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The VIA360™ Surgical System is indicated for delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

The VIA360™ Surgical System is a manually operated surgical instrument used by ophthalmologists to deliver controlled amounts of ophthalmic viscoelastic fluid into the anterior segment of the eye. The VIA360™ Surgical System is comprised of a surgical-grade stainless steel cannula and a nylon microcatheter. The cannula is attached to a nose piece that can be rotated to a desired position for use in either eye. The microcatheter is advanced and retracted up to 40 mm per cycle by rotating the scroll wheel. The microcatheter has patterned markings every 10 mm to help measure the extended length. A controlled amount of viscoelastic fluid is dispensed through multiple outlets located on the microcatheter's distal tip by depressing the scroll wheel or the surrounding button. An external reservoir is included for the purpose of priming the device. The device is single-use only.

The provided text describes the 510(k) submission for the VIA360™ Surgical System. This device is a manually operated surgical instrument for ophthalmic procedures, specifically for delivering viscoelastic fluid and cutting trabecular meshwork tissue.

Based on the document, it's clear that this is not a submission for an AI/ML medical device. The device is a physical, manually operated surgical instrument. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, etc.) are not applicable to this submission.

The acceptance criteria and device performance evaluation detailed in the document are for a physical medical device, not a software or AI/ML product.

Here's a breakdown of the acceptance criteria and study information provided for the VIA360™ Surgical System, as it pertains to a physical device:

Acceptance Criteria and Reported Device Performance

Study Details (Non-AI/ML Device):

1. Sample size used for the test set and the data provenance:

   • The document does not specify a numerical sample size for "test sets" in the context of typical AI/ML validation datasets. Instead, it refers to "samples" or "units" for each specific non-clinical test (e.g., "All samples met the acceptance criteria" for visual inspection). The number of samples for each test is not detailed.
   • Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), as this is non-clinical performance and biocompatibility testing of a physical device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is a physical device; ground truth in the AI/ML sense (e.g., for image annotations) is not relevant. The "ground truth" here is compliance with engineering specifications, material properties, and biological safety standards.

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

   • Not applicable. This is not a human-in-the-loop diagnostic study requiring adjudication.

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:

   • Not applicable. This is a physical surgical device, not an AI-assisted diagnostic tool.

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

   • Not applicable. Again, this is not an algorithm. The "performance" is the physical function and safety of the device itself, evaluated through non-clinical bench testing.

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

   • For this physical medical device, the "ground truth" is defined by established engineering standards (ASTM, ISO), biocompatibility guidelines (ISO 10993 series), and the functional requirements of the device (e.g., accurate fluid dispense, sufficient joint strength). Compliance with these defined standards and specifications forms the basis of "truth."

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/ML model for this physical device. Device design and manufacturing processes are iterative but not "trained" in this manner.

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

   • Not applicable for the same reason as point 7.

Key takeaway from the document: The applicant demonstrates substantial equivalence for the VIA360™ Surgical System by comparing its design, materials, and non-clinical performance data to a legally marketed predicate device (OMNI Surgical System). The 510(k) summary explicitly states: "Clinical data is not included in this submission and is not required. Substantial equivalence is based on technological comparison." This further confirms that no AI/ML specific evaluations (which often require clinical data or extensive simulation/test data for model validation) were conducted or needed.

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The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

The Sight Sciences OMNI Surgical System is a handheld, manually operated device used by ophthalmologists to access, microcatheterize, and viscodilate Schlemm's canal ("canaloplasty") and to re-access Schlemm's canal and cut trabecular meshwork tissue ("trabeculotomy"). The OMNI Surgical System is provided sterile and disposed after single-patient use. The device is fabricated from biocompatible materials standard to the medical device industry. Each OMNI device dispenses fluid on the principle of exchanging volumes much like a syringe and is designed to function with commercially available cohesive viscoelastic fluids (also known as ophthalmic viscosurgical device, or "OVD").

The OMNI device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. A single advancement wheel is located on each side of the handle. This allows the OMNI device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter. To perform the combined and sequential canaloplasty/trabeculotomy procedures, the canaloplasty is performed first, followed by trabeculotomy as explained in further detail below.

