Search Results

The Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer are indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.

The unmodified device is Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer. Both are Goldman type tonometers to measure intraocular pressure to aid in the screening and diagnosis of glaucoma. In applanation tonometry the intraocular pressure (IOP) is calculated from the force required to flatten a constant area of the cornea. Goldmann tonometry is considered to be the gold standard test and is the most widely accepted method in current practice. The Keeler Tonomate is a flattening cone containing biprism that converts the circular image of the flattened cornea to two semicircles that touch and cross at the time of flattening the cornea. The force required to flatten the cornea is converted to millimeters of mercury (mmHg).

The provided text describes a 510(k) submission for a Keeler Disposable Tonomate (also referred to as Keeler Tonomate), an accessory for the Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer. The submission primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study with specific acceptance criteria and performance metrics for the accessory itself.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or a formal study designed to measure the performance of the Keeler Tonomate against such criteria. Instead, the submission relies on the concept of substantial equivalence to predicate devices. The primary "acceptance criteria" here is that the modified device (with the disposable prism) should not raise new issues regarding the safety and effectiveness of the existing tonometers.

A table of acceptance criteria and reported device performance, as typically seen in a clinical trial or performance study, is not available in this document. The document argues that the technical characteristics of the disposable prism are identical to non-disposable prisms that have been in successful use since the 1950s.

Study Information (or lack thereof)

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

• Acceptance Criteria: Not explicitly defined in a quantitative manner for the disposable prism. The implicit acceptance criterion is "substantial equivalence" to the predicate non-disposable prisms, meaning no new safety or effectiveness concerns.
• Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, precision) are reported for the Keeler Tonomate itself in comparison to a defined acceptance criterion. The document states that the "technical characteristics of Phakos Tonoclean and Keeler Tonomate were kept identical to those of the nondisposable prisms."

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

• Sample Size: Not applicable/not provided. No specific test set of patients or measurements with the Keeler Tonomate is described.
• Data Provenance: Not applicable/not provided.

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

• Not applicable. There was no specific test set requiring expert ground truth establishment for this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable. No test set requiring adjudication was performed.

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

• No MRMC study was conducted. This device is a tonometer prism, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a manual measurement tool, not an algorithm.

7. The type of ground truth used:

• Not applicable. No direct "ground truth" was established for the performance of the disposable prism through a new study. The argument is based on the long-standing clinical acceptance and identical technical characteristics of the non-disposable predicate prisms.

8. The sample size for the training set:

• Not applicable. The Keeler Tonomate is a physical medical device accessory, not a machine learning model that requires a training set.

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

• Not applicable.

Summary of the Study and Rationale:

The document explicitly states: "No clinical investigations were required as the safety and effectiveness in clinical use of the tonometer prism has been well established for the original equipment manufacturer (OEM) version of the prism, which has been sold into the European market by the manufacturer since 2014. In addition, the technical characteristics of Phakos Tonoclean and Keeler Tonomate were kept identical to those of the nondisposable prisms which were in successful use since 1950s."

This indicates that instead of new performance studies, the submission relies on:

• The established safety and effectiveness of a predicate device (the OEM version of the prism in the European market since 2014).
• The historical, successful use of non-disposable prisms with identical technical characteristics since the 1950s.
• Design control activities, risk management, verification/validation for the manufacturing process of the disposable prism (e.g., packaging and sterilization cycle validation), to ensure the addition of the Keeler Tonomate "does not raise new issues on the safety and effectiveness."

Therefore, the "study" demonstrating the device meets "acceptance criteria" here is a substantiation of equivalence argument based on existing data, manufacturing controls, and the identical technical characteristics of the disposable prism compared to its well-established non-disposable counterparts, rather than new clinical trials or performance assessments of the disposable prism itself.

Ask a specific question about this device

The Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital are AC-powered Slit lamp bio-microscopes and 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 This device is intended to be used only by suitably trained and authorized healthcare professionals

The Keeler Slit Lamp Z-series (modified device) exists in two variants: non-digital and digital. The Z-series variant of the product is introduced as a lower cost alternative of the H-series to meet expectations of the optometry market. The Keeler Slit Lamp Zseries includes bottom-illuminating tower assembly instead of top-illuminating Haagtype illuminating tower. The high percentage of components/assemblies used on cleared Keeler Slit Lamp H-series (unmodified device) will be utilized on the Z-series slit lamp.

The modified device will come in a few different configurations assembled from the same components (022 Configurations of the Modified Device). High percentage of components shared between H-series and Z-series slit lamps are used on the cleared H-series device.

