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The intended use of the MICOR 700 System with Auto I/A is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting

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I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the MICOR 700 with Auto I/A does not contain information regarding the acceptance criteria or the study that proves the device meets those criteria. The letter primarily focuses on the regulatory aspects of the clearance, such as the substantial equivalence determination, applicable regulations, and administrative requirements.

To answer your request, I would need access to a different document, such as the 510(k) summary or the full submission, which typically contains details about performance testing, validation studies, and the established acceptance criteria.

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The intended use of the MICOR® 700 Lens Removal System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

It appears there has been a misunderstanding. The provided FDA 510(k) clearance letter for the MICOR 700 System is for a Phacofragmentation System, which is a medical device used for surgery, specifically for cataract removal.

This document does NOT contain information about any AI/ML-based device, nor does it detail acceptance criteria, study data, ground truth establishment, or sample sizes related to AI/ML performance.

Phacofragmentation systems are mechanical and electronic devices, and their "performance" criteria are typically related to:

• Power output and control: How effectively and safely they fragment the lens.
• Aspiration rate and vacuum control: How efficiently they remove fragmented lens material.
• Irrigation flow: Maintaining proper eye pressure during the procedure.
• Safety features: Overpressure limits, heat generation, sterile components.
• Biocompatibility: Materials used.

Therefore, I cannot fulfill your request for information regarding AI/ML device acceptance criteria and study details based on this document. The information you're asking for (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is relevant to the evaluation of AI/ML algorithms, not to a traditional surgical device like the MICOR 700 System.

If you have a document describing an AI/ML-based medical device, I would be happy to analyze it according to your requested criteria.

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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 Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation, as well as ancillary functions such as vitreous cutting along with bipolar diathermy.

Faros is used for these surgical interventions in the anterior eye segment:

• Irrigation and aspiration (I/Afunction)
• Ultrasound phaco (PHACO function)
• Biopolar diathermy for hemostasis and coaptation of the conjunctiva (DIA function)
• Bipolar diathermic capsulotomy (CAPS function)
• Operation of a vitrectomy instrument (VIT function)

The device may only be used with the instruments recommended and supplied by Oertli.

The Faros Surgery System is designed for use in anterior segment eye surgery, primarily for removal of cataractous lenses. The system generates high-frequency ultrasound to emulsify the eye's natural lens, which is then aspirated using fluidics. The system also includes functions for bipolar diathermy (for hemostasis, conjunctival coaptation, and capsulotomy), as well as for anterior vitrectomy, a procedure associated with cataract surgery.

The Faros Surgery System consists of a main unit (an AC-powered tower-like device with a control panel governing surgical functions, and ports to connect surgical instruments), with a mounted infusion pole and a foot pedal used by the surgeon to control system functions. An irrigation tubing system is mounted onto the main unit. Surgical handpieces connected to the main unit are used to perform irrigation and aspiration, ultrasound phacoemulsification, bipolar diathermy, bipolar diathermic capsulotomy, and anterior vitrectomy functions.

I apologize, but the provided text from the FDA 510(k) notification for the Oertli Instrumente AG Faros Surgical System does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML-driven medical device.

Here's why and what information is missing:

• Device Type: The Faros Surgical System is a phacoemulsification system, which is a hardware device used in cataract surgery. It is not described as an AI/ML software device or a device that relies on complex AI algorithms for diagnosis or prediction.
• Performance Data Scope: The "Summary of Performance Data" section primarily details compliance with various consensus standards (electrical safety, EMC, software lifecycle, cybersecurity, usability, biocompatibility, reprocessing, sterility). These are performance aspects of the hardware and its embedded software, not the performance of an AI model in interpreting medical images or data.
• Absence of AI/ML Specifics: There is no mention of:
  • Diagnostic accuracy metrics (sensitivity, specificity, AUC)
  • Test sets, training sets, or validation sets for an AI model
  • Ground truth establishment by expert consensus or pathology for AI model evaluation
  • Multireader multicase (MRMC) studies
  • Comparison of human readers with and without AI assistance
  • Standalone algorithm performance

Therefore, I cannot generate the requested table and study description based on the provided document. The document is a standard 510(k) clearance letter for a conventional medical device, not an AI/ML medical device.

