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The Keeler TonoCare Tonometer is a hand-held, battery operated, non-contact tonometer intended to be used for measuring intraocular pressure (IOP) of the human eye with less than 3D in corneal astigmatism.

The Keeler TonoCare Tonometer is designed to measure Intra Ocular Pressure (IOP) to aid in the screening and diagnosis of glaucoma without contacting the eye. The Keeler TonoCare Tonometer has been designed using the same ergonomics as the predicate device described in 510(k) submission K093298. Both products consist of an air generation system in the form of a vacuum Diaphragm pump, an air reservoir, a solenoid valve, a light source and an opto-electronic platform which is used for position detection and IOP measurement. The basic concept of operation is the same. The user positions the instrument close to the patient's cornea using a targeting system. As the user moves the instrument closer to the patient, the reflection off the cornea from the built-in light source increases until the predefined firing thresholds on the built-in photodiodes have been met. Once this condition has been met, a quantized puff of air is automatically projected toward the patient's cornea. As the cornea flattens due to the force of the puff of air, the light being reflected off of the cornea changes shape which in turn changes the profile of the light being reflected back onto the photodiodes. The rate of change of this reflection is monitored by the photodiodes and converted into intraocular pressure in units of mmHg by the on-board microprocessor.

The document provided describes performance testing for the Keeler TonoCare Tonometer, primarily focusing on its equivalence to a predicate device and a reference standard tonometer. However, it does not detail acceptance criteria or a study that proves a device meets those acceptance criteria in the context of an AI/algorithm's performance. The document is for a physical medical device (a tonometer for measuring intraocular pressure), not an AI or algorithm.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance) was done," or "sample size for the training set," are not applicable to this document as it does not describe an AI medical device.

I will interpret the request as asking for the acceptance criteria and the study that proves the Keeler TonoCare Tonometer (a physical device) meets its performance requirements, based on the provided text.

Here's a breakdown based on the provided text, adapted to the context of a physical medical device:

Device: Keeler TonoCare Tonometer
Intended Use: Measuring intraocular pressure (IOP) of the human eye with less than 3D in corneal astigmatism.

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

The acceptance criterion is derived from ISO 8612 (comparable to ANSI Z80.10) for comparison with a reference tonometer.

*   **Data Provenance:** The study was a "single visit, single-center" study. While the document mentions "Keeler Ltd, Clewer Hill Road, Windsor, Berkshire, United Kingdom" as the manufacturing location, the specific country of origin for the clinical data is not explicitly stated, but implies a UK or European context given the European market launch mentioned. It was a **prospective** study ("Subjects were recruited according to the following inclusion and exclusion criteria").

• Repeatability/Reproducibility Bench Test:
  • Sample Size:
    • Repeatability: Approximately 50 individual readings for each of 5 pressure values on a manometrically controlled test eye.
    • Reproducibility: Measurements from three different TonoCare units by two different operators across 5 pressure values.
  • Data Provenance: Bench testing. Location not specified, but likely at the manufacturing facility.

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

• Number of Experts: Two experienced observers.
• Qualifications of Experts: Described as "experienced observers." No further detail (e.g., specific clinical specialty, years of experience) is provided.

4. Adjudication method for the test set:

• The study design was a "paired crossover study" comparing the TonoCare NCT to the Perkins Applanation Tonometer (AT). The "ground truth" for IOP measurements in this context was established by the reference standard Perkins AT (which itself is described as using the same basic principle as the Goldmann AT, a recognized reference).
• There's no mention of an adjudication process between the "two experienced observers" for the clinical measurements. It's implied that both observers took measurements using both devices.

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:

• N/A. This was a study for a physical tonometer device, not an AI or algorithm. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or is relevant to this submission.

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

• N/A. This was a physical device, not an algorithm. The device measures IOP. Human operators are required to use the device.

7. The type of ground truth used:

• Clinical Performance Study: The ground truth for IOP measurement was established by comparison to a reference standard clinical device, specifically the Perkins Applanation Tonometer (AT), which is considered an "established, gold standard" comparable to the Goldmann Tonometer.
• Repeatability/Reproducibility Study: The ground truth was a manometrically controlled test eye with known pressure values.

8. The sample size for the training set:

• N/A. This refers to a physical device, not an AI/ML algorithm that requires a training set. The device was likely designed and calibrated, not "trained" in the typical ML sense.

