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The CHROMOPHARE® E 778 and E 558 is intended to be used to provide visible illumination to the surgical field of the patient. The surgical lights BERCHTOLD CHROMOPHARE® E 778 and E 558 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

The new BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical lights are suitable for all types of surgical procedures. With the use of Light Emitting Diodes (LEDs) in these lights, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" and/or with downward "GuideLite" for endoscopic procedures. The lights could be combined among each other.

The provided 510(k) summary for the BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical lights does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/ML-driven medical devices.

This document describes a traditional medical device (surgical lamps) seeking substantial equivalence to a predicate device. The performance data provided are technical specifications of the surgical lights themselves, not a medical "performance" in the sense of diagnostic accuracy or clinical outcome that would require a study with a test set, ground truth, or expert review.

Therefore, many of the requested details are not applicable or cannot be extracted from this document.

However, I can extract the "acceptance criteria" in the context of device specifications and the "study" (referring to the testing against standards) as best as possible from the provided text.

Acceptance Criteria and Device Performance for BERCHTOLD CHROMOPHARE® E 778 and E 558 Surgical Lights

The acceptance criteria for the BERCHTOLD CHROMOPHARE® E 778 and E 558 surgical lights are primarily defined by their compliance with recognized international standards for medical electrical equipment and the direct comparison of their technical specifications to a predicate device. The "study" proving the device meets these criteria refers to the testing conducted to demonstrate conformance to these standards and the tabulated comparison to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the technical specifications of the predicate device and the specified performance standards. The "Reported Device Performance" column reflects the new device's compliance or its specific values where applicable.

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

• Sample Size: Not applicable in the context of clinical/diagnostic performance. The "test set" for this device would refer to sample units of the manufactured surgical lights that underwent laboratory testing to verify compliance with the specified standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-41). The document does not specify the number of units tested.
• Data Provenance: The testing data would be generated from laboratory tests conducted on the physical devices. The country of origin for the data is not explicitly stated but would presumably be Germany, where BERCHTOLD Holding GmbH is located, or a certified testing laboratory. The data is prospective in the sense that it describes the performance of the newly manufactured devices.

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

Not applicable. This is not a device that generates diagnostic output requiring expert interpretation for ground truth. The "ground truth" for a surgical light is its adherence to physical performance specifications (e.g., illuminance, color temperature, safety standards).

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method (like 2+1, 3+1) is relevant for evaluating the performance of a surgical light's physical specifications or compliance with engineering standards.

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

No. A MRMC study is not relevant for this type of medical device. This is not an AI/ML device, nor one where human readers interpret output.

6. Standalone (Algorithm Only) Performance Study

No. This is not an algorithmic device. Performance is determined by the physical properties and operation of the surgical light.

7. Type of Ground Truth Used

The "ground truth" for this device is the defined technical specifications outlined in international standards (e.g., IEC 60601-2-41) and the predicate device's performance. Measured physical parameters of the surgical light (e.g., central illuminance, irradiance, color rendering index) are compared directly against these established values/ranges.

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. No training set is used.

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The CHROMOPHARE® Exxx is intended to be used to provide of the device: visible illumination of the surgical field or the patient. The surgical lights BERCHTOLD CHROMOPHARE® E805, E800, E 655, E 650, E 550 and E 520 are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

The new BERCHTOLD CHROMOPHARE® E805, E800, E655, E650, E550, and E520 (collectively known and referred to in this document as CHROMOPHARE® Exxx) surgical lights are suitable for all types of surgical procedures. With the use of gas-discharging lamps or Halogen bulbs in these lights, BERCHTOLD realizes high illumination intensity with a lower heat radiation and less pattern variation compared to previous generations of BERCHTOLD products. The light features easy-to-operate swivel arms, auto switching to the secondary lamp in case of failure of the primary lamp, and an easy-to-exchange lamp cartridge. Each light functions with an optional integrated CCD video camera and/or with upward "EndoLite" for endoscopic procedures. The lights could be combined among each other.

The CHROMOPHARE® Exxx surgical lamps' acceptance criteria and the study that proves the device meets the acceptance criteria are described below.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CHROMOPHARE® Exxx surgical lights are based on their similarity to predicate devices (CHROMOPHARE® X65 and CHROMOPHARE® D650) and compliance with relevant electrical and surgical lamp performance standards.

