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The Scintillant Surgical Lights are intended to provide localized illumination of surgical sites.

The Scintillant Dual Tip Light is a sterile, single-use device designed to provide surgeons with localized brilliant white illumination of the surgical site. Utilizing an internal battery, the device is designed to stay operational for up to three hours of continuous use. Dual light tips in combination with flexible leads containing memory wire allows for the surgeon to direct light from multiple locations optimizing the illumination provided by the device and allowing for increased visibility within the surgical site.

The provided text describes a Special 510(k) submission for the Scintillant Dual Tip Surgical Light. This type of submission is for modifications to a manufacturer's own legally marketed device, where the modifications do not significantly alter the device's fundamental scientific technology, design, or indications for use.

Crucially, this submission does not involve an AI device. It's a traditional medical device (a surgical light) and the "study" referred to is non-clinical engineering rationale and confirmatory testing, not a clinical trial or performance study against acceptance criteria in the way one would for an AI/ML device. Therefore, many of the requested categories are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Acceptance: The proposed device ("Scintillant Dual Tip Surgical Light") was deemed substantially equivalent to the predicate device ("Scintillant Surgical Light K071180") because its fundamental scientific technology, design features, and indications for use are identical. The proposed device's lower operating temperature was seen as an improvement, not a new risk.

The following information is NOT APPLICABLE as the device is a surgical light, not an AI/ML device.

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

• N/A. This was a non-clinical submission for a physical device. Testing involved engineering rationales and confirmatory tests, not a "test set" in the context of AI/ML.

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)

• N/A. No expert ground truth was established for a "test set" as this is not an AI/ML device. Engineering rationales and confirmatory tests would have been performed by qualified engineers/technicians.

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

• N/A. No adjudication method for a "test set" was described for this device.

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

• N/A. This is not an AI device, so no MRMC study involving AI assistance would have been conducted or is relevant.

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

• N/A. This is not an AI algorithm.

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

• N/A. The "ground truth" for this device's performance was its ability to provide localized illumination, operate for a specified duration, and maintain safety, as demonstrated through engineering analysis and physical testing. This isn't a "ground truth" for a diagnostic or predictive algorithm.

8. The sample size for the training set

• N/A. This is not an AI/ML device that requires a training set.

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

• N/A. This is not an AI/ML device that requires a training set or associated ground truth.

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MAQUET TRIOP VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.

MAQUET TRIOP VOLISTA® Surgical Light Systems have been developed in order to provide any operating room with LED technology. An innovative design combined with a functional shape offers an efficient product to the surgical staff. The TRIOP VOLISTA® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations. The TRIOP VOLISTA® product family is composed by two different lightheads, Volista 400 and Volista 600. The System is available on ceiling versions and may be composed by one, two or three lightheads, which can be every possible combination of VOLISTA 400 and VOLISTA 600. Accessories such as integrated cameras and screen supports can be included to the TRIOP VOLISTA® Surgical Light System.

Here's an analysis of the provided text regarding the TRIOP VOLISTA® Surgical Light System, focusing on acceptance criteria and supporting studies:

This submission is for a surgical light system, which is generally a low-risk device. As such, the "acceptance criteria" and "studies" are primarily focused on compliance with recognized performance and safety standards rather than clinical efficacy studies often seen with diagnostic or therapeutic AI/ML devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (a surgical light), the "acceptance criteria" are embodied in compliance with established national and international standards for medical electrical equipment and surgical luminaires. The reported performance is the device's conformance to these standards.

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

The provided documentation does not detail a "test set" in the context of data-driven AI/ML models. For a physical device like a surgical light, the testing would involve validating prototypes or production units against the specified standards. The sample size would typically refer to the number of physical units tested to ensure design conformance, but this specific information (number of units tested) is not provided in the summary.

Data Provenance: Not applicable in the context of clinical or image-based data for an AI/ML device. The "data" here are the test results from physical evaluations of the device against engineering and safety standards.

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

This question is not applicable to this submission. The "ground truth" for a surgical light is its ability to perform according to established engineering and safety standards. This is typically assessed through technical measurements and testing by qualified engineers and technicians, not clinical experts establishing a ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This question is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used in studies where there is subjective interpretation (e.g., medical image reading) that requires expert consensus to establish ground truth. For a surgical light system's performance validation against standards, the results are typically objective measurements (e.g., light intensity, electromagnetic emissions, safety features), which do not require a subjective adjudication process.

