Search Results

The SLIT LAMP SL-2000 is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. This device is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

The SLIT LAMP SL-2000 is used to magnify the eyeball, eyelid, and eyelash of patients for observation, using slit illumination light.

The SL-2000 comprises the main unit that incorporates the microscope unit, illumination unit, base plate unit, and power supply box.

This document is a 510(k) premarket notification for the Nidek Co., Ltd. Slit Lamp SL-2000. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria. Therefore, much of the requested information regarding specific performance metrics, clinical study design, and ground truth establishment is not present in this document because it is not typically required for a 510(k) submission for a device like a slit lamp.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) for the slit lamp, as it is a diagnostic tool observed by a human, not an automated diagnostic system. Instead, it focuses on demonstrating that the device meets safety and performance standards equivalent to predicate devices. The "performance" mentioned primarily refers to compliance with international standards for ophthalmic instruments and electrical safety.

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

The document does not detail specific "test set" sample sizes in the context of clinical performance data for diagnosis of diseases. The testing described is primarily limited to bench testing and compliance with engineering and safety standards. There is no mention of clinical data or patient samples being used in the validation tests outlined.

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

Not applicable, as a clinical test set with ground truth established by experts is not described in this document for a device like a slit lamp in a 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable, as a clinical test set with expert adjudication is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

Not applicable. The Slit Lamp SL-2000 is a manual observation device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI improvement metrics are relevant or discussed.

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

Not applicable, as this is a manually operated medical device without an AI algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of clinical diagnostic accuracy. The "ground truth" for the tests performed would be the specifications and requirements outlined in the referenced ISO, IEC, and AAMI/ANSI standards (e.g., a specific light intensity, magnification, or electrical characteristic).

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that requires a training set.

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

Not applicable, as this is not an AI/machine learning device.

Ask a specific question about this device

The SLIT LAMP is an AC-powered slit lamp biomicroscope that is intended for use in examining the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye.

The slit lamp is an instrument consisting of a high-intensity light source that can be focus to shine a thin sheet of light into the eye. The binocular slit-lamp examination provides a stereoscopic magnified view of the eye structure in detail, enabling diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye. The device consists of a base plate, chin rest, fixation light, illumination light, slit project, focusing ring and other accessories that in aid of examination. The patients can rest their chin and forehead on a support to keep the head steady.

It is powered by the specified adapter (model: MDS-060BAS12A) which is certificated by ANSI/AAMI ES 60601-1 and considered as part of this equipment. Appliance coupled with US Plug.

The provided document is a 510(k) summary for a medical device called "SLIT LAMP, Model: YF-100." This document outlines the device's technical specifications, intended use, and its comparison to a legally marketed predicate device to demonstrate substantial equivalence.

However, the document describes a traditional medical device (a physical slit lamp biomicroscope), not an AI/ML-driven device. As such, it does not contain information about acceptance criteria or a study proving an AI device meets those criteria. The testing performed is related to electrical safety, EMC compliance, environmental tolerance, and photo-biological safety of the hardware, not the performance of an algorithm or AI model in diagnostic tasks.

Therefore, I cannot extract the specific information requested regarding AI/ML device acceptance criteria and study data because the provided text does not describe such a device or study.

To address your request, if this were an AI/ML device, the sections would typically describe:

1. A table of acceptance criteria and the reported device performance: This would involve metrics like sensitivity, specificity, accuracy, AUROC, positive/negative predictive values, or agreement rates for a diagnostic task. The document would list the target values for these metrics and the actual achieved values from the study.
2. Sample size used for the test set and the data provenance: Details on the number of cases (e.g., images, scans, patient records) in the test set, and whether the data was collected retrospectively or prospectively, and its geographic origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For AI in medical imaging, this would involve radiologists, ophthalmologists, pathologists, etc., with specified experience levels (e.g., board-certified, years of experience).
4. Adjudication method for the test set: How disagreements among experts were resolved to establish the final ground truth (e.g., majority vote, senior expert arbitration, additional expert review).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: An MRMC study assesses the performance of human readers with and without AI assistance to quantify the improvement. The effect size (e.g., increase in sensitivity, decrease in false positives) would be reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Performance metrics of the AI algorithm operating independently, without human interaction.
7. The type of ground truth used: Whether it was expert consensus, pathology confirmation, clinical outcomes data, or a combination.
8. The sample size for the training set: The number of cases used to train the AI model.
9. How the ground truth for the training set was established: The process for labeling or annotating the training data to provide the AI with correct answers to learn from.

