FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Subject Device is basically Predicate, which is currently on the market, but integrated with OEM Ultrasonic Phacoemulsification (USP) system. The Subject Device and the USP are both required to complete the capsulotomy. The Subject Device includes the following system components:

. Power Console with Power Supply
. Reusable Pneumatic Connection, USP VIT-to-ZeptoLink
. Disposable Handpieces
USP Support Mounts .
The Power Console includes a LCD touchscreen display, which can rotate for viewing at different angles. The console is mounted to the USP with customized support mounts design for various USPs. The console includes hardware and software, which the software establishes a safe state in the event of faults. The safe state is redundant electrical isolation components and pressure isolation. Low positive pressure irrigation is allowed in the safe state to ensure release from the lens capsule. This mimics USP system's safe state architecture.
No electricity is shared between the Power Console and USP. The console is connected to an electrical outlet via a separate 12V power adapter module "power brick". The Disposable Handpiece's power cord is connected to the console. Energy delivery to the handpiece's capsulotomy tip is solely provided through the console.
Priming the handpiece's suction line, the suction used to create apposition of the capsulotomy tip, and positive pressure irrigation used to release the capsulotomy tip after capsulotomy are all performed with the USP's fluidics (i.e., irrigation and aspiration). The handpiece suction line is connected to the irrigation/aspiration lines of the USP's pack. A 0.22-micron filter incorporated on the suction line is inserted into the pressure sensing module located on the console's front panel. The filter provides a sterile barrier between the suction path of the handpiece and the console.
Initial priming of the suction line is conducted by pressing the USP continuous irrigation icon on the user interface, or by pressing the fill functions icon in the USPs vitrectomy state. Should additional priming be required, the vitrectorny fill icon can be pressed more than once. If the suction line requires additional priming just prior to surgery, the surgeon can accomplish this by pressing the USP's footswitch to position one (1) to generate irrigation.
The surgeon initiates suction by pressing the USP's footswitch to position two (2), which triggers the console to pinch off the irrigation line. Suction is maintained with continued pressure to the footswitch. The delivery of energy will not be authorized until a threshold vacuum pressure for a specified duration has been achieved. Note: To stop suction, the surgeon simply releases pressure from the footswitch.
To release the capsulotomy tip after capsulotomy, the Surgeon releases pressure from the foot pedal. The console will release "un-pinch" the irrigation line after energy delivery.
There are a couple of ways to initiate energy delivery. The first method is to press the associated icon on the console's touch screen, which the sterile nurse will perform with verbal communication from the surgeon. The second method is through the USP's footswitch, which sends a signal through the vitrectomy port to the console, via the reusable pneumatic connection. The pneumatic pulse signal is recognized by the console and initiates energy delivery. The surgeon controls energy delivery with the second method. In both methods, energy delivery cannot occur without the suction parameters being met and the energy being unlocked, either manually by depressing the energy unlock icon on the console.
The Disposable Handpiece part of the Subject Device is identical to the Predicate with the exception of extending the suction line to incorporate the irrigation/ aspiration connections to the USP's disposable pack and 0.22-micron filter. The functional portion that executes that capsulotomy is the capsulotomy tip located at the distal end of the 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. This is identical to the Predicate.
Other than the above-mentioned procedural activities, the capsulotomy procedure is identical to the Predicate.The capsulotomy tip is elongate by sliding the finger slider distally, this allow 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, which the capsulotomy tip will applanate, seating the cutting element to anterior capsule.
Once suction is achieved, energy is initiated. 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. Depending on which handpiece configuration is used the capsulotomy size is nominally 5.1 or 5.4mm.
The surgeon will remove the capsulotomy tip from the anterior chamber through the corneal incision when it releases from the capsule button will either come out when the capsulotomy tip is removed or be free-floating in the chamber where manual removal with forceps is required.
The Disposable Handbiece and the sterile drape for the Power Console display are packaged in a sterile barrier thermoform tray with Tyvek lid. Ten (10) packaged devices are inserted into an inner carton with the IFU then inserted into a shipper box. The contents in the sterile barrier are sterile via Ethylene Oxide (EO) sterilization.
The Power Console is packaged into an ESD protective bag and foam protectors are positioned of both side of the console then inserted into a shipper box. The power supply, power cord, and user manual are also provided in the shipper.
Reusable pneumatic connection and USP support mounts are be packaged separately.

AI/ML Overview

The provided document is a 510(k) summary for the "ZeptoLink IOL Positioning System." It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or detailed results of a study proving the device meets said criteria in the format requested.

The document states that "Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use" and "The results of the evaluation demonstrate that the Subject Device is substantially equivalent to the Predicate Devices as it pertains to the indications for use and device performance." but does not provide the quantitative values that constitute these "safety and performance requirements" or the data from the evaluations.

Therefore, I cannot populate the table or answer most of the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document
(e.g., Capsulotomy Diameter Accuracy: ±0.1mm)	(e.g., Achieved an average capsulotomy diameter of 5.10mm ± 0.05mm)
(e.g., Success Rate of Complete Capsulotomy: >95%)	(e.g., 98% success rate in simulated use)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "Simulated Use (Human Factors Evaluation)" as one of the tests performed, which suggests laboratory or simulated environment testing rather than clinical data from human subjects.

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):

Not specified. The document does not mention the use of experts to establish ground truth for testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

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/Not specified. This document is for a medical device (capsulotomy system), not an AI-assisted diagnostic or interpretive system that involves "readers" in the typical sense of MRMC studies. The device performs a physical action (capsulotomy), and its safety and performance would be assessed through objective measurements and functional tests, not reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not specified. The device is not an algorithm-only system; it's a physical medical device. The "Software" testing mentioned would be for the device's control system, not a standalone diagnostic algorithm. There is a "Human Factors Evaluation" (simulated use) listed, indicating human involvement in the device's interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not specified. Given the nature of the device (capsulotomy), ground truth would likely involve objective measurements of the capsulotomy's characteristics (e.g., diameter, circularity, completeness) achieved in simulated environments or animal models, rather than expert consensus on images, pathology, or direct patient outcomes in this particular documentation context.

8. The sample size for the training set:

Not applicable/Not specified. The document is for a medical device, not an AI system that undergoes a "training set" in the machine learning sense. The software mentioned would be deterministic control software, not a learned model.

9. How the ground truth for the training set was established:

Not applicable/Not specified. (See point 8).

Summary

Regulation Number and Section

§ 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.