The provided text describes a new version of the OMNI Surgical System (catalog #1-106) and compares its features and performance to predicate and reference devices to demonstrate substantial equivalence for FDA clearance.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate OMNI Surgical System (K202678) and the reference OMNI PLUS Surgical System (K201953), which have already met their own performance requirements. The key performance change for the subject device is the volume of viscoelastic fluid dispensed.

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

The document states that formal test sets (in the sense of independent clinical trials specifically for this K232214 submission) were not conducted for the subject device. Instead, the clearance relies on:

• Bench Testing: Leveraged from the OMNI PLUS Surgical System (K201953), which is physically identical. No specific sample sizes for these bench tests are detailed in the provided text, but it included design verification, functional product testing, sterilization, packaging and shelf-life testing, biocompatibility testing, bacterial endotoxin testing, and simulated use testing. Extended shelf-life testing involved subjecting devices to worst-case radiation and simulated aging.

• Clinical Data Leverage: "[Evaluation of the effect on the clinical outcomes from the change to increase the delivery volume of OVD provided in the clinical assessment comparison of the predicate OMNI device and reference iTrack device, it was appropriate to leverage the clinical data used in support of the cleared predicate device."

  • Data Provenance: The document does not explicitly state the country of origin of the data or whether the leveraged clinical data was retrospective or prospective. It refers to existing cleared devices (K202678 and K080067) and their associated clinical data.

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

This information is not provided in the given text. The document refers to "clinical data used in support of the cleared predicate device" and a "clinical assessment comparison of the predicate OMNI device and reference iTrack device" to justify the change in OVD volume. Details about the ground truth establishment for these underlying clinical studies, including the number and qualifications of experts, are not present.

4. Adjudication Method for the Test Set

This information is not provided in the given text. Since direct clinical test sets or studies for this specific K232214 submission are not detailed, any adjudication methods for those would be found in the documentation of the predicate or reference device studies.

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

This information is not applicable as the device described (OMNI Surgical System) is a surgical tool, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This information is not applicable for the same reason as point 5. The OMNI Surgical System is a manually operated surgical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the non-clinical (bench) testing, the "ground truth" would be established by:

• Defined Specifications: The device meeting its engineering and design specifications (e.g., volume dispensed, material properties, sterility levels).
• Functional Performance: Proper operation of mechanical components in simulated use.

For the leveraged clinical data, the ground truth would likely be outcomes data related to intraocular pressure (IOP) reduction in adult patients with primary open-angle glaucoma, as stated in the Indications for Use. However, the specific details of how this ground truth was established for the predicate's clinical studies are not in this document.

8. The Sample Size for the Training Set

This information is not provided as there is no mention of a "training set" in the context of an algorithm or AI model development for this device. The device is a surgical instrument.

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

This information is not applicable as there is no training set for an AI/algorithm mentioned.

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The TrabEx Pro Handpiece is a manual ophthalmic surgical instrument with irrigation and aspiration functions.

The MicroSurgical Technology TrabEx Pro is a single use, sterile, manual ophthalmic knife. The device can be connected to an ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration while the procedure is being performed. TrabEx PRO has an incision sealing sleeve.

The MicroSurgical Technology TrabEx Pro is a manual ophthalmic knife with irrigation and aspiration functions. The device was compared to the Trabectome (K040584) to demonstrate substantial equivalence, specifically for its irrigation and aspiration performance.

Here's an analysis of the acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the performance testing of the TrabEx Pro (bench testing). It mentions that "The TrabEx Pro and the Trabectome were tested using the same test methods," implying a comparative bench test.

The data provenance is from bench testing conducted by MicroSurgical Technology, Inc. It does not involve human subjects or clinical data, thus there is no information on country of origin or retrospective/prospective nature.

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

Not applicable. The ground truth for this device's performance (irrigation and aspiration rates) was established through objective physical measurements in a lab setting, not through expert opinions or clinical evaluation. The performance was directly measured against the specified rates of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. Since the "ground truth" was based on objective physical measurements of flow rates, there was no need for adjudication involving human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This device is a surgical instrument whose performance was evaluated based on physical operating parameters (irrigation and aspiration rates) in a bench test, not on an imaging-based diagnosis or interpretation that would typically involve a multi-reader study.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, in essence. The performance evaluation of the TrabEx Pro for irrigation and aspiration was a standalone assessment of the device's physical capabilities in a controlled bench test environment, without human surgical interaction being part of the primary performance measurement for regulatory submission.