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

• N/A. As above, no training set in the AI/ML sense.
• However, the document mentions:
  • "The TonoCare Tonometer unit was initially cross calibrated on several rubber eyes against Keeler Pulsair IntelliPuff (K093298)."
  • "In addition, a mini trial on volunteers have been conducted to further refine the calibration of the TonoCare Tonometer in order to minimize the error between the devices."
  • The "ground truth" for calibration appears to be mechanical phantom eyes and real-world "mini trial" data compared against a known predicate device (Keeler Pulsair IntelliPuff) and the reference Perkins/Goldmann AT.

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The Pulsair IntelliPuff Non-Contact Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

The Pulsair Desktop Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

The Keeler Pulsair Tonometer product family are non-contact tonometers and are used to measure intraocular pressure without contacting the eye to aid with the screening and diagnosis of glaucoma. The product family consists of the Pulsair Intellipuff (Hand Held device) and the Pulsair Desktop which is mounted on a desk. The Pulsair Intellipuff Tonometer has been designed using the same ergonomics as the predicate device described in 510(k) submission K990257 whilst the Pulsair Desktop Tonometer ergonomics have been adapted to suite the Desktop mounted market place. Both products use the same concept of measurement as the predicate device and contain many common components. All of the products consist of an air generation system in the form of a vacuum Diaphragm pump, an air reservoir, a solenoid valve, a light source and an opto-electronic platform which is used for position detection and IOP measurement.

The basic concept of operation is the same. The user positions the instrument close to the patient's cornea using a targeting system. As the user moves the instrument closer to the patient, the reflection off the cornea from the built in light source increases until the predefined firing thresholds on the built in photodiodes have been met. Once this condition has been met, a quantised puff of air is automatically projected toward the patient's cornea. As the cornea flattens due to the force of the puff of air, the light being reflected off of the cornea changes shape which in turn changes the profile of the light being reflected back onto the photodiodes. The rate of change of this reflection is monitored by the photodiodes and converted into intraocular pressure in units of mmHg by the on board microprocessor.

The Keeler Pulsair IntelliPuff and Pulsair Desktop Tonometers are non-contact tonometers used to measure intraocular pressure (IOP) to aid in the screening and diagnosis of glaucoma.

Here's an analysis of their acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

• Pulsair IntelliPuff Tonometer: The document does not explicitly state the exact sample size for the "new independent clinical study" used to show design compliance. It only mentions "over 95% of the eyes tested," implying a statistically significant number of eyes were included to meet the 5% tolerance criterion.
  • Data Provenance: The study was "new," "independent," and conducted to ISO 8612:2001, which is an international standard. No specific country of origin is mentioned, but the manufacturing location is the UK, suggesting the study likely occurred in Europe or the UK. It was a prospective clinical trial.
• Pulsair Desktop Tonometer: "An additional small scale trial was conducted within a clinical environment on 28 eyes."
  • Data Provenance: Conducted within a "clinical environment." No specific country is mentioned, but likely similar to the IntelliPuff. This was also a prospective study.

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

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications for the test sets. However, the ground truth standard was the Goldmann Tonometer, which is considered the "gold standard" for IOP measurement, implying its use by trained clinicians.

4. Adjudication Method for the Test Set:

Not explicitly stated. The studies describe comparing device readings directly to Goldmann Tonometer readings and to each other, but not a consensus-based adjudication process for discrepancies.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned. The studies focus on comparing the device's readings to a "gold standard" (Goldmann Tonometer) or to another version of the device, rather than assessing human reader improvement with or without AI assistance. The device is a measurement instrument, not an AI diagnostic aid requiring human interpretation to improve.

6. Standalone Performance Study (Algorithm Only):

Yes, the described clinical trials for both the Pulsair IntelliPuff and the Pulsair Desktop effectively demonstrate their standalone performance. The devices directly output an IOP measurement, and this output was compared against the Goldmann Tonometer, representing the algorithm's performance without specific human-in-the-loop steps designed to alter the measurement itself. The "IntelliPuff readings tended to fall slightly below the Goldmann readings at IOP's exceeding 30mmHg" is an observation about its standalone performance.

7. Type of Ground Truth Used:

The primary ground truth used was measurements obtained from a Goldmann Tonometer, which is the clinical "gold standard" for intraocular pressure measurement.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set. It mentions the "algorithm for IOP calculation remains the same" as the predicate Pulsair 3000 and that the software was "sub-contracted for further development" based on a "Product Design Requirements Specification." This implies the algorithm was developed and refined, but the training data specifics are not detailed.

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

The document does not explicitly detail how the ground truth for the training set (if a distinct training set was used for the algorithm's development) was established. Given the algorithm's continuity from the predicate device (Pulsair 3000), it's implied that it was originally developed and validated against a known standard, likely the Goldmann Tonometer, similar to how the current devices were tested. The development involved functionality and usability improvements rather than a complete re-training of a new core IOP calculation algorithm.

