Search Results

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

The Z-type 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 text is a 510(k) summary for a modified medical device, the Z-type Digital Keeler Applanation Tonometer. The primary focus of this document is to demonstrate "substantial equivalence" to a predicate device, rather than to establish new performance criteria for a novel device. As such, it relies heavily on the fact that existing performance characteristics (like measurement deviation, range, and technique) remain unchanged.

Here's an analysis of the acceptance criteria and study information available in the document:

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

Since this is a submission for a modified device claiming substantial equivalence, the "acceptance criteria" are essentially the performance characteristics of the predicate device, which the modified device is expected to match. The document explicitly states "No change" for most performance-related characteristics when comparing the modified device to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Verification tests have been carried out in accordance to the FDA guidelines 'Tonometers - Premarket Notification [510(k)] Submissions'." However, it does not specify the sample size for any clinical or performance test set, nor does it provide details about data provenance (country of origin, retrospective/prospective). The tests mentioned are primarily engineering verification tests (electrical safety, EMC, software).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No information is provided regarding the number or qualifications of experts used to establish ground truth for any clinical test set. Given it's a 510(k) for a modification and claims substantial equivalence based on engineering verification, explicit clinical ground truth establishment with experts is not detailed.

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

No information is provided regarding an adjudication method.

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 device is not an AI-assisted diagnostic tool. It is a physical tonometer. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

The device is a manual contact tonometer that requires a human operator for its use. It is not an algorithm-only standalone device.

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

For the mechanical and electrical verification mentioned, the ground truth would be based on established engineering standards (e.g., ISO 8612:2009 for tonometer calibration, BS EN 60601-1 for electrical safety, BS EN 60601-1-2 for electromagnetic compatibility). For the primary function of measuring IOP, the gold standard is stated as the "Goldmann tonometer." The document indicates that the device's operating principle is based on the Goldmann method, and its measurement deviation aligns with previous models.

8. The sample size for the training set

This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense. The device's "training" or calibration is factory-based using known pressures and a calibration arm.

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

For the calibration process, the ground truth is established by "known pressures covering the measurement range applied to the measurement arm using a calibration arm verified using the calibration procedure outlined in the Tonometer standard ISO 8612:2009." This means the ground truth for the device's accuracy is derived from international standards for tonometer calibration.

Ask a specific question about this device

The Keeler Cryomatic System and probes are for use in ophthalmic surgery such as 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).

The Cryomatic MKII console is a self-contained system. The console consists of a rigid PU enclosure, housing the principle subsystems, switch mode power supply, controller PCB and pneumatic control module. On the front of the console is an LCD screen and membrane key panel. The console provides the connection point for the range of probe (reusable and disposable), footswitch, mains electricity, gas supply and scavenging system.

There is a variety of Keeler Re-usable Cryomatic Probes whose stainless tips are shaped depending on surgical application. The plastic handle is permanently connected to flexible pressure hose and integral connector, which connects to Cryomatic MKII Console.

The Keeler Disposable Cryo Probe comprises a stainless steel stem with a metal handle connected to a 2m long bi-lumen high-pressure plastic hose contained within a protective outer tube and terminated with a customdesigned plastic connector for insertion into the Cryomatic MKII console.

Here's a breakdown of the acceptance criteria and study information for the Keeler Cryomatic MKII System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific sample sizes for each verification test. It refers to "verification tests" and "all tests," implying a comprehensive evaluation.

• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that Keeler Instruments Inc. is based in Broomall, PA, USA, and the 510(k) is submitted to the FDA, it is highly probable that the testing was conducted in a manner consistent with US regulatory requirements for medical devices. The nature of the modifications (simplification of a coupling mechanism) suggests bench testing and internal validation rather than clinical trials with patient data.

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

The document does not mention the use of experts to establish "ground truth" in the context of diagnostic accuracy. This submission is for a modification to an existing surgical system, not a diagnostic imaging device that requires expert interpretation. The "ground truth" for this device's performance would be established through engineering and performance testing against predefined specifications and recognized standards.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this is a modification to a surgical device, not a diagnostic AI system requiring adjudication of expert interpretations.

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

No. An MRMC comparative effectiveness study is not mentioned and would not be relevant for this type of device modification. This device is a surgical instrument, not an assistive technology for diagnostic interpretation.

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

Not explicitly applicable in the context of a "standalone algorithm." The device itself functions as a "standalone" surgical tool in that it performs its intended function without requiring human input beyond operating it. The "verification tests" described are essentially standalone performance evaluations of the modified hardware and associated software.

7. The Type of Ground Truth Used

The "ground truth" for this device modification is based on:

• Engineering Specifications: The device's performance (probe temperature, iceball growth, defrost, tractive power) was measured against established specifications for the predicate device and the new design.
• Safety Standards: Compliance with recognized international standards (IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility).
• Sterilization Validation: Specific protocols and measurements to ensure the re-usable probes could be adequately sterilized according to defined parameters.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for this device would be its design, engineering tolerances, and manufacturing processes.

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

Not applicable for the same reasons as point 8.

Ask a specific question about this device

The Keeler Slit Lamp is an AC-powered Slit lamp biomicroscope 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.

An AC-powered slit lamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into the patient's eye through a control diaphragm a thin, intense beam of light.

This Keeler Slit Lamp has an XYZ translation base that is either mounted onto a custom table top supplied by Keeler or can be mounted on a third parties 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 illumination system rotates around its mounting axis and has a number of filters and graticules allowing the user to control precisely the characteristics of the examination light. The magnification body has a magnification change systems and eyepieces adjustable for the user's individual pupillary distance and distance correction.