7. The Type of Ground Truth Used

The ground truth used for establishing substantial equivalence was based on objective, quantitative physical measurements of irrigation and aspiration rates, mimicking the performance parameters of the legally marketed predicate device (Trabectome).

8. The Sample Size for the Training Set

Not applicable. This device is a manual surgical instrument, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of an algorithm.

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

Not applicable for the same reason as point 8.

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The iPRIMETM Viscodelivery System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HEALON® PRO from Johnson & Johnson Vision, Amvisc@ from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery.

The iPRIMET™ Viscodelivery System is a sterile, single-use ophthalmic surgical instrument for dispensing cohesive viscoelastic fluid (supplied separately, at point of use) during ophthalmic surgery. The iPRIMET™ Viscodelivery System is a delivery device for delivering viscoelastic fluid. The procedure is performed by a trained ophthalmic professional in a sterile surgical setting. The iPRIME device is filled by the user, at the point of use, with FDA approved commercially available cohesive viscoelastic fluid (e.g. HEALON® PRO, Amvisc® or PROVISC®; sold and supplied separately). The iPRIME device consists of a handpiece which includes a reservoir, dispense trigger, cannula, slide button, rotatable hub, and microcatheter manufactured from medical grade materials. The slide button allows the user to adjust the microcatheter length. The dispense trigger dispenses the viscoelastic fluid. The rotatable hub allows the user to adjust the angle of the cannula in order to dispense viscoelastic fluid into other areas within the anterior chamber. The iPRIMET™ Viscodelivery System serves as dispensary means to deliver cohesive viscoelastic fluid. The OVD device containing the viscoelastic fluid is connected to the iPRIME luer fitting and viscoelastic is pumped into the iPRIME device. After the device is fully primed and the microcatheter has been extended to the desired location, the user advances forward the dispense trigger delivering a small amount of viscoelastic fluid into the desired location within the anterior chamber of the eye.

The iPRIME™ Viscodelivery System was subjected to various non-clinical tests to demonstrate its performance and substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes for each non-clinical test. It only states that the device was "subjected to the following functional and performance tests." The data provenance is from non-clinical testing performed on the iPRIME™ Viscodelivery System by the manufacturer, Glaukos Corporation. This is not patient data, so concepts like country of origin or retrospective/prospective do not apply in the same way.

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

Not applicable. The ground truth for these non-clinical tests is based on objective measurements and established engineering and biological standards, not expert clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. The non-clinical tests involve objective measurements against predefined acceptance criteria, rather than subjective interpretation requiring adjudication.

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

No. The document explicitly states: "Clinical data are not included in this submission and are not required. Substantial equivalence is based on technological comparison." Therefore, no MRMC comparative effectiveness study was performed.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The iPRIME™ Viscodelivery System is a medical device, not an algorithm or AI software. Its performance is evaluated through non-clinical functional, performance, and biocompatibility testing.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests used objective measurements and adherence to established standards and criteria for device functionality, material biocompatibility (ISO 10993-1: 2018), and package integrity. For the dispensed volume, the ground truth is the measured volume of viscoelastic fluid dispensed per activation.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a software algorithm, so there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for this device.

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The Streamline® Viscoelastic Injector is intended to deliver small amounts of viscoelastic fluid during Ophthalmic Surgery.

The Streamline® Surgical System is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.

The Streamline® Viscoelastic Injector is a single use disposable device designed to deliver small amounts of viscoelastic fluid.

The device consists of a single-use disposable device comprised of a surgical grade stainless steel cannula and a polymer handset, actuator button and priming port (Figure 1). The cannula is comprised of a long thin neck with an outer sleeve at its tip and allows access through a minimum 1.8 mm clear corneal incision. The cannula is long enough to reach across the eye 180 degrees from the clear corneal incision.

The device outer sleeve is transparent which allows the dispensing cannula with a clearly identifiable color to be visible at 12X magnification.

The priming port allows interfacing with commonly used viscoelastic containers used during priming and filling of the device.

The actuator button is located at the top of the handset and is colored for easy identification and incorporates a slight depression giving the user a tactile feel and correct finger placement. Each actuation of the actuator button causes an internal mechanical cam to rotate causing a snap action which rapidly retracts the outer sleeve at the device's distal tip. This action allows the cannula to dispense viscoelastic fluid through opposing side outlets located at an acute angle from the perpendicular plane of tip (Figure 2).

