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The TearCare MGX System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.

The TearCare MGX System is designed to deliver controlled, precise heat to the tarsal plates and underlying meibomian glands of the eyelids for 15 minutes, followed by an optional warming hold time of up to 10 minutes to allow for manual expression. The TearCare MGX System is comprised of a reusable SmartHub, SmartCable, Charging Nest and charging adapter, and single use SmartLids.

The TearCare MGX System is operated by an eye care practitioner, who affixes the SmartLids to the patient's eyelids, connects the SmartLids to the SmartHub with the SmartCable, and initiates the therapy session on the SmartHub. In the same manner as the predicate device, the system increases the temperature from the lowest warmth setting (41°C) to the highest warmth setting (45°C) when the therapy starts. The SmartHub controls the temperature until the 15-minutes of therapy are complete, at which time the system visually and audibly signals the end of therapy. At the end of the 15-minute core therapy, the TearCare MGX System transitions to an optional Warming Hold Time (WHT) that may last up to a maximum of 10 minutes. WHT holds the temperature at the lowest warmth setting (Warmth setting 1 and temperature set point of 41°C) allowing the eye care practitioner to individually express each eyelid while the lids are warm. To complete the TearCare MGX procedure, the eye care practitioner removes the SmartLid devices one at a time from the patient, then uses the separately available meibomian gland expression forceps (Clearance Assistant) to manually express the meibomian glands immediately following the eyelid heat therapy. Heat is discontinued once the SmartLid is removed prior to expression, at the end of the optional 10-minute WHT, or at any time the eye care practitioner utilizes the SmartHub control to interrupt (pause or stop) treatment.

The subject TearCare MGX System is technologically the same as the predicate TearCare MGX System cleared under 510(k) K231084. Notably, there are no changes to the system impacting thermal exposure and limits regarding temperature control and regulation. The subject device of this submission proposes changes to the TearCare MGX System that impact the Instructions for Use (IFU), rather than a device technological change. The procedural instructions for use are updated with additional instruction for the application of the SmartLids including an earpiece fitment check to assess whether the ear loop requires further support.

The provided FDA clearance letter for the TearCare MGX System (K242786) focuses on demonstrating substantial equivalence to a predicate device (K231084). The core of this submission is a change to the Instructions for Use (IFU) to improve the fitment of the SmartLids, rather than a change to the device's technological characteristics or its core therapeutic performance.

Therefore, the primary "study" described in this document is a clinical validation study of the updated IFU for SmartLids fitment, not a study exploring the therapeutic effectiveness of the device itself or its standalone performance in a medical diagnosis context. The acceptance criteria and device performance listed below directly relate to this fitment validation.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 21 subjects
• Data Provenance: The document does not explicitly state the country of origin, but it is a clinical validation study performed to address a specific usability/fitment aspect of the device. The study is prospective, as it was conducted to validate new instructions for use.

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

The study described is a clinical validation of device fitment, not a diagnostic accuracy study requiring expert adjudication of medical images or conditions. The "ground truth" was whether the device remained affixed. This was directly observed during the study.

• Number of Experts: Not applicable in the context of diagnostic "ground truth" establishment. The assessment of whether earloop components remained affixed would have been performed by the study staff (e.g., eye care practitioners or study coordinators) as part of the observation.
• Qualifications of Experts: Not specified or applicable for a fitment validation. The study involved eye care practitioners applying the device, but their role was in applying the device and observing its fit, not in establishing a medical "ground truth."

4. Adjudication Method for the Test Set

Not applicable. This was a direct observation study of device fitment and retention, not a study requiring adjudication of expert interpretations for a ground truth. The success criterion was whether the device remained affixed, which is a binary, observable outcome.

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

No. The provided document describes a clinical validation study focused on the fitment and retention of the TearCare MGX System's earloop components and SmartLids, specifically for the purpose of validating updated Instructions for Use. It is not a multi-reader multi-case (MRMC) comparative effectiveness study evaluating the therapeutic effectiveness of the device or human reader performance with or without AI assistance.

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

No. The TearCare MGX System is an Eyelid Thermal Pulsation System, a physical device intended for localized heat therapy. It is not an AI algorithm or a diagnostic software that would have "standalone" performance in the sense of processing data without human involvement for diagnosis. The closest equivalent to "standalone" performance for such a device would be its ability to maintain therapeutic temperature or its physical function, which is assessed through bench testing (e.g., thermal safety, electrical safety, EMC). The clinical validation study described is about the usability and fitment of its components when applied by a human practitioner.

7. The Type of Ground Truth Used

The ground truth for the clinical validation study was direct observation of device fitment and retention. Specifically, whether the earloop components and SmartLids remained securely affixed to the ears and eyelids, respectively, for the duration of the simulated treatment.

