(143 days)
The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraccular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the Lenstec Softee I IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.
The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated on the IOL approved labeling.
The set consists of a single-use, sterile svringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge.
The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunger is advanced by applying a direct forward motion.
Note: LubriMATRIX™ is a proprietary treatment composed of a hydrophilic polymer and a lubricious polymer engrafted onto the surface of the cartridge via a chemical polymerization process. Refer to MAF-1963 for further information.
The provided document is a 510(k) summary for the pioli™ IOL Delivery System. It describes the device, its intended use, and its equivalence to a predicate device. The document details performance data from non-clinical tests to demonstrate that the device meets its acceptance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| IOLs show no damage or scratches after delivery. | All delivered lenses showed no damages or scratches. |
| IOLs are within dimensional specifications after delivery. | All delivered lenses were within dimensional specifications. |
| Cartridges show no damage after lens delivery. | All cartridges showed no damages after lens delivery. |
| IOL optical properties, sagitta, and overall surface/bulk homogeneity are maintained after surgical manipulation with the pioli™ IOL Delivery System. (Evaluated per ISO 11979-2 and ISO 11979-3). | The resulting data from simulated surgical manipulation showed that the pioli™ IOL Delivery System (Model: PIOLI-D) can successfully deliver Lenstec's hydrophilic Softec 1 IOLs of low to high diopters and IOL models validated for use with this device... without affecting the functionality of the lens. |
| The pioli™ IOL Delivery System can successfully deliver Lenstec's hydrophilic Softec 1 IOLs of low to high diopters and other validated IOL models without affecting lens functionality. | The resulting data... showed that pioli™ IOL Delivery System (Model: PIOLI-D) can successfully deliver Lenstec's hydrophilic Softec 1 IOLs of low to high diopters and IOL models validated for use with this device as indicated on the IOL approved labeling without affecting the functionality of the lens. |
| Packaging validation: packaging seals meet specified parameters (e.g., appearance, peeling strength, adhesion). | The resulting data from packaging validation showed that the most suitable parameter to seal the packaging of pioli™ IOL Delivery System was under the condition of 129°C, 3.6 seconds, with all blisters passing the appearance inspection, peeling strength and adhesion tests. |
| Biocompatibility of components in direct/indirect patient contact is established. (Implied, as based on similarity to predicate device). | The components of pioli™ IOL Delivery System that have direct and indirect contact with the patient are manufactured of the same materials and same manufacturing processes as the predicate device, lioli™ IOL Delivery System. Therefore, the biocompatibility testing on the predicate device is applicable to the subject device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for the IOLs and cartridges tested in the non-clinical performance study. It mentions "All lenses were delivered..." and "All delivered lenses showed no damages..." and "all cartridges showed no damages...", which implies that a set of lenses and cartridges were tested, but the specific number is not provided.
- Sample Size: Not explicitly stated (referred to as "All lenses" and "all cartridges").
- Data Provenance: The study was a "simulated surgical manipulation" non-clinical test conducted by the device manufacturer (AST Products, Inc.). The country of origin of the data is not specified, but the manufacturer is based in Billerica, MA, USA. It is a prospective non-clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- The document does not mention the use of experts to establish ground truth for the non-clinical performance tests. The evaluation of IOL damage/scratches, dimensional specifications, and cartridge damage appears to be based on objective inspection and adherence to ISO standards, rather than expert interpretation of a 'ground truth' per se.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. The non-clinical tests described involve objective measurements and observations against pre-defined criteria (e.g., ISO standards, presence of damage, dimensional specifications). It does not involve subjective assessment requiring adjudication.
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, a TRMC comparative effectiveness study was not done. The device is an IOL delivery system, not an AI-assisted diagnostic or interpretive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The pioli™ IOL Delivery System is a physical medical device (an IOL delivery system), not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical performance study was based on objective measurements and observations per established standards and specifications. This includes:
- ISO standards: ISO 11979-2 (Optical properties and test methods) and ISO 11979-3 (Mechanical properties and test methods) for IOL evaluation.
- Visual inspection: For damages, scratches, and homogeneity of IOLs and cartridges.
- Dimensional specifications: For IOLs after delivery.
- Functional assessment: The ability to successfully deliver IOLs without affecting their functionality.
- Packaging tests: Appearance inspection, peeling strength, and adhesion tests.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set. The "training" for such a device involves engineering design, material selection, and manufacturing processes validation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of an IOL delivery system as described.
§ 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.