(91 days)
Zepto™ is indicated for use in performing anterior capsulotomy during cataract surgery.
The Zepto™ is an electrosurgical device indicated for use in performing anterior capsulotomies during cataract surgery. The Zepto™ Capsulotomy System consists of a console, disposable handpiece, and a fluid isolator assembly (consisting of the fluid isolator, roller dispenser, and clamp). The handpiece power cord connector is connected to the front panel of the console to provide power for the capsulotomy procedure. The medical grade PVC suction tubing from the handpiece is connected to the fluid isolator. The fluid isolator is then connected to the console's front panel to provide suction during the treatment to a silicone suction cup containing the capsulotomy element. The Zepto 110 console delivers pulsed DC energy from a storage capacitor to a circular capsulotomy element on the tip of the disposable handpiece for creation of a nominal 5mm diameter capsulotomy.
The provided text doesn't describe a study that uses an AI/ML device, but rather a medical device (Zepto™) for anterior capsulotomy during cataract surgery. Therefore, many of the requested elements for AI/ML device studies (such as MRMC studies, training set details, and expert adjudication of ground truth for AI) are not applicable to this document.
However, I can extract information related to the acceptance criteria and the study that proves the device meets its performance goals based on the provided FDA 510(k) summary.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the primary safety and effectiveness endpoints and additional parameters evaluated. The document doesn't present a formal table of pre-defined acceptance criteria with pass/fail thresholds for each metric, but rather describes the achieved performance against certain target outcomes (e.g., matching historical rates for the "gold standard" technique).
| Metric / Endpoint | Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|---|
| Primary Safety Endpoint: | |||
| Posterior capsule rupture and vitreous loss | Rate should be comparable to or better than "gold standard" CCC (historically derived). | 0 out of 100 eyes treated with Zepto. | Meets implied criterion. |
| Primary Effectiveness Endpoint: | |||
| Completeness of capsulotomy (successful 360-degree capsulotomy) | High rate of completeness. Specific numerical target not explicitly stated but implied to be near 100%. | 98 out of 100 cases (98%). | Two incomplete cases attributed to user error/suboptimal visualization, not device failure. |
| Additional Safety Parameters: | |||
| Anterior Capsule Tear | Low occurrence, ideally no vitreous loss. | 2 out of 100 eyes. Neither had vitreous loss. One device-related. | Reported. |
| Corneal Touch | No cases reported. | 0 cases reported. | Meets implied criterion. |
| Adverse Events | Low incidence, and few device-related. | Epithelial erosion, macular edema, anterior/posterior capsule tear, IOP elevation, ache. Only 1 case (AC/PC tear) was noted to be device-related. | Reported. |
| Additional Effectiveness Parameters: | |||
| Diameter of Capsulotomy | Consistent, nominal 5mm. | Mean 5.14 mm +/- 0.14 mm (range 4.9-5.5 mm). | Consistent and close to nominal. |
| Circularity of Capsulotomy | High rate of circularity. | 99 out of 100 cases recorded as circular without zonular damage. | Meets implied criterion. |
| Pre- and Post Zepto Corneal Incision Size | Minimal increase. | Mean increase 0.0305 mm (range 0-0.2 mm). | Reported as minimal. |
| Ease of cortex removal | Similar or easier than manual capsulorhexis. | 97 out of 100 cases reported as similar or easier. | Meets implied criterion. |
| Capsulotomy centration | High rate of centration. | 96 out of 100 reported as centered. | High rate of centration. |
| IOL centration | 100% intracapsular fixation and centered. | 100% reported with IOL intracapsular fixation and centered. | Meets implied criterion. |
| BCVA at 1 month | Good visual outcome (e.g., 20/20). | Mean BCVA 20/20. | Meets implied criterion. |
| Capsular abnormalities / Slit lamp findings | No clinically significant abnormalities. | No capsular abnormalities reported. No clinically significant slit lamp exam findings. | Meets implied criterion. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: 100 eyes.
- Data Provenance: The study was a "clinical trial" conducted specifically to evaluate the device performance, indicating it was prospective data collection. The document does not explicitly state the country of origin for the clinical data, but it's an FDA submission, implying the study was likely conducted under U.S. clinical trial regulations or internationally recognized standards for submission to FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The study involved ophthalmic surgeons using the device. The "ground truth" (e.g., successful capsulotomy, complications) would have been established by the performing surgeons and/or study investigators who observed the procedures and patient outcomes. The document does not specify the number of experts/investigators who established the ground truth in terms of adjudication, nor their specific years of experience. It simply states the device is to be used by "ophthalmic surgeons."
4. Adjudication Method for the Test Set
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus by independent readers) for the clinical study's outcomes. The reporting of safety and effectiveness parameters (e.g., "2 cases of incomplete capsulotomy," "2 of 100 eyes had anterior capsule tear") suggests that these were observed and reported by the clinical investigators as part of standard clinical trial data collection. There's no mention of an independent panel reviewing cases to establish ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance on diagnostic performance) is relevant for AI/ML diagnostic devices. The Zepto™ is a surgical device, not a diagnostic imaging AI. The clinical trial focused on the device's performance during surgery and post-operative outcomes, not on human diagnostic interpretation or improvement with AI assistance. The comparison was against the "historically derived rate for the 'gold standard' surgical technique" (CCC), not against human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not applicable in the context of an AI/ML algorithm. The Zepto™ device itself is the "standalone" entity whose performance is being evaluated. It functions as a surgical instrument. The clinical study evaluates its performance in vivo when used by a surgeon.
7. The Type of Ground Truth Used
- The ground truth for the clinical study was based on clinical observation of surgical outcomes and patient follow-up data. This includes:
- Direct observation of capsulotomy completeness and characteristics during surgery.
- Observation of intraoperative complications (e.g., posterior capsule rupture, vitreous loss, anterior capsule tear).
- Post-operative patient outcomes (e.g., BCVA, IOL centration, slit lamp findings, adverse events).
- For the pre-clinical studies, animal histopathology and biomechanical testing of human cadaver eyes were used to establish ground truth for specific parameters like endothelial cell condition, zonular stress, and capsule edge strength/extensibility.
8. The Sample Size for the Training Set
- Not applicable as this is not an AI/ML device study with a "training set" in the machine learning sense. The device is a physical instrument.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as above. The "training" for this device largely comes from engineering design, bench testing, and pre-clinical studies (animal and cadaver). The clinical study served as a validation of its performance in humans.
§ 886.4100 Radiofrequency electrosurgical cautery apparatus.
(a)
Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.(b)
Classification. Class II.