The length of the gear assembly allows for up to eight (8) total activations of the device. Each activation of the delivers approximately 7 µL of OVD and approximately 56 µL of OVD for the total maximum 8 activations allowed by the device. Once all activations are completed the gear assembly will have reached the end of travel and cannot be reset. Additionally, activation of the actuator button causes the priming port to disengage from the fluid pathway, to prevent re-priming of the device. This prevents the device from further priming preventing re-use.

Materials used to manufacture the Streamline® Viscoelastic Injector are of medical grade quality and no toxic substances are used in the manufacturing process. The materials used in the Streamline® Viscoelastic Injector were selected from materials safe for use in a clinical setting. These materials include stainless steel, polycarbonate, ABS polymer and silicone.

The provided document is a 510(k) premarket notification for the Streamline® Viscoelastic Injector. It details the device's technical characteristics, intended use, and provides a comparison to a predicate device. It also lists performance testing conducted to demonstrate conformance to design specifications and applicable standards.

However, the document does not contain specific acceptance criteria values or detailed results of a study that directly proves the device meets those criteria in a quantitative sense as typically presented with metrics like sensitivity, specificity, or F1-score. The "Performance Testing" section describes what types of tests were performed but does not provide the numerical acceptance criteria or the reported performance outcomes beyond qualitative statements (e.g., "assuring cannula integrity", "Qualitatively verify activation").

Furthermore, the document does not describe a study involving human readers or comparative effectiveness studies (MRMC) as it is a medical device for injecting viscoelastic fluid, not an AI/imaging diagnostic device.

Here's an attempt to answer your questions based only on the provided document, highlighting where information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria and reported performance values (e.g., precise strength values, exact force measurements, or quantitative pass/fail rates for functional tests) are not detailed in this document. The document lists the types of tests performed to ensure the device meets design specifications and conformance to standards.

2. Sample size used for the test set and the data provenance

The document does not specify exact numerical sample sizes for most of the performance tests (e.g., "100% of units during sample build" is mentioned for drivetrain motion, but no number of units is given). For Human Factors Engineering, "15 surgeons" were used.

Data provenance (e.g., country of origin, retrospective/prospective) is not stated. These tests are likely laboratory-based functional and material tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the context of this device and the provided document. The ground truth for functional engineering tests, material science tests, and biological safety is established by adherence to recognized international and national standards, and by engineering specifications, rather than expert consensus on diagnostic interpretations. The "experts" involved would be the engineers, test technicians, and possibly medical professionals (for cadaver evaluation and human factors) conducting these specific tests. For the Human Factors Engineering evaluation, 15 surgeons were used. Their specific qualifications beyond being "surgeons" are not detailed.

4. Adjudication method for the test set

This is not applicable as the tests described are primarily objective engineering and material science evaluations against predefined mechanical, biological, and material specifications, not subjective assessments requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted diagnostic tools, not for a surgical instrument like the Streamline® Viscoelastic Injector.

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

No, this is not applicable. The Streamline® Viscoelastic Injector is a manually operated surgical device, not an algorithm.

7. The type of ground truth used

The ground truth for the performance testing is based on:

• Established engineering specifications (e.g., required force for actuation, dispensed volume).
• Compliance with recognized international and national standards (e.g., ISO 10993 series for biocompatibility, ISO 80369-7 for Luer fittings, ISO 9626 for cannulas, ASTM standards for packaging).
• Qualitative assessment by trained personnel during functional checks (e.g., visual verification of drivetrain motion, qualitative verification on cadaver eyes).

8. The sample size for the training set

This is not applicable. The Streamline® Viscoelastic Injector is a mechanical surgical device, not an AI or machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

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The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

The Sight Sciences OMNI Surgical System (with modified indication) is a handheld, manually operated device used by ophthalmologists to access, microcatheterize, and viscodilate Schlemm's canal ("canaloplasty") and to re-access Schlemm's canal and cut trabecular meshwork tissue ("trabeculotomy"). The OMNI Surgical System is provided sterile and disposed after single-patient use. The device is fabricated from biocompatible materials standard to the medical device industry. Each OMNI Surgical System device dispenses fluid on the principle of exchanging volumes much like a syringe and is designed to function with commercially available cohesive viscoelastic fluids (also known as ophthalmic viscosurgical device, or "OVD").

