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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:

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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 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 indirect ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered 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 OMEGA® 500 is an indirect ophthalmoscope, worn on the user's head to provide illumination and viewing optics in order to examine the retina of a patient's eve. The ophthalmoscope can be operated either by rechargeable battery or directly by mains power supply. The HEINE OMEGA® 500 allows wireless comfortable movement for the user and mobile charging (depending on chosen power source).

The provided document is a 510(k) summary for the HEINE OMEGA® 500 indirect ophthalmoscope. This type of submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria through clinical studies. Therefore, the information regarding acceptance criteria and performance studies in the traditional sense of a clinical trial (e.g., sample size, expert reader qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not present.

However, the document does provide information that can be interpreted as demonstrating the device meets certain performance expectations by showing its similarity to already cleared predicate devices. The "acceptance criteria" here are effectively the characteristics and performance levels of the predicate devices which the HEINE OMEGA® 500 aims to match or justify as equivalent.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission uses a comparative table to demonstrate substantial equivalence to predicate devices across various technical and safety parameters. The "Acceptance Criteria" for the HEINE OMEGA® 500 are implied by the characteristics of the predicate devices, and the "Reported Device Performance" is the stated characteristic of the HEINE OMEGA® 500.

Justification for differences (Justification 1, 2, 3):

• Justification 1 (Light Output/Irradiance): The HEINE OMEGA® 500 has lower maximum light output (lx) and retinal irradiance (mW/cm²) compared to some predicate devices. The justification argues that this lower output is acceptable because:
  • The FDA guidance advises using the minimal brightness needed for visualization.
  • Lower levels allow for longer exposure durations and reduce potential ocular damage.
  • Referenced literature ([12b]) suggests a minimum retinal irradiance of 6.3 mW/cm² is needed for viewing human fundi. The HEINE OMEGA® 500's measured irradiance (323.54 mW/cm² for LED and 465.77 mW/cm² for Halogen) is significantly higher than this minimum (51-74 times higher).
  • Therefore, the lower light output is considered safe and effective, and the device is equivalent.
• Justification 2 (Light apertures): The HEINE OMEGA® 500 has a slightly smaller "small circle" diameter for light apertures compared to the NEITZ IO-a. This difference is stated not to affect the safety or effectiveness of the device.
• Justification 3 (Interpupillary distance adjustment): The HEINE OMEGA® 500 allows for a smaller minimum interpupillary distance (46 mm) compared to predicate devices, benefiting users with eyes that are close together. This is stated not to affect the safety or effectiveness of the device.

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

Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical study involving a test set of patient data to evaluate algorithmic performance. The "testing" referred to is non-clinical performance and safety testing (e.g., electrical safety, optical radiation hazard).

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

Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was used.

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 ophthalmoscope, a diagnostic instrument that is directly used by a medical professional. It does not incorporate AI or provide assistance to human readers in the way an AI-powered image analysis tool would. Therefore, an MRMC comparative effectiveness study regarding AI assistance is irrelevant.

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

Not applicable. The HEINE OMEGA® 500 is a physical medical device, an indirect ophthalmoscope, and does not have an "algorithm-only" or "AI" component to be evaluated in standalone performance.

7. The type of ground truth used

Not applicable in the context of a clinical performance study. The "ground truth" here is the established performance and safety characteristics of the predicate devices and relevant industry standards (e.g., IEC 60601-1, ISO 10943). The device's compliance with these standards and its similarity to predicate performance data are the basis for equivalence.

8. The sample size for the training set

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

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

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

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HEINE GAMMA aneroid sphygmomanometers are exclusively designed for measuring blood pressure at the upper arm or thigh on healthy skin.

The HEINE Gamma aneroid sphygmomanometers are non-invasive blood-pressure measurement devices to measure systolic and diastolic blood pressure in adults and pediatric patients. The HEINE Gamma sphygmomanometers consist of a large insufflation bulb, a gauge with a large diameter scale, a valve, and a single tube cuff with Velcro fastener.

The HEINE Gamma sphygmomanometers come in five models; G5, G7, GP, GST, and XXL LF. The models comprise either a push-button valve or a spin valve. The HEINE Gamma GST comprises an integrated stethoscope for self measurement. The HEINE Gamma XXL LF is a wall-, desk-, or rail-mounted devices and is available with a wheeled stand. HEINE Gamma G5, G7, GP, and XXL LF will be available in five cuff sizes; child small, child, adult small, adult, and thigh. The HEINE Gamma GST comes with an adult cuff.

The HEINE Gamma aneroid sphygmomanometers are intended for use in a wide variety of settings. This includes hospital departments, medical practices, and nursing homes, as well as home health care.

The provided text describes the HEINE Gamma aneroid sphygmomanometers and their substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a detailed study description with performance metrics in the format requested.

The document states:

• Bench Testing was conducted to demonstrate Safety and Effectiveness by conformance to the ANSI/AAMI SP9-1994 standard for non-automated Sphygmomanometers.

This indicates that the device's performance was evaluated against a recognized standard for non-automated sphygmomanometers. However, the specific acceptance criteria within that standard (e.g., maximum allowable error) and the reported device performance against those criteria are not detailed in the provided text.

Therefore, I cannot populate the table or answer most of the specific questions as the information is not present in the given document.

Here's a breakdown of what can and cannot be answered based only on the provided text:

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

• Cannot provide. The document states conformance to the ANSI/AAMI SP9-1994 standard, but it does not list the specific numerical acceptance criteria from that standard nor the actual measured performance of the HEINE Gamma devices against those criteria.

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

• Cannot provide. The document mentions "Bench Testing" but does not detail the sample size or data provenance for any test set.

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 for this type of device/study as described. For a blood pressure monitor, "ground truth" would typically come from a reference measurement (e.g., mercury sphygmomanometer) and not an expert consensus on interpreting images or clinical cases. The document does not describe such a process.

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

• Not applicable/Cannot provide. Adjudication methods are typically used in studies involving expert review of ambiguous cases, which is not described for this device's 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

• No. This is not an AI-assisted diagnostic device, but a manual blood pressure monitor. MRMC studies are not relevant here.

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

• Not applicable. This is a manual, non-automated device, so there is no algorithm in the traditional sense or standalone performance to evaluate. The device itself is the "standalone" entity in terms of measurement.

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

• Inferred: For blood pressure monitors, "ground truth" for accuracy studies typically involves comparison against a reference standard measurement, often a mercury sphygmomanometer or another highly accurate calibrated device. However, the document does not explicitly state the method of ground truth establishment.

8. The sample size for the training set

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

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

• Not applicable. As above, no training set.

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