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Alcon 27GA Chandelier
The 27GA Chandelier is indicated for use during posterior segment ophthalmic surgery.

Alcon 27+ DS Wide Angle Endoilluminator
The 27+DS Wide-Angle Endoilluminator is indicated for use during posterior segment ophthalmic surgery.

Alcon 27+ DS Endoilluminator
The 27 + DS Endoilluminator is indicated for use during posterior segment ophthalmic surgery.

As part of this premarket notification Alcon presents three new endoilluminators, compatible with the UNITY VCS device cleared in K233876 (clearance date: June 21, 2024).

Alcon 27GA Chandelier: The Alcon 27GA Chandelier provides a hands-free wide field of illumination for vitreoretinal procedures. The distal end of the device incorporates a short, tapered fiber optic to provide wide angle illumination projected from a pars plana position of the eye. The distal end consists of a tapered fiber, which is inserted into the eye through the Alcon 27GA entry system. The fiber is malleable so the physician can shape it to form a stable service loop, position the tip, and minimize interference with the lid speculum.

Alcon 27+ DS Wide Angle Endoilluminator: The Alcon 27+ DS WA Endoilluminator offers wide-angle illumination, featuring a sapphire lens at the distal end of the probe. This design ensures consistent, low-glare illumination across a broad field of view. Additionally, it incorporates a Dynamic Stiffener (DS) element-a retractable stiffener designed to minimize needle deflection at the proximal end of the stainless steel cannula. as opposed to the fixed stiffener used in previous models.

Alcon 27+ DS Endoilluminator: The Alcon 27+ DS Endoilluminator transmits light energy into the eye and incorporates a DS element at the proximal end of the stainless-steel cannula.

This FDA 510(k) summary does not contain the specific acceptance criteria or performance data in a format that directly matches the requested table. This document is a "Substantial Equivalence" submission, which focuses on demonstrating that new devices (Alcon 27GA Chandelier, Alcon 27+ DS Wide Angle Endoilluminator, Alcon 27+ DS Endoilluminator) are as safe and effective as previously cleared predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria for a novel device.

The document primarily relies on non-clinical testing to demonstrate substantial equivalence. Here's a breakdown of the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding performance results in a quantitative manner for specific clinical metrics. Instead, it states that the devices "met ISO 10993" for biocompatibility, "passed the predetermined acceptance criteria" for sterilization and shelf life, and that "safety tests demonstrated the compliance of the subject devices to the appropriate standards" for performance testing. For light hazard testing, it states the devices "meet aphakic and thermal safety standards comparable to the predicate devices."

The comparisons in Tables 1-3 highlight similarities in technological characteristics between the subject devices and their predicates, rather than presenting numeric acceptance criteria.

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

• Non-Clinical Testing: The document refers to "tested devices" for sterilization, "tested units" for packaging integrity, and "three subject devices" for light hazard testing. However, specific sample sizes (e.g., number of units tested for biocompatibility, number of sterilization cycles validated) are not provided.
• Data Provenance: All testing described is non-clinical. There is no mention of human subject data, therefore no information on country of origin or retrospective/prospective nature.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable, as this submission concerns non-clinical testing of medical devices (endoilluminators and a chandelier) for surgical use, not AI/diagnostic devices requiring expert adjudication for ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as this submission concerns non-clinical testing of medical devices (endoilluminators and a chandelier), not AI/diagnostic devices requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This submission is for physical medical devices, not AI software where such studies are typically performed.

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

Not applicable. This is not an AI device. The "performance testing" referenced is for the physical attributes and safety of the endoilluminators (e.g., light transmission, mechanical integrity, biocompatibility), which are inherently "standalone" in their assessment as device components.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by:

• Biocompatibility: ISO 10993 standards.
• Sterilization: ISO 11135 and ISO 10993-7 standards; achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
• Shelf Life/Packaging: ASTM D4169, ASTM F1980, and ISO 11607-1 standards.
• Performance (General): ISO 14971, ISO 15004-1, ISO 15752, and ANSI Z80.36 standards.
• Light Hazard: ANSI Z80.36 and ISO 15752 standards, and comparability to predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device; therefore, there is no training set in the AI sense.

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

Not applicable. There is no training set.

Summary of Device Acceptance:

The acceptance of these devices is based on demonstrating substantial equivalence to existing predicate devices (cleared under K875005 and K110951) through a battery of non-clinical tests. The tests confirm they meet established safety and performance standards (ISO, ASTM, ANSI) and have comparable technological characteristics and risk profiles to their predicates, making them safe and effective for their intended use in posterior segment ophthalmic surgery.