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Keeler PSL Classic Slit Lamp is an AC-powered Slit lamp biomicroscope. It is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

The Keeler Portable Slit Lamp comprises a rechargeable hand held portable illuminated biomicroscope system and a desk mounted base charger unit that is powered from a low voltage (12V) power supply.

The hand held unit incorporates a built-in rechargeable battery powering the illumination system. The illumination system and fixation targets are activated using a single/double click trigger located on the front of the grip/handle. To increase or reduce the light intensity there is a rheostat located below the eyepieces on the rear of the grip /handle.

The 10 x and 16 x magnifications optical system is controlled using the lever located under the adjustable eyepieces.

The Keeler PSL Classic Slit Lamp is a medical device designed for non-invasive illumination, magnification, and observation of the human eye. It is used to examine the anterior and posterior segments of the eye, aiding in the diagnosis of various eye conditions.

Here's an analysis of its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific numerical acceptance criteria for performance metrics. However, based on the Summary of Performance Testing and the regulatory context of a slit lamp, the implicit acceptance criteria are related to safety, effectiveness, and functional equivalence to the predicate device.

Note: The 510(k) summary does not provide specific quantitative metrics or thresholds for "acceptance criteria" (e.g., minimum luminescence, maximum scatter, specific dimensions of the slit). Instead, it relies on demonstrating compliance with recognized safety standards and functional equivalence to a legally marketed predicate device.

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

The document does not explicitly state the sample size used for any specific "test set" in the context of device performance. It mentions "units under test" for the safety evaluations and "field trial in clinical environment" for performance, but no numbers are provided for either.

The data provenance is not specified regarding country of origin, nor is it explicitly stated whether the clinical data was retrospective or prospective. Given the nature of a 510(k) summary for a slit lamp, any clinical "field trial" would likely be a limited prospective observation to confirm usability and basic functionality rather than a large-scale, long-term clinical trial.

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

This information is not provided. The relevant "ground truth" for a slit lamp device would typically involve clinical observations and diagnoses made by healthcare professionals. While a "field trial in clinical environment" is mentioned, there's no detail on how many experts were involved or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This type of detail is typically not included in a 510(k) for a device like a slit lamp, especially when demonstrating substantial equivalence. The focus is more on demonstrating that the device functions correctly and safely, rather than on diagnostic accuracy studies requiring expert adjudication.

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 explicitly mentioned or indicated in the provided 510(k) summary. These types of studies are more common for diagnostic imaging devices where human interpretation interacts with AI algorithms. The "comparative study with its predicative devices" mentioned seems to refer to a technical and functional comparison rather than a human reader study.

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

This question is not applicable as the Keeler PSL Classic Slit Lamp is a physical optical instrument, not an AI algorithm. Its performance is always "standalone" in the sense that it is the direct observation tool, with the human eye being the "reader."

7. The Type of Ground Truth Used

For the safety and technical performance tests (Optical Radiation Safety, Electrical Safety, EMC), the "ground truth" would be established by compliance with recognized international and national standards (e.g., IEC standards for medical electrical equipment).

For the "comparative study with its predicative devices" and "field trial in clinical environment," the "ground truth" would implicitly be the established clinical utility and performance of existing slit lamps, particularly the predicate KOWA SL-15, as interpreted by healthcare professionals using the device for its intended purpose. The document states its performance was "judged to be as safe, as effective and performs as well to predicate devices," implying informal clinical observation and feedback.

8. The Sample Size for the Training Set

This is not applicable. The Keeler PSL Classic Slit Lamp is an optical-mechanical device, not a machine learning or AI system that requires a "training set."

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

This is not applicable, as there is no "training set" for this type of device.

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The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy procedures in refractory glaucoma, for retinal detachment, cryo destruction, cataract extraction, cryo destruction of lash follicles, extraction of fragments within the eye, and treatment of retinopathy of prematurity (ROP).

Cryomatic System and Probes comprising of: a) Cryomatic Console b) Cryomatic Probes

This looks like a 510(k) premarket notification for a medical device. Based on the provided text, there's no information about a study with acceptance criteria and device performance as typically understood for AI/ML or diagnostic devices.

The submission is for the Cryomatic System and Probes, which is an ophthalmic cryo system. This device is classified as a Class II cryogenic surgical device.

The core of this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices, which are identified as:

• K992954 Keeler Cryomaster and Probes
• K874555 Keeler ACU 22 XT Ophthalmic Cryo unit.

The substantial equivalence is based on "similarity of the subject device to the predicate devices in intended use, materials, design and principles of operation."