The OMNI Surgical System device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. A single advancement wheel is located on each side of the handle. This allows the OMNI Surgical System device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter.

The stainless-steel cannula has a curved shape with a beveled tip for entry through the trabecular meshwork into Schlemm's canal. To perform the combined and sequential canaloplasty/trabeculotomy procedures, the canaloplasty is performed first, followed by trabeculotomy as explained in further detail below.

Performing Canaloplasty First: the microcatheter is advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20mm). When the device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid along the length of Schlemm's canal and collector channels. The microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating the advancement wheel. The microcatheter can be fully advanced/retracted multiple times, however, viscoelastic fluid can only be dispensed during the first two advancement/retraction cycles in order to dispense viscoelastic fluid along each hemisphere of Schlemm's canal. Thus, the OMNI Surgical System device is designed to be used twice within Schlemm's canal to deliver a controlled volume of viscoelastic fluid along the first 180 degrees of the canal, followed by a second delivery of viscoelastic fluid along the other 180 degrees. The OMNI Surgical System delivers a total viscoelastic fluid volume of 11 microliters throughout Schlemm's canal (approximately 5.5 microliters for each of the first two advancement/retraction cycles).

Performing Trabeculotomy Second: the beveled tip of the curved stainless-steel cannula is repositioned into the same Schlemm's canal location after finishing canaloplasty. The polymeric microcatheter is re-advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20 mm). With the microcatheter resting in the canal, the cannula is removed from the corneal incision and out of the eye causing the microcatheter to cut through the trabecular meshwork. This process can be repeated in the second Schlemm's hemisphere.

The provided text describes the OMNI® Surgical System and its substantial equivalence to a predicate device, focusing on bench testing and clinical evidence rather than explicitly defining acceptance criteria and subsequent studies in the typical AI/ML context. This document is a 510(k) summary for a medical device (infusion pump), not an AI/ML device. Therefore, the questions related to AI/ML device performance (like experts for ground truth, adjudication methods, MRMC studies, standalone performance, training sets) are not directly applicable or answerable from the provided text.

However, I can extract information related to the device's performance based on the clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a non-AI/ML medical device, there aren't explicit acceptance criteria in the way one would define them for an AI/ML algorithm (e.g., target specificity, sensitivity, etc.). Instead, the device's performance is demonstrated through its ability to reduce intraocular pressure (IOP) and its safety profile, which are compared against a historical control and expected outcomes. The key performance indicators evaluated were IOP reduction and medication reduction.

2. Sample Size for the Test Set and Data Provenance

• Sample Size:
  • Clinical Study (ROMEO): 129 patients with a single qualifying eye.
    • +Cataract group: 81 procedures
    • Standalone group: 48 procedures
  • Bench Testing (Cadaver Eyes): 4 cadaver eyes, using 8 OMNI Surgical System devices.
• Data Provenance:
  • Clinical Study (ROMEO): Retrospective, observational, multi-center, single-arm, consecutive case series study conducted at 11 sites throughout the U.S.
  • Bench Testing: Human cadaver eyes.

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

This is not applicable as the device is a surgical instrument, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth on a test set. The clinical performance data involves measuring physiological parameters (IOP) and observing real-world outcomes over time. The "ground truth" here is the clinical efficacy and safety observed in patients. The document mentions the study was performed by an ophthalmologist and a physician assistant during cadaver eye testing.

4. Adjudication Method for the Test Set

Not applicable for this type of medical device study. Data collected in the ROMEO study would have followed standard clinical trial data collection and monitoring practices, but not specific adjudication for ground truth in the AI/ML sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is a manually operated surgical instrument.

7. The Type of Ground Truth Used

• Clinical Study (ROMEO): The "ground truth" for effectiveness was direct physiological measurement (intraocular pressure, number of medications) and observed clinical outcomes (adverse events, need for secondary surgery) in live human patients. The study compared its findings to a reference literature control (Lewis RA, von Wolff K, Tetz M, Kearney JR, Shingleton B, Samuelson TW. Canaloplasty: circumferential viscodilation and tensioning of Schlemm's canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults: interim clinical study analysis. J Cataract Refract Surg. 2007 Jul;33(7):1217-26.)
• Bench Testing (Cadaver Eyes): The ground truth was the validated ability of an ophthalmologist to perform the intended surgical steps (access, microcatheterize, viscodilate, cut trabecular meshwork) using the device in cadaveric tissue as per the Instructions For Use.