The table below summarizes the key performance characteristics of the new devices (CHROMOPHARE® E805 and CHROMOPHARE® E655 are shown as examples for the metal halide discharging lamp technology, and CHROMOPHARE® E800, E650, E550, and E520 for the Halogen lamp technology) and compares them to the predicate devices, effectively serving as the reported device performance against the implicit acceptance criteria set by the predicate devices and performance standards.

Study Proving Device Meets Acceptance Criteria

The study demonstrating that the CHROMOPHARE® Exxx devices meet the acceptance criteria is a performance summary and comparison to predicate devices, and compliance with recognized standards. This is a common approach for 510(k) submissions where substantial equivalence is being claimed.

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

   • The document** does not specify a separate "test set" in the context of a clinical study or a dataset for an algorithm.**
   • The evaluation is based on a comparison of the technical specifications and performance metrics of the new devices against established predicate devices (CHROMOPHARE® X65 and CHROMOPHARE® D650) and relevant standards.
   • Data provenance: The data appears to be derived from the product specifications and performance testing conducted by the manufacturer, BERCHTOLD Holding GmbH, presumably in Germany (country of origin of the submitter). The nature of the data is technical specifications and performance characteristics, not patient-derived data, and thus doesn't fit the retrospective/prospective dichotomy in the typical clinical study sense.

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

   • This question is not applicable as the submission does not describe a study involving expert assessment of a test set to establish "ground truth" for a diagnostic or AI algorithm. The device is a surgical lamp, and its performance is evaluated against engineering and performance standards, as well as comparison to existing legally marketed devices.

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

   • This question is not applicable for the same reasons as above. There was no test set requiring expert adjudication.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (often AI-powered) where human reader performance is being evaluated, typically with and without AI assistance. The CHROMOPHARE® Exxx is a surgical lamp, not a diagnostic or AI-assisted device in that context.

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

   • No, a standalone algorithm performance study was not done. The CHROMOPHARE® Exxx is a physical medical device (surgical lamp), not an algorithm.

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

   • The "ground truth" in this context refers to established engineering and performance standards for surgical lamps, specifically:
     • IEC 60601-2-41:2001 for performance of surgical lamps.
     • IEC 60601-1 for electrical safety.
     • IEC 60601-1-2 for electromagnetic compatibility (implied by electrical safety).
   • Additionally, the performance of the predicate devices (CHROMOPHARE® D650 and CHROMOPHARE® X65) serves as a benchmark for "ground truth" to establish substantial equivalence.

7. The sample size for the training set:

   • This is not applicable. The device is not an AI/ML algorithm that requires a training set.

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

   • This is not applicable for the same reasons as above.

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The CHROMOPHARE® X 65 is intended to be used to provide used to provide visible illumination of the surgical field or the patient.
The surgical light BERCHTOLD CHROMOPHARE® X65 is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

The new BERCHTOLD CHROMOPHARE® X 65 surgical light is suitable for all types of surgical procedures. With the use of gas-discharging lamps in the new light BERCHTOLD realizes a higher illumination intensity with a lower heat radiation. The light incorporates easy-to-operate swivel arms auto switching on the second lamp in case of failure of the main lamp and an easy-to-exchange lamp cartridge. Also an optional CCD-video-camera is available and a special version with "EndoLite" for endoscopical working. The light could be combined with other BERCHTOLD lights.

The provided text is for a 510(k) premarket notification for a surgical lamp (CHROMOPHARE® X 65). This type of device approval primarily relies on demonstrating substantial equivalence to a previously approved predicate device, rather than performing clinical studies with specific acceptance criteria and outcome measurements like those for diagnostic AI devices.

Therefore, the requested information about acceptance criteria, device performance, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this submission.

Here's why and what information is provided:

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

• Not Applicable. For a surgical lamp, "acceptance criteria" would generally refer to adherence to design specifications, electrical safety standards (e.g., IEC 60601-1), electromagnetic compatibility (EMC), and performance specifications like illumination intensity, color temperature, and shadow reduction. The document does not provide a formal table of such criteria against measured performance for the CHROMOPHARE® X 65.
• What is reported: The device "realizes a higher illumination intensity with a lower heat radiation." This is a qualitative claim of improvement over the predicate, but not quantitative data against defined acceptance criteria within the provided text.