The patient is seated in front of the slit lamp with his/her chin in the chin rest and forehead against the forehead rest. The chin rest can be adjusted in height to align the eyes of the patient with the optics/light beam.

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 base unit has a rheostat to control the illumination level.

Various magnifications can be selected on the microscope. For different observations the slit width can be changed, the slit can be tilted horizontally, and the angle between the illumination unit and the microscope can also be varied horizontally.

The Keeler Slit Lamp - H Series is an AC-powered slit lamp biomicroscope 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 affecting the structural properties of the anterior eye segment.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a quantitative sense for performance metrics like sensitivity, specificity, or accuracy, as would be common for AI/diagnostic devices. Instead, the focus is on demonstrating substantial equivalence to a predicate device (Haag-Streit Slit Lamp BQ 900, K100202) through comparison of technical specifications and compliance with recognized safety and performance standards.

The "acceptance criteria" can be inferred to be compliance with relevant safety and performance standards and demonstrating that any differences from the predicate device do not affect safety or effectiveness.

The study that proves the device meets the acceptance criteria is described as the "Summary of Performance, EMC and Safety Testing."

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

The document does not describe a test set involving patient data or clinical samples for performance evaluation in the context of diagnostic accuracy (e.g., retrospective or prospective studies with a specific sample size). Since this is a hardware device (slit lamp biomicroscope), testing primarily focuses on engineering performance, electrical safety, EMC, and radiation safety.

Therefore, there is no mention of:

• Sample size for a test set.
• Data provenance (e.g., country of origin of the data, retrospective or prospective).

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

Not applicable. This device is a viewing instrument, and its "performance" is evaluated against technical specifications and safety standards, not against clinical ground truth established by experts.

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

Not applicable. No clinical test set or ground truth adjudication process is described for this type of device.

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 device is an ophthalmic instrument, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for this device's acceptance is its compliance with internationally recognized consensus standards for medical electrical equipment and ophthalmic instruments (IEC 60601-1, IEC 60601-1-2, ISO 15004-2, ISO 10939). The testing involved objective measurements against these standards, rather than clinical ground truth like pathology or expert consensus on disease diagnosis.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no training set in the context of machine learning or AI.

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

Not applicable. As there is no training set mentioned, no ground truth needed to be established for it.

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 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 a non-active medical device and is completely mechanical, therefore without electrical components. The operation principal is based on Goldmann applanation method. The product is installed on a special support on the slit lamp and is used in conjunction with commercially available slit lamps.

Let's break down the information provided about the Keeler Applanation Tonometer (KAT) and its performance study.

Based on the provided K093445 submission, the Keeler Applanation Tonometer is a manual contact tonometer and its submission is based on substantial equivalence to predicate devices, rather than a standalone clinical study with defined acceptance criteria and specific performance metrics in the way one might see for an AI/software device. For mechanical devices like this, the 'acceptance criteria' are typically met by demonstrating that the device functions identically or equivalently to legally marketed devices, and passes relevant engineering standards.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" for a diagnostic accuracy as seen in AI or complex diagnostic devices isn't directly applied here. Instead, the "acceptance criteria" are implied by substantial equivalence to predicate devices and adherence to relevant standards. The performance is assessed by comparison.

Study Information & Data Provenance

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

   • Test Set Sample Size: Not explicitly stated as a numerical sample size for patients or measurements in the provided document. The "bench testing" would involve a sample of the manufactured devices, and the "field trial" would involve some number of patients/eyes tested by an ophthalmic professional. However, specific numbers are not given.
   • Data Provenance: The bench testing and field trial were likely conducted by the manufacturer or on their behalf. The country of origin of the data is implied to be within the UK (where the manufacturer is located), but this is not explicitly stated for the studies themselves. The studies appear to be prospective in nature, as they were conducted to test the performance of the new device.

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. The field test was conducted by "an ophthalmic professional." This implies at least one expert, but doesn't specify if it was a single individual or a group, nor are their specific qualifications (e.g., years of experience, sub-specialty) detailed.
   • Qualifications of Experts: Described as "ophthalmic professional." No further detail (e.g., ophthalmologist, optometrist, specific experience) is provided.

3. Adjudication method for the test set:

   • Not applicable/Not explicitly stated in the context of this submission. For substantial equivalence of a general-purpose mechanical device, an adjudication method for ground truth is typically not required as it would be for a complex diagnostic algorithm. The comparison is against established, legally marketed devices.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant to evaluating AI (artificial intelligence) systems or other diagnostic aids where human interpretation is assisted. The Keeler Applanation Tonometer is a purely mechanical device, not an AI system. Therefore, this question is not applicable.

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

   • No. This question is also not applicable as the Keeler Applanation Tonometer is a manual, mechanical device and does not involve an algorithm or AI. Its operation inherently requires a human operator ("manual contact tonometer").

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

   • For the bench testing, the "ground truth" was adherence to the Tonometer Standard BSENISO 8612:2001 and direct comparison of measurements against the predicate devices.
   • For the field trial, the "ground truth" was likely the intraocular pressure (IOP) readings obtained by the "ophthalmic professional" using both the Keeler Applanation Tonometer and the predicate device(s) on actual patients, with comparability being the key outcome. It's not based on pathology or outcomes data in the sense of disease progression, but on the agreement of the measurement value itself.

7. The sample size for the training set:

   • Not applicable. The Keeler Applanation Tonometer is a mechanical device, not a machine learning model. Therefore, it does not have a "training set."

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

   • Not applicable. As there is no training set, there is no ground truth for a training set.

Ask a specific question about this device