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HEINE Direct ophthalmoscopes are intended for examination of the media (cornea, aqueous humour, lens, vireous humour) and retina of the eye.

HEINE BETA® 200, HEINE BETA® 200S and HEINE K180® Ophthalmoscopes are battery powered hand-held devices to that provide illumination, viewing optics, apertures and filters in order to examine the media and the retina of a patient's eye. Each device consists of an instrument head with bulb and a battery handle that can be attached to the instrument head. The devices are differentiated by the various number and type of apertures and filters and by the different range and number of corrective lenses.

This document is a 510(k) premarket notification for HEINE BETA® 200, HEINE BETA® 200S, and HEINE K180® Direct Ophthalmoscopes. It asserts substantial equivalence to a predicate device. As such, it does not detail a clinical study with acceptance criteria and device performance in the way a de novo or PMA submission might.

Therefore, many of the requested criteria cannot be directly extracted from this document, as a substantial equivalence filing focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, often through non-clinical testing and comparison of technological characteristics.

Here’s what can be inferred or directly stated from the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in a 510(k) summary focused on substantial equivalence. The document states that the devices were "tested according to the 'Ophthalmoscope Guidance' in respect to optical radiation hazard with ophthalmoscopes (ISO 10942)" and "additional testing in accordance with applicable requirements of ISO 15004-2 'Ophthalmic instruments - Fundamental requirements and test methods' has been performed." However, specific acceptance criteria for these tests or the quantitative performance results are not detailed.

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

No clinical test set data or sample sizes are mentioned because this is a 510(k) submission based on substantial equivalence, relying on non-clinical performance testing and comparison to a predicate device.

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):

Not applicable, as no clinical test set requiring expert-established ground truth is described.

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

Not applicable, as no clinical test set requiring adjudication is described.

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 a direct ophthalmoscope, a diagnostic tool used by a human practitioner. It is not an AI-assisted diagnostic system, nor is an MRMC study described.

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

Not applicable, as this is a physical diagnostic device, not an algorithm, and is intended for human-in-the-loop use.

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

Not applicable, as no clinical test set requiring ground truth is described. The performance testing appears to be against international standards for ophthalmoscopes, which would specify technical requirements rather than clinical performance metrics based on ground truth.

8. The sample size for the training set:

Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.

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The HEINE SIGMA® 250 (M2) are battery powered indirect ophthalmoscopes for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

The HEINE SIGMA® 250 (M2) are indirect ophthalmoscopes, worn on the user's head to provide illumination and viewing optics in order to examine the media and the retina of a patient`s eye. The indirect ophthalmoscopes are battery operated.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification for an ophthalmoscope, which is a physical diagnostic device, not an AI/software-based device.

Therefore, it does not include:

1. Acceptance criteria or device performance for an AI algorithm.
2. Sample sizes for test sets, data provenance, or details about training sets.
3. Information on expert involvement (number, qualifications, adjudication methods) for establishing ground truth.
4. Details on AI-specific studies like MRMC comparative effectiveness or standalone algorithm performance.
5. Types of ground truth used in the context of AI models (e.g., pathology, outcomes data).

The document focuses on demonstrating substantial equivalence to a predicate ophthalmoscope based on intended use, technological characteristics, and safety standards for the physical device. It mentions "non-clinical performance testing" for the ophthalmoscope itself, referring to compliance with ISO standards for optical radiation and fundamental requirements, not the performance of a diagnostic AI.

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The HEINE mini 3000 Ophthalmoscope is a battery powered hand-held device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

The HEINE mini 3000® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the media and the retina of a patient's eye. It consists of an instrument head and a battery handle that can be screwed onto the instrument head. The ophthalmoscope can be either operated by replaceable AA batteries or a rechargeable option in combination with the HEINE mini NT® charger.

This document describes the HEINE mini 3000® Ophthalmoscope and its compliance with relevant standards. Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The device's acceptance criteria are based on safety limits for optical radiation hazards as defined by the "Ophthalmoscope Guidance" (ISO 10942) and "Ophthalmic instruments - Fundamental requirements and test methods" (ISO 15004-2). The study demonstrates that the HEINE mini 3000® Ophthalmoscope meets these safety requirements.

Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria

The study conducted to prove the device meets the acceptance criteria is a Summary of Non-Clinical Performance Testing. This involved bench testing according to specific international standards.

