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The VISULAS 532s laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary, delivery or intraocular endoprobe delivery.

The VISULAS 532s laser represents an improved version of the predicate Zeiss-Diode Pumped Solid State Laser (K925642). The improvement includes the following 2 modifications: In addition to the known laser slit lamp, the slit lamp adapter VISULINK 532/U or the Laser Indirect Ophthalmoscope LIO 532 may be used now as a laser application system. Laser console and user interface were improved to allow operation, setting, and monitoring of the different laser treatment procedures.

The provided text does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of medical device validation for AI-powered diagnostic tools. Instead, the document describes a special 510(k) premarket notification for a modification to an existing ophthalmic surgical laser, the VISULAS 532s.

The key points from the document are:

• Device: VISULAS 532s, an ophthalmic surgical laser.
• Modification: Improvements to the predicate device (Zeiss-Diode Pumped Solid State Laser (K925642)) include:
  • Addition of new laser application systems: VISULINK 532/U (slit lamp adapter) or LIO 532 (Laser Indirect Ophthalmoscope).
  • Improved laser console and user interface for operation, setting, and monitoring.
• Conclusion: The FDA determined the modified device (VISULAS 532s) is substantially equivalent to the predicate device based on side-by-side comparisons. The modifications do not raise new questions for safety and efficacy.

Therefore, the specific questions regarding acceptance criteria, reported device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for a diagnostic or AI-powered device are not applicable to the content provided for this surgical laser modification.

The FDA's substantial equivalence determination for this device modification primarily relies on the comparison to the predicate device, demonstrating that the changes do not alter the fundamental safety or effectiveness of the product for its intended use. There is no mention of analytical or clinical performance studies with acceptance criteria in the context of AI or diagnostic accuracy.

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This device will be used in the same manner as all ophthalmic diagnostic devices used to obtain ocular measurements (for axial length, anterior chamber depth and corneal radius), and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.

The IOLMaster is a non-invasive, non-contact system for measuring the parameters of the human eye required to determine the appropriate power of IOL for implantation, (axial eye length, anterior chamber depth, and corneal radius), and for calculating the optimal power of IOL.
Axial eye length is measured using the principle of partial coherence interferometry (also referred to as laser Doppler interferometry), with a Michelson interferometer.

Corneal radius is measured using traditional keratometery principles. whereby light from LEDs is projected on the cornea of the eve, and after image capturing of the reflected marks and image processing provides the measurement.

Anterior chamber depth is measured by slit lamp illumination. The slit light is scattered by the cornea and the eye lens, generating an image of the cornea and the lens. The image is captured by a CCD-camera. Image processing and edge detection algorithms allow for calculation of the distance between the anterior surface of cornea and lens ( == anterior chamber depth).

These three measurements provide the physician with the data required to calculate the power of IOL to use for a patient. The physician can then choose from one of up to five internationally accepted formulas, built into the IOLMaster, to perform the calculation. The IOL power is then calculated according to the IOL type.

Users can also enter information regarding the different IOL types into the IOLMaster database, which can then be used to suggest the optimal IOL. This calculation and selection process is already performed by ultrasound and other diagnostic devices. However, the choice of formula and final determination of the appropriate IOL is at the physicians' discretion.

Here's an analysis of the provided 510(k) summary regarding the IOLMaster device, focusing on its acceptance criteria and the study used to validate its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state "acceptance criteria" in a quantitative manner. Instead, it presents the device's performance as the deviation from established comparative devices. This deviation serves as the functional equivalent of performance criteria, where smaller deviations indicate better agreement and thus, acceptable performance relative to the established gold standards.

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

• Test Set Sample Size:
  • The second stage testing involved 155 human eyes.
  • Prior to this, a "first stage testing" involved 678 human eyes. It's important to note that the detailed performance metrics are given for the 155 human eyes in the second stage testing, which seems to be the primary dataset for the reported deviations.
• Data Provenance: The study was conducted at the University Eye Clinic, Wuerzburg, Germany in February 1999. The data is prospective, as it describes the measurement of human eyes with the IOLMaster prototype and comparative devices.

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

The document does not specify the number of experts used to establish the ground truth. The "ground truth" was established by measurements from existing, cleared devices (Grieshaber Biometry System, AL-1000 A-scan device, ALCON Ocuscan keratometer). These are considered established methods, and the expertise would lie in operating these devices and interpreting their results. There's no mention of a separate expert panel adjudicating the measurements from these objective devices.

4. Adjudication Method for the Test Set

There is no mention of an adjudication method in the traditional sense (e.g., 2+1, 3+1). The "ground truth" was established by direct measurements from the comparative devices, not by human consensus or review of IOLMaster results. The study directly compared IOLMaster measurements to these reference device measurements.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the agreement between the IOLMaster device and existing measurement devices, not on the improvement of human readers with or without AI assistance. The IOLMaster is a diagnostic measurement device, not an AI-assisted diagnostic aid for human interpretation.