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The Midfield Light Pipe is a disposable microsurgical instrument used to conduct a field of light to the posterior seqment of the eye in order to visualize the internal structures of the eyes during ophthalmic surgery.

The Midfield Light Pipe will be offered in a 23 gauge (GA), 25GA and 27GA size. Each device consists of an ABS handpiece, 304 stainless steel illumination connector, LDPE EVA jacket material, PMMA illumination fiber, 304 stainless steel needle and a PMMA scleral depressor. The Midfield Light Pipe is an external communicating device, in contact with tissue/bone/dentin for a limited duration (

I am sorry, but based on the provided text, there is no information about acceptance criteria and a study that proves a device meets these criteria in the context of AI/ML performance, human reader studies, or associated metrics like AUC, sensitivity, specificity, etc.

The document discusses a 510(k) premarket notification for a medical device called "Midfield Light Pipe." The performance testing described is related to the physical characteristics and safety of the device, such as light output, needle strength, phototoxicity, sterilization, shelf-life, packaging, and biocompatibility.

Therefore, I cannot provide the requested information.

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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 Nam illumination probe with chopper is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and manipulation during cataract surgery.

This product transmits light through the optical fiber to the inside of the eye to illuminate the intraoperative field of the eyeball. It consists of tube, handle, optical fiber, fiber cloth, and connector.

Please note that the provided document is a 510(k) summary for the "Nam illumination probe with chopper," a non-powered device used for illumination during cataract surgery. These types of devices typically do not involve the same kind of performance studies (e.g., diagnostic accuracy, reader studies) as AI/ML-driven or image-analyzing software as a medical device (SaMD).

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for a diagnostic/AI performance study with corresponding performance metrics like sensitivity, specificity, or AUC. Instead, the performance data focuses on demonstrating the device's physical and biological safety, and benchtop performance against relevant standards.

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 or not provided in the document. The studies conducted are primarily benchtop or laboratory-based (sterilization, biocompatibility, mechanical performance) on the device itself, rather than studies involving patient data or a "test set" in the context of diagnostic accuracy.

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 as the studies are not diagnostic performance studies requiring expert ground truth for patient data.

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

This information is not applicable as the studies are not diagnostic performance studies requiring adjudication of ground truth.

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 MRMC study was conducted. This device is an illumination probe, not an AI-driven diagnostic tool.

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

No standalone algorithm performance study was done as this is a physical medical device, not a software algorithm.

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

The concept of "ground truth" as typically defined for diagnostic or AI performance studies is not applicable here. The "truth" for the performance data presented (e.g., sterility, biocompatibility, mechanical properties) is established by adherence to recognized international standards (ISO, ASTM, USP) and validated laboratory testing methodologies.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device that requires a training set.

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

This information is not applicable as this is not an AI/ML device.

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Adjustable Chandelier Illuminator family of ophthalmic illuminators is for wide angle illumination during ophthalmic surgery.

The 23ga and 25ga Adjustable Chandelier Illuminators are made to work with the Bausch and Lomb surgical system and Bausch and Lomb Valved ESA (Entry Site Alignment) systems (K012435). These devices are to be manufactured with distally located "Infusion Cannulas" that adequately secure themselves within 23ga and 25ga Bausch and Lomb Valved ESA Systems. The 23ga and 25ga Adjustable Chandelier Illuminators consist of a PMMA (Polymethylm-ethacrylate with Flourinated Polymer Cladding) acrylic fiber (for light transmission), white acetal handle assembly with finger slide for adjustability, PTFE (Polytetrafluor-oethylene) jacket (for fiber) and Stellaris style light connector to fit into the Bausch and Lomb Stellaris PC Vision Enhancement System (K133486). The 23ga and 25ga Adjustable Chandelier Illuminators are to be provided sterile to the user, is a single-use device and is packaged in double Tyvek-to-poly pouches to facilitate introduction to the sterile environment. These provide illumination for eye surgery.

This document describes the premarket notification (510(k)) for the Peregrine 23ga and 25ga Adjustable Chandelier Illuminator. The purpose of this notification is to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical performance tests conducted to evaluate the device. The reported performance is that all results were "acceptable" and the device "satisfactorily met the requirements." Specific numerical acceptance criteria or performance metrics are not provided in this summary.