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

No, a MRMC comparative effectiveness study was not done.
MRMC studies are relevant for diagnostic or screening devices where human readers interpret medical data, and the study aims to assess the impact of an AI aid on their performance. This surgical light system is a physical device providing illumination, not an interpretive aid for human readers.

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

Not Applicable.
This question refers to the performance of an AI algorithm operating independently. The TRIOP VOLISTA® Surgical Light System is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

For this device, the "ground truth" is defined by the safety and performance requirements outlined in the referenced national and international standards (e.g., UL 60601-1, IEC 60601-2-41, IEC 60601-1, IEC 60601-1-2, FCC Part 15). The device is deemed acceptable if it meets these objective, measurable criteria. It is not based on expert consensus, pathology, or outcomes data related to disease diagnosis or treatment efficacy in the human body.

8. The Sample Size for the Training Set

Not Applicable.
This device is a physical product (surgical light), not an AI/ML system that requires a "training set" of data for algorithm development.

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

Not Applicable.
As there is no AI/ML component or a "training set" for this device, the establishment of ground truth for such a set is irrelevant.

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Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms.

Double light

The combination of two operating lights as an operating light system enables the use in operating and treatment rooms.

Versions

• Polaris 100 light

• Polaris 200 light

The Polaris 100/200 light is designed for use in as an operating light. For the Polaris 100/200 light, LED bulbs are used.

The Polaris 100 light combines the illumination intensity of 48 white LED bulbs, the Polaris 200 light combines the illumination intensity of 66 white LED bulbs to form a homogeneous illumination volume of considerable illumination depth and low shadiness. A color temperature similar to natural light with good color rendering and dimmable illumination intensity ensure working conditions for surgical and treatment procedures.

The provided document is a 510(k) summary for the Dräger Polaris 100/200 surgical lamp. It does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML device performance or clinical trials as typically expected. Instead, it describes performance testing related to general medical electrical equipment standards.

However, I can extract information related to the performance testing that was conducted to verify the device's compliance with safety and effectiveness standards for a surgical lamp.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Performance testing was conducted to verify that the proposed Polaris 100/200 Surgical lamp meet the requirements for Medical Electrical Equipment as defined in IEC 60601-1 and IEC 60601-2-41."

It does not provide a table of specific numerical acceptance criteria (e.g., minimum illumination intensity, color rendering index, etc.) for each parameter from these standards, nor does it report the specific measured performance values for the Polaris 100/200 against those criteria. It only states that the device "meet the requirements."

An example of what such a table would look like if the information were available might be:

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

This information is not provided in the document. The performance testing described is likely type testing conducted on a sample of manufactured devices (e.g., one or more units of the Polaris 100 and Polaris 200) to confirm design compliance with standards, rather than a clinical study with a test set of data.

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

This information is not applicable/not provided. For a surgical lamp, "ground truth" is typically established by objective measurements against engineering and performance standards (like IEC 60601-2-41) using calibrated equipment, not by expert consensus in the way it would be for diagnostic imaging or AI algorithms.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for human expert review in diagnostic studies, not for the direct measurement of a physical device's performance against engineering standards.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic tools where human readers interpret medical images, often with and without AI assistance. The Dräger Polaris 100/200 is a surgical illumination device, not a diagnostic imaging tool or AI product.

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

No, a standalone study was not done. This term applies to the performance of an AI algorithm independent of human interaction. The Polaris 100/200 is a physical surgical lamp, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance testing of the surgical lamp would be based on objective measurements against established performance standards, specifically IEC 60601-1 (Medical Electrical Equipment general requirements) and IEC 60601-2-41 (Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis). These standards define measurable parameters (e.g., illumination levels, color temperature, color rendering, depth of field, shadow reduction, electrical safety) that the device must meet.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The Polaris 100/200 is a hardware device; it does not involve machine learning algorithms that require a "training set."

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

This information is not applicable/not provided as there is no training set for this type of device.

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The AtriCure Dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.

The AtriCure Dissector™ is a hand held, single use, surgical articulated dissector with intearal light source intended to for use by qualified surgeons only. The surgeon is able to articulate the distal member of the device by means of hand actuated rotation knob. The surgeon directly controls the amount of articulation and tissue dissection. A small light source is attached to the distal tip of the articulation member, which remains illuminated for a minimum of four (4) hours. Multiple models of the Dissector™ are available with varving shaft lengths to accommodate surgeon preference and differing patient habitus.

