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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 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 Nova Eye iTrack™ Advance is indicated for fluid infusion or aspiration during surgery.

The Nova Eye iTrack™ Advance is indicated for catheterization of Schlemm's Canal to reduce intraocular pressure in adults patients with open-angle glaucoma.

The iTrack™ Advance is a sterile, single-use manual handheld ophthalmic instrument used by ophthalmologists for infusion and aspiration of fluids during ophthalmic surgery and for catheterization and viscodilation of the Schlemm's canal (Canaloplasty) to reduce intraocular pressure in adults with open-angle glaucoma. After catheterization and viscodilation of the entire circumference of Schlemm's canal, the device may also be used to place a tensioning suture within the canal.

The iTrack™ Advance has a handpiece preloaded with an illuminated and flexible microcatheter. The addition of the handpiece provides for improved ergonomics and user interface by allowing single handed delivery of the microcatheter into the eye. The actuator on the handpiece is pushed forward slowly and this advances the catheter around the Schlemm's canal the full 360 degrees. By then sliding the actuator on the handpiece back the catheter is withdrawn back into the handpiece and as this takes place the viscoelastic is injected into the canal using the Ophthalmic ViscoInjector.

The iTrack™ Advance is manufactured from biocompatible materials, common within the medical device industry, such as stainless steel, nitinol, and thermoplastics such as polycarbonate, Pebax®, and polymethyl methacrylate (PMMA). The device includes a stainlesssteel cannula, a composite microcatheter, and a polymeric manual handpiece.

Additionally, the device is used with a single use manually operated infusion pump (the Ophthalmic ViscoInjector™) and the iLumin™ Fiberoptic Illuminator console (cleared separately in K050716 and K062259 and as a kit in iTrack™ 510(k) K080067).

The provided document describes the Nova Eye iTrack™ Advance Canaloplasty Microcatheter with Advanced Delivery System, and compares it to its predicate device, the iTrack™ 250A. The document primarily focuses on demonstrating substantial equivalence through non-clinical performance testing.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for most of the performance tests (e.g., biocompatibility animal numbers, number of devices for sterilization, endurance, mechanical, or actuator force testing).

• Human Factors Evaluation: Utilized "trained surgeons" in a "simulated surgical environment." The specific number of surgeons is not provided.
• Ex-Vivo and Simulated Use Testing: Performed in "human cadaver eyes." The specific number of cadaver eyes used is not provided.
• Data Provenance: The studies are described as non-clinical performance and preclinical studies, likely conducted in a controlled laboratory setting (e.g., "model eye," "human cadaver eyes"). There is no mention of country of origin for the cadaver eyes or data, nor whether the data is retrospective or prospective, though performance testing is inherently prospective.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Human Factors Evaluation: "Trained surgeons" were used. Their specific qualifications (e.g., years of experience, subspecialty) are not detailed beyond being "trained."
• Ex-Vivo and Simulated Use Testing: "Trained physicians" were involved. Their specific qualifications are not detailed.
• For other tests (biocompatibility, sterilization, mechanical), the ground truth is based on established international standards (ISO, AAMI, EN, FDA regulations) and internal device specifications, which are typically evaluated by qualified engineers and scientists rather than clinical experts.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods (like 2+1 or 3+1) for the performance tests. These methods are typically associated with subjective assessments by multiple reviewers, common in clinical imaging studies. The performance tests described here are primarily objective and based on established physical, chemical, and biological standards.

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

No MRMC comparative effectiveness study was done. The submission is a 510(k) for a device with physical and mechanical characteristics, not an AI or imaging diagnostic device that would typically require such a study demonstrating human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a manual surgical instrument, not an algorithm or AI system. Its performance is inherently tied to human use.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance tests is based on:

• Established Standards: International and national standards (ISO, AAMI, EN, FDA regulations) for biocompatibility, sterilization, shelf-life, endotoxin levels, human factors, and light hazard.
• Device Specifications: Internal specifications for mechanical, dimensional, endurance, and actuator force testing.
• Simulated Use Outcomes: For ex-vivo testing, the ability to achieve specified surgical tasks (visualization, viscoelastic injection, 360° cannulation) in cadaver eyes.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set. The "design input" and "bench testing" phases would be somewhat analogous to training in terms of iterative refinement, but there's no data training set in the AI sense.

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

Not applicable, as there is no training set for this type of medical device. Product specifications and design requirements would be established through a combination of engineering analysis, clinician feedback, and regulatory standards.

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The EVA NEXUS™ Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic subretinal microinjection of gases or aqueous fluids.

In addition, the optional laser is indicated for the following:

The EVA NEXUS™ Ophthalmic Surgical System (EVA NEXUS) is a combined anterior and posterior procedure ophthalmic system that is modular in design and is identical in most respects to the recently cleared predicate EVA Ophthalmic Surgical System (K190875). EVA NEXUS (see Figures 1, and 2 for external views) is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy as well as photocoagulation.