If you have a document describing an AI/ML medical device, please provide that, and I would be happy to help describe its acceptance criteria and the supporting study.

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UNITY VCS:
The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery.

In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures.

UNITY CS:
The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.

The UNITY VCS is a multifunctional surgical instrument for use in anterior and posterior segment ophthalmic surgeries. The capabilities of the UNITY VCS include driving a variety of handpieces that provide the ability to cut vitreous and tissues, emulsify the crystalline lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding. Flow-controlled or vacuumcontrolled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven. The operator provides inputs using the touchscreen panel, the remote control, and the foot controllers.

An optional, fully integrated laser module is available that can be installed in the base of the UNITY VCS configuration for vitreoretinal surgery. The laser delivers the same visible 532-nm green treatment beam designed for ophthalmic use as in the predicate device.

When used with compatible components and accessories, the system will perform anterior and posterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, diathermy coagulation, intraocular illumination, photocoagulation, viscous fluid control, tissue grabbing and cutting.

The UNITY CS is a multifunctional surgical instrument for use in anterior segment ophthalmic surgeries. The capabilities of the UNITY CS include driving a variety of handpieces that provide the ability to cut anterior vitreous and tissues, emulsify the crystalline lens, and apply diathermy to stop bleeding. Flow-controlled or pressure-controlled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven, and the operator provides inputs using the touchscreen panel, the remote control, and the foot controllers.

When used with compatible components and accessories, the system will perform anterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, and diathermy coagulation.

The UNITY VCS and UNITY CS are intended to be used within a clinic(s)/hospital(s)/surgical practice network.

Both devices are for prescription use only.

The provided text does not contain information about studies involving AI/ML components or their acceptance criteria. The document is an FDA 510(k) premarket notification for two ophthalmic surgical systems, UNITY VCS and UNITY CS, demonstrating their substantial equivalence to predicate devices. The studies summarized are non-clinical testing for biocompatibility, sterilization and shelf life, electromagnetic compatibility/wireless/electrical safety, software, and performance testing, all of which are standard for medical device clearance and do not involve AI/ML performance metrics, expert consensus, or MRMC studies.

Therefore, I cannot provide the requested table and information as it is not present in the given text.

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The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a 532 nm laser module for photocoagulation. The Stellaris Elite™ vision enhancement system was initially cleared under K 162342 which included the introduction of an Adaptive Fluidics feature as well as increase in vitrectomy cut rate. The Vitesse vitrectomy handpiece was introduced and cleared for use on the Stellaris Elite™ vision enhancement system under K170052.

A selection of disposable single-use procedure packs is available for use with this system. These packs contain the necessary tubing to facilitate delivery and removal of air and fluids to/from the patient as well as a selection of components (cannulas, cutters, probes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility. Additional Stellaris Elite™ vision enhancement system procedure packs have been made available and these packs contain components that have been used in previously available procedure packs. Some of these Stellaris Elite™ vision enhancement system procedure packs now include the BiBlade vitrectomy cutter produced by Medical Instruments Development Lab (separately cleared via K153168).

The previously cleared Stellaris Elite™ vision enhancement system introduced new feature sets that are not available on the legacy Stellaris PC systems previously cleared under K133242/K133486 respectively. A summary of these additional feature sets for the Stellaris Elite™ vision enhancement system are listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

The most recent clearance to the Stellaris Elite™ vision enhancement system introduced the Vitesse vitrectomy feature and was cleared via K170052 on April 19, 2017.

This traditional 510(k) incorporates updates to User Interface Computer System on Module (SOM) with an introduction of a new replacement Congatec SOM. In addition. the Stellaris Software platform is updated to Windows 10, since the current Stellaris software platform Windows XP is obsolete/incompatible with the new Congatec SOM.

The features remain the same as the previously approved Stellaris Elite™ vision enhancement system. The configuration matrix is listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

The provided document is a 510(k) Summary for the Bausch + Lomb Stellaris Elite™ vision enhancement system. It primarily focuses on demonstrating substantial equivalence to a predicate device after software and hardware updates, rather than presenting a study proving a device meets specific acceptance criteria for performance.

