(49 days)
The intended use of this device is to provide illumination to the tip of the phacoemulsification tip cap sleeve to aid in the safe removal of the cataract lens. The illumination that is provided at the tip of the sleeve will provide enhanced visualization within the eve, so the powerful overhead surgical lights that are currently used can have decreased light levels during surgery. The Phaco Illuminator tip cap has the same intended use as many competitive Phaco tip caps already in commercial distribution.
Infusion Sleeve for Cataract Surgery Handpieces which also provides illumination.
This device is a modification of the silicone sleeve in current use. The modification consists of a silicone sleeve that does not contain opaque additives or tints. This clear sleeve allows for transmission of light to the surgical site when coupled to a fiber optic light pipe. The fiber optic light pipe attaches to the side of a phacofraqmentation handpiece.
The provided text is a 510(k) summary for the Welch Allyn Phaco Illuminator, a surgical illuminating infusion sleeve. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way modern AI/medical device submissions typically do.
Therefore, many of the requested categories for a rigorous AI/device study are not applicable or cannot be extracted from this document. This submission pre-dates the common methodologies for evaluating AI performance in healthcare.
Here's an attempt to answer the questions based on the provided text, with many fields marked as "Not Applicable" or "Not Provided" due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as quantitative thresholds for performance metrics. Instead, it relies on demonstrating substantial equivalence to an existing predicate device (Michael Reynard, M.D.'s Accessory Illuminating Infusion Sleeve, 510(k) #K964018) and adherence to general safety standards. The "performance" is described in terms of improved illumination and visualization, but without quantifiable measures.
| Criterion Type | Specific Criterion / Aspect Evaluated | Reported Device Performance / Comparison to Predicate |
|---|---|---|
| Intended Use | Provide illumination at surgical site of intraocular structures | Same as predicate device. "The Phaco Illuminator tip cap has the same intended use as many competitive Phaco tip caps already in commercial distribution." |
| FDA Class | Class II medical device | Same as predicate device (Class II). |
| Infusion Sleeve Material | Silicone | Same as predicate device (Silicone). Materials are identical to predicate device materials with a history of contact bio-compatibility. |
| Illumination Source | Light source through fiber optics | Welch Allyn #46100 Xenon Light Source through fiber optics (predicate used unspecified light source through fiber optics). "Effectiveness... improved by the source of illumination being at the tip... This results in improved illumination and visualization during the phacoemulsification procedure for the physician." |
| Sterility | Conventional methods including autoclave | Disposable - one time use (Predicate was autoclavable). This represents a difference, but is assessed as safe and acceptable. |
| Design | Silicone sleeve illuminated by external light source | Same as predicate device. |
| Where Used | Hospital, Surgical Center | Same as predicate device. |
| Safety Factors | Established over many years and widely used method of cataract surgery | Same as predicate device. "The device offers a potentially lower risk of light dibtribution [exposure] as it minimizes the need for high powered overhead surgical lights." Specific safety areas considered: Toxicity (bio-compatible materials), Electrical (agency approvals for light source), Light Output (consistent with previous safe use, reference ACGIH and Endoscopic Illumination), Corrosion (non-corrosive), Explosion (highly unlikely), Surface Temperature (evaluated), Mechanical/Sharp Edges (blended and rounded, shape established as safe), Safety/Risk Analysis (performed, risks reduced to acceptable level). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not Applicable. This submission does not involve a "test set" in the context of an algorithm or diagnostic device evaluation common today. It's a review of a physical medical device.
- Data Provenance: Not Applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not Applicable.
- Qualifications of Experts: Not Applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not Applicable.
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
- MRMC Study: No, this was not done. The device is a direct illumination tool, not an AI-powered diagnostic or assistive tool for human readers.
- Effect Size: Not Applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not Applicable. This is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not Applicable in the sense of a diagnostic or AI study. The "ground truth" for this submission is historical data and established safety standards for similar devices and materials (e.g., bio-compatibility of silicone, electrical safety standards for light sources, historical safe use of phacoemulsification techniques). The "effectiveness" is based on the physical principle of localized illumination and an assertion of improved visualization.
8. The sample size for the training set
- Sample Size: Not Applicable.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not Applicable.
§ 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.