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The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.

The NOVAPROBE LED LEUKOS 175 is specifically designed to provide the cold light intensity required for modern day Endoscopic procedures. The LED light provides the color temp of 6500 deg K also known as white light. The white light offers unmatched quality for the single chip, three chip and HD cameras. The LED light intensity is controlled digitally. Using LED nullifies any skin burning problems that may occur due to the use of arc lamps. The NovaProbe LED Light source assures that the light passing through the fiber optic cable is a cold light.

The provided text is a 510(k) summary for the NovaProbe LED Light Source (LEUKOS 175). This document focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than providing unique performance data or clinical study results for the new device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria, detailed study design, or specific performance metrics in the way a clinical trial report would.

Here's the breakdown of what can be extracted based on the provided text, and what cannot:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it states that "Design verification testing demonstrates that the devices function as intended, and the Performance did not raise any new issues of safety and effectiveness, and that formal user training is not required." It also mentions that the device "performs to its specifications, operates as intended, is safe and effective, and is substantially equivalent to legally marketed devices."

The "performance" information provided is primarily comparative to predicate devices, focusing on technological characteristics like:

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

The document explicitly states: "No clinical data was required to confirm safety and effectiveness." Therefore, there is no test set, sample size, or data provenance as would be found in a clinical study report. The evaluation was based on non-clinical design verification testing and comparison to predicate devices.

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 data or test set involving expert review was utilized for this 510(k) submission.

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

Not applicable, as no clinical data or test set requiring adjudication was performed.

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. The device is an LED light source, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. The device is a physical light source, not an algorithm.

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

The concept of "ground truth" as typically defined in diagnostic algorithm studies is not applicable here. The evaluation of this device relies on non-clinical design verification testing to ensure it functions as intended and meets safety standards, and on its substantial equivalence to predicate devices which have already established their safety and effectiveness through their own approval processes.

8. The sample size for the training set

Not applicable. This device is a physical medical device (LED light source), not a machine learning algorithm that requires a training set.

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

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

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Cold light sources are designed to supply light for endoscopic diagnostic and surgical procedures.

The power LED 175 is a high power medical cold light source used for endoscopic diagnostic and surgical procedures. The device can be controlled via buttons on the front panel or via SCB (STORZ Communication Bus). This device provides high light intensity at low power consumption with intelligent cooling concept for minimal noise emission. This device includes a cold light source power LED 175, power cord, and the 100 cm SCB connection cable. The light is transmitted through an optical cable and a scope to illuminate surgical sites during minimally invasive surgical procedures.

The provided text is a summary of a 510(k) premarket notification for a medical device, the KARL STORZ Power LED 175. It outlines the device description, intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not explicitly contain a formal "acceptance criteria" table with corresponding "reported device performance" data in the manner typically found in a detailed clinical or performance study report.

Instead, the document states that "performance testing to verify light output of Power LED 175 was done as per the Comparative Bench Testing attached in Enclosure # 6" and that "Design Verification Testing (DVT) demonstrates that the device functions as it is intended and its performance does not raise any new issues of safety and effectiveness." It also mentions software verification. These statements indicate that testing was performed to verify the device's functionality and safety, but the specifics of the acceptance criteria and the detailed results are not provided within this summary for public consumption. The "Comparative Bench Testing" enclosure would contain the detailed information.

Given the information available:

1. Table of acceptance criteria and the reported device performance:
   The document does not explicitly provide a table titled "acceptance criteria" and "reported device performance" with specific numerical values for metrics like light intensity, color temperature stability, etc. It broadly states that "Design Verification Testing (DVT) demonstrates that the device functions as it is intended and its performance does not raise any new issues of safety and effectiveness." The "Technological Characteristics" table compares the Power LED 175 to its predicate devices, showing:

   Parameter	Power LED 175 (Subject Device)	LED NOVA 100 (Predicate Device)	300 Watt Xenon (Predicate Device)
   Lamp Type	LED	LED	Xenon
   Color Temperature	6500 K	5600 K	6000 K

   The implication is that the Power LED 175's performance (e.g., light output, color temperature) is deemed acceptable if it is comparable to or better than the predicate devices and meets design specifications. However, the specific quantitative acceptance criteria and the exact measured performance values are not detailed in this summary.

