgery." The device "met the acceptance criteria for fold and recovery testing." |
| Stability testing for the plunger material showed no significant shifts in tensile and and flexural properties following sterilization. | "Stability testing for the plunger material met the acceptance criteria showing no significant shifts in tensile and flexural properties following sterilization." |
| Biocompatibility testing for the polypropylene material (main device) and polyphthalamide (new plunger material) demonstrates device safety. | "The Akreos Single Use Insertion Device, Model AI-28 was shown to be safe using the results of the biocompatibility testing for the polypropylene material as well as polyphthalamide, the new plunger material." |
| Sterilization and Shelf-life test results confirm equivalence to the predicate device. | "Sterilization and Shelf-life test results confirm that the subject device is substantially equivalent to the marketed predicate device." |
| Labeling differences regarding specified IOL types do not affect safety and effectiveness when used as labeled, as each insertion device is specifically made to fit the indicated IOL. | "The labeling for the Akreos Single Use Insertion Device, Model AI-28 and the Passport foldable lens placement system differ in the type of intraocular lens specified for use. These differences in the labeling that specify use, do not affect safety and effectiveness of the device when used as labeled because each insertion device is specifically made to fit the size and shape of the indicated intraocular lens." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the performance or safety tests. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the involvement of any experts to establish ground truth for the device's performance testing. The reported performance refers to non-clinical performance data and testing rather than expert evaluations of clinical outcomes.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method, as the reported studies are primarily non-clinical performance and safety tests, not studies requiring expert interpretation or consensus on a dataset.
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. The device is a physical medical instrument (an IOL insertion device), not an AI-powered diagnostic or interpretive tool that would involve human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the Akreos Single Use Insertion Device. This device is a physical tool for delivering an IOL. It does not involve algorithms or AI. Its performance is inherent to its mechanical properties and design when used by a surgeon.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Non-clinical performance data: Specifically, the ability to successfully fold and deliver the specified IOL into an in vitro or simulated setting ("fold and recovery testing").
- Material properties data: Results from stability testing (tensile and flexural properties).
- Biocompatibility testing results: Demonstrating the safety of the materials.
- Sterilization and Shelf-life test results: Confirming the device maintains its properties and sterility.
There is no mention of pathology, expert consensus on clinical cases, or outcomes data from human use as "ground truth" for this specific submission's documented performance.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical instrument, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for this device.
§ 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.