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

Yes, this was a standalone performance study. The IOLMaster directly generates measurements (axial eye length, corneal radii, anterior chamber depth) using its internal algorithms, and these measurements were directly compared against the measurements obtained from the predicate devices. The performance metrics (deviations) are for the device itself. While physicians use the device, the measurements themselves are output by the algorithm.

7. The Type of Ground Truth Used

The ground truth used was measurements obtained from established, high-accuracy comparative devices.

• For Axial Eye Length and Anterior Chamber Depth, the Grieshaber Biometry System ("GBS"), a high-accuracy ultrasound biometry unit in immersion technique, was used as the ground truth. The TOMEY "AL-1000" A-scan device was also mentioned as a comparative device in the broader first-stage testing.
• For Corneal Radii, the ALCON "Ocuscan" keratometer was used as the ground truth.

8. The Sample Size for the Training Set

The document does not explicitly state a sample size for a training set. The study describes validation and verification testing of a "prototype" with specific performance data. While the device utilizes image processing and algorithms, there's no mention of a separate set of data specifically used for machine learning model training. The development process likely involved an internal testing and calibration process, but this is not detailed as a "training set" in the submission. The "first stage testing of 678 human eyes" could be considered part of an early development or internal validation, but it's not explicitly called a training set.

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

Since a "training set" is not explicitly described, the method for establishing its ground truth is also not detailed. If the 678 human eyes in the first stage testing served as an internal development/training set, it would likely have used similar comparative devices as the reported validation study.

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This device will be used in the same manner as all: (a) surgical microscopes are used and (b) as all lasers are used in ENT and general surgery not requiring photocoagulation. The device is primarily intended to allow surgeons to perform tissue ablation with minimal peripheral thermal effects. More specifically, the device can be used for: general surgery which does not require photocoagulation; and in ENT applications, including microsurgery in the middle ear, stapedoplasty, for preparation of sites for osteosynthesis, microsurgery on ossicles, tympanic membrane, ablative surgery on soft tissues (for example: ligament severance of the stapes muscle), and removal of exostosis.

The OPMI® TwinER Surgical Microscope is a surgical microscope with an integrated solid-state Er: YAG (Erbium Yttrium aluminum garnet) laser. The Er:YAG laser is used for the ablation of biological tissue. The OPMI® TwinER is designed for use in general surgery where coagulation is not required, and otology, rhinology, and laryngology ("ENT") applications. Because the Er: YAG laser operates in the 2,940 nm wavelength and is absorbed very well by water, it causes minimal damage to the peripheral tissues from thermal absorption. This makes the Er: YAG particularly effective in traditional and microsurgery in the ear.

The therapy beam is a Class IV laser with adjustable power output between 10 mJ and 100 mJ. The OPMT® TwinER also uses an aiming beam to position the therapy beam, which operates in the 660-680 nm wavelength. The aiming beam is a Class IIIA laser with adjustable power output between 0.2 mW and 3 mW.

The therapy and aiming beams are delivered to the surgical field via a micromanipulator. A mirror, which can be finely adjusted using a joystick, allows the exact positioning of the laser beam.

The provided text describes the OPMI® TwinER Surgical Microscope, a device combining a surgical microscope with an integrated solid-state Er:YAG laser. It discusses the device's intended use, its substantial equivalence to predicate devices, and the underlying technology. However, the text does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.

The document is a 510(k) summary and the subsequent FDA clearance letter, which focuses on demonstrating substantial equivalence to pre-market cleared devices rather than providing detailed performance studies against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:

Information that CANNOT be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: This level of detail about specific performance metrics and their acceptance thresholds is not present.
• Sample size used for the test set and the data provenance: There is no mention of a specific "test set" or a study performed with a defined sample size.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a specific test set is not discussed.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information is available regarding adjudication.
• 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 is irrelevant as the device is a surgical microscope with a laser, not an AI-assisted diagnostic tool for "human readers."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not discussed in the context of a specific study for this device.
• The sample size for the training set: Not applicable as it's not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

Information that CAN be inferred or stated from the provided text:

While a formal "study" proving acceptance criteria isn't detailed, the document makes a claim based on existing literature:

"Numerous studies have proven that the Er: YAG laser, such as that used by the OPM10 TwinER, is safe and effective. Studies indicate that the Er. YAG laser is in fact safer and more effective than CO2 lasers for certain ENT applications."

This statement serves as the general "proof" for the underlying technology's safety and effectiveness. The acceptance criteria, therefore, are implicitly tied to the general understanding and regulatory acceptance of Er:YAG lasers for the stated applications.

