(232 days)
The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
The Abbott Medical Optics (AMO) irrigation sleeve is a device that is intended to direct irrigation solution across the shaft of the phacoemulsification tip, allowing the irrigation solution to enter the eye during ocular surgery. It is a small, molded component that is placed over the phacoemulsification tip. The proposed irrigation sleeve is made of silicone, with a hardness specification of 80+/-5 durometer units. The flow rate of the sleeve is greater than or equal to 18cc, with a length of 0.75 -1.50 inches.
The provided text describes the K103023 510(k) summary for the AMO Irrigation Sleeve. This device is a medical accessory, not an AI/ML powered device, so several of the requested sections (e.g., MRMC study, human reader improvement, AI assistance, standalone algorithm performance, AI training data) are not applicable.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material: Silicone, Hardness | 80 +/- 5 durometer units (Meets specification) |
| Flow Rate: ≥ 18 cc | Greater than or equal to 18cc (Meets specification) |
| Length: 0.75 - 1.50 inches | 0.75 - 1.50 inches (Meets specification) |
| Biocompatibility: Conformance to ISO 10993-1:2003 | In compliance (Reported as "In compliance") |
| Sterilization: Conformance to ISO 11137 Series (Parts 1, 2, 3) | In compliance (Reported as "In compliance") |
| Risk Management: Conformance to ISO 14971:2007 | In compliance (Reported as "In compliance") |
| Product Integrity after Sterilization: | Tested (Reported as "product integrity after sterilization") |
| Durometer and Tensile Strength: | Validated (Reported as "validation of the durometer and tensile strength") |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the testing of the AMO Irrigation Sleeve. The testing appears to be conducted in-house by Abbott Medical Optics, Inc. ("The proposed AMO irrigation sleeve has undergone testing..."). The provenance is therefore internal to the manufacturer. This is a non-clinical device so the concept of retrospective or prospective data does not apply in the same way as it might for a diagnostic AI device; the device is tested against established engineering and biological safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a device like an irrigation sleeve, "ground truth" would likely be established through engineering specifications, validated test methods, and compliance with recognized standards (e.g., ISO for biocompatibility and sterilization), rather than expert consensus on medical images or diagnoses.
4. Adjudication method for the test set
Not applicable. This device is an accessory that has its performance evaluated against engineering specifications and compliance with standards, not through clinical adjudication by experts.
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
Not applicable. The AMO Irrigation Sleeve is a medical device accessory, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The AMO Irrigation Sleeve is a medical device accessory, not an AI algorithm.
7. The type of ground truth used
The ground truth for this device is based on:
- Engineering Specifications: Defined parameters for hardness, flow rate, and length.
- International Standards (ISO): Compliance with ISO 10993-1 (biocompatibility), ISO 11137 (sterilization), and ISO 14971 (risk management).
- Validated Test Methods: Procedures to verify durometer, tensile strength, flow rate, and product integrity after sterilization.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no training set or ground truth established for it in that context. The "ground truth" for its performance is established through adherence to manufacturing specifications and compliance with recognized industry and regulatory standards.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.