8. The Sample Size for the Training Set

Not applicable. This submission concerns a physical medical device (Eyelid Thermal Pulsation System) and a clinical validation of updated instructions for its use. There is no "training set" in the context of machine learning or AI algorithms for this device. The development of the device itself would involve engineering design, testing, and simulated use, but not typically a "training set" like in software development.

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

Not applicable, as there is no training set in the context of AI or machine learning for this device.

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The TearCare MGX™ System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.

The TearCare MGX™ System is a powered device intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD). The TearCare MGX™ System is comprised of a TearCare SmartLids" device (PN 07064) and a TearCare System Kit (PN 06985), containing the TearCare SmartHub™ (PN 07066), SmartCable (PN 06998), Charging Nest (PN 07067), and IFU (PN 06988). The TearCare MGX™ System warms the eyelid(s) by heating the SmartLids to a maximum set point of 45°C. Heat is applied to the external or cutaneous surface of the eyelids via the adherent, disposable SmartLids that are powered by the SmartHub. The TearCare MGX™ System can warm the eyelids of one or both eyes at a time. A medical grade silicone adhesive on the SmartLid device surface physically and thermally couples the devices to the external (cutaneous) surface of the eyelids. The SmartHub includes a device port for SmartLid device attachment via a SmartCable. Additionally, the SmartHub includes an intuitive touchscreen interface, temperature control processor, and a rechargeable battery. The operator affixes the devices to the patient's eyelids to initiate a treatment session and may adjust the system warmth level during a session. After completion of the core thermal cycle, an extended warming time will automatically begin and stay active for up to 10 minutes at a set target temperature of 41°C that is not permitted to not exceed 43°C. The SmartLid devices are disposable and are not intended to contact the cornea or conjunctival surfaces of the eye. The system automatically and gradually increases the temperature over 2-3 minutes until it reaches the target range of 41-45°C to melt the meibum blocking the meibomian glands. The core thermal cycle lasts 15 minutes, followed by an optional extended warming time which may last up to an additional 10 minutes. After TearCare MGX treatment the eye care professional then uses a separately available Clearance Assistant™ to express the meibomian glands manually immediately following the eyelid heat treatment. The separately packaged sterile, single-use Clearance Assistant instrument is available from Sight Sciences and used in conjunction with the TearCare product. The Clearance Assistant instrument is a Class I, 510(k) exempt, meibomian gland expressor (Classification Product Code HNS, Regulation Number 886.4350). Safety and effectiveness of the TearCare MGX System has not been established when used in conjunction with any other meibomian gland expressor. Effectiveness of the TearCare MGX System has not been established without manual meibomian gland expression.

The provided text describes the nonclinical bench testing and a clinical validation study performed for the TearCare MGX System to demonstrate its substantial equivalence to the predicate TearCare System. The device is a thermal pulsation system for treating evaporative dry eye disease due to meibomian gland dysfunction (MGD).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define a column titled "Acceptance Criteria" with pass/fail thresholds for a broad set of performance metrics. Instead, it details that the device "met the minimum and maximum temperature specifications with 95% confidence and 90% reliability" in the clinical study, and that bench testing demonstrated compliance with applicable requirements. The core performance is related to maintaining a specific temperature range on the eyelid and ensuring corneal safety.

Based on the "Clinical Validation Study Summary" section (pages 16-17):

2. Sample Sizes and Data Provenance

• Test Set (Clinical Validation Study):
  • Sample Size: 15 adult subjects (30 eyes)
  • Data Provenance: Retrospective or Prospective is not explicitly stated, but the description "clinical validation testing... to demonstrate in acute clinical study" implies a prospective study. Country of origin not specified, but the submission is to the US FDA.
• Additional Clinical Validation Study (for Earloop Fit):
  • Sample Size: 21 subjects
  • Data Provenance: Similar to the above, likely prospective and in the US.

3. Number of Experts and Qualifications for Ground Truth

The text does not mention the use of experts to establish a "ground truth" in the traditional sense of image interpretation for AI. The clinical study focused on direct physiological measurements (temperature) and clinical observations (slit lamp exams, adverse events) to assess performance and safety. Therefore, this section is not directly applicable to the described studies. The measurements themselves are the "ground truth."

4. Adjudication Method for the Test Set

Not applicable, as the data are direct quantitative measurements (temperatures) and clinical observations (adverse events, slit lamp findings) rather than subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study was a clinical validation of the device's thermal performance and safety, not a study evaluating human reader performance with or without AI assistance. The device itself is not an AI-assisted diagnostic tool, but rather a therapeutic heat delivery system.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical system that applies heat; it does not have a standalone algorithm for diagnostic or interpretative purposes. The software controls the device's function, and its functionality was verified through bench testing, alongside the hardware performance.

