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The ZeptoLink IOL Positioning System is indicated for use in performing anterior capsulotomy during cataract surgery.

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.

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:

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).

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ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery.

The Subject Device consists of a Power Console, Disposable Handpiece, 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 a breakdown of the acceptance criteria and study information for the ZEPTO Precision Capsulotomy System, based on the provided FDA 510(k) summary:

This document primarily describes the substantial equivalence of the Subject Device (K221188) to a Predicate Device (K210827), which is also the "ZEPTO Precision Capsulotomy System." The information presented focuses on demonstrating that the new device is essentially the same as the previously cleared one. Therefore, the "reported device performance" and details about separate clinical studies for this specific 510(k) submission are limited.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance" values for this specific 510(k) submission (K221188). Instead, it relies on demonstrating substantial equivalence to a predicate device (K210827) that presumably met those criteria previously.

The document indicates that "Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use." This is a general statement affirming compliance, not a detailed report of specific performance metrics against pre-defined acceptance criteria.

The key performance characteristic mentioned for both the Subject and Predicate Devices is:

• Capsulotomy Size: 5.0mm (nominal)

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details about a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) for clinical effectiveness studies. The "Summary of Testing Performed" mentions "A program of design verification and validation testing," indicating engineering and software testing. It does not refer to clinical studies with patient data to establish performance anew for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. As noted, there's no mention of a clinical test set requiring expert ground truth for this submission.

4. Adjudication Method for the Test Set

This information is not provided in the document. Without a described clinical test set, an adjudication method is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

This information is not provided in the document. No MRMC study is mentioned, nor is there any discussion of AI assistance or human reader improvement. The device described is a physical surgical tool, not an AI diagnostic or assistive software.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This information is not applicable to the "ZEPTO Precision Capsulotomy System," as it is an electrosurgical device for performing a physical procedure, not an algorithm.

7. Type of Ground Truth Used

Based on the nature of the device (a surgical tool), the ground truth for its performance would typically involve:

• Physical measurements: E.g., verifying the actual size and circularity of the created capsulotomy.
• Histopathology/Gross examination: Examining the cut edges for cleanliness and integrity.
• Clinical outcomes data: Assessing post-operative complications related to the capsulotomy (e.g., capsule tears, IOL decentration).

However, the provided text does not explicitly detail the type of ground truth used for this specific submission. It relies on the substantial equivalence to the predicate device, which would have established such ground truth in its own clearance process.

8. Sample Size for the Training Set

This information is not provided in the document. "Training set" is typically relevant for machine learning algorithms, which is not the nature of this device. The documentation focuses on engineering and performance validation of the physical device.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable, as there is no mention of a "training set" in the context of the ZEPTO Precision Capsulotomy System.

In summary:

The provided 510(k) summary for the ZEPTO Precision Capsulotomy System (K221188) primarily focuses on demonstrating substantial equivalence to its predicate device (K210827). It confirms that "Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use" through a "program of design verification and validation testing," which includes software testing. However, it does not offer detailed quantitative acceptance criteria, specific clinical study sample sizes, expert qualifications, or ground truth establishment methods for this particular submission, as these were presumably established and accepted during the clearance of the predicate device. The device itself is a physical surgical tool, not an AI-driven diagnostic or assistive system, which explains the absence of information related to AI-specific metrics (e.g., MRMC studies, training sets).

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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

Study Details

1. 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.

2. 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.

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

   • Not applicable/Not provided.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI device that requires a training set.

8. 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).

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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).

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.

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