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

• Not Applicable. There is no "test set" in the context of clinical performance data for this device. The assessment is primarily based on engineering design, specifications, and comparison to existing technology.

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 experts were used for establishing a "ground truth" for a test set, as this is not a diagnostic device.

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

• Not Applicable. No test set or adjudication method akin to clinical performance studies were 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 is a surgical lamp, 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 is not an algorithm or AI device.

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

• Not Applicable. Ground truth in the context of clinical diagnostic accuracy is not relevant here. The "ground truth" for a surgical light's performance would be objective measurements of its physical properties (e.g., lux values, color rendering index, temperature at surgical site). These are not detailed in the summary.

8. The sample size for the training set:

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

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

• Not Applicable. (See point 8).

Summary of Relevant Information from the Provided Text:

The entire submission is focused on demonstrating substantial equivalence of the new device (CHROMOPHARE® X 65) to a legally marketed predicate device (BERCHTOLD CHROMOPHARE® D650, K965130).

• Rationale for Equivalence: "Any difference that exists between the CHROMOPHARE® D650 and the X 65 has no negative effect on safety or efficacy and actually enhances the usefulness in the chosen application."
• Key Technological Difference/Improvement: The new light uses "gas-discharging lamps" which enables "a higher illumination intensity with a lower heat radiation."
• Intended Use: To provide visible illumination of the surgical field or the patient.
• Predicate Device: BERCHTOLD CHROMOPHARE® D650 (K965130).

In essence, for this type of device, the "study" is the comparison against the predicate device based on technical specifications and design principles, rather than clinical performance data with specific acceptance criteria that would be expected for a diagnostic or therapeutic AI device.

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The surgical light, CHROMOPHARE® D 530 LDR, is intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

The new Berchtold CHROMOPHARE® D 530 LDR surgical light is suitable for all types of surgical procedures and offers the physician a natural (whiter) and "colder" light. The light quality is based on an optical double filter technique. The CHROMOPHARE® D 530 LDR provides a light intensity of up to 85000 lux. The light has features like a suspension mechanism will allow to move the light head motordriven up and down, auto-switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. The new suspension allows the surgeon to move the light out of the treatment area, which is of interest e.g. in labor and delivery rooms. The light has been designed to and meets the requirements of the IEC 601 and UL 544 regulation for safety.

This document is a 510(k) summary for a surgical light, the CHROMOPHARE® D 530 LDR. It seeks substantial equivalence to a predicate device, the CHROMOPHARE® D 500, based on safety and performance standards, not a clinical study involving specific acceptance criteria or an AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI-powered device is not applicable to this document.

The document does state:

• Device Performance (as described): The CHROMOPHARE® D 530 LDR provides a light intensity of up to 85000 lux. It offers a "natural (whiter)" and "colder" light based on an optical double filter technique. It also has features like motor-driven light head movement, auto-switching to a second lamp upon main lamp failure, and an easy-to-exchange lamp cartridge.
• Study Proving Device Meets Acceptance Criteria: The document states that the device "has been designed to and meets the requirements of the IEC 601 and UL 544 regulation for safety." This indicates compliance testing to established safety standards, which serve as the "acceptance criteria" in this context. It also states, "Safety of the lights, as indicated above, has been established by meeting the requirements of IEC 601 and UL 544."

No other information relevant to your specific questions about AI algorithm performance, sample sizes for AI training/testing, expert ground truth, or MRMC studies is present in this regulatory submission.

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The Surgical lights CHROMOPHARE® D500, D630 and D650, are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

The Berchtold CHROMOPHARE® D Series lights are suitable for all types of surgical procedures and offers the physician a natural (whiter) and "colder" light. The light intensity from 85000lx up to 150000 lux. The light incorporates easy-to-operate switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. For the CHROMOPHARE® D650 and D530 is also an optional CCD-video camera available and a special version with "EndoLite" for endoscopical work. The light could be combined with other Berchtold lights and the Hermes OR Control Center from Voice - Sense - See in the EC and Hermes Motion, Inc. The light has been designed to and meets the requirements of the IEC 601 and UL 544 regulation for safety.