7. Type of Ground Truth Used

• For Thermal Performance: Direct temperature measurements using thermocouples (outer eyelid) and an IR camera (cornea).
• For Safety: Clinical observations including slit lamp exams and adverse event reporting.
• For Earloop Fit: Direct observation of earloop retention (whether they remained affixed with tape).

8. Sample Size for the Training Set

The document does not mention an AI/machine learning model that would require a "training set." The studies described are for validation of a medical device, not for the development or testing of an AI algorithm based on patient data.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no apparent training set for an AI model mentioned in the document.

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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 TearCare® System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.

To use the TearCare System, the flexible SmartLids are applied to the external surface of the upper and lower eyelids of the right and left eye of the patient. The SmartLids are then connected to the SmartHub. When the SmartHub is turned on and the eye care professional initiates the procedure, the TearCare System begins delivering heat to the eyelids. The system automatically and gradually increases the temperature over 2-3 minutes until it reaches the target range of 41-45°C to melt the meibum blocking the meibomian gland orifices. A complete TearCare session lasts 15 minutes.

After TearCare treatment the eye care professional then uses a separately available Clearance Assistant™ to express the meibomian glands manually immediately following the eyelid heat treatment. The separately packaged sterile, single-use Clearance Assistant instrument is available from Sight Sciences and used in conjunction with the TearCare product. The Clearance Assistant instrument is a Class I, 510(k) exempt, meibomian gland expressor (Classification Product Code HNS, Regulation Number 886.4350). Safety and effectiveness of the TearCare System has not been established when used in conjunction with any other meibomian gland expressor. Effectiveness of the TearCare System has not been established when used without manual meibomian gland expression.

The TearCare System is comprised of the following key components and accessories:

• . SmartHub – a reusable component that incorporates hardware and software to power the SmartLids during treatment. The SmartHub has 5 temperature set points (ranging from 41 to 45°C), which allow the user to manually adjust the temperature up or down to a level that is comfortable for the patient. The SmartHub is powered by an internal lithium-ion battery and has an intuitive 4-function, 3-button interface which provides the user the status and control of treatment initiation, treatment temperature setting, remaining treatment duration, and treatment termination.
• . Charging Nest - a reusable plastic desktop cradle that holds one SmartHub in order to recharge the SmartHub battery.
• Charging Adapter and Wall Plug - a reusable AC/DC wall-mount adapter that accommodates 80-264 VAC input voltage and provides 9.0 VDC output voltage to the SmartHub through the Charging Nest.
• SmartLids – a single use component of the TearCare System that is designed to conform to the upper and lower eyelid. They contain flexible circuits, sensors and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. Each SmartLid is connected to the SmartHub by a cable integrated into the SmartLid. The integrated cable is four feet in length.

The provided text details the acceptance criteria and a clinical validation study for the TearCare® System, however, it does not describe an AI/ML device. Therefore, some of the requested information (like effect size of AI assistance, standalone algorithm performance, number and qualifications of experts for ground truth, and adjudication method) is not applicable or cannot be extracted from the given text.

Here's the available information presented in the requested format:

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

The document focuses on demonstrating substantial equivalence to a predicate device (LipiFlow® Thermal Pulsation System) rather than explicit, quantifiable acceptance criteria with pass/fail thresholds for each performance metric as would be typical for an AI/ML device. However, it does present performance data for various safety and effectiveness endpoints that implicitly serve as criteria for demonstrating equivalence.

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

• Sample Size for Clinical Validation Study (Thermal Safety): 15 adult subjects (30 eyes).
• Sample Size for Randomized Clinical Trial ("OLYMPIA"): 235 subjects (470 eyes) from 10 investigative centers. This was split into two cohorts due to a SmartLid design change:
  • Cohort 1: 93 subjects (47 LipiFlow / 46 TearCare)
  • Cohort 2: 142 subjects (73 LipiFlow / 69 TearCare)
  • Effectiveness endpoints assessed using data from Cohort 2.
  • Safety endpoints evaluated separately for Cohort 1 and 2.
• Data Provenance:
  • Clinical Validation Study: Not explicitly stated, but likely prospective.
  • Randomized Clinical Trial ("OLYMPIA"): Prospective, multicenter, randomized, non-inferiority, masked, controlled clinical trial conducted in the United States (10 investigative centers).

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 document. The study evaluates the device's performance based on clinical measurements (e.g., TBUT, MGSS, OSDI, staining scores, temperature measurements) and adverse event reporting, rather than expert-established ground truth for an AI/ML diagnostic output.

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

This information is not provided in the document. As this is not an AI/ML diagnostic device, an adjudication method for establishing ground truth from multiple expert interpretations would not be directly applicable in the same way.

