Search Results

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

The iLED surgical light mobile family is suitable for all types of surgical procedures. TruLight 5000 light heads consists of two light modules and the iLED 3 consists of three light modules. The modules contain the LEDs with their optical devices. Each LED with its optical device illuminates the complete light field. Each light module has its own control to adjust the illumination parameters. The light heads operate the same and use the same electronics and software as the ceiling mounted iLED family surgical light systems.

Here's an analysis of the provided text regarding the acceptance criteria and study for the iLED Surgical Family, Mobile device:

Important Note: The provided text is a 510(k) summary for a surgical light, not an AI/ML medical device. Therefore, many of the requested categories, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only) performance," "ground truth," and "training set sample size," are not applicable to this type of device and submission. The FDA 510(k) process for a device like a surgical light focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing against established standards and comparison of technical specifications.

Acceptance Criteria and Device Performance for TRUMPF iLED Surgical Family, Mobile

Since this is a conventional medical device (surgical lamp) and not an AI/ML-driven device, the "acceptance criteria" are implied by the performance characteristics demonstrated and compared to the predicate devices and general standards for surgical lights. The "study" here refers to the justification for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of an AI/ML device where a "test set" implies specific patient data. For this surgical light, performance is demonstrated through technical specifications, testing against industry standards, and comparison to predicate devices. There isn't a "test set" of patient cases.
• Data Provenance: Not applicable in the AI/ML sense. The performance characteristics of the device were assessed through engineering design, component testing, and comparison of technical specifications, implied to be conducted by the manufacturer, TRUMPF Medizin Systeme GmbH + Co. KG, Germany.

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

• Number of Experts/Qualifications: Not applicable. Ground truth, in the AI/ML context, refers to expert labeling of data. For a surgical light, the "ground truth" of its performance is derived from physical measurements against established engineering and medical device standards. No external experts are mentioned for "ground truth labeling."

4. Adjudication Method for the Test Set

• Adjudication Method: 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

• MRMC Study: Not applicable. This device is a surgical lamp, not an AI-assisted diagnostic or therapeutic tool that enhances human reader performance.

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

• Standalone Performance: Not applicable. This is not an AI algorithm. Its performance is inherent to its physical design and functionality.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the AI/ML data labeling sense. The "ground truth" for a surgical light's performance would be objective measurements against established international and national standards for surgical illumination, such as those related to illuminance, color temperature, shadow dilution, and radiated heat, as well as verification of mechanical and electrical safety. The submission implies these standards were met, and the design is substantially equivalent to existing approved devices.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

Summary of the Study Proving Substantial Equivalence (Not "Meets Acceptance Criteria" in the AI/ML Sense):

The "study" presented in K091246 is a substantial equivalence determination based on a comparison to predicate devices, rather than a clinical trial or performance study against specific acceptance criteria for a novel AI algorithm.

• Device: iLED Surgical Family, Mobile
• Predicate Device 1: iLED (lamp heads are identical) K# 061317 (This refers to the ceiling-mounted version of the iLED surgical light family).
• Predicate Device 2: Trumpf surgical light models 301, 501, 701, and 1001 (mobile stand option was included) K# 011693.

Key Arguments for Substantial Equivalence:

1. Identical Lamp Heads: The iLED surgical light mobile family uses identical LED light heads to the previously cleared ceiling-mounted iLED surgical light system (K#061317). This implies that the core illumination technology meets established performance and safety characteristics.
2. Identical Electronics and Software: The device uses the same electronics and software as the ceiling-mounted iLED family. This suggests consistent control and performance characteristics.
3. Same Spring Arm: The mobile version uses the same spring arm as the ceiling-mounted version, indicating similar articulation and positioning capabilities.
4. Main Difference - Mounting: The primary difference is the method of mounting (to a mobile stand with a base and casters) making it mobile, a feature already present in a predicate device (K#011693).
5. No New Safety/Effectiveness Concerns: The submitter asserts, and the FDA agrees by clearning the device, that "There is no difference between the devices that raise any significant issues of safety and effectiveness."

In essence, the "study" for this device is a regulatory submission demonstrating that its design, performance characteristics, and intended use are similar enough to existing, legally marketed surgical lights that it does not raise new questions of safety or effectiveness.

Ask a specific question about this device

Ask a specific question about this device

Aesculap's Xenon Light Source is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contain fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laparoscopy, gynecology, broncoscopy, urology, neuroendoscopy and vascular endoscopy.

The Xenon Light Source consists of a light source control unit and fiber optic cables. Technological characteristics are provided below:
Design: Light Source in stainless steel / aluminum housing
Dimensions: 305mm x 305mm x 82mm
Weight: 6.5kg
Lamp: 180W Xenon
Circuit: Transistorized
Voltage: 100 - 240V
AC Power Freq.: 50 - 60 HZ

The provided text is a 510(k) summary for the "Aesculap Xenon Light Source". It describes the device, its intended use, and states its compliance with certain performance standards. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effectiveness.