In summary, the provided document focuses on regulatory approval through substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria for the OPMI® TwinER Surgical Microscope itself. The safety and effectiveness are established by referencing existing knowledge and studies on Er:YAG lasers in general.

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The Surgical Microscope Navigator (SMN) and the Surgical Tool Navigator (STN) System are a modular product group intended to provide the surgeon with navigational support during surgery They permit the surgical team to load radiological imaging studies onto a workstation equipped with image processing and visualization software. After correlation of the patient position with the images, (the registration procedure) the system displays the position, trajectory and other localization information of the current "tool" interactively throughout the surgical procedure.

The Surgical Microscope Navigator (SMN) and the Surgical Tool Navigator (STN) System are a modular product group intended to provide the surgeon with navigational support during surgery. The SMN's primary "tool" is a surgical microscope. The STN uses a variety of "Pointers" and instruments as tools. Both systems localize the tools in space via an industry standard infra-red LED based camera system. The LED's coordinates are then transferred to the workstation which in turn converts them to the coordinate system of the imaging data and interactively displays them.

The provided 510(k) summary for K965739 does not contain the information required to answer your questions regarding acceptance criteria and the study that proves the device meets the acceptance criteria.

This 510(k) summary focuses primarily on:

• Device Description and Intended Use: Explaining what the SMN and STN systems are and how they function.
• Substantial Equivalence Claims: Comparing the new devices to previously cleared devices (MKM system and StealthStation) based on their intended use, technology, and operating principles.
• Legal Basis for Submission: Referencing an exemption for surgical microscopes or substantial equivalence to existing devices.

Missing Information:

To answer your questions, the following information would typically be found in a more detailed technical report or study summary submitted as part of the 510(k) application, which is not present in this publicly available summary:

1. Acceptance Criteria and Reported Device Performance Table: This would require specific performance metrics (e.g., accuracy, precision) and defined thresholds for "acceptable" performance, along with the measured results from a validation study.
2. Sample Sizes and Data Provenance for Test Set: Details about the number of cases/patients used to evaluate the device's performance, where the data came from (e.g., specific hospitals, geographic regions), and whether it was collected retrospectively or prospectively.
3. Number and Qualifications of Experts for Ground Truth: Information about the professionals (e.g., surgeons, radiologists) who reviewed the test cases to establish the reference standard, including their number and years of experience.
4. Adjudication Method: How disagreements among experts were resolved (e.g., 2+1, 3+1, consensus).
5. MRMC Comparative Effectiveness Study: Whether a study comparing human performance with and without the device's assistance was conducted, and the quantitative effect size.
6. Standalone Performance Study: Data on the algorithm's performance without human interaction.
7. Type of Ground Truth Used: The specific method used to establish the truth for the test cases (e.g., histopathology, clinical outcome, expert consensus).
8. Sample Size for Training Set: The amount of data used to develop and train the device's algorithms (if applicable, though this device appears hardware-focused with localization algorithms).
9. Ground Truth Establishment for Training Set: How the reference standard was created for the training data.

Conclusion:

Based solely on the provided 510(k) summary, it is not possible to provide the requested details regarding acceptance criteria, study design, and performance metrics. The summary focuses on establishing substantial equivalence rather than detailing the specifics of a performance validation study against defined acceptance criteria.

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The CPC Probe is used to reduce the intraocular pressure associated with the eye disease Glaucoma.

The Zeiss CPC Probe is a laser delivery system designed for use with the Visulas Diode II laser from Carl Zeiss. When used in tandem they form an ophthalmic laser treatment device. The contact probe is applied with slight pressure to the sclera and located approximately 1.5 mm behind the limbus. This method significantly increases the transmission of the sclera and also reduces the scattering of the laser beam. The power is adjusted and increased successively until the proper effect is heard. The power is then reduced and remaining coagulations can be performed if needed.

This document is a 510(k) summary for a medical device (Zeiss CPC Probe Laser Probe) submitted in 1997. It describes the device's function, its intended use, and its substantial equivalence to a predicate device.

However, the provided text does NOT contain any information about acceptance criteria or a study demonstrating that the device meets those criteria.

The 510(k) process in 1997 for a device like this primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance statistics in the manner often seen for more novel or higher-risk devices today or for AI/ML-based devices.

Therefore, I cannot fulfill your request for the comprehensive table and study details as they are not present in the provided input.