The provided text is a 510(k) Summary for a medical device called the AtriCure Dissector™. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample size, ground truth, or expert involvement in such a study.

The document does mention:

• "Appropriate product testing was conducted according to the Design Control requirements as defined in 21 CFR 820.30 to evaluate conformance to product specification and substantial equivalence to the legally marketed device."
• "These activities included Risk Analysis, Process Verification, and Biocompatibility Testing."
• **"Biocompatibility testing was conducted according to ISO 10993-1 to confirm that the modified Dissector™ is safe for limited use (

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HM-LAMP II is a device intended to be used to provide visible illumination of the surgical/field or the patient. They are designed for minor surgical procedures.

The HM-LAMP II Series are operating lamps with high performance. Flexible movement arm and mobile stand. Designed for minor surgical procedures as well as additional operating room needs.

This document, K100234, is a 510(k) summary for a surgical lamp (HM-LAMP II Series). It demonstrates substantial equivalence to a predicate device, rather than providing a study with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of submission.

Here's an breakdown of the information that can be extracted and a clear indication of what is not applicable or not provided in this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (ST. FRANCIS OPERATING THEATRE LAMPS, K003423). The comparison is primarily qualitative, stating that the devices are used in "exactly same manner" and both provide "excellent visible illumination." The only specific differences mentioned are "Weight and Dimension only."

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

No specific test set or clinical study data is provided. This type of 510(k) submission generally relies on comparisons to the predicate device's established safety and effectiveness, conformity to recognized standards, and design specifications.

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

Not applicable, as no test set requiring ground truth establishment is described.

4. Adjudication Method for the Test Set

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

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

No MRMC study was conducted or reported in this 510(k) summary.

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

Not applicable, as this is a medical device (surgical lamp), not an AI algorithm.

7. The Type of Ground Truth Used

Not applicable, as no specific clinical or performance study requiring ground truth is detailed. The "ground truth" for this submission is based on the predicate device's established safety and effectiveness, and the device's adherence to relevant standards.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable, as this is a physical medical device.

Summary of available relevant information from the document:

• Device Name: HM-LAMP II Serie (Hill-Med)
• Classification Name: Lamp, Surgical (Class II, Regulation # 878.4580, Product Code: FTD)
• Predicate Device: ST. FRANCIS OPERATING THEATRE LAMPS, K003423
• Intended Use: To provide visible illumination of the surgical field or the patient, designed for minor surgical procedures.
• Performance Standards: The device complies with ISO 9001-2000, CE, and ISO 13485. (These are quality management system and safety standards, not performance criteria for a specific clinical outcome).
• Comparison to Predicate: Used in the exact same manner, provides excellent visible illumination. Main differences are Weight and Dimension.

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The Stryker Knifelight is a manual surgical instrument used for the release of the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site which allows for a minimally open technique with minimal disturbance of surrounding tissue.

The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The device is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the device has integral protective retractors which provide for additional protection of the surrounding tissue during surgery. The Knifelight consists of two integrated components: a handpiece that acts as a power source that is connected to a blade assembly. They are sold as one device.

The provided text is for a K100884 510(k) submission for the Stryker Knifelight, which is a medical device (a lighted surgical knife), not an AI algorithm or a diagnostic tool that would typically involve acceptance criteria and a study to prove its performance in the way described in the prompt.

Therefore, much of the requested information (like performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets) is not applicable to this type of device and submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study for a new AI algorithm.

However, I can extract the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This submission is for a labeling change and a legal manufacturer location change for an existing device. The primary method of demonstrating safety and effectiveness for a 510(k) for such changes is substantial equivalence to a predicate device, not through specific performance metrics against pre-defined acceptance criteria in the way an AI algorithm would be evaluated.

Therefore, there are no specific numerical acceptance criteria or reported device performance metrics in the provided text. The "performance" is implicitly deemed equivalent to the predicate device.

Regarding the study that proves the device meets acceptance criteria:

Based on the provided text, there is no study in the sense of a clinical trial or performance evaluation with specific data points to prove the device meets acceptance criteria. The submission is a 510(k) premarket notification focused on substantial equivalence for a labeling change and legal manufacturer location change.

The entire submission implicitly "proves" that the device still meets regulatory requirements (which are the implicit "acceptance criteria" here) because:

• It is substantially equivalent to a legally marketed predicate device (Stryker Knifelight, K961122).
• The proposed modifications (manufacturer location, disposal info, warnings, contraindications) do not alter the fundamental safety or effectiveness of the device that was previously cleared.