2. Sample size used for the test set and the data provenance:
   The provided text does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "Comparative Bench Testing" and "Design Verification Testing (DVT)," which are typically internal engineering and validation tests rather than clinical studies with human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable and not provided in the document. The testing described is technical "performance testing" and "design verification testing" of a light source, not a diagnostic device requiring expert interpretation of results to establish ground truth.

4. Adjudication method for the test set:
   This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for studies where multiple human readers assess cases, typically for diagnostic accuracy. The testing described focuses on the device's technical performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
   No MRMC study was done, and this information is not applicable. The device is a light source, not an AI-powered diagnostic tool, and the submission does not involve human-in-the-loop performance evaluation in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This information is not applicable. The device is a medical light source, not a standalone algorithm.

7. The type of ground truth used:
   For the "performance testing" and "design verification testing," the ground truth would be based on engineering specifications, established measurement standards, and comparison to the performance characteristics of the predicate devices. For example, light output would be measured against a specified lumen or candela output, and color temperature against a CCT (Correlated Color Temperature) value.

8. The sample size for the training set:
   This information is not applicable. There is no mention of a training set as the device is not an AI/machine learning system.

9. How the ground truth for the training set was established:
   This information is not applicable as there is no training set mentioned.

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The OVS 1 Video System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The OVS1 Video System is indicated for use with a compatible Olive Medical Camera Head and other accessory devices including an endoscope, optical coupler, and light cable

The OVS I Video System is a Camera Control Unit with integrated LED Light Source and Video Display for use in a surgical environment to view endoscopic images when interfaced with the Olive Medical TCK I HD Camera Head, an endoscope, a light cable, and other accessory devices.

The Olive Medical OVS1 Video System is a surgical video system that includes a Camera Control Unit with an integrated LED Light Source and Video Display. It is intended for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body.

Here's an analysis of the provided information regarding its acceptance criteria and the study proving it meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided documentation does not explicitly list quantitative acceptance criteria in the typical sense (e.g., minimum resolution, specific light output intensity). Instead, the acceptance criteria are implicitly defined by demonstrating substantial equivalence to existing predicate devices. The "reported device performance" is a comparative qualitative assessment against these predicates, highlighting similarities in technology and function.

Note: The document states "Output resolution unknown. Vertical lines of input listed" for Tele Pack X, implying the 494 lines is an input spec, not necessarily output resolution.

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

The document explicitly states: "No comparison of clinical performance data was used for demonstration of substantial equivalence." This means there was no "test set" in the context of clinical data for performance evaluation. The substantial equivalence was based on comparison of technological characteristics and non-clinical safety testing against predicates.

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

N/A. As no clinical performance data was used, there was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

N/A. No clinical test set.

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 device is an endoscopic video system, not an AI-powered diagnostic tool. No MRMC study was performed, and the concept of "human readers improving with AI" is not applicable here.

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

N/A. This device is hardware for visualization, not a standalone algorithm.

7. The type of ground truth used:

N/A. As no clinical performance data was used, no ground truth was established for a clinical test set. The "ground truth" for demonstrating substantial equivalence was effectively the established safety and performance records of the predicate devices and compliance with relevant electrical and EMC standards.

8. The Sample Size for the Training Set:

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

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

N/A. No training set was used.

Summary of the Study Proving Device Meets Acceptance Criteria:

The Olive Medical OVS1 Video System demonstrates it meets acceptance criteria (which are defined implicitly by substantial equivalence) through a non-clinical comparative study and safety testing:

• Comparative Assessment: The primary "study" was a detailed comparison of the OVS1 Video System's technological characteristics (display, light source, control unit, resolution) and intended use against several legally marketed predicate devices (Tele Pack X, Image 1 Video Imaging System, InnerVue Diagnostic Scope System, Flexible Video Endoscope, LED Light Source, Lightsource or Illuminator). The study concluded that the OVS1 is "substantially equivalent" because its technology and design are similar, its indications for use are similar, and differences do not negatively affect performance, function, or intended use.
• Non-Clinical Testing: The device underwent compliance testing with recognized international standards for medical electrical equipment:
  • ISO 60601-1: General requirements for basic safety and essential performance.
  • ISO 60601-1-2: Electromagnetic compatibility (EMC) requirements and tests.