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

• Test Set Sample Size: Not explicitly stated as this is non-clinical bench testing of the device itself, not a study involving human subjects or data sets. The testing focuses on the physical properties and emissions of a single device or device type.
• Data Provenance: The testing was conducted by Seibersdorf Laboratories in Germany (indicated by the report date "11.06.2013" and the "Issued by Seibersdorf Laboratories" line). This is non-clinical, prospective testing on the physical device.

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

• Not applicable. This is not a study requiring expert readers or interpretation of medical images. The ground truth is established by the specified international standards and measurement protocols, conducted by the testing laboratory.

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

• Not applicable. This is not a study requiring adjudication of expert opinions. The measurements directly compare device performance against defined safety limits in established standards.

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 (ophthalmoscope) and its safety compliance, not an AI-powered diagnostic system.

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

• Not applicable. This is a physical medical device, not an algorithm. The testing is a standalone assessment of the device's physical properties.

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

• The ground truth is defined by the safety limits and test specifications set forth in the international standards ISO 10942 and ISO 15004-2. These are established engineering and medical device safety standards.

7. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

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This instrument is designed for examination of the eye.

BETA handles are designed exclusively for use with medical examination instruments with bulb illumination.

The HEINE BETA 200® Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the retina of a patient's eye. It consists of an instrument head and a battery handle that can be attached to the instrument head.

Here's an analysis of the provided text regarding the HEINE BETA 200® Ophthalmoscope, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not outline specific, quantified acceptance criteria for performance; instead, it demonstrates substantial equivalence to a predicate device (HEINE mini 3000® LED Ophthalmoscope) mainly through comparisons of design, intended use, and technical specifications. The general acceptance criterion seems to be that the new device performs at least equivalently or acceptably based on known standards for ophthalmoscopes.

The focus is on demonstrating that the new device (HEINE BETA 200® Ophthalmoscope) does not introduce new safety or effectiveness concerns compared to the predicate. Therefore, the "reported device performance" is largely presented in the context of these comparative characteristics rather than discrete pass/fail metrics.

Table of Acceptance Criteria and Reported Device Performance

Note 3 Explanation for Differences in Illumination (from text):
a) LED color temperature is constant with changing battery voltage; halogen changes. This implies LED is superior in color consistency.
b) Color reproduction of LED (4000K) is comparable to halogen. This indicates that despite different technologies, the outcome in terms of color is equivalent.
c) XHL (halogen in new device) has lower light output than LED, but maximum exposure time is specified in instructions for use. This mitigates potential safety concerns due to light intensity.

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 primarily describes a desk-based substantial equivalence comparison against a predicate device and non-clinical performance testing (bench testing). It does not mention a clinical study with a "test set" of patients or data in the way an AI/software device would generally have.

The compliance testing against ISO standards (ISO 10942, ISO 15004-2) would involve testing individual devices or components, but details of sample sizes for these tests are not provided in this summary. The data provenance is implied to be from internal HEINE Optotechnik testing (Germany).

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 as the submission is for a hardware ophthalmoscope and relies on a substantial equivalence claim and non-clinical testing, not a study requiring expert-established ground truth on clinical images or diagnoses.

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

This information is not applicable as there is no clinical study involving human readers or a test set requiring adjudication in the context of this 510(k) submission.

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

An MRMC comparative effectiveness study was not done. This 510(k) is for a hardware medical device (an ophthalmoscope), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

A standalone performance study was not done. This is a hardware device; there is no a standalone "algorithm" to evaluate.

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

The concept of "ground truth" as typically applied to AI or diagnostic imaging software is not applicable here. For this hardware device, the "ground truth" for its performance is established by its adherence to specified technical parameters, functionality, and compliance with recognized international standards (ISO 10942, ISO 15004-2, IEC 60601-1). These standards set benchmarks for device output (e.g., light intensity), safety (e.g., temperature), and performance characteristics.

8. The sample size for the training set

This information is not applicable as there is no AI algorithm or software being trained. The device is a traditional hardware ophthalmoscope.

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

This information is not applicable as there is no AI algorithm or software being trained, and thus no training set or ground truth for it.

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The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics intended to examine media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.

The ophthalmoscope is a hand-held, battery-powered device containing illumination and viewing optics.

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific acceptance criteria. The document is an FDA 510(k) clearance letter for "Ophthalmoscopes Diagnostic Instrument Kits." It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.