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

The document does not explicitly state the numerical sample size for individual tests. However, it indicates that "Biocompatibility and sterility testing has been conducted on the 25ga Adjustable Chandelier Illuminators as a 'worst case device' and a family representative." This suggests a limited sample size, focusing on one representative (25ga).

The data provenance is internal, originating from Peregrine Surgical Ltd. It is retrospective, as these are bench tests conducted to support a premarket submission. No information about the country of origin of the data is provided beyond the company's location (New Britain, PA, USA).

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

Not applicable. This device is not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on a test set. The tests performed are bench tests evaluating physical and functional characteristics of a medical illuminator. The "ground truth" for these tests would be the established standards and specifications outlined in the referenced ISO and ASTM methods, or the company's internal test protocol specifications.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic assessment requiring adjudication among experts. The tests are objective measurements against defined standards.

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. This is not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is not an AI/ML device. The "standalone" performance refers to the device's functional characteristics as an illuminator, which were assessed through the listed bench tests.

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

The "ground truth" for the non-clinical performance data is the defined acceptance criteria and specifications within the referenced ISO, ASTM, and Internal Test Methods. For example:

• Sterility: The device must meet the sterility assurance level (SAL) specified in ISO 11135-1.
• Biocompatibility: The device materials must meet the biological safety requirements outlined in ISO 10993-01.
• Light Output: The device's light output must meet the specified lumen value (3.7 lumen, as indicated in Table 5.2).

8. The Sample Size for the Training Set

Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set.

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

Not applicable. No training set was used.

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The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.

The PHOTON EX is a table-top, xenon lamp lightsource used for intraocular illumination during vitreoretinal surgery. The lightsource employs two channels from a single lamp. The channels terminate with entry ports on the unit's front panel. Each channel has a dedicated filter wheel; the filter wheels include the following band pass filters with an upper cut-off at 650 nm and lower cut-offs at 435nm, 475nm, 475nm, and 515nm respectively. The user inputs are controlled by membrane switches on the front panel.

The provided text describes a 510(k) premarket notification for a medical device called PHOTON EX, an ophthalmic light source. The document focuses on establishing substantial equivalence to a predicate device (Synerlight) rather than providing detailed acceptance criteria and a comprehensive study for de novo approval.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, especially with specific details like ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, cannot be found in this document.

This type of submission (510(k)) primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device. The information provided is generally a comparison of technological characteristics and a summary of non-clinical tests to show equivalence.

However, I can extract the information that is present in the document which relates to performance and testing:

Device: Synergetics PHOTON EX
Predicate Device: Synergetics Synerlight FiberOptic Lightsource, K032598
Intended Use: The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery.

Here's an attempt to answer the questions based on the available information, noting where information is explicitly not present in the document:

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics (e.g., "illumination intensity must be > X lumens with a tolerance of Y%"). Instead, it focuses on demonstrating equivalence to the predicate device.

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 provided in the document. The document mentions "comparative bench test" but does not detail the sample size (e.g., number of units tested, number of test cycles), data provenance, or study design.

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 provided in the document. For a physical device like an ophthalmic light source, "ground truth" as it applies to diagnostic interpretation or clinical outcomes (which would involve experts) is not typically the focus of a 510(k) submission. Performance is usually assessed through engineering benchmarks and comparative tests against the predicate.

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

This information is not provided in the document.

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

An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. The PHOTON EX is an ophthalmic light source, a non-diagnostic device used for illumination during surgery. Therefore, an MRMC study is not applicable and was not performed for this device in the context of this 510(k) submission.

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

A "standalone" performance evaluation typically refers to the performance of an algorithm or an automated system without human intervention, again common in AI-driven diagnostic devices. Since the PHOTON EX is a surgical light source, this concept is not applicable and was not performed. Its performance is assessed through its physical characteristics and functionality.

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

For a physical light source, "ground truth" would relate to measurable physical parameters (e.g., light output intensity, spectral purity, color temperature, beam uniformity, operational safety). The document states "The PHOTON EX has undergone testing and complies with the applicable requirements of safety standards." and "The subject device performed equivalently to the predicate device in a comparative bench test." This implies that the ground truth for performance was established through engineering specifications, safety standards, and direct comparative measurements against the predicate device's measured performance. Details of these specific ground truths (e.g., the exact safety standards, detailed performance metrics) are not provided.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" is typically associated with machine learning or AI models, which are not described as part of this device.

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

As the concept of a "training set" is not applicable or discussed for this device, information on how its ground truth was established is not provided.