These non-clinical tests and the detailed comparative analysis against predicate devices established that the OVS1 Video System is as safe and effective as the already-marketed devices, thus meeting the requirements for its 510(k) clearance. No clinical trials or human performance studies were conducted or required to demonstrate substantial equivalence for this type of device.

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The ENDOLIGHT LED Light Source Projector is intended to illuminate the surgical site during minimally invasive surgical procedures by producing light that is transmitted from the light source through fiber optic cable and a scope.

The ENDOLIGHT LED Light Source is a fiber optic light source utilizing a single, solid state, high power, white light emitting diode (LED) to produce visible light that used to illuminate surgical sites during minimally invasive surgical procedures. The light from the ENDOLIGHT LED Light Source is transmitted through an optical cable and a scope. ENDOLIGHT LED 1.1 and 1.2 are comprised of light source and power supply cord. The units consist of aforementioned LED, cooling fan, light port, and protective housing. ENDOLIGHT LED 1.1 and 1.2 are portable and are very similar in design, format, and functionality to other LED light sources including the predicate devices. This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.

The provided text describes a 510(k) premarket notification for the ENDOLIGHT LED Light Source. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study that proves the device meets specific performance thresholds in a clinical or AI-assisted context.

Therefore, many of the requested categories cannot be answered from the provided document. This document describes a medical device rather than an AI/ML powered device.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not present a table of specific quantitative acceptance criteria alongside reported performance data. Instead, it states that "Design verification testing demonstrates that the devices function as intended" and lists adherence to voluntary safety and performance standards.

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

Not applicable. The document describes a traditional medical device (LED light source), not an AI/ML-powered device that would typically involve test sets of data for performance evaluation. The "testing" mentioned refers to design verification and adherence to electrical safety standards.

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

Not applicable. Ground truth and expert consensus are relevant for AI/ML-powered diagnostic or interpretive devices, which this is not. The "ground truth" for this device would be its physical properties and adherence to engineering and safety standards.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of an adjudication method as it relates to evaluating data for an AI/ML-powered device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI/ML algorithm. The device stands alone as a light source.

7. The Type of Ground Truth Used:

For this device, the "ground truth" for its performance is established by engineering specifications, international safety standards (e.g., IEC standards for medical electrical equipment), and functional design verification tests. The document explicitly states "Design verification testing demonstrates that the devices function as intended" and lists conformity to specific IEC safety standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML-powered device, so there is no "training set."

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

Not applicable.

In summary: The provided document is for a traditional medical device (an LED light source) and outlines its substantial equivalence to predicate devices based on technological characteristics and adherence to established safety standards. It does not involve AI/ML technology, and therefore, many of the requested categories related to AI/ML performance evaluation (such as test sets, ground truth establishment by experts, adjudication, and clinical effectiveness studies with AI) are not applicable.

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The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the light source through a fiber optic cable and a scope.

LED Light Source (LLS-050 LED Illuminator)

The provided text is a 510(k) summary for the Sunoptic Technologies® LED Light Source (LLS-050 LED Illuminator). This document establishes the substantial equivalence of the LLS-050 to a legally marketed predicate device (Stryker L9000 LED Light Source, K082813).

The information requested pertains to the acceptance criteria and the study that proves a device meets those criteria. However, the provided 510(k) summary does not contain details of specific performance acceptance criteria or a study designed to directly prove the device meets these criteria in the context of clinical accuracy or diagnostic performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device by stating: "The technological differences between the LED Light Source (LLS-050) and the Styker LED Light Source (L9000) do not raise new questions of safety or effectiveness." It also mentions that the device will conform to voluntary safety and performance standards (UL60601-1, CAN/CSA C22.2 No.601.1 (SUP1+AM2), Medical EMC Stds. EN 60601-1-2).