Similar to the H-series slit lamp, the Z-series will offer a digital option for recording and storing images and a range of magnifications from x6 to x40. The Z-series slit lamp will only come with LED as a light source, the same as in cleared H-series device, but unlike the H-series slit lamp the bulb version will not be available for the Z-series. The modified device will offer converging and parallel viewing optics, the same options as available on the unmodified device.

The provided document is a 510(k) premarket notification for the Keeler Slit Lamp Z-series and Keeler Slit Lamp Z-series Digital. It focuses on demonstrating substantial equivalence to a previously cleared device (Keeler Slit Lamp H-series). The document does not describe a study that establishes acceptance criteria for diagnostic performance or compares the device's diagnostic abilities against a ground truth.

Instead, the document details engineering, safety, and performance testing related to the physical device itself, primarily to ensure it meets recognized medical device standards and is safe for use.

Here's an analysis based on the information provided, highlighting why it doesn't fit the requested criteria for diagnostic performance evaluation:

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

This document does not provide acceptance criteria or reported performance for diagnostic accuracy (e.g., sensitivity, specificity) as it is not a study evaluating the diagnostic capability of the device.

The "performance" described pertains to engineering and safety standards:

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

This is not applicable as the document describes engineering and safety testing on device prototypes/configurations, not a diagnostic study using patient data. The "test set" in this context refers to the device configurations themselves. The provenance of raw patient data is not mentioned because no such data was used for diagnostic performance evaluation.

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

This is not applicable. The evaluations conducted relate to device safety and functionality based on engineering standards and design specifications, not expert interpretation of diagnostic output.

4. Adjudication method for the test set

This is not applicable. No expert adjudication of diagnostic outcomes was performed.

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

This is not applicable. This document describes a physical medical device (slit lamp) and not an AI or software-as-a-medical-device (SaMD) product. Therefore, no MRMC study, AI assistance, or effect size is mentioned.

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

This is not applicable. The device is a physical diagnostic tool for human operators, not a standalone algorithm.

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

For the engineering and safety tests, the "ground truth" or reference was the established requirements and limits of the relevant international standards (e.g., ISO 15004-2, IEC 60601-1, IEC 60601-1-2).

8. The sample size for the training set

This is not applicable as no AI or machine learning model was developed or trained.

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

This is not applicable as no AI or machine learning model was developed or trained.

In summary: The provided document is a regulatory submission for a physical medical device. It demonstrates the device's adherence to safety and operational standards and its substantial equivalence to a predicate device. It does not contain information about studies evaluating diagnostic performance, human-in-the-loop performance, or AI-driven diagnostic accuracy, as these are outside the scope of this type of submission for this particular device.

Ask a specific question about this device

The Keeler Slit Lamp is an AC-powered slit lamp bio-microscope and 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

This device is intended to be used only by suitably trained and authorised healthcare professionals.

The Keeler Slit Lamp H-Series device is AC-powered slit lamp bio-microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light. It is mounted on an XYZ translation base that is either mounted onto a custom table top supplied by Keeler or can be mounted on a third party's table top {refraction unit} by suitably trained technicians.

Fitted to the XYZ base is the illumination and observation system; fitted to the table top is the chinrest assembly with fixation target. The patient is seated in front of the slit lamp with his/her chin in the adjustable chin rest and forehead against the forehead rest. With the control lever the instrument can be moved back and forward until the slit appears in focus on the cornea. The image can be observed through the microscope.

The digital option for the H-Series Slit Lamp enables digital photographs to be taken to capture the image being observed, for further viewing and record purposes. It comprises an additional USB camera module that can be fitted by the user between the binocular eyepiece assembly and the main body of the microscope, which is connected to a powered USB3 hub enclosed within the microscope base, for onward connection to a medically approved PC.

Addition of this option necessitates modifications to the illumination tower to provide background lighting via a fibre optic light tube when capturing digital images.

There are two variants of the H-Series Digital Slit lamp. The first variant uses an incandescent light source, which is used to illuminate the eye during examination and provide background illumination to aid digital photography.

The bulb is more powerful than the bulb sited in the predicate 510(k) [K131589] due to the requirement for additional background illumination for digital photography. The quantity of light for illuminating the eye is comparable to the product sited in K131589, and therefore posses no additional risk to the safety and effectiveness of the product.

The second product variant is an LED illumination option, which again provides light to illuminate the eye during examination and provides background illumination for digital photography. Both variants are factory fitted and comply with ISO 15004-2:2007.