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The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery. The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma.

The iScience Interventional Canaloplasty Microcatheter is a flexible microcatheter designed to allow atraumatic catheterization of spaces in the eye for infusion and aspiration of fluids during surgery. The device allows catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. The microcatheter incorporates an optical fiber to allow transmission of light to the microcatheter tip for surgical illumination and guidance. The device is provided sterile and is intended for single use.

The provided text describes the iScience Interventional Canaloplasty Microcatheter and its regulatory clearance. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding acceptance criteria, specific performance metrics, test set details (sample size, provenance, expert qualifications, adjudication), MRMC studies, or training set specifics for an AI/ML device.

This document describes a medical device clearance process for a physical surgical tool, not an AI/ML diagnostic or assistive device. Therefore, many of the questions related to AI/ML evaluation (like ground truth establishment, expert adjudication, MRMC studies, training set size) are not applicable or the information is not present in this type of submission.

Here's a breakdown of what can be extracted and what information is missing:

Acceptance Criteria and Device Performance for iScience Interventional Canaloplasty Microcatheter

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines conformity to established standards and general performance tests. It does not provide specific numerical acceptance criteria (e.g., "tensile strength must be >X Newtons") or corresponding quantitative results. Instead, it states that tests were performed "to ensure that performance requirements were met" and that "performance testing demonstrates that the iScience Interventional Canaloplasty Microcatheter is functionally equivalent to the predicate devices."

Detailed Information Not Available in the Provided Text:

Questions 2, 3, 4, 5, 6, 7, 8, and 9 relate to the evaluation of AI/ML or diagnostic performance, which is not the primary focus of this 510(k) summary for a surgical microcatheter. Therefore, the specific details you requested are not present.

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

• Information not available. The document mentions "Ex-vivo studies" and "A multi-center prospective study," but does not provide sample sizes for these studies or specific details on data provenance (e.g., country of origin, retrospective/prospective for test sets). The prospective study is a clinical study for safety and efficacy, not explicitly a "test set" for performance evaluation in the context you've outlined.

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

• Information not available. This is typically relevant for diagnostic AI/ML devices where expert consensus defines ground truth. For a surgical device, "ground truth" relates to functional performance and safety, evaluated through engineering tests and clinical outcomes, rather than expert interpretation of images/data.

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

• Information not available. Adjudication methods are specific to diagnostic evaluations, especially in AI/ML performance studies. Not applicable here in the way you've framed it.

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 / Information not available. This device is a surgical microcatheter; it's a tool, not an AI assistant meant to improve human reader performance. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's evaluation.

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

• Not applicable / Information not available. This is not an algorithm; it's a physical surgical device.

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

• For the engineering/performance tests, ground truth would be established by physical measurements and adherence to engineering specifications.
• For the clinical study, the "ground truth" for efficacy would likely be outcomes data (e.g., reduction in intraocular pressure) and for safety, it would be adverse event reporting. The document doesn't detail the specific outcome measures beyond "reduce intraocular pressure".

8. The sample size for the training set:

• Not applicable / Information not available. This is not an AI/ML device, so there is no "training set."

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

• Not applicable / Information not available. As there is no AI/ML training set, this question is not relevant.

In summary, the provided document details the regulatory clearance for a physical medical device. While it lists adherence to various standards and types of performance testing, it does not provide the granular data points concerning specific acceptance thresholds, quantitative results, or the detailed methodology of test/training sets, experts, and adjudication that would be required for an AI/ML or diagnostic device evaluation.

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The Xenon BrightStar Illumination System is intended to provide intraocular illumination in vitreoretinal surgery.

The Xenon BrightStar Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a Xenon Short Arc Lamp and utilizes two internal focusing systems to focus the light into the end of an optical fiber of two individually controlled ports. Both ports can be individually controlled by choice of an UV cut-off filter and a light intensity setting. Accessories trother system include single use and reusable fiber optic probes, fibers and micro instruments which are delivered sterile or require sterilization prior to use.

This 510(k) summary describes a traditional medical device (an ophthalmic light source), not an AI/ML-driven device. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or AI performance metrics.

The document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use. There is no mention of a study to "prove the device meets acceptance criteria" in terms of algorithmic performance, as this device does not involve an algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and study details for an AI/ML device based on the provided text.

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The iScience Surgical Fiberoptic Illuminator is indicated for illumination during anterior and posterior segment ophthalmic surgery.