The document does not contain details regarding:

• A table of acceptance criteria and reported device performance
• Sample sizes or data provenance for any test sets
• Number or qualifications of experts for ground truth establishment
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes
• Standalone algorithm performance studies
• Type of ground truth used
• Sample size for training sets
• How ground truth for training sets was established

The letter primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence.

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The HEINE mini 3000® LED Ophthalmoscope is a battery powered hand-held device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

The HEINE mini 3000® LED Ophthalmoscope is a battery powered hand-held device to provide illumination and viewing optics in order to examine the retina of a patient's eve. It consists of an instrument head and a battery handle that can be screwed onto the instrument head. The ophthalmoscope can be either operated by replaceable AA batteries or a rechargeable option in combination with the HEINE mini NT® charger.

This document is a 510(k) premarket notification for a medical device, the HEINE mini3000® LED Ophthalmoscope. It primarily focuses on demonstrating substantial equivalence to a predicate device (Piccolight® E50 Ophthalmoscope), rather than providing a detailed study proving the device meets specific acceptance criteria via clinical performance data.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the typical sense of performance metrics for a diagnostic accuracy study (e.g., sensitivity, specificity, AUC). Instead, it compares the technical specifications and intended use of the HEINE mini3000® LED Ophthalmoscope to a predicate device, Piccolight® E50 Ophthalmoscope, to establish substantial equivalence.

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is a premarket notification (510(k)) for substantial equivalence. It does not involve a clinical trial or performance study in the way a new diagnostic algorithm would. Instead, it argues that the HEINE mini3000® LED Ophthalmoscope is as safe and effective as a legally marketed predicate device (Piccolight® E50 Ophthalmoscope) because:

• Its intended use is the same.
• Its technological characteristics are similar, and any differences (e.g., LED vs. halogen, additional apertures, red-free filter) do not raise new questions of safety or effectiveness and in some cases offer benefits.
• It complies with relevant consensus standards for medical devices and ophthalmic instruments (ISO 10942, ISO 15004-2, IEC 60601-1, IEC 60601-1-2).

Specific Information Requested:

1. A table of acceptance criteria and the reported device performance: See above. The acceptance criteria here are demonstrated "sameness" or justified differences compared to the predicate, and compliance with recognized standards.

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

   • Not applicable / No specific test set in the clinical performance sense. This submission is based on engineering design, technical specifications, and compliance with international standards, rather than clinical performance data from a "test set" of patients or images. The "data" provenance would be internal engineering tests and standard compliance reports.

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):

   • Not applicable. No ground truth was established by experts for a clinical performance test set in this context.

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

   • Not applicable. No clinical test set or adjudication was performed for this type of submission.

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 device is a manual ophthalmoscope, not an AI-assisted diagnostic tool.

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

   • No. This device is not an algorithm; it's a physical medical instrument requiring human operation.

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

   • Not applicable. The "ground truth" for this submission revolves around engineering specifications, safety testing (e.g., electrical safety, optical radiation hazards), and comparison to the predicate device's established safety and effectiveness.

8. The sample size for the training set:

   • Not applicable. No "training set" in the context of machine learning or clinical study data was used.

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

   • Not applicable.

In summary, this document demonstrates substantial equivalence for a medical device by comparing its design, intended use, and technical specifications to those of a legally marketed predicate device, and by showing compliance with relevant safety and performance standards. It is not a clinical study assessing diagnostic performance or AI effectiveness.

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The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.

The ophthalmoscope kits described in this submission include a battery handle and attachments which serve the intended use below. The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details (sample size, data provenance, expert numbers/qualifications, adjudication methods), or study types (MRMC, standalone). The document is a 510(k) clearance letter from the FDA for an Ophthalmoscope Diagnostic Instrument Kit, primarily confirming substantial equivalence and outlining regulatory compliance requirements. It does not include a performance study summary.

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An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.

All Kirchner & Wilhelm ophthalmoscopes are battery powered. The Piccolight E50 and Eurolight E10 and E30 are single aperture ophthalmoscopes while the Piccolight E56 and Eurolight E36 have six apertures each. The Piccolight and Eurolight series are different in the handles, with Piccolight handles made of PA 6 GF 30% while Eurolight handles are made of metal. The Piccolight E50 and Eurolight E10 heads are same as the Eurolight E30 head except for the locking system. Similarly, but for the locking system, the Piccolight E56 and Eurolight E36 heads are the same.