Therefore, I cannot populate the requested table and sections with specific details about acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), sample sizes for test/training sets, expert qualifications, or ground truth methods, because such information is not present in the provided 510(k) summary. This type of detail is typically found in clinical study reports or validation documents, which are not part of this 510(k) summary.

Based on the provided document, here is what can be inferred or stated as "not applicable" given the nature of a substantial equivalence submission for an LED light source:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable, as this is a substantial equivalence submission for a light source, not a diagnostic device requiring a clinical test set for performance metrics like sensitivity/specificity. The evaluation focuses on engineering and safety comparisons.
• Data Provenance: Not applicable for a clinical test set. The submission is based on engineering design, performance specifications, and safety standard adherence.

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

• Number of Experts: Not applicable. Ground truth establishment for a diagnostic test is not relevant for an LED light source substantial equivalence submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There was no clinical test set requiring adjudication in this 510(k) summary.

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

• Was an MRMC study done? No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, which is not the function of an LED light source.
• Effect size of human reader improvement: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No. This device is a hardware component (light source), not an algorithm or AI system.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for a diagnostic or algorithmic "ground truth." The "truth" in this context revolves around engineering specifications, safety standards compliance, and functional performance as an illuminator, which are evaluated against a predicate device.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

• How Ground Truth for Training Set Was Established: Not applicable.

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The Karl Storz LED NOVA 100 Cold Light Fountain is indicated for use to transmit light through an optical cable to an endoscope in order to illuminate the site of surgery during minimally invasive endoscopic surgical procedures.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Karl Storz LED NOVA 100 Cold Light Fountain) and its indications for use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical study details of the nature you've requested (e.g., MRMC studies, effect sizes of AI assistance).

The document is purely administrative, confirming that the device is substantially equivalent to a predicate device for its intended use as a light source for endoscopes. Therefore, I cannot extract the information you've asked for from this text.

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The Stryker LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.

The Stryker LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.

The provided text describes a 510(k) submission for the Stryker LED Light Source (L9000). A 510(k) submission establishes substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested details such as acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not available in the provided document. The document focuses on regulatory approval based on demonstrating equivalence, not on a detailed clinical performance study with specific metrics as one would find for a novel device.

Here's what can be extracted and what cannot:

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

• Not Available: The document does not provide specific performance acceptance criteria or quantitative performance results from a study. It states the device "will conform to the voluntary standards listed in section 5.1" (which is not provided) and that "The technological differences... do not raise new questions of safety or effectiveness." This implies equivalence in performance rather than meeting new, specific metrics.

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/Not Available: This type of information is related to a clinical performance study, which is not detailed in this 510(k) summary. The submission primarily relies on demonstrating substantial equivalence to a predicate device rather than conducting a new, independent clinical assessment with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Available: Ground truth establishment by experts is typically part of a clinical validation study, which is not described.

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

• Not Applicable/Not Available: Adjudication methods are relevant for studies involving human interpretation and ground truth establishment, which are not detailed in this document.

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: No MRMC study is mentioned. This device is a light source, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant to its function.

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

• Not Applicable: The Stryker LED Light Source is a physical illuminator, not an algorithm. Standalone algorithm performance is not relevant.

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

• Not Applicable/Not Available: As no clinical study results are presented with a "test set," no ground truth type is mentioned. The primary "ground truth" for a 510(k) is the performance of the legally marketed predicate device.

8. The sample size for the training set

• Not Applicable/Not Available: "Training set" is a term relevant to machine learning or AI models, which this device is not. No equivalent concept applies to a light source in this context.

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

• Not Applicable/Not Available: As above, this concept doesn't apply to this device.

Summary of available information:

The provided document describes a 510(k) submission for the Stryker LED Light Source (L9000). The key to its acceptance is demonstrating substantial equivalence to a predicate device, the Stryker Quantum 5000 Light Source (K961971).