Based only on the provided text, I can infer the following about what is missing from the prompt's request:

• Acceptance Criteria and Reported Device Performance: Not mentioned. The submission focuses on substantial equivalence to a predicate device, not on specific performance metrics or thresholds.
• Sample size for the test set and data provenance: Not mentioned. No specific "test set" or clinical study data is described.
• Number of experts and qualifications for ground truth: Not mentioned. No ground truth establishment is described for a performance study.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The device is a laser probe, not an AI/ML diagnostic tool, so such a study would be highly unlikely and irrelevant.
• Standalone (algorithm-only) performance: Not applicable. This is a hardware device.
• Type of ground truth used: Not applicable for a performance study.
• Sample size for the training set: Not applicable. This is a hardware device, not an AI/ML model.
• How ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary for the Zeiss CPC Probe Laser Probe does not contain the type of information typically associated with acceptance criteria and a detailed performance study as requested in your prompt, particularly concerning AI/ML device evaluation.

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This device will be used in the same manner as all OCT scanner devices are used for two dimensional cross-sectional imaging of the posterior segment of the eye. It incorporates the original intended uses of our earlier claimed substantially equivalent products. It is used primarily for diagnosing and monitoring retinal diseases and disorders that manifest themselves in the posterior pole of the eye. Clinical studies with the OCT have demonstrated its effectiveness in detecting and quantifying the extent of macular edema, macular holes, retinal detachments and central serious chorioretinopathy.

In general OCT Scanners permit the user to obtain and analyze crosssectional tomograms of ocular tissue in a non-contact and non-invasive manner. The Humphrey Optical Coherence Tomography Scanner measures optical reflectivity to obtain cross sectional tomograms of the eye.

The Humphrey OCT employs the principle of low coherence interferometry based upon the Michelson interferometer. In a Michelson interferometer, the light from a source is split into a sample path and a reference path containing a mirror. Light reflected back from the sample path and the reference path will create an interference pattern on a detector if the optical path lengths between the reference and sample are identical. Adjusting the length of the reference path will allow a semi-transparent sample, such as the retina, to be cross-sectionally scanned.

The Super-Luminescent Diode (SLD) used in the Humphrey OCT Scanner permits a short coherence length in air. Accounting for the index of refraction of the eye, this translates to an even shorter coherence length within the retina. The SLD emits near infrared light which is scattered by the various interfaces and structures of the retinal tissue. As the reference arm is moved, a depth profile of the retina is produced which is similar to ultrasound A-scan. The profile plots variations in optical reflectivity between the different layers of the retina. Two mirrors mounted to galvanometers deflect the SLD beam within the eye. Scanning the retina in this manner produces cross-sectional images similar to ultrasound B-scan but of much higher resolution. The tomographic images of the retina produced by the OCT scanner provide an important tool in the diagnosis of retinal disorders and diseases that manifest themselves in the posterior pole of the eye.

The provided FDA 510(k) summary is for the Humphrey Optical Coherence Tomography (OCT) Scanner. This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria and performance metrics typically found in a PMA (Premarket Approval) or later clinical trial documentation.

Therefore, much of the requested information regarding specific acceptance criteria, study details, and performance metrics is not explicitly available in this summary. The document states that the device is "substantially equivalent" to a legally marketed predicate device.

Here's what can be extracted and noted from the provided text:

Acceptance Criteria and Device Performance

Study Details (Based on the 510(k) Summary)

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

   • Not explicitly stated. The summary mentions "Clinical studies were mentioned above" but does not provide details on the sample size for a test set. This document is a 510(k) for substantial equivalence, not a detailed clinical trial report.

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

   • Not explicitly stated. The summary refers to "Clinical studies" but gives no details on expert involvement or qualifications.

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

   • Not explicitly stated.

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

   • Not applicable for this device and document. This device is an imaging scanner, not an AI-assisted diagnostic tool in the sense of software interpreting images for a reader. The document describes the scanner's ability to produce images and its effectiveness in detecting conditions.

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

   • Not applicable/Not explicitly stated. The device is an imaging scanner; its "performance" is in producing images. The mention of its "effectiveness in detecting and quantifying" conditions implies its use by a clinician. There's no separate algorithm that performs diagnosis independently described.

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

   • Not explicitly stated. The summary only mentions "Clinical studies" demonstrated effectiveness in detecting and quantifying various retinal conditions. The nature of the ground truth used in these studies (e.g., comparison to a different gold standard imaging modality, surgical findings, subsequent clinical course, expert diagnosis) is not detailed.

7. The sample size for the training set:

   • Not applicable/Not explicitly stated. This summary describes an imaging device, not a machine learning algorithm that requires a "training set."

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

   • Not applicable. As above, no training set for a machine learning model is described.

Summary of Limitations:

This document is a 510(k) Premarket Notification, which aims to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. It is not a detailed clinical study report providing exhaustive data on performance against specific acceptance criteria, expert involvement, or AI-specific metrics. The "clinical studies" mentioned are likely part of the evidence supporting the claim of effectiveness and substantial equivalence, but their methodologies and results are not presented in detail within this summary.

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