Instead, the document focuses on:

• Substantial Equivalence: The primary "study" mentioned here is a comparison to legally marketed predicate devices (EG&G Electro-Optics, Lutex, Karl Storz, Wolf) to establish substantial equivalence in features and function. This is a regulatory pathway, not a performance study in the sense of accuracy metrics.
• Safety Standards Compliance: The document states that the device complies with recognized safety standards (IEC 60601-1, IEC 60601-1-2, UL 2601-1). This is about electrical safety and electromagnetic compatibility, not clinical performance or diagnostic accuracy.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's a breakdown of what can be inferred or explicitly stated based on the text, and where information is missing:

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not applicable. No performance study involving a test set of data is described. The "test" here refers to meeting safety standards and demonstrating substantial equivalence.
• Data provenance: Not applicable.

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

• Not applicable. No ground truth establishment for a diagnostic or performance test set is described.

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

• No MRMC comparative effectiveness study was done. This device is a light source, 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 device is a light source, not an algorithm.

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

• Not applicable. The "ground truth" for this device's regulatory clearance is its adherence to specified safety standards and its functional similarity to existing predicate devices.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is mentioned.

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

• Not applicable.

Ask a specific question about this device

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.

Lightsource or illuminator M-300

The provided text is a 510(k) clearance letter from the FDA for a device called "Cuda Products Corp. Model M300 (M-300) Lightsource". This document is a regulatory approval and does not contain information about acceptance criteria, study design, or performance metrics that would typically be found in a clinical study report.

Therefore, I cannot extract the information required in your request from this document. The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is approved for marketing. It specifies the product code, regulatory class, and indications for use, but no performance data.

Ask a specific question about this device

The VES 3001/w use is indicated in the following situations:

• Whenever there is a need for head lamp illumination of the fiber-optic type .
• When ever there is a need for a fiber-optic illuminator for an endoscope .
• . When ever there is a need to use video either as a visual aid for as a method of recording or both.
• When ever there is a requirement for any or all of the above at the same . time.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "VES 3001/2 Dual Output Video Illuminator."

This document does not contain the kind of information requested in your prompt regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, ground truth methods, or details about training sets. The letter is a regulatory approval document confirming substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information from this text.

Ask a specific question about this device

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: Ilightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.

Lightsource or illuminator CERMAX300

This document is a 510(k) clearance letter from the FDA for a medical device called "Cermax300 Lightsource." It does not contain information about acceptance criteria or specific study details proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Ask a specific question about this device

The EG&G Xenon 300mx is intended to be used with fiber optic cables for endoscopes, surgical headlamps and other lighted tools that contain fiber optic bundles. Illumination from this device is to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, borncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various surgical procedures.

The Xenon 300mx Illuminator is intended for use as a high intensity light to be used with Fiberoptic cables. Applications include endoscopes, surgical headlamps, and other lighted tools that contained Fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs, and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology, and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.

EG&G Optoelectronics has engineered the Xenon 300mx to provide a high intensity white light source for fiber optic cables. The system consists of a single cabinet containing a power supply, a Xenon Lamp with focusing optics, a variable light attenuator, a selector for four standard fiber optic cable sizes, and a forced air cooling system.

This document is a 510(k) summary for a Xenon Light Source (Xenon 300mx). The core of this document is a claim of substantial equivalence to predicate devices, rather than a detailed study proving performance against defined acceptance criteria.

As such, no comprehensive study proving the device meets acceptance criteria is present in the provided text. The document explicitly states: "No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

However, based on the information provided, we can infer some details and present what is available:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

Since no explicit "acceptance criteria" are provided as a formal table, we can infer them from the "Effectiveness" statement and the claim of substantial equivalence. The primary acceptance criterion appears to be achieving a certain light output sufficient for intended use, and being comparable to predicate devices.

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

• Sample Size: Not applicable. No formal "test set" or clinical study data is presented for direct evaluation of the device's performance against detailed acceptance criteria. The submission relies on demonstrating substantial equivalence to predicate devices.
• Data Provenance: Not applicable. The "performance data" mentioned (for the lamp and power supply, and a database search for adverse effects of marketed devices) is not described in detail regarding its origin or nature (retrospective/prospective, country of origin).

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

• Not applicable. There's no "test set" and thus no ground truth established by experts for that purpose. The determination of "sufficiency" for light output (800 lumens for endoscopic tasks) is a generalized statement, not attributed to a specific expert consensus on a test set.

4. Adjudication Method for the Test Set

• Not applicable. No test set where adjudication would be necessary is described.

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

• No. This document does not describe an MRMC study. It pertains to a light source, not an AI or diagnostic device that typically undergoes such studies for human-in-the-loop performance.

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

• Not applicable in the typical sense for medical device performance (e.g., pathology, outcomes data). The "ground truth" for this submission revolves around the functional characteristics (light output, temperature control) of the device being comparable to those of legally marketed predicate devices and adequate for its intended use. The "effectiveness" statement implicitly defines this ground truth.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that would require a training set.

