(270 days)
ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery.
The Subject Device consists of a Power Console. Disposable Handbiece, and a disposable Fluid Isolator. The Disposable Handpiece's power cord connector is connected to the front panel of the Power Console to provide power for the capsulotomy procedure. The suction tubing from the Disposable Handpiece is connected to the Fluid Isolator. The Fluid Isolator is then connected to the Power Console's front panel to provide suction during the treatment to a suction cup containing the cutting element. The functional portion used for capsulotomy is the capsulotomy tip located at the distal end of the Disposable Handpiece, which consists of a circular, silicone suction cup, and circular cutting element. Energy pulses are delivered to the cutting element to create the capsulotomy.
Prior to conducting the capsulotomy, the Disposable Handpiece's suction line is primed Balanced Salt Solution (BSS).
The capsulotomy tip is elongate by sliding the finger slider distally, this allows it to be easy inserted into the anterior chamber through the corneal incision. Once inserted into the anterior chamber the finger slider is pulled back to return the suction cup/cutting element to their original circular shapes. After centering the cutting element at the desired location on the anterior capsule, suction is initiated on the Power Console, which provides vacuum at the capsulotomy tip to properly seat the cutting element to anterior capsule.
Once suction is achieved, enerqy is initiated on the Power Console. A series of electrical pulses lasting a total of 4 milliseconds is delivered to the cutting element causing rapid phase transition of water molecules trapped between the bottom edge of the cutting element and the anterior capsule. The rapid volume expansion results in the capsule cutting action. Suction is then vented to atmosphere. The capsulotomy is nominally 5mm.
A nurse assistant will, upon command from the physician, introduce a small amount of BSS into the suction cup to allow for a gentle release of the suction cup from the capsule, and to allow the free-floating capsule button to stay behind in the anterior chamber for manual removal with forceps. This is done by advancing the fluid displacement syringe forward. Upon completion of the capsulotomy, the capsulotomy tip is removed from the anterior chamber of the eye through the corneal incision.
The Disposable Handpiece with Fluid Isolator is packaged in a sterile barrier thermoform trav. The contents in the sterile barrier are sterile via Ethylene Oxide (EO) sterilization.
Here's an analysis of the provided text to extract information related to acceptance criteria and the study proving the device meets them:
The provided text describes the ZEPTO Precision Capsulotomy System and its 510(k) clearance by the FDA. However, it does not explicitly detail specific acceptance criteria values or a "study" in the sense of a clinical trial with a test set, ground truth, expert adjudication, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing.
Therefore, many of the requested fields cannot be filled directly from the provided text. I will indicate where information is not provided or inferred from the types of tests mentioned.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Met safety and performance requirements |
| Sterility | Met safety and performance requirements (Ethylene Oxide, SAL 10-6) |
| EO Residual | Met safety and performance requirements |
| Packaging Integrity (Sterile Barrier) | Met safety and performance requirements (Thermoform Tray/Tyvek Lidding Stock) |
| Transportation | Met safety and performance requirements |
| Electromagnetic Compatibility & Electrical Safety | Met safety and performance requirements |
| Stability/Shelf-Life | Met safety and performance requirements |
| Performance/Functionality/Safety | Met safety and performance requirements |
| Software | Met safety and performance requirements |
| Simulated Use (Human Factors Evaluation) | Met safety and performance requirements |
| Capsulotomy Size | 5.0mm (nominal) |
| Cutting Element Shape | Circular |
| Patient Contact Component | Capsulotomy Tip of the Disposable Handpiece |
| Single-use Components | Disposable Handpiece, Disposable Fluid Isolator |
Study Details
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document mentions "Summary of Testing Performed" but does not specify sample sizes for these tests. The nature of these tests (e.g., biocompatibility) suggests in-vitro or bench testing, not a clinical "test set" in the context of AI/diagnostic device evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This device is a surgical instrument, not a diagnostic AI. The "ground truth" for its performance would be engineering specifications and successful operation, not expert consensus on medical images.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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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. This is a surgical device, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. Not an AI algorithm. Its performance is inherent to the device's mechanical and electrical design.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's acceptance is based on engineering specifications, regulatory standards (e.g., biocompatibility, electrical safety), and successful functional operation during various performance and simulated use tests. For capsulotomy size and shape, the ground truth would be precise measurements against design specifications.
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The sample size for the training set:
- Not applicable/Not provided. This is not an AI device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable/Not provided. This is not an AI device.
Summary of the Study:
The "study" described is a design verification and validation testing program rather than a clinical study with a patient test set. The testing covered:
- Biocompatibility
- Sterility and EO Residual
- Packaging Integrity (Sterile Barrier)
- Transportation
- Electromagnetic Compatibility and Electrical Safety
- Stability/Shelf-Life
- Performance/Functionality/Safety
- Software
- Simulated Use (Human Factors Evaluation)
The results of these evaluations demonstrated that the Subject Device met the safety and performance requirements as it relates to its indication for use and was substantially equivalent to the predicate device. The provenance of the data is not specified but would typically be from in-house or contracted laboratory testing (bench testing, in-vitro testing).
§ 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.