Therefore, many of the requested categories cannot be fully addressed in the traditional sense of a clinical or performance study aimed at defining and meeting specific analytical or clinical performance metrics. The document describes how substantial equivalence was demonstrated, which involves various types of testing, but not a study designed to prove new performance claims against defined acceptance criteria.

Below is the information extracted and interpreted based on the context of this 510(k) submission, highlighting what is available and what is not.

Acceptance Criteria and Device Performance Study for K232084

This 510(k) submission (K232084) is for updates to the Bausch + Lomb Stellaris Elite™ vision enhancement system, not for a new device making novel performance claims. The primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device (K170052 Stellaris Elite™ vision enhancement system) after changes to the User Interface Computer System on Module (SOM) and an update to the operating system from Windows XP to Windows 10. Consequently, the "acceptance criteria" and "device performance" are framed in terms of meeting regulatory standards and maintaining performance equivalent to the predicate device, rather than achieving specific performance thresholds for a novel diagnostic or therapeutic claim.

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

Given the nature of this 510(k) for system updates, the "acceptance criteria" are regulatory compliance and maintained functionality, rather than specific numerical performance metrics for a clinical task.

2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a dataset for AI or clinical study. Instead, it refers to "representative units" for hardware testing (electrical safety, EMC) and software verification/validation.

• Test Set Sample Size: Not applicable in the context of an AI-driven clinical test set. Testing was performed on the device itself and its software.
• Data Provenance: Not applicable as no patient data or image data was used for a test set. This submission is for hardware/software updates to an ophthalmic surgical system. The standards cited (IEC standards for electrical safety, EMC, software lifecycle) are international regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for a test set (e.g., diagnostic labels, disease states) was established by experts in this submission, as it's not a diagnostic AI device.

4. Adjudication method for the test set
Not applicable. There was no test set requiring expert 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
Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an ophthalmic surgical system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a clinical performance study. For software and hardware validation, the "ground truth" would be the functional requirements and established performance specifications of the predicate device and relevant international standards.

8. The sample size for the training set
Not applicable. This device does not use a "training set" in the sense of machine learning for interpretation or diagnosis.

9. How the ground truth for the training set was established
Not applicable.

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The Centurion™ Vision System (Active Sentry™) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection.

The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof™ intraocular lenses into the eye following cataract removal.

The AutoSert™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ IOL Injector Handpiece is indicated for use with AcrySof ™ lenses SN60WF. SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof ™ lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Alcon's CENTURION™ Vision System is an ophthalmic surgical instrument designed to provide cataract extraction using the CENTURION™ OZil™handpiece, the CENTURION™ Active Sentry™ handpiece, and the INFINITI™ OZil™ handpiece.

The CENTURION™ Vision System is intended for use in small incision cataract extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the eye, while replacing aspirated fluid and lens material with balanced salt solution (BSS™). This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration vacuum, and the flow of BSS™ irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.

I'm sorry, but the provided text from the FDA 510(k) summary for the Centurion™ Vision System (Active Sentry™) (K233902) does not contain the detailed information required to answer your request.

Specifically, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or details about retrospective/prospective studies.
3. Information on the number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Details about a standalone (algorithm only) performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This 510(k) summary states that the current submission (K233902) is for a modification to add a new Warning statement in the labeling for the TurboSonics™ ultrasonic tips. It explicitly states that "Non-clinical testing was previously performed in the predicate device and can be referenced in K161794." Therefore, this document focuses on demonstrating substantial equivalence based on the minor labeling change, rather than presenting new performance data from a comprehensive clinical or non-clinical study.

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QUATERA System (QUATERA 700) is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation and anterior vitrectomy.

This device is for Prescription Use (Rx) only.

QUATERA 700 is a mobile phacoemulsification system designed for use in the ophthalmic surgical operating rooms during surgery of the anterior eye segment. When QUATERA 700 is used with compatible components and accessories, the system will perform the following surgical procedures: irrigation and/or aspiration, phacoemulsification of crystalline lens, anterior vitrectomy, and bipolar coagulation.

