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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 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™ 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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