Therefore, there isn't a "study" in the sense of a clinical trial or performance evaluation with specific acceptance criteria as you've outlined for diagnostic or AI/ML devices. Instead, the "proof" the device meets acceptance criteria (i.e., being safe and effective for its indicated use) is established by its similarity to already approved devices.

To directly answer your questions based only on the provided text:

1. Table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence to predicate devices, not performance against specific numerical acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. There's no test set described for performance evaluation.
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 establishment for a test set is mentioned.
4. Adjudication method: Not applicable.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for a surgical instrument (an ophthalmic cryo system) seeking clearance based on substantial equivalence to existing devices, not unique performance data from a new clinical study.

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The Keeler Vamage Plus Indirect Ophthalmoscope is intended to examine the Cornea, aqueous, lens, vitreous and retina of the eye.

The Vantage Plus is a head mounted Binocular Indirect ophthalmoscope designed to be used by trained personnel for illuminating and viewing parts of the eye such as the Cornea and retina when used in conjunction with an ophthalmic lens. The instrument has two main elements i) The illumination element ii) the viewing element. The illumination element consists of a 6Volt, 5Watt Xenon filament lamp, a condensing lens, IR filtration, User filters for diagnostic purposes, variable stop sizes for increasing/decreasing light aperture sizes, a projection lens and an illumination mirror used by the user to direct the light. The binocular Viewing element consists of low powered Viewing Lenses (+2 dioptre) and directional mirrors which are adjustable to obtain optimal views of the eye. The unit has adjustable illumination levels and is powered by the same power sources to that used on the Vantage (Re: 510(k) K942104).

To improve the ease of use of the instrument, the Vantage Plus combines the Aperture selector control and the Viewing mirror adjustments to achieve optimal instrument setting with minimum fuss. This feature is not present on the Vantage (Re: 510(k) K942104).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Keeler Vantage Plus Binocular Indirect Ophthalmoscope, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Vantage Binocular Indirect Ophthalmoscope) rather than presenting a study with specific acceptance criteria that the device meets to establish a new performance benchmark. Instead, it compares the technological characteristics and safety features of the new device against the predicate.

Here's a table based on the provided "Comparison of Indirect Ophthalmoscope Technological Characteristics," where the "Acceptance Criteria" are implied by the predicate device's characteristics and the new device's performance aligns with or is considered equivalent to those.

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

The document does not describe a clinical "test set" in the traditional sense for evaluating diagnostic accuracy or a specific performance metric against a ground truth. Instead, the submission details a technical comparison and safety assessment against a predicate device.

• Test Set/Sample Size: Not explicitly applicable in the context of a clinical performance study. The "measurements" for characteristics like light output and aperture sizes were taken from a "selection of bulbs" and from "440mm from the front of the instrument" on "a fully functional prototype." Specific numbers for how many prototypes were tested for these physical characteristics are not provided.
• Data Provenance: The testing appears to have been conducted internally by Keeler Ltd., located in Windsor, Berkshire, United Kingdom. The data is retrospective in the sense that it's a comparison to an already marketed device, but the testing on the "Vantage Plus" prototype would be prospective for the new device.

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

This information is not provided because the submission does not involve a clinical study requiring expert-established ground truth for a diagnostic outcome. The "ground truth" for the technical characteristics is established by the measurements and adherence to international standards.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring adjudication of diagnostic outcomes.

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 performed or mentioned. This device is a manual ophthalmoscope, not an AI-powered diagnostic device.

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

Not applicable. The Vantage Plus Binocular Indirect Ophthalmoscope is a medical instrument used by a human operator, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" here is based on:

• Physical measurements and engineering specifications: For characteristics like light output, aperture size, lens power, etc.
• International safety and quality standards: BS EN ISO 15004:1998 (Light Hazard), BS EN ISO 14971:2001 (Risk Management), BS EN 60601-1 and 60601-1-2 (Electrical Safety).
• Performance of the legally marketed predicate device (Keeler Vantage): The predicate's characteristics serve as the baseline for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable, as there is no training set mentioned for this device.

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The Keeler Wide Angle Ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous, and retina of the eye. It has the same operating principles and intended use as many competitive ophthalmoscopes already in commercial distribution. The device is intended to be used by trained personnel within a medical or school environment.