This document is a 510(k) summary for ophthalmoscopes. It's a regulatory submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study reporting on the device's performance against specific acceptance criteria in a clinical trial or stand-alone testing. Therefore, many of the requested details, such as sample sizes, expert qualifications, and specific effectiveness metrics, are not applicable or available within this type of document.

However, I can extract information related to product specifications and how the device aims to meet the regulatory requirements for safety and effectiveness through comparison to predicate devices.

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

Since this is a 510(k) submission and not a clinical study report, formal "acceptance criteria" for performance metrics in the typical sense of a clinical trial are not presented. Instead, the document demonstrates substantial equivalence to predicate devices based on functional characteristics and intended use. The "reported device performance" is essentially its similarity to the predicate devices in the listed attributes.

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

This document does not describe "test sets" in the sense of patient data for evaluating a diagnostic or therapeutic algorithm. The assessment is qualitative by comparing device specifications and intended use to predicate devices and adherence to recognized standards. Therefore, there is no sample size or data provenance in this context.

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)

Not applicable. This is not a study assessing diagnostic performance against a ground truth.

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

Not applicable. This is a submission for a medical device (ophthalmoscope) and 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 involves a physical medical device.

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

Not applicable. The "ground truth" for this submission are the established safety and effectiveness profiles of the predicate devices and conformity to recognized international standards.

8. The sample size for the training set

Not applicable. There is no machine learning or AI algorithm described in this submission.

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

Not applicable.

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The 66 Vision Tech Ophthalmoscopes (Indirect and Direct) are intended to examine the cornea, aqueous, lens and vitreous and the retina of the eye.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA to Suzhou 66 Vision Tech Co., Ltd. for their ophthalmoscopes. It confirms that the device is substantially equivalent to a legally marketed predicate device.

This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter is an administrative approval based on substantial equivalence, meaning the device is considered as safe and effective as a previously cleared device. It does not typically require detailed performance studies and acceptance criteria to be submitted or reviewed in the same way a Premarket Approval (PMA) would.

Therefore, I cannot provide the requested information based solely on the provided text. The document primarily focuses on the regulatory approval process and not on the specifics of a performance study demonstrating acceptance criteria.

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The Optyse™ Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used by trained professionals to examine the fundus or the inside of the back of the eye.

The Optyse™ is a compact battery-powered handheld direct ophthalmoscope for use by trained personnel for viewing the fundus or the inside of the back of the eye of a patient.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Clarity of View	Equivalent performance
   Ability to Visualize Abnormalities	Equivalent performance

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

   • Sample Size: Not explicitly stated, but described as "user studies comparing the effectiveness of the Optyse™ with legally marketed ophthalmoscopes."
   • Data Provenance: Not explicitly stated, but the studies were conducted by "practising optometrists," suggesting they involved real-world clinical use. It is prospective as it describes clinical performance which would be observed during testing.

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

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: The ground truth was established by "practising optometrists." The specific number or their experience level (e.g., years of experience) is not provided.

4. Adjudication Method for the Test Set:

   • Not explicitly stated. The document mentions "user studies comparing the effectiveness," which might imply a qualitative assessment rather than a formal adjudication method.

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

   • Not applicable/Not performed. The submission describes "user studies" that assessed "equivalent performance" by optometrists using the device in comparison to other ophthalmoscopes. This is not presented as an MRMC study designed to quantify human reader improvement with or without AI assistance.

6. Standalone Performance:

   • Yes, a standalone performance was done for the device itself.
     • Non-clinical tests: The Optyse™ device underwent compliance testing to two engineering standards: ISO 10942:1998 (Ophthalmic Instruments – Direct Ophthalmoscopes) and IEC 60601-1:1988 (Medical Electrical Equipment - Part 1 Requirements for Safety (General)). Declarations of conformity were provided for both.
     • Clinical performance: User studies were conducted to compare the device's effectiveness.

7. Type of Ground Truth Used:

   • Expert consensus/clinical assessment by "practising optometrists" regarding "clarity of view and ability to visualise abnormalities."

8. Sample Size for the Training Set:

   • Not applicable/Not stated. The Optyse™ is a hardware medical device (an ophthalmoscope), not an AI/algorithm. Thus, it does not have a "training set" in the context of machine learning.

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

   • Not applicable, as it's a hardware device and not an AI/algorithm that requires a training set.

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