Breakdown of other requested information:

• 2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving 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. No ground truth establishment for a test set is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method for a test set is mentioned.
• 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 not an AI device, and no MRMC study is mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical instrument, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth established for a study.
• 8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
• 9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for it is mentioned.

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The Scintillant light is intended to provide localized illumination of surgical sites.
The Scintillant Surgical Light is intended to provide localized illumination of surgical sites.

The Scintillant Surgical Light is an untethered, self-contained medical lighting device that allows illumination inside the surgical field. The light can be hand-held and is provided with accessories which allow it to be attached to almost any surgical tool or instrument.
The light is provided sterile and is battery powered. The light consists of light-emitting diode (LED) mounted on the end of a flexible wand. A single button turns the light on and off. A battery and circuit board are contained in the device handle.

This is a 510(k) premarket notification for the Scintillant Surgical Light, a surgical lamp. The provided documents establish substantial equivalence to predicate devices, but do not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary (K071180) merely states that:

• The Scintillant Surgical Light is an untethered, self-contained medical lighting device for illumination inside the surgical field.
• It's hand-held, sterile, battery-powered, and uses an LED on a flexible wand.
• Its intended use is to provide localized illumination of surgical sites.
• It is technologically similar to predicate devices (AtriCure Dissector, Light Port Surgical Illuminator, VersaLight Multi-Function Surgical Illuminator, LightMat Surgical Illuminator), all being sterile, hand-held, battery-powered surgical field illuminating devices with the same overall intended use.
• The conclusion is that the device is as safe and effective as the predicate device and does not raise any new questions regarding safety and effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies with defined acceptance criteria and performance metrics for all new devices.

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Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.

Whether in the doctor's office, examination rooms, emergency facilities, intensive care clinics, pre- or post-operative rooms, the Iris provides high intensity light where it is needed. The Iris is user friendly. With its high quality illumination, the halux® Iris is perfect for lighting all kinds of examinations and treatments. Outstanding features of this luminaire include the unique shape of the lamp housing, the combination facetted and parabolic technology of its reflector, and its smooth operating and spring-loaded articulating arm. Highlights of our examination lamp:

Smooth Operation and adjustability

Precise positioning

Compact and enclosed articulation system with counterbalance system.

A specially designed reflector system insures a precise light source that renders true colors. The Iris is available in ceiling wall and floor versions.

halux® Iris is a medical product manufactured in accordance with EG 93/42 Class 1 and is constructed in accordance with EN 60 601-2-41 (UL2601).

This document describes a 510(k) premarket notification for the "Halux® Iris Examination and Surgical Lamp". The primary purpose of this notification is to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets an extensive set of acceptance criteria in the way a clinical trial for a novel AI device would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of regulatory submission for a simple medical lamp. The "study" here is primarily an engineering and bench testing comparison to a predicate device.

Here's the information that can be extracted and what is not applicable:

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

   Items	Acceptance Criteria (Predicate Device K042395)	Reported Device Performance (Halux® Iris)
   Manufacturer	Burton Medical	Waldmann Lighting
   Model number(s)	Outpatient Plus or CoolSpot	Halux® Iris
   K number	K042395	SAME (Implied substantial equivalence)
   Electrical requirements	120 V. 50-60 Hz	SAME (120 V. 50-60 Hz)
   Light Output	4800 footcandles	45000 lux at 0.8 m (4180 footcandles)
   Color temperature	3600 K	4000 K
   Wattage	150 watts (three 50 watt halogen)	One 50 watt Halogen
   Power source	Transformer	SAME (Transformer)
   Operating environment	Minor surgeries	SAME (Minor surgeries, examinations)
   Bulb operating life	2000 hrs.	Up to 4000 hrs.
   Case material	Steel and plastics	SAME (Steel and plastics)
   Warranty	3 years	2 years
   Safety listing	UL	UL

   Note: The "acceptance criteria" for this submission are effectively the specifications and performance of the predicate device, which the new device aims to be "substantially equivalent" to or better in some aspects.

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

   • Sample Size: Not specified. The document mentions "bench and laboratory testing" and "user testing data" but does not provide specific sample sizes for these tests. For a medical lamp, this would likely involve a small number of units tested in a lab setting rather than human subjects or a large data set.
   • Data Provenance: The testing was conducted by Waldmann Lighting, the manufacturer. The document doesn't specify country of origin for the data beyond that. It is "retrospective" in the sense that it's a comparison to an existing device, but the testing itself would be prospective to evaluate the new device.