The provided text describes a 510(k) summary for surgical lights (CHROMOPHARE® D500, D530, D650). It details the device, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain any information regarding acceptance criteria or a study proving device performance against such criteria for AI/ML-driven medical devices.

The document pre-dates widespread use of AI/ML in medical devices and focuses on the physical and functional aspects of surgical lighting, referencing compliance with safety regulations like IEC 601 and UL 544.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval for basic medical equipment, not sophisticated analytical devices requiring performance studies with ground truth and expert adjudication.

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The surgical lights, CHROMOPHARE® D 500 and D 530, are intended to illuminate locally the operating site on the patient's body with a high intensity, shadow free, "cold" light.

The new Berchtold CHROMOPHARE® D 500 and D 530 surgical lights are suitable for all types of surgical procedures and offer the physician a natural (whiter) and "colder" light. The light quality is based on a optical double filter technique.

The CHROMOPHARE® D 530 provides a light intensity of up to 110000 lux and the CHROMOPHARE® D 500 up to 85000 lux.

The lights have features like easy-to-operate swivel arms, auto-switching on the second lamp in case of failure of the main lamp and an easy to exchange lamp cartridge. For the CHROMOPHARE® D 530 there is also an optional CCD-video camera available and a special version with "EndoLite" for endoscopical procedures. The lights could be combined with other Berchtold lights. The lights have been designed to and meet the requirements of the IEC 601 and UL 2601 regulation for safety.

The provided document is a 510(k) summary for the Berchtold CHROMOPHARE® D 500 and D 530 surgical lights. It describes the device, its intended use, and its substantial equivalence to a previously approved device (CHROMOPHARE® D 650, K965130).

However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/algorithm-based medical devices. Instead, it focuses on demonstrating safety and performance equivalence to a predicate device through compliance with general electrical safety standards (IEC 601 and UL 2601) and specifications like light intensity.

Therefore, for the information requested in your prompt, I can only extract limited details based on the provided text. Many aspects you've asked for (e.g., sample size, expert ground truth, MRMC study, AI performance) are not applicable to this type of medical device submission.

Here's an attempt to answer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets acceptance criteria:

The document indicates that safety has been established by meeting the requirements of IEC 601 and UL 2601 regulations. These are international and national (US) standards for the safety of medical electrical equipment. Compliance with these standards typically involves a series of tests performed by accredited laboratories to verify electrical safety, mechanical safety, thermal safety, and other aspects relevant to the device's operational environment and user interaction.

The "study" in this context is the testing and documentation demonstrating compliance with these recognized safety standards, rather than a clinical trial or performance study comparing diagnostic accuracy or clinical outcomes, which would be typical for an AI/algorithm-driven device.

Additional Information (where applicable based on the document):

2. Sample size used for the test set and the data provenance: Not applicable for this type of device and submission. Compliance with safety standards involves testing of the device itself according to the standard's methodologies, not 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 typically understood for AI devices (e.g., disease presence) is not relevant here. Compliance with safety standards is verified by testing against predefined engineering and safety specifications.
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 device is a surgical light, not an AI-assisted diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not contain an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI sense. "Ground truth" for this device's performance would be the measurements of light intensity, color temperature, electromagnetic compatibility, and other physical parameters, verified against the specifications in IEC 601 and UL 2601.
8. The sample size for the training set: Not applicable. No AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

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The Surgical light. CHROMOPHARE®D-650. is intended to illuminate locally the operating site on the patient's body with a high light intensity. "cold" light.

Surgical light. CHROMOPHARE®D-650.

I am sorry, but the provided text does not contain the acceptance criteria, study details, or performance data for the CHROMOPHARE®D-650 surgical light. The document is a 510(k) clearance letter from the FDA, which indicates that the device has been found substantially equivalent to a predicate device and can be legally marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not include performance specifications or the results of any specific studies demonstrating how the device meets acceptance criteria.

The only performance-related information is a brief "Indication for Use" stating that the device "is intended to illuminate locally the operating site on the patient's body with a high light intensity, 'cold' light." This is a functional description, not a set of measurable acceptance criteria with corresponding study results.

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