Given the content of the provided document, I must state that it does not contain the information necessary to fulfill your request for an AI/ML device.

Ask a specific question about this device

The Slit Lamp SL-D301 is an AC-powered slitlamp 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 which affect the structural properties of the anterior eye segment.

This instrument is a slit lamp to observe, examine and photograph the eyeball and appendage of the eye. The slit lamp has the illumination unit for illumination and the binocular stereo microscope, and allows for stereoscopic observation. This instrument allows users to photograph and save the observed images by combining with an accessory, the digital camera unit DC-4. This instrument consists of the main body and accessories.

The document is a 510(k) summary for the Topcon Slit Lamp SL-D301, which is an AC-powered slitlamp biomicroscope.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide a table with specific acceptance criteria (e.g., numerical thresholds for performance metrics) or directly compare the device performance against such criteria in a quantitative manner. Instead, it states that the device was found to be "substantially equivalent" to a predicate device based on its intended use, indications for use, and similar technological characteristics, and compliance with recognized consensus standards.

The closest to "acceptance criteria" and "reported device performance" are statements of compliance with standards:

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

The document explicitly states "The following bench testing was conducted...". This indicates that the study primarily involved laboratory-based evaluations against engineering and safety standards, rather than clinical studies using patient data. Therefore, concepts like "sample size for the test set" or "data provenance (country of origin, retrospective/prospective)" in the context of patient data do not apply here.

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)

Given that the study was bench testing for compliance with technical standards, there were no "experts" in the sense of clinical specialists establishing ground truth on patient data. The "ground truth" was defined by the requirements of the recognized consensus standards themselves.

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

Not applicable, as this was bench testing against technical standards, not a clinical study requiring adjudication of expert interpretations.

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 was performed or mentioned. This device is a Slit Lamp, a diagnostic instrument for direct observation by clinicians, and does not involve AI or human-in-the-loop assistance in the diagnostic aid sense that would warrant an MRMC study.

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

Not applicable. The device is a physical instrument for observation. It does not perform an "algorithm only" task in the absence of a human operator.

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

The "ground truth" in this context refers to the requirements and specifications set forth in the recognized consensus standards (e.g., IEC 60601-1, ISO 10939, etc.). The device was tested to ensure it met these predetermined engineering and safety specifications.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that would require a training set.

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

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

Ask a specific question about this device

The MediWorks Model S series Slit Lamps are AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

AC-powered slit lamp biomicroscopes

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Shanghai Mediworks Precision Instruments Co., Ltd. for a Slit Lamp Microscope. This document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or study details. It primarily focuses on the FDA's determination of substantial equivalence to a predicate device and regulatory requirements. Therefore, I cannot fulfill your request based on the given input.

Ask a specific question about this device

The Slit Lamp SL-D701 is an AC-powered slittlamp 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 which affect the structural properties of the anterior eye segment.

The Slit Lamp SL-D701 is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. The Slit Lamp SL-D701 is composed of the following components: microscope unit, illumination unit, base unit, chinrest, table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.

This document is a 510(k) Summary for the Topcon Slit Lamp SL-D701, a medical device. It provides information for substantial equivalence to previously cleared predicate devices. However, it does not include information about acceptance criteria and a study proving that the device meets those criteria, as typically seen in submissions for AI/ML-enabled devices.

The document states that the Topcon Slit Lamp SL-D701 is substantially equivalent to the predicate devices:

• Haag-Streit AG Slit Lamp BM 900, BQ 900, BP 900 (K100202)
• TOPCON CORPORATION Slit Lamp SL-2G (K110489)

The key takeaway is that this is a traditional medical device (Slit Lamp Biomicroscope), and the submission focuses on demonstrating substantial equivalence to existing devices based on similar intended use, technological characteristics, principles of operation, and compliance with recognized consensus standards. There is no mention of AI/ML, algorithms, or any associated acceptance criteria, test sets, or ground truth establishment studies typically required for such technologies.

Therefore, most of the requested information regarding acceptance criteria and a study proving an AI/ML device meets them is not applicable to this document.

Here's an attempt to answer the questions based on the provided document, highlighting where the information is not present or not applicable:

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

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

This information is not applicable to this 510(k) submission, as it describes a traditional hardware device (slit lamp) and not an AI/ML diagnostic algorithm that would require a test set of data samples. The performance data presented refers to bench testing against international standards for ophthalmic instruments.