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

   • Not Applicable. This is a physical device (medical lamp), not an AI/diagnostic software. "Ground truth" in the context of expert consensus on medical images or diagnoses is not relevant here. The "truth" is established by direct measurement of physical properties (e.g., light output, color temperature, safety standards).

4. Adjudication method:

   • Not Applicable. See point 3.

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 not an AI device or a diagnostic device.

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

   • Not Applicable. This is not an algorithm.

7. The type of ground truth used:

   • The "ground truth" for this device's performance is based on direct physical measurements and adherence to safety standards. For example, light output is measured in footcandles/lux, color temperature in Kelvin, and electrical safety is verified against UL standards and EN 60 601-2-41 (UL2601). The "ground truth" for substantial equivalence is the performance and specifications of the predicate device.

8. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device; there is no "training set."

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

   • Not Applicable. See point 8.

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The AtriCure dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.

The AtriCure dissector™ is a hand held, single use, surgical articulated dissector with integral light source.

The provided text is a 510(k) summary for the AtriCure dissector™, a surgical device. It does not describe a study that proves the device meets specific acceptance criteria in the way an AI/software device submission would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through product testing and material suitability.

Therefore, many of the requested elements for an AI/software device study, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable or not provided in this document.

However, I can extract the information that is present and indicate where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is not an AI/software device being evaluated with a test set of data. The "testing" refers to product testing for device function and biocompatibility.

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

Not applicable. Ground truth for an AI test set is not relevant for this type of medical device submission.

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 not an AI-assisted device for diagnostic interpretation.

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

Not applicable. This is a physical surgical tool.

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

Not applicable. Ground truth as typically understood for AI evaluation is not relevant here. The "ground truth" for this device would be its ability to perform its intended mechanical and lighting functions safely and effectively, which is assessed through engineering and biocompatibility testing against predefined specifications and predicate device equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/software device that undergoes a training process.

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

Not applicable.

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The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff.

The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The system consists of a center-mounted lighthead suspension, which supports horizontal arms of possible differing lengths and lighthead assemblies and operates via an electronic control system. Optional features for the system include a fiber optic light for task lighting, voice control of the system via the HERMES system, a camera integrated in surgical lighthead, optional standard or flat screen monitor or a high end audio visual system. The system components can be arrayed to produce various system configurations depending upon the needs of the user. The Amsco Harmony Surgical Lighting and Media System has a sterile disposable sheath for postioning of the sterile field during surgical procedures. The sterile sheath is latex free and is made of approved medical grade material. The Amsco Harmony Surgical Lighting and Media System is designed to assure compilance with IEC 60601-2-41 (Ed.1.0 (2000-02) Medical Electrical Equipment - Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis, IEC 60601-1 (Electrical Safety US, Canada). The device carries the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings.

The provided document is a 510(k) premarket notification for the Amsco® Harmony Surgical Lighting and Media System. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, it explicitly states that clinical testing was not performed, and therefore, no study proving the device meets specific acceptance criteria is included.

The document focuses on non-clinical testing and comparison to predicate devices' specifications.

Here's an analysis based on the information provided, highlighting the absence of a study proving the device meets acceptance criteria:

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

   The document provides a comparative table of specifications between the Amsco Harmony Surgical Lighting and Media System and its predicate devices. While these are specifications and not explicitly labeled acceptance criteria, the implication is that matching or demonstrating similar performance to predicate devices is a form of acceptance criterion for substantial equivalence.

   Item	Predicate Device (Amsco SQ240, Hill-Rom BrightStar, Berchtold Chromophare "D-series")	Amsco Harmony Surgical Lighting and Media System Performance
   Illumination Area	(Range from 7-8.5" to 11" for diameter, 20-31.5" for depth)	large: 6-14" (diameter), medium: 5-12" (diameter), small: 8" (diameter)
   Light beam diameter		30" (depth)
   Light beam depth
   Light focusing mechanism	Fixed or Adjustable (varies by predicate)	Adjustable
   Illumination @ 1m	9,293 (100,000) to 12,000 (130,000) Foot-candles (Lux)	large: 13,000 (140,000), medium: 12,000 (130,000), small: 6,000 (65,000)
   Color Temperature (°K)	4,200°K to 4,500°K	4,400°K
   UV (≤400nm) Output

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