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

• Not applicable. (See #8)

Ask a specific question about this device

Not Found

Hanaulux blue 80 Hospital is an Examination and Surgical Stand Light. The Hanaulux® blue 80 Hospital is principally the same as the Hanaulux® blue 80 Stand in design, material and function. The only difference is that the Hanaulux(") blue 80 Hospital is equipped with an additional bettery supply unit fitted to the stand pole and stand foot. The batteries will be charged up while the Hanaulux® blue 80 Hospital is connected to a mains supply. In case of a failure of the mains supply the light will be automatically switched over to the battery supply.

This document describes a medical device, the HANAULUX blue 80 Hospital, which is an examination and surgical stand light. It does not describe an AI/ML powered device or a study involving such a device.

Therefore, I cannot provide the requested information regarding:

• Acceptance criteria and reported device performance related to a study. The document confirms compliance with safety standards (UL 2601, IEC 601-1, UL 153) and states a maximum UV irradiance (< 8 W/m²), but these are device specifications and regulatory compliance, not performance metrics from a study measuring accuracy, sensitivity, specificity, etc., as would be relevant for an AI/ML device.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document is a 510(k) summary for a conventional medical device, focusing on its design, function, safety standards, and substantial equivalence to existing devices. It does not mention any kind of study that would generate the type of performance data relevant to AI/ML or diagnostic devices.

Ask a specific question about this device

The Stryker Endoscopy Q-5000 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 endoscopy (general, gastroenterological and ENT surgery).

The Stryker Endoscopy Q-5000 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 endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope. The light source is an integral component of a visualization system which consist of the a video camera, a video monitor, a light cable and a scope.

The Q-5000 light source is AC powered and is designed to meet international medical devices safety standards (IEC 601-1, UL, CSA) to provide safe operation and eliminates or minimizes risks of burns, fire, explosion eye damage, electromagnetic interference or electrical shock that may be associated with it.

This document is a 510(k) premarket notification for a medical device, specifically the Stryker Endoscopy Q-5000 light source. It's a regulatory submission, not a study report.

Therefore, the prompt's request for detailed information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth establishment, and effect sizes cannot be fulfilled from the provided text.

Here's why and what information can be extracted:

• No "acceptance criteria" in the traditional sense of AI/Algorithm performance: This document is about a manufactured physical device (a light source), not an algorithm or AI. Its "acceptance" is based on regulatory clearance for manufacturing and marketing, not on performance metrics like sensitivity, specificity, AUC, or reader improvement.
• No "study" in the sense of a clinical trial proving performance: The document states "The Stryker Endoscopy Q-5000 light source is substantially equivalent to the Circon-ACMI MV9082 light source and raises no additional safety or effectiveness issues." This is a key part of 510(k) submissions. Instead of conducting new clinical trials, manufacturers demonstrate that their new device is "substantially equivalent" to a device already legally marketed (the "predicate device"). This avoids the need for extensive, new clinical studies.
• No "device performance" in terms of clinical outcomes: The performance described relates to its function (illuminating the surgical site) and safety (meeting standards to prevent burns, fire, etc.).

Information that can be extracted or inferred from the text related to the prompt's categories:

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

   • Acceptance Criteria (Implied by 510(k) process): Substantial equivalence to a predicate device and adherence to relevant safety standards.
   • Reported Device Performance:
     • Function: Illuminates the site of surgery during minimally invasive surgical procedures.
     • Safety: Designed to meet international medical device safety standards (IEC 601-1, UL, CSA) to eliminate or minimize risks of burns, fire, explosion, eye damage, electromagnetic interference, or electrical shock.
     • Equivalence: Substantially equivalent to the Circon-ACMI MV9082 light source.

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. No test set or data provenance in the context of clinical performance evaluation is mentioned, as this is a substantial equivalence claim for a physical device.

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

   • Not applicable. No ground truth establishment for a test set is mentioned. The ground truth for this type of submission is the regulatory standard and the performance of the predicate device.

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

   • Not applicable. No test set or adjudication process for clinical performance 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 device is a light source, not an AI or diagnostic tool that assists human readers. No MRMC study was performed or is relevant here.

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

   • Not applicable. This is a physical light source, not an algorithm.

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

   • Primary Ground Truth: Regulatory standards (IEC 601-1, UL, CSA) and the established safety and effectiveness of the predicate device (Circon-ACMI MV9082 light source). Historical use of light sources ("Light sources have been used in endoscopic surgical procedures for at least 15 years. They have been safe and effective...") also serves as a basis for general safety and effectiveness claims.

8. The sample size for the training set:

   • Not applicable. No training set for an algorithm is mentioned.

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

   • Not applicable. No training set is involved.

In summary, this document is a regulatory filing for a medical device that relies on the concept of "substantial equivalence" to a predicate device, rather than a clinical study evaluating novel performance through a test set and ground truth.

Ask a specific question about this device

Ask a specific question about this device