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)

This information is not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices, not for the physical performance testing of a slit lamp as described here. The "performance data" refers to compliance with engineering and safety standards.

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

This information is not applicable. Adjudication methods are used in studies involving human interpretation or AI/ML evaluations to resolve disagreements in ground truth or diagnostic outputs. This submission focuses on bench testing.

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This type of study is typically conducted for AI/ML-assisted diagnostic devices to measure the impact of the AI on human reader performance, which is not relevant for this traditional slit lamp submission.

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

This information is not applicable. The device is a physical slit lamp biomicroscope; there is no standalone algorithm to evaluate.

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

This information is not applicable. The "ground truth" for this device's performance is its adherence to specified engineering and safety standards (e.g., light hazard protection, general requirements for ophthalmic instruments), as demonstrated through bench testing. There is no diagnostic "ground truth" in the context of disease detection or image interpretation for a software algorithm.

8. The sample size for the training set

This information is not applicable. There is no mention of a training set, as the device is a physical instrument, not an AI/ML algorithm that learns from data.

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

This information is not applicable, as there is no training set mentioned or implied for this traditional medical device.

Ask a specific question about this device

The SL 115 Classic Slit Lamp, SL 120 Slit Lamp and SL 130 Slit Lamp are AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. They are used to aid in the diagnosis of disease or trauma which affect the structural properties of the anterior eye segment.

The optional SL cam 5.0 is a digital imaging solution that allows the user to take images and video sequences for documentation purposes of the anterior eye segment during slit lamp examinations.

The SL 115 Classic Slit Lamp, SL 120 Slit Lamp and SL 130 Slit Lamp, combined with SL cam 5.0 are intended for use by physicians and ophthalmologists.

The SL 115 Classic Slit Lamp, SL 120 Slit Lamp and the SL 130 Slit Lamp can perform a wide range of eye care applications. They are used for ophthalmic observation and image documentation of structural properties of the eye. The slit controls of the SL 115 Classic Slit Lamp, SL 120 Slit Lamp and the SL 130 Slit Lamp allow horizontal slit adjustment from either the right or left, vertical slit adjustments with a pinhole-type slit and allow viewing with the slit illuminator in the middle position. The instrument is primarily used by physicians, ophthalmologists, optometrists and eye care providers.

The optional SL cam 5.0 digital imaging solution provides an additional function to capture images and video sequences during an eye examination. It is not a data management system and it is not used for diagnosis. The SL cam 5.0 digital imaging solution does not control the slit lamps.

Here's a summary of the acceptance criteria and the study information based on the provided text for the Zeiss Slit Lamps with SL cam 5.0 digital imaging system:

1. Acceptance Criteria and Reported Device Performance

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

The document does not describe a clinical test set or data provenance for the SL 115 Classic Slit Lamp, SL 120 Slit Lamp, SL 130 Slit Lamp, or the SL cam 5.0. The non-clinical tests specified focus on conformance to international standards for safety, EMC, and software development. The primary evidence for performance is demonstrating substantial equivalence to predicate devices, rather than a new clinical study with a specific test set.

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

Not applicable. The submission is based on demonstrating compliance with standards and substantial equivalence to existing devices, not on a clinical study requiring expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set or adjudication method for the device's performance in a diagnostic or clinical context.

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. The device is a slit lamp with an optional imaging system for documentation and observation, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. The SL cam 5.0 is an imaging solution for documentation, not an algorithm that performs analysis without human interaction. The text explicitly states, "It is not a data management system and it is not used for diagnosis. The SL cam 5.0 digital imaging solution does not control the slit lamps."

7. The type of ground truth used

Not applicable. The submission relies on adherence to recognized performance standards and comparison to predicate devices, not on ground truth derived from expert consensus, pathology, or outcomes data for a new clinical performance claim.

8. The sample size for the training set

Not applicable. The device is not an AI/ML device that requires a training set.

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

Not applicable. The device is not an AI/ML device that requires a training set or associated ground truth.

Ask a specific question about this device

The Slit Lamp SL-2G is an AC-powered slitlamp 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 which affect the structural properties of the anterior eye segment.

The Slit Lamp SL-2G is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. The Slit Lamp SL-2G is composed of the following components: microscope unit, illumination unit, chinrest, table and power unit. The slitlamp biomicroscope is used for the observation of the eye. It has an illumination unit to illuminate the eye, and a binocular stereoscopic microscope to zoom and observe patient's eyes, and also can observe the three-dimensional image.