8. The Sample Size for the Training Set

Not applicable. This is a non-AI/ML device.

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

Not applicable. This is a non-AI/ML device.

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The OMNI® PLUS Surgical System is an ophthalmic surgical tool for the delivery of controlled amounts of viscoelastic fluid into the anterior segment and the cutting of trabecular meshwork when a trabeculotomy is indicated.

The OMNI PLUS Surgical System is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic fluid into the anterior segment of the eye during ophthalmic surgery and cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI PLUS device is provided sterile and disposed after singlepatient use. The device is fabricated from biocompatible materials standard to the medical device industry. The OMNI PLUS Surgical System dispenses fluid on the principle of exchanging volumes much like a syringe and are designed to function with commercially available cohesive viscoelastic fluids (also known as an ophthalmic viscosurgical device, or "OVD") that are commercially available from companies such as Johnson & Johnson, Bausch & Lomb, and Alcon.

The OMNI PLUS device includes a stainless-steel cannula, polymeric microcatheter, removable priming lock, internal reservoir and plunger tube, a Luer fitting for direct connection with an OVD cartridge to prime the internal reservoir, and two advancement wheels. A single advancement wheel is located on each side of the handle. This allows the OMNI PLUS device to be used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning the device 180 degrees along its vertical axis. These wheels are used to advance and retract the microcatheter.

The microcatheter can be advanced/retracted up to 20 mm per cycle by manually rotating either advancement wheel. The microcatheter can be fully advanced/retracted multiple times, however, viscoelastic fluid can only be dispensed during the first two advancement/retraction cycles. When the OMNI PLUS device is being used to deliver viscoelastic fluid, retraction of the microcatheter causes a plunger tube to advance into the viscoelastic fluid reservoir thereby automatically dispensing viscoelastic fluid as the microcatheter is being retracted back into the stainless-steel cannula.

When the OMNI PLUS Surgical System is used to perform a trabeculotomy procedure, the beveled tip of the curved stainless-steel cannula is used to enter Schlemm's canal through the trabecular meshwork. The polymeric microcatheter is advanced into Schlemm's canal up to 180 degrees (one hemisphere) by rotating the advancement wheel forward until the wheel stops (about 20 mm). With the microcatheter resting in the canal, the cannula is removed from the corneal incision and out of the eye causing the microcatheter to cut through the trabecular meshwork. This process can be repeated in the second Schlemm's hemisphere.

The OMNI PLUS Surgical System is an additional model based on the current OMNI Surgical System design; OMNI PLUS is designed to dispense a nominal volume of 21 microliters of viscoelastic fluid.

The provided text describes a 510(k) premarket notification for the OMNI® PLUS Surgical System, classifying it as an Infusion Pump. This document focuses on demonstrating substantial equivalence to a predicate device (OMNI® Surgical System, K173332) through non-clinical bench testing. It does not contain information about studies involving AI, human readers, or clinical ground truth.

Here's the information gleaned from the text as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance statistics in a traditional format. Instead, it describes various performance evaluations that were performed to demonstrate that the OMNI PLUS Surgical System "meets the defined specifications and functioned as intended." The key performance differences from the predicate device are related to the volume of viscoelastic fluid dispensed.

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

The document refers to "test samples" and "representative device samples" for various bench tests. However, it does not explicitly state the specific sample sizes used for each performance test (e.g., how many units were tested for viscoelastic fluid dispensing, or how many units for sterility verification).

The data provenance is from non-clinical bench testing conducted by the manufacturer, Sight Sciences, Inc., and approved contract laboratories. The document indicates these are verification studies for a new device, not data from human subjects.

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

This document describes non-clinical bench testing for a medical device. There is no "ground truth" established by medical experts in the context of clinical data or image interpretation. The "ground truth" for these tests would be the design specifications and applicable standards, verified through objective measurements.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving expert review or adjudication of clinical cases.

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

No such study was conducted or mentioned in this document. The OMNI PLUS Surgical System is a manually operated ophthalmic surgical tool, not an AI-powered diagnostic or interpretive device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. The device is a surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical bench tests is based on design specifications, pre-defined performance requirements, and established industry standards (e.g., ISO 11137-2 for sterility, ISO 10993-1 for biocompatibility, USP <85> for bacterial endotoxin).