QUATERA 700 has fluidic, ultrasound and pneumatic modules for emulsification and aspiration of the cataractous lens from eye and maintain the pressure and volume of the eye intraoperatively. The required values are pre-set via a Graphical User Interface and controlled directly by the surgeon using the Foot Control Panel of the device and delivered in the eye via a range of accessories. The systems control mechanism verifies the output values and the pre-set values.

QUATERA 700 has the following functions:

• · Irrigation and Aspiration
• · Ultrasound Capability
• · Diathermy
• · Anterior Vitrectomy
• Reflux

QUATERA 700 is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

The provided text is an FDA 510(k) clearance letter for a medical device called QUATERA 700. It asserts the device's substantial equivalence to a predicate device (also a QUATERA 700, but with older software) rather than presenting a performance study against specific acceptance criteria for a novel AI/software component.

Therefore, many of the requested details, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models, are not applicable or not present in this document.

The document focuses on non-clinical performance testing and substantial equivalence to an existing device, primarily due to minor software changes and component updates. There is no mention of an AI/machine learning component that would require the rigorous performance evaluation typically outlined by the questions.

However, I can extract and infer information relevant to the types of "acceptance criteria" and "study" that were performed to demonstrate substantial equivalence, based on the provided text, even if not in the AI-specific format you requested.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of quantitative performance metrics against specific predefined acceptance criteria in the way one would for an AI algorithm's diagnostic accuracy. Instead, the "acceptance criteria" for this 510(k) are essentially the demonstration of compliance with established medical device standards and the maintenance of equivalence to the predicate device. The "performance" is a statement of compliance or "passed."

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

• Sample Size for Test Set: Not applicable in the context of an AI model's performance on a dataset. The "tests" performed here are primarily engineering verification and validation (e.g., software testing, electrical safety, bench testing for performance against standards). The document does not specify "sample sizes" for these types of tests (e.g., how many times an electrical test was run, or how many components were tested for sterility).
• Data Provenance: Not applicable in the context of clinical data for AI model evaluation. The "data" here refers to test results from engineering and lab assessments.

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

Not applicable. The "ground truth" for this filing is compliance with engineering standards, functional equivalence to a predicate device, and successful verification/validation testing. This is typically established through documented test procedures and adherence to regulatory guidelines, not clinical expert consensus on medical images.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to adjudication of discrepancies in expert readings for clinical test sets.

5. MRMC Comparative Effectiveness Study:

No. The document explicitly states: "Animal and Clinical testing was not conducted." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone Performance:

Not applicable in the context of an AI algorithm's standalone performance. The device itself (QUATERA 700) performs specific surgical functions. Its "performance" is demonstrated through engineering tests and comparison to a predicate device, not as a standalone diagnostic algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• Compliance with recognized international and national standards (e.g., ISO, IEC, FDA guidance documents).
• Successful completion of verification and validation testing protocols.
• Functional equivalence to the legally marketed predicate device, demonstrated through comparative tables of specifications.

8. Sample Size for the Training Set:

Not applicable. This device is a phacofragmentation system, not an AI/machine learning model that undergoes a "training" phase on a dataset of clinical cases.

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

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

In summary: The K230858 clearance for QUATERA 700 is for a surgical device that has undergone minor software and component changes. The "acceptance criteria" and "study" described in the document are primarily focused on demonstrating continued safety, efficacy, and substantial equivalence to an existing predicate device through engineering verification and validation, rather than a clinical performance study of a novel AI component.

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The intended use of the MICOR System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

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I am sorry, but the provided text is a 510(k) clearance letter for the MICOR Lens Fragmentation System and does not contain any information about acceptance criteria or specific study details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the given document.

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The intended use of the miCOR System is fragmentation and removal of cataracts, as well as associated procedures such as irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting.

Not Found

The provided text is an FDA 510(k) clearance letter for the miCOR System Lens Fragmentation System. This document, while indicating the device's clearance for market and its intended use, does not contain any information regarding specific acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information in the table or the subsequent numbered points based solely on the text provided. The document focuses on regulatory compliance and the determination of substantial equivalence, not on the detailed technical study results.

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