This submission describes a slit lamp biomicroscope, a medical device used for eye examinations. The acceptance criteria and supporting studies for this type of device are primarily focused on compliance with recognized performance standards related to safety, electromagnetic compatibility, and specific ophthalmic instrument requirements, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested elements (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable in the context of this traditional medical device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable for this type of device. The "test set" here refers to the device itself undergoing engineering and performance testing against established standards, not a clinical data set.

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

Not applicable. Ground truth for a physical medical device's compliance with safety and performance standards is established through engineering tests, measurements, and adherence to manufacturing specifications, not typically through expert consensus on a clinical test set.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" is not relevant for testing against engineering and performance standards.

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. This is a traditional medical device (slit lamp), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC comparative effectiveness study was performed or is relevant.

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

No. This is a manual medical device operated by a human, not an algorithm.

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 (IEC, ISO) and its demonstration of similar technological characteristics and performance parameters to previously cleared predicate devices. This involves direct measurement, engineering verification, and comparison of specifications.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not a machine learning algorithm.

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

Not applicable. There is no training set for this device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" demonstrating the device meets the acceptance criteria is a substantial equivalence comparison to predicate devices, supported by compliance with recognized international consensus standards.

• Substantial Equivalence: The Topcon Slit Lamp SL-2G was compared to the HAAG-STREIT Slit Lamps BM 900/BQ 900/BP 900 (K100202) and BC 900 (K982057).

  • Identical Intended Use/Indications for Use: Both the proposed device and predicates are intended for eye examination of the anterior eye segment to aid in diagnosing diseases or trauma.
  • Similar Technological Characteristics: Both are AC-powered slit lamp biomicroscopes that project a light beam into the patient's eye.
  • Equivalent Performance Parameters: "Exposure parameters including slit image width, slit image length, illumination field diameter and slit direction are all within the specifications of the previously cleared predicate devices."
  • Light Source: While the SL-2G uses an LED (max 160,000 Lux), this is noted as one of the available light sources for the predicate BM 900/BQ 900/BP 900 series (which has a maximum brightness up to 450,000 Lux). The SL-2G's brightness is within an acceptable range for a slit lamp.
  • Magnification: The SL-2G has the same magnification steps and eyepiece lens magnification as the predicate BP 900.

• Compliance with Standards: The device conforms to the following standards, which define electrical safety, electromagnetic compatibility, and specific requirements for ophthalmic instruments and slit lamp microscopes:

  • IEC 60601-1 (General Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • ISO 15004-1 (Ophthalmic Instruments - General Requirements)
  • ISO 15004-2 (Light Hazard Protection)
  • ISO 10939 (Slit Lamp Microscopes Specific)

The conclusion is that the Topcon Slit Lamp SL-2G is "substantially equivalent" to its predicate devices because it shares the same intended use, similar technological characteristics, and conforms to the same recognized performance standards. This demonstrates that the device meets safety and effectiveness requirements without raising new questions of safety or effectiveness.

Ask a specific question about this device

An AC-powered slitlamp biomicroscope 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 affect the structural properties of the anterior eye segment.

An AC-powered Slitlamp Biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light. The slit lamp illumination is composed of the light source, the slit; collimation and imaging optics, and infrared and ultraviolet filters and a dielectric mirror. The slit lamps have the option to combine a background illumination together with the slit illumination.

This 510(k) summary describes a traditional medical device (Slit Lamps BM 900 / BQ 900 / BP 900) and not an AI/ML powered device. As such, the input document does not contain the information required to answer the requested questions about acceptance criteria and a study proving device conformance for an AI/ML device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Slit Lamp BC 900) based on similar technology and function, and compliance with general safety and performance standards.

Therefore, I cannot provide a response for the following:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

The document only details the comparison of technological characteristics between the new devices and the predicate device, and the general safety and EMC data derived from testing one of the new models (BQ 900) against recognized standards (ISO 15004-2, ISO 10939, IEC 60601-1, IEC 60601-1-2). It concludes that the new devices are substantially equivalent to the predicate device and meet safety and effectiveness standards, but does not provide performance metrics or studies in the format requested for an AI/ML product.

Ask a specific question about this device

The Slit Lamps HS-5500, HS-7000, HS-7500 are 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 affect the structural properties of the anterior eye segment.

A slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, form the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. These devices are designed for use by ophthalmologists and optometrists (within the realms of their respective professions) for specific diagnostic procedures (bio-microscopic examination of the eye). The instrument is consist of a microscope, a swiveling illumination system providing a slit image and a power supply.

The provided document is a 510(k) summary for a Slit Lamp device (HS-5500, HS-7000, HS-7500). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical performance studies to meet specific acceptance criteria.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML or novel diagnostic device.

Here's why and what information is available:

• Acceptance Criteria & Reported Device Performance: This section is not applicable as the submission leverages substantial equivalence. There are no specific performance metrics like sensitivity, specificity, or accuracy that are typically associated with acceptance criteria for new diagnostic devices.
• Study Details (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, ground truth type, training set size/ground truth): These details are also not present because the submission for the Slit Lamp is based on demonstrating that its technological characteristics and intended use are similar to a previously cleared device (the predicate device HS-5000). The safety and effectiveness are established through compliance with electrical, mechanical, and environmental safety standards (IEC 60601-1 and IEC 60601-1-2), rather than through performance studies against a clinical ground truth.

What the document does state about "performance":

The "Performance Data" section (Section 8) focuses on safety and electrical compliance, not clinical performance or diagnostic accuracy.

• Acceptance Criteria (Implied for Safety & Electrical Performance):
  • Compliance with IEC 60601-1 (Electrical, mechanical, and environmental safety).
  • Compliance with IEC 60601-1-2(2001) (EMC testing).
• Reported Device Performance (for Safety & Electrical Compliance):
  • "The devices meet all requirements and passed all tests." (Page 2)

In summary, for the given Slit Lamp device 510(k) submission:

• A table of acceptance criteria and the reported device performance: Not applicable in the context of clinical performance. The "acceptance criteria" are compliance with specified electrical and safety standards, which the device reportedly met.
• Sample sized used for the test set and the data provenance: Not applicable. Performance was assessed via engineering and safety tests, not clinical data sets.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is a physical medical device, not an algorithm.
• The type of ground truth used: For safety testing, the "ground truth" is compliance with engineering standards.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

This 510(k) submission is indicative of a Class II medical device where the primary pathway to market is through demonstrating substantial equivalence to a predicate, often relying on engineering standards and shared technological characteristics rather than extensive new clinical performance studies.

Ask a specific question about this device

The SLIT LAMP, HS-5000 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 affect the structural properties of the anterior eye segment.

A slit lamp biomicroscope 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 affect the structural properties of the anterior eye segment. These devices are designed for use by ophthalmologists and optometrists (within the realms of their respective professions) for specific procedures (biomicroscopic examination of the eye). The instrument is consist of a microscope, a swivelling illumination system providing a slit image and a power supply. AC Power is converted to DC Power through the SMPS. DC Power is supplied to the Lamp providing the light. Light is converted to the slit image through the aperture, filter etc. The slit image is illuminate the eye. Observe the eye through the microscope.

The provided text describes a 510(k) premarket notification for a medical device called the "Slit Lamp HS-5000" by HUVITZ Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device, the "Slit lamp SL 990" by C.S.O.S.R.L.

However, the provided text does not describe a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML medical device would. Instead, it focuses on demonstrating safety and effectiveness for a traditional medical device (a slit lamp) through comparison with a predicate device and adherence to established safety and performance standards.

Therefore, many of the requested sections related to AI/ML device study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission confirms the device's adherence to relevant safety and EMC standards as its "acceptance criteria" for demonstrating safety and effectiveness. The "reported device performance" is its successful testing against these standards. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy) provided as would be expected for an AI/ML device.

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

• Not Applicable. This is a traditional medical device submission based on engineering and safety standards, not a clinical performance study with a test set of data.

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

• Not Applicable. Ground truth as understood in AI/ML is not relevant here. The "ground truth" for the device's functionality is its adherence to engineering and safety standards.

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

• 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:

• No. This is not an AI-powered device, and no MRMC study was conducted.

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

• No. This is not an algorithm-only device. It's a physical medical instrument.

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

• Not Applicable in the context of clinical "ground truth" for diagnostic performance. For the purpose of this submission, the "ground truth" for the device's safety and functionality is established by its compliance with recognized international safety and electromagnetic compatibility (EMC) standards (IEC 60601-1 and IEC 60601-1-2).

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable.

Ask a specific question about this device