The Keeler Wide Angle Ophthalmoscope is a hand held indirect monocular device for use by trained personnel for viewing the cornea and retina of a patient. The viewing path in conjunction with the large solid angle projection of the illumination path provides two angles of view which provides larger fields of view than attainable with a conventional direct ophthalmoscope. The viewing optical system composes of two objective lenses, relay components and eyepiece provide an erect, un-reversed image of the patients retina to the doctor. The illumination path of the instrument consists of a filament lamp, a condensing system, two full mirrors and one semi-reflector mirror. The illumination path is imaged iust below the viewing optics axis as they combine at the semi-reflector mirror. The condensing lenses image the lamp filament essentially onto the patient's cornea. The filament image at the corneal plane is small permitting an increase ease of entry into undilated pupil. Any reflections of the filament from the surface of the cornea are trapped on light stops, which are positioned within the viewing optics. This allows the practitioner to obtain reflex free images of the retina.

The provided text describes a 510(k) summary for the Keeler Wide Angle Ophthalmoscope. This type of regulatory submission demonstrates substantial equivalence to a predicate device, rather than proving effectiveness through clinical trials with specific acceptance criteria, sample sizes, or ground truth establishment in the manner of AI/software devices. The document explicitly states: "The effectiveness of the Keeler Wide Angle Ophthalmoscope is the same as current monocular indirect ophthalmoscopes already on the market."

Therefore, the study described is not designed to meet specific acceptance criteria with quantifiable performance metrics such as sensitivity, specificity, or AUC against a defined ground truth, as would be typical for an AI/CADe device. Instead, the effectiveness is established by demonstrating equivalence in intended use and operating principles to existing predicate devices.

However, I can extract the information related to how "effectiveness" was assessed, even if it's not a quantitative study in the sense of AI performance evaluation.

Here's the breakdown of the information based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Test Set Sample Size: Not explicitly quantified. The document refers to "practicing physicians" participating in "assessments" to establish if the device met their needs.
   • Data Provenance: Not specified, but implied to be from clinical use by practitioners. Retrospective or prospective is not mentioned, but "assessments" with "practicing physicians" suggests a prospective evaluation.

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

   • Number of Experts: Not explicitly stated as a specific number. The document mentions "the evaluating physicians," implying multiple individuals.
   • Qualifications: "practicing physicians" who were "users of either the Keeler Ophthalmoscope or a competitor's model (all have the same intended use)." No specific experience levels (e.g., "radiologist with 10 years of experience") are provided.

3. Adjudication method for the test set:

   • No formal adjudication method (like 2+1, 3+1) is described. The "assessments" by evaluating physicians led to a qualitative conclusion about meeting needs.

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 MRMC study was conducted. This device is a manual ophthalmoscope, not an AI-assisted device, so this type of study is not applicable. The comparison was about the device's performance versus predicate devices, not human reader improvement with AI.

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

   • Not applicable. This is a medical instrument, not an algorithm. Its performance is inherently human-in-the-loop as it's operated by a physician.

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

   • Ground Truth: The "ground truth" in this context was qualitative, based on the subjective assessment and feedback from "practicing physicians" regarding whether the device met their "needs" and performed equivalently or better than existing devices for "documentation procedure." It was not based on objective diagnostic criteria like pathology or outcomes data.

7. The sample size for the training set:

   • Not applicable. This is a hardware medical device, not a machine learning model, so there is no concept of a "training set" in the conventional sense for AI.

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

   • Not applicable, as there is no training set for this type of device.

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The Keeler CryoMaster & Probes are for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP).

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Keeler CryoMaster & Probes." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Information on the number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Results of any standalone algorithm performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

This document merely states that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. Substantial equivalence is a regulatory standard, not a performance metric defined by a specific study with acceptance criteria.

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Measurement of the Intraocular Pressure

Not Found

The provided text is an FDA 510(k) clearance letter for the Keeler Pulsair 3000 Non Contact Tonometer. It generally confirms that the device is substantially equivalent to legally marketed predicate devices and states its intended use (measurement of Intraocular Pressure).

However, the document does not contain the specific information requested about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert qualifications for the device's performance. These details are typically found in the 510(k) submission itself or in separate scientific publications, not in the clearance letter.

Therefore, I cannot provide the requested table and study details based solely on the given text.

To answer your request, I would need access to the actual 510(k) submission for the Keeler Pulsair 3000 or a summary of its performance studies.

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Specular Observation of the tear film

Not Found

This document is a 510(k) clearance letter from the FDA for the KEELER TEARSCOPE-PLUS. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the acceptance criteria, details of a study proving the device meets those criteria, or any information about AI/algorithm performance.

The 510(k) process primarily evaluates substantial equivalence based on indications for use, technological characteristics, and safety and effectiveness information, often relying on comparisons to existing devices rather than new performance studies with pre-defined acceptance criteria in the way you've described.

Therefore, I cannot provide the requested information based on the provided text.

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