• Intended Use: To illuminate the site of surgery during minimally invasive surgical procedures (arthroscopy, laparoscopy, endoscopy).
• Regulatory Basis: The device is deemed substantially equivalent to the predicate device, meaning "The technological differences between the LED Light Source (L9000) and the Stryker Quantum 5000 Light Source do not raise new questions of safety or effectiveness."
• Acceptance Criteria (Implied): Conformance to voluntary safety and performance standards (not explicitly listed in the provided text but mentioned as "section 5.1"). The primary "acceptance criterion" for a 510(k) is meeting the standard for substantial equivalence to a legally marketed predicate device.
• Study Proving Acceptance: The "study" is the submission itself, which compares the new device to the predicate device in terms of technology, intended use, and safety/effectiveness data available for the predicate. No new clinical performance study with specific device metrics is detailed. The FDA review determined that the information provided (including presumably technical comparisons and adherence to standards) was sufficient to demonstrate substantial equivalence.

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The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure.

The Integra Luxtec MLX Light Source should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye.

Not Found

I am sorry, but based on the provided text, I cannot extract the acceptance criteria, device performance, or details about a study.

The text is a Medical Device 510(k) clearance letter from the FDA for the "Luxtec MLX Light Source." It confirms that the device is substantially equivalent to legally marketed predicate devices and is being cleared for market.

The letter explicitly states:

• It does not contain details of any specific study conducted by Integra Luxtec, Inc. to prove the device meets acceptance criteria. It refers to the FDA's review of the "Section 510(k) premarket notification of intent to market the device."
• No acceptance criteria or reported device performance are listed. The clearance is based on substantial equivalence, not on specific performance metrics outlined in this document.
• There is no mention of sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or details about training sets.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the information given.

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The Acueity Medical Light Source is indicated for use in illuminating the operative site and providing video images that can be displayed on a monitor. The device is designed for attachment to endoscopes and laparoscopes that are used in medical procedures.

The Medical Light Source was specifically designed for medical applications. Therefore, the highest safety requirements for the patient as well as for the physician are applied. The Light Source combines highest illumination requirements with high-resolution video capabilities through an integrated highresolution ¼", ½" or 1/3" CCD camera board.

This document does not contain information about specific acceptance criteria or an analytical study with performance metrics for the Acueity Medical Light Source beyond general claims of safety and effectiveness.

Based on the provided text, the device's approval relied on demonstrating substantial equivalence to a predicate device (Welch Allyn Illumination Platform K951647) rather than meeting predefined numerical performance targets in a study specific to this submission.

Here's a breakdown of why the requested information cannot be extracted and what the document does state:

Missing Information:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence, not detailed performance metrics against specific criteria.
• 2. Sample size used for the test set and the data provenance: Not provided. No specific test set data is mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set with ground truth.
• 4. Adjudication method 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 light source and video system, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding acceptance criteria and study:

The document states:

• Substantial Equivalence: "The Acuiety Light Source and Video Camera System is substantially equivalent to the Welch Allyn Illumination Platform (K951647). The Medical Light Source is substantially equivalent to the predicate device in intended use, technological characteristics, materials, manufacturing processes, and components."
• General Testing: "All necessary testing was performed on the Medical Light Source to ensure that the product is substantially equivalent to the predicate devices and to ensure that the device does not raise new questions of safety and effectiveness."

Conclusion:

The provided 510(k) summary is for a medical light source and video camera system, not an AI-powered diagnostic device. Its approval hinges on demonstrating substantial equivalence to a previously cleared predicate device, rather than through a study with specific, numerically defined acceptance criteria for performance as would be expected for a novel AI or diagnostic tool. The document confirms that "all necessary testing was performed" to support this claim of substantial equivalence and to ensure safety and effectiveness, but it does not specify what those "necessary testing" protocols entailed or provide quantitative results for them.

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The intended use for the Metal Halide Light Sources is to provide optimized light for viewing procedures carried out with flexible and rigid endoscopes.

Metal Halide Light Sources Models, MV-9088-T and MV-9088

The provided document is a 510(k) premarket notification approval letter for a medical device: "Metal Halide Light Sources Models, MV-9088-T and MV-9088." This letter states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. It is a regulatory approval letter based on substantial equivalence, not a detailed study report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

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