The iScience Surgical Fiberoptic Illuminator (FI) is a portable light source intended to provide illumination during anterior and posterior segment ophthalmic surger. It is designed to be used only with the iScience Surgical iTrack Ophthalmic Microcannula to illum nate tissues during advancement into intraocular structures of the anterior and posterior segment.

The FI consists of a splash proof sheet metal enclosure with panel mounted rocker switches for operational control, and a custom light output connector. The FI houses a laster dionel illumination source, and is specific for the iScience Surgical iTrack Ophthalmic Microcannula. The FI is not intended to be sterilized or placed in a sterile enclosure.

The FI has a custom designed light output connector that contains two redundant safety interlock switches. These switches, in conjunction with electronic circuitry in the Fly ensure that laser light can only emanate from the laser aperture when an iScience Surgical iTrack Ophthalmic Microcannula is installed in the connector. The interlock switches independently detect the proper insertion of the iScience Surgical iTrack Ophthalmic Microoannulaipe into thre connector, ensuring that the microcannula is fully engaged and retained in the connector before laser output is enabled.

The provided 510(k) summary for the iScience Surgical Fiberoptic Illuminator (K062259) does not contain the level of detail typically found in a clinical study for medical device clearance. This submission primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and a limited in-vitro test rather than a full clinical study with acceptance criteria and statistical analysis of performance.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not explicitly provided in the text. I will extract the information that is available and note when details are missing.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" as applied to a quantitative performance metric is not explicitly stated in the document. The study's conclusion is qualitative, focused on the sufficiency of illumination.

Study Details

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

   • Test Set Sample Size: Not explicitly stated. The study states "enucleated cadaver eyes," implying more than one, but no specific number is given.
   • Data Provenance: Retrospective (cadaveric eyes), country of origin not specified.

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

   • Not specified. The statement "demonstrated equivalent results" implies an assessment was made, but the number or qualifications of individuals performing this assessment are not provided.

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

   • Not specified.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This study is an in-vitro comparison of two illumination devices, not an AI-assisted diagnostic device study. The concept of "human readers improve with AI" is not applicable here.

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

   • This is not an AI algorithm. The study was an in-vitro comparison of two illumination devices, one of which (the subject device) uses a different light source technology than its predicate.

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

   • The "ground truth" was the qualitative assessment of "sufficient illumination" for the task of advancing the microcannula into intraocular structures. This would likely be assessed by an expert (e.g., an ophthalmic surgeon), but this is not explicitly stated.

7. The sample size for the training set:

   • Not applicable. This is an in-vitro operational test, not a machine learning model.

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

   • Not applicable. This is an in-vitro operational test, not a machine learning model.

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The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, as well as illumination, during surgery.

The iScience Surgical Ophthalmic Microcannula, or iTRACK, is a flexible microcannula designed to allow atraumatic cannulation of spaces in the eye such as the anterior chamber and posterior segment, for infusion and aspiration of fluids during surgery, including saline and viscoelastics. The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance.

This document is for an Ophthalmic Microcannula, a physical surgical device, and not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as acceptance criteria, study details, ground truth, sample sizes for training/test sets, MRMC studies, etc.) are not applicable here.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through:

1. Device Description: Outlining the design and function of the iScience Surgical Ophthalmic Microcannula (iTRACK).
2. Indication for Use: Stating its purpose for fluid infusion and aspiration, and illumination during surgery.
3. Predicate Devices: Identifying existing devices it claims substantial equivalence to (American Medical Devices Endolight, Syntec True Light, Micron Surgical Weiss Retinal Cannula).
4. Technological Characteristics: Asserting that its intended use and technological features do not differ from predicate devices, using similar materials and methods of operation.
5. Performance Data (Non-AI/ML): Mentioning conformance to standards for sterilization, shelf-life, and packaging integrity (e.g., ANSI/AAMI/ISO 11137-1994, ANSI/AAMI/ISO 10993, ANSI/AAMI/ISO 11607-1997). This "performance data" refers to compliance with manufacturing and safety standards, not AI model performance.
6. Conclusion: Stating that due to meeting stated standards and similar technological characteristics to predicate devices, it is substantially equivalent, safe, and effective.

Since the device is not an AI/ML product, it does not have "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way an AI/ML model would to demonstrate diagnostic accuracy or clinical effectiveness. Instead, acceptance is based on demonstrating substantial equivalence to existing, legally marketed devices, and adherence to relevant safety and manufacturing standards for medical devices.

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