8. The Sample Size for the Training Set

Not applicable. This document describes bench testing for a physical medical device, not the development or training of an AI algorithm.

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

Not applicable, as there is no training set for an AI algorithm.

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The OMNI™ Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® or Healon GV® from Abbott Medical Optics (AMO), Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

The Sight Sciences OMNI™ Surgical System ("OMNI") is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic into the anterior segment of the eye during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures. The OMNI is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The OMNI dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir and plunger tube, and finger wheels. The finger wheels on the handle of the device are used advance and retract the microcatheter. In addition, when the device is being used to deliver viscoelastic, retraction of the microcatheter causes the plunger tube to advance into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid.

The provided document is a 510(k) summary for the OMNI Surgical System, a medical device. It describes the device, its intended use, and comparisons to predicate and reference devices. However, it does not contain the detailed clinical study information typically provided for AI/ML-driven devices to demonstrate performance against acceptance criteria.

The document states:

• Performance Data: "The OMNI's descriptive characteristics are well-defined and adequate to ensure equivalence to the predicate devices. Additionally, the following performance testing and inspection was conducted on the OMNI device: dimensional and visual inspections, visual inspection of labeling and component inspections, mechanical testing of joint strength and actuation force, simulated use testing, and human cadaver eye performance testing. Acceptance criteria was based on predicate VISCO360's dispensing performance, intrinsic strength of the materials, and the load and conditions to which the OMNI would be subjected during use. Testing demonstrated that the OMNI performs as intended and is functionally equivalent to the predicate devices."

Based on this, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes "performance testing" and "acceptance criteria based on predicate VISCO360's dispensing performance, intrinsic strength of the materials, and the load and conditions to which the OMNI would be subjected during use." However, it does not provide specific numerical acceptance criteria or detailed quantitative performance results in the format typically expected for AI/ML device evaluations (e.g., sensitivity, specificity, AUC). Instead, it makes a general statement of functional equivalence.

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

• Sample Size for Test Set: Not specified in the provided text. The phrase "human cadaver eye performance testing" indicates a form of testing but doesn't quantify the sample size.
• Data Provenance: "Human cadaver eye performance testing." This implies the data was collected in a laboratory setting using cadaveric eyes. The country of origin is not specified, but the submission is to the U.S. FDA. Retrospective/prospective is not applicable as this is a device performance test on cadavers, not a clinical data study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • Self-correction: For this type of mechanical device testing, "ground truth" would likely be established by engineering measurements and observations rather than expert clinical consensus as might be the case for image-based AI/ML devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. The testing described (dimensional, mechanical, simulated use, cadaver eye performance) would involve objective measurements and observations against pre-defined engineering or performance specifications, not a consensus-based adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable. This device is a manually operated surgical tool, not an AI/ML algorithm intended to assist human readers in interpretation tasks.

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

• Standalone Study: No, this is not an AI/ML algorithm. The device is a physical, manually operated surgical instrument.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical and simulated use testing, the ground truth would be based on engineering specifications, direct measurements, and observations of physical performance (e.g., dispensing volume accuracy, force required for actuation, structural integrity, cutting efficacy in cadaveric tissue) rather than clinical outcomes, pathology, or expert consensus on diagnostic interpretations.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning. The device design and verification would rely on engineering principles, material science, and iterative testing/refinement.

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

• How Ground Truth was Established: Not applicable, as there is no training set in the AI/ML sense. Device design and validation would follow standard medical device development processes.

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The Sight Sciences VISCO360® Viscosurgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISCTM from Alcon, during ophthalmic surgery.

The Sight Sciences VISCO360 Viscosurgical System is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small amounts of viscoelastic into the eye during ophthalmic surgery. The VISCO360 is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The VISCO360 dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir, plunger tube and finger wheels. The finger wheels on the handle of the device are used to advance the plunger tube into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid. The finger wheels are placed on both sides of the handle facilitating viscoelastic delivery in either the left or right eye (OD or OS) using either hand.

Here's a breakdown of the acceptance criteria and study information for the VISCO360® Viscosurgical System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size used for the test set during the performance testing. It mentions "Testing demonstrated...", implying a study was conducted, but the number of devices tested is not provided.