This document describes the EVA NEXUS™ Ophthalmic Surgical System, a combined anterior and posterior procedure ophthalmic system. The submission (K213467) seeks to demonstrate substantial equivalence to its predicate device, the EVA Ophthalmic Surgical System (K190875), and other components cleared under different K numbers.

The device includes several modifications and new components compared to its predicate, such as a redesigned infusion pole, a second infusion/irrigation port, "Smart IOP" functionality, microinjection capability, a digitally controlled phaco board, increased cutter speed, and a video overlay device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for efficacy or safety endpoints. Instead, it relies on demonstrating substantial equivalence to predicate devices through a combination of bench testing, compliance with international standards, and verification/validation testing. The performance aspects are primarily evaluated by comparison to the predicate device and relevant standards.

However, based on the "Comparison of Technological Characteristics with the Predicate Devices" (Table 5 and subsequent detailed comparisons for individual components like vitrectomy probes, tubing, and laser probes) and "Performance (Bench) Testing" sections, we can infer some performance requirements and reported outcomes:

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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 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 MicroDose Injector is indicated for low volume ophthalmic injections into the subretinal space.

The MicroDose Injector is designed for low volume ophthalmic injection into the subretinal space. It consists of one (1)1mL syringe and one (1) connector, which is joined to VFC tubing that is attached to a pneumatic air source, enabling a surgeon control for administering subretinal injections. The device is supplied sterile and intended for single-use only and cannot be reused or resterilized.

This document is a 510(k) summary for the MedOne Surgical, Inc. MicroDose™ Injector. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested sections (sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of regulatory submission, as they pertain to studies involving performance metrics like sensitivity, specificity, or reader agreement, which are not the subject of this 510(k). This submission primarily covers technical, safety, and functionality aspects to establish equivalence.

Here's an analysis of the available information:

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

The document does not provide a table of acceptance criteria in the typical sense of numerical performance targets (e.g., sensitivity > X%, specificity > Y%). Instead, it establishes equivalence based on meeting various technical, safety, and functional testing requirements.

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

This information is not applicable/available from the 510(k) summary. The "tests" performed are engineering and laboratory tests (biocompatibility, sterilization, shelf-life, package testing), not clinical or diagnostic performance studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/available. Ground truth as understood in AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant to the types of tests conducted for this device.

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

This information is not applicable/available. Adjudication methods are typically used in clinical studies involving human interpretation or consensus, which are not presented here.

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/available. The MicroDose™ Injector is a physical medical device (syringe system), not an AI-powered diagnostic or assistive tool.

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

This information is not applicable/available. The device is not an algorithm.

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

The "ground truth" for the tests performed can be characterized as follows:

• Biocompatibility: Established standards and validated laboratory methodologies (e.g., cell viability assays for cytotoxicity, skin reaction assessment for sensitization, animal models for systemic toxicity).
• Sterilization: Microbiological methods to confirm the absence of viable microorganisms to the specified SAL.
• Shelf-life: Real-time or accelerated aging studies with functional testing at intervals to determine the point at which the device no longer meets specifications.
• Package integrity: Physical testing (e.g., burst strength, seal integrity) according to recognized standards.
• Functionality: Direct measurement against engineering specifications (e.g., flow rate, volume delivery accuracy).

8. The sample size for the training set

This information is not applicable/available. There is no "training set" as this device is not an AI/machine learning algorithm.

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

This information is not applicable/available. As there is no training set for an AI algorithm, there is no associated ground truth in that context.

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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 Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.

The Orbit Subretinal Delivery System (SDS) is comprised of 3 primary component sets including the Subretinal Injection Device Set, the Tubing Set, and the Dosing Set. Each Orbit SDS Set contains sterile single-use only components. The Subretinal Injection Device set includes the magnetic pad, ophthalmic marker, and subretinal injection device (SID). The Tubing Set includes the components for priming the BSS line and pneumatic BSS control via a vitreoretinal surgical console. The Dosing Set includes the syringe for delivery of a precise dose of Balanced Salt Solution (BSS) or BSS PLUS® infusate.

I am sorry, but the provided text is a 510(k) summary for a medical device called the "Orbit Subretinal Delivery System." This document focuses on demonstrating substantial equivalence to a predicate device and outlines various performance tests conducted.

However, it does not contain the specific information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML powered device. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance for an AI/ML component.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
6. Details about a standalone (algorithm only) performance study.
7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set for an AI/ML model.
9. How the ground truth for the training set was established for an AI/ML model.

The document describes performance data related to biocompatibility, sterilization, packaging, shelf life, and simulated use for a physical medical delivery system, not an AI/ML algorithm.

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