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. The device is a thermal pulsation system for treating meibomian gland dysfunction, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. The device is a physical medical device (thermal pulsation system), not an AI/ML algorithm.

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

For the "clinical validation study" (thermal safety): The ground truth for temperature measurements was established using physical sensors (thermocouples) and an IR camera, directly measuring tissue temperatures.

For the "randomized clinical trial" ("OLYMPIA"): The "ground truth" for effectiveness and safety was established by direct clinical measurements and patient-reported outcomes, comparing the TearCare System to a predicate device (LipiFlow). This includes metrics like Tear Break-up Time (TBUT), Meibomian Gland Secretion Score (MGSS), Ocular Surface Disease Index (OSDI), corneal and conjunctival staining scores, meibomian gland function, adverse event reporting, pain/discomfort scores, visual acuity, and intraocular pressure.

8. The sample size for the training set

Not applicable. The described device is a physical medical device, not an AI/ML system that requires a "training set."

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

Not applicable. The described device is a physical medical device, not an AI/ML system that requires a "training set."

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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.

• Baseline Mean IOP: 19.5 ± 3.8 mmHg
• 12 Month Mean IOP: 15.2 ± 3.0 mmHg
  Standalone Group (Baseline IOP ≥ 16 mmHg, n=38):
• Baseline Mean IOP: 20.0 ± 3.6 mmHg
• 12 Month Mean IOP: 15.3 ± 2.7 mmHg
  Responders (≥ 20% IOP reduction at 12 months, no medication increase, no secondary surgery):
• Standalone (Pre-op IOP > 18 mmHg): 58.3% (14/24)
• Standalone (Lewis criteria, Baseline IOP ≥ 16 mmHg): 45.7% (16/35)
• +Cataract (BL > 18 mmHg): 62.5% (15/24)
• +Cataract (Lewis criteria, Baseline IOP ≥ 16 mmHg): 43.5% (20/46) |
  | Effectiveness: Medication Reduction | Reduction in the number of ocular hypotensive medications or at least no increase. | All Patients (n=129):
• Baseline Mean Medications: 1.8 ± 1.3
• 12 Month Mean Medications: 1.1 ± 1.2 |
  | Safety and Adverse Events | Adverse events should be infrequent, mild, non-serious, transient, and consistent with those expected in the target population. No serious device-related adverse events. | Adverse events were generally infrequent, mild, non-serious, transient, and resolved with or without treatment. No serious adverse events or serious device-related adverse events reported.
  Most common (12-month visit): Posterior capsular opacity (14.7%), Mild anterior chamber inflammation (10.9%), Cystoid macular edema (5.4%), Corneal edema (4.7%), IOP increase ≥ 10 mmHg above baseline >30 days postoperative (4.7%), Hyphema > 1 mm (3.9%). |
  | Secondary Surgical Interventions | Acceptable rate of re-intervention. | 7.0% (9/129 eyes) required secondary surgical intervention to reduce IOP.
• +Cataract: 4.9% (4/81)
• Standalone: 10.4% (5/48) |

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 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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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 (OD or OS) using either hand.

The provided text describes a 510(k) premarket notification for the Sight Sciences Viscoelastic Injector, a medical device for delivering viscoelastic fluid during ophthalmic surgery. While the document mentions performance testing, it does not contain the specific details required to fully answer the request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that acceptance criteria were "based on viscoinjector dispensing performances, intrinsic strength of the materials, and the load to which the Sight Science Viscoelastic Injector would be subjected during intended use." However, it does not explicitly state the quantitative or qualitative targets for these criteria (e.g., "dispensing accuracy within X%", "material strength > Y MPa"). The reported performance is a general statement that "testing demonstrated that the proposed device performs as intended and is functionally equivalent to the predicate device," without specific data points to correlate to the acceptance criteria.

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

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: 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

• MRMC study: Not applicable. This device is a manually operated instrument for delivering fluid, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

• Standalone performance: Not applicable. This is a mechanical device, not an algorithm. Its performance is inherent in its physical and mechanical functions, not in an independent algorithm. The "simulated use testing" would be the closest analogue, but it still involves human interaction, albeit in a controlled test environment.

7. The type of ground truth used

• Type of ground truth: Not explicitly stated, but based on the nature of the device (a fluid injector), the "ground truth" would likely be derived from:
  • Metrological measurements: Precise measurement of dispensed volumes, flow rates, and consistency.
  • Physical properties analysis: Testing material strength, durability, and sterility.
  • Functional performance: Observational and quantitative data from simulated use, verifying the device's ability to inject viscoelastic fluid smoothly, accurately, and without issues.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is a mechanical device, not an AI model that requires a training set.

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

• Ground truth for training set: Not applicable (as above).

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