The provided 510(k) summary for the Keeler Slit Lamp H-Series Digital does not contain information about specific acceptance criteria or a study proving the device meets performance criteria in the way typically expected for AI/ML-driven devices (e.g., sensitivity, specificity, accuracy against a recognized standard).

This document describes a traditional medical device (a digital slit lamp biomicroscope), which primarily focuses on substantial equivalence to predicate devices rather than novel performance metrics. The "device performance" in this context refers to its
functional capabilities and safety compliance, not diagnostic accuracy in the way AI algorithms are evaluated.

Therefore, many of the requested details about acceptance criteria for AI models, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable or not present in this type of submission.

However, I can extract the relevant information regarding what constitutes "acceptance" for this device, which relies on demonstrating substantial equivalence and compliance with established standards.

Here's an attempt to answer your request based on the provided document, adapting where necessary due to the nature of the device:

Acceptance Criteria and Device Performance for Keeler Slit Lamp H-Series Digital (K140451)

Given that the Keeler Slit Lamp H-Series Digital is an AC-powered slit lamp biomicroscope with an added digital camera module, the "acceptance criteria" discussed in this 510(k) submission primarily revolve around demonstrating substantial equivalence to a predicate non-digital slit lamp and a predicate digital camera option, and compliance with relevant safety and performance standards. There are no specific diagnostic or AI performance metrics (like sensitivity, specificity, or AUC) as the device is an imaging tool, not a diagnostic algorithm.

The "study" proving the device meets the acceptance criteria is the 510(k) submission itself, which presents a comparison of features and compliance with standards.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional medical device submission, the "acceptance criteria" are derived from the substantial equivalence comparison and compliance with recognized standards. "Device performance" refers to its technical specifications and demonstrated compliance.

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

• Not Applicable in the traditional sense of an AI/ML test set. This submission does not describe a "test set" of images to evaluate an algorithm's diagnostic performance. Instead, it relies on engineering testing and comparisons to predicate devices.
• Data Provenance: The document refers to compliance with international standards (e.g., ISO, IEC) and comparisons to existing devices on the market (UK for Keeler's non-digital, and Haag Streit for a digital camera module, which operates in the US market). The engineering tests conducted would typically occur in the manufacturer's facilities (UK).

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

• Not Applicable. As there is no "test set" for an AI algorithm's diagnostic performance, there were no experts establishing ground truth for such a purpose. The device's safety and effectiveness are evaluated through engineering tests and comparison to predicates, which would involve qualified engineers and regulatory affairs personnel but not clinical "ground truth" experts in this context.

4. Adjudication Method for the Test Set

• Not Applicable. Without a test set for an AI algorithm, there is no adjudication method described.

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

• No. An MRMC study is typically performed for diagnostic devices, especially those incorporating AI, to assess the impact of the AI on human reader performance. This device is an imaging system, not a diagnostic algorithm, and therefore such a study was not performed or necessary for this 510(k) submission.

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

• Not Applicable. This device is a hardware imaging system. There is no standalone algorithm being evaluated for diagnostic performance. The digital camera module captures images, which are then viewed by a human operator, making it inherently "human-in-the-loop."

7. The Type of Ground Truth Used

• Not Applicable in the context of diagnostic performance. The "ground truth" for this device relates to:
  • Functional specifications: Whether the camera captures images at the stated resolution and frame rate.
  • Safety compliance: Ensuring the device meets phototoxicity limits (ISO 15004-2), electrical safety standards (IEC 60601-1, IEC 60601-1-2), and other relevant standards.
  • Substantial equivalence: Demonstrating that its features and performance are acceptably similar to legally marketed predicate devices without raising new questions of safety or effectiveness.

8. The Sample Size for the Training Set

• Not Applicable. This device does not employ machine learning or AI algorithms that would require a training set of data.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for it.

Ask a specific question about this device

The Keeler Kapture Software Package is used by Health Professionals to capture, store and manage output images from Retinal Cameras, Fundus Cameras and Video Slit Lamps

The Keeler Kapture software is an ophthalmic imaging system. The Kapture software package is intended to run on a PC and will allow the user to capture images from a digital slit lamp or other camera for review and storage. Images can have basic adjustments (such as colour, brightness and contrast) and images can be visually compared.

The provided text describes the Keeler Kapture Software, an ophthalmic imaging system, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer all parts of your request. Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with quantitative metrics. Instead, it details a comparison of functional features between the Keeler Kapture Software and the predicate device, EyeCap Imaging System. The acceptance criterion implicitly seems to be functional equivalence to the predicate device.