The data provenance is not specified. It's likely an in-house engineering or laboratory study, given the nature of the test (friction force). It is a prospective study in the sense that the modified device was specifically tested to assess this characteristic.

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

This type of testing (friction force measurement) does not typically involve human expert adjudication for ground truth. It's a quantitative measurement using calibrated instruments. Therefore, human experts were not used to establish the ground truth for this specific performance test.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was a quantitative engineering measurement, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes a performance test related to a mechanical characteristic (friction force) of the device, not an MRMC comparative effectiveness study involving human readers and clinical outcomes or image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the VISCO360® Viscosurgical System, as it is a manually operated medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for this specific test was a quantitative measurement of friction force. This would have been established through controlled experimental procedures using appropriate force-measuring equipment.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical instrument, not an AI/ML algorithm that requires a training set.

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

Not applicable. As noted above, this device does not involve a training set.

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The Sight Sciences Viscoelastic Injector is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon™ or HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISC™ from Alcon, during ophthalmic surgery.

The Sight Sciences Viscoelastic Injector is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small amounts of viscoelastic into the eye during ophthalmic surgery. The Viscoelastic Injector is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The Sight Sciences Viscoelastic Injector dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, injection tube, internal reservoir, plunger tube and finger wheels. The finger wheels on the handle of the device are used to advance the plunger tube into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid. The finger wheels are placed on both sides of the handle facilitating viscoelastic delivery in either the left or right eye (00 or OS) using either hand.

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the typical format for medical device performance studies (e.g., sensitivity, specificity, accuracy for diagnostic devices, or specific numerical targets for functional performance).

The document is a 510(k) summary for a "Viscoelastic Injector," indicating it's a submission for regulatory clearance in the US, asserting substantial equivalence to a predicate device. The information provided is primarily for regulatory purposes and highlights manufacturing, design, and general performance testing rather than a clinical efficacy study with detailed metrics and statistical analysis.

Based on the available text, here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: Specific, quantifiable acceptance criteria (e.g., "dispenses fluid within +/- X% of target volume," "material strength exceeds Y MPa," "withstands Z N of force") are not provided. The reported performance is general and qualitative ("performs as intended," "functionally equivalent").

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

• Sample Size: Not specified. The document states "performance testing was conducted," but no number of devices tested or the amount of data collected (e.g., number of injections, duration of tests) is given.
• Data Provenance: Not specified, but given the nature of a 510(k) submission for a manufacturing and design modification, it's highly likely this was retrospective testing performed on manufactured devices in an engineering lab setting, rather than human-centric prospective studies. The country of origin for the data is not mentioned but can be inferred to be within the US or by the manufacturer, Sight Sciences, Inc., based in California.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable for this type of device and study. The "ground truth" for a mechanical device like a viscoelastic injector typically refers to engineering specifications, material properties, and functional output (e.g., volume dispensed, pressure exerted). It doesn't involve clinical "experts" establishing a ground truth in the same way as a diagnostic imaging device. The testing would be against established engineering standards and validated measurement techniques.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (2+1, 3+1, etc.) are used in clinical studies where human interpretation of data (e.g., medical images) requires consensus. This device's performance testing would involve objective measurements against engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No comparison study mentioned. The document states the device is "manually operated" by ophthalmologists, but there's no mention of a comparative effectiveness study involving human readers (ophthalmologists) with and without the device, or against a different device, to measure improvement in human performance "with AI vs without AI assistance." This device is a tool, not an AI diagnostic assistant.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a manually operated mechanical injector, not an AI algorithm. Its performance is tied directly to its physical function.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance testing would be based on engineering specifications and validated metrology/measurement standards. For example, the accuracy of dispensed volume would be measured against a known reference standard using calibrated equipment. The material strength would be tested against established mechanical engineering limits. The text broadly refers to "viscoelastic injector dispensing performance, intrinsic strength of the materials, and the load to which the Sight Science Viscoelastic Injector would be subjected during intended use" as the basis for acceptance criteria, implying these engineering and functional benchmarks.

8. Sample Size for the Training Set:

• Not applicable. This is a mechanical device, not an AI system that requires a training set.

9. How Ground Truth for the Training Set was Established:

• Not applicable. As above, no training set for an AI-like system is involved.

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