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

The document states, "A number of functional tests were carried out to verify the performance of the Keeler Kapture Software against the EyeCap Imaging System." It does not specify a numerical sample size for a test set in terms of patients or images. The data provenance is not mentioned. The study appears to be a functional verification against a predicate device, not a clinical study involving patient data.

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

This information is not provided. The testing described focuses on functional equivalence to the predicate device, not on establishing a clinical ground truth with expert consensus.

4. Adjudication method for the test set

This information is not provided.

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 such study is mentioned in the provided text. The Keeler Kapture Software is described as an ophthalmic imaging system for capturing, storing, and managing images, not an AI-powered diagnostic tool for interpretation or assisting human readers.

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

This is not applicable in the context of the Keeler Kapture Software as described. It is a software package for managing images, not an algorithm performing a diagnostic task independently. Its performance is evaluated based on its functionality matching a predicate device.

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

The "ground truth" in this context is the functional behavior and features of the predicate device, the Clement Clarke International Ltd EyeCap Imaging System. The Keeler Kapture Software was tested to ensure its functions matched those of the EyeCap.

8. The sample size for the training set

This information is not provided. The Keeler Kapture Software is not an AI/ML model that would typically have a "training set" in the sense of supervised learning. It's application software.

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

This is not applicable, as it's not an AI/ML model requiring a training set with established ground truth from data. Its ground truth for development and testing was likely the functional specifications derived from the predicate device.

Ask a specific question about this device

The Keeler Applanation Tonometer is indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.

The Digital Keeler Applanation Tonometer is a screening device used to measure intraocular pressure which is one of the factors considered in diagnosing glaucoma. The product is an active medical device, powered by a single AA battery. The operation principal is based on Goldmann applanation method.

The provided document describes the modification of a Keeler Applanation Tonometer (KAT) to a Digital Keeler Applanation Tonometer (D-KAT). The D-KAT is intended to provide a digital readout of intraocular pressure (IOP) as an alternative to the manual dial reading of the predicate device.

Acceptance Criteria and Reported Device Performance

The primary acceptance criterion described for the D-KAT is its measurement deviation, which is based on the Tonometer standard ISO 8612:2009. The device needs to achieve a measurement deviation comparable to the predicate device.

Study Details:

The provided document describes verification tests and compliance with various standards to demonstrate substantial equivalence to the predicate device, rather than a clinical study with human readers and AI.

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

   • Test Set Sample Size: Not explicitly stated as a number of patients or cases. The performance validation was conducted through "bench testing using a balance system" and "usability tests."
   • Data Provenance: Bench testing would be laboratory data. Usability tests were conducted by healthcare professionals, implying an in-situ or simulated clinical environment. No specific country of origin is mentioned for the data, but the manufacturer is Keeler Instruments Inc. in the USA. The data is likely prospective for these validation tests.

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

   • For the bench testing, the "ground truth" was established by applying "known pressures covering the measurement range" using calibration bars verified according to ISO 8612:2009. This relies on the accuracy of the calibration system rather than human experts.
   • For the usability tests, "healthcare professionals" were involved, but their number and specific qualifications (beyond being healthcare professionals) are not detailed. Their role was to compare the D-KAT against the predicate device, not necessarily to establish ground truth for IOP measurements.

3. Adjudication method for the test set: Not applicable. The primary performance evaluation was bench testing against a standard, not a scenario requiring adjudication between human readers or device outputs.

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. This document describes a medical device (tonometer) with a digital display, not an AI-powered diagnostic tool requiring MRMC studies to compare human reader performance with and without AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is an "algorithm only" in the sense that the software processes the raw measurement to display the IOP. The "bench testing using a balance system" is a form of standalone performance evaluation for the device's accuracy in measuring force/pressure, conforming to the ISO standard.

6. The type of ground truth used:

   • For measurement performance: The "known pressures" provided by a calibrated balance system, verified against ISO 8612:2009.
   • For usability: Comparison against the predicate device by healthcare professionals. No objective "ground truth" for usability is described, rather a subjective comparison.

7. The sample size for the training set: Not applicable. The device is a measurement instrument, not an AI model that requires a training set in the conventional sense. The "software uses information stored / programmed during the factory setup / calibration" which could be considered akin to a "training" or calibration phase, but it's not a data-driven machine learning training set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set in the typical machine learning context. The calibration information for the device's setup is established during "factory setup / calibration" by applying "known pressures" and relating them to the rotating measuring drum's position, as outlined in ISO 8612:2009.

Ask a specific question about this device