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The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.

The TruView Light Cable is a fiber optic surgical light designed to be compatible with a variety of fiber optic light sources.

The provided text describes the submission of a 510(k) premarket notification for a medical device called the "TruView Light Cable" and its variants. This document does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. Instead, it focuses on the substantial equivalence of a physical medical device (a fiber optic light cable) to existing predicate devices.

Therefore, many of the requested criteria related to AI/ML model performance, such as sample sizes for training/test sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable to this document.

However, the document does contain information about performance testing for the physical device. Here's a breakdown of the relevant information provided:

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

The document states that the TruView Light Cable was subjected to three performance tests and "met the acceptance criteria for the testing performed." While specific numerical acceptance criteria and performance values are not explicitly detailed in a table, the document lists the types of tests and their purpose:

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

• Sample Size: Not specified. The document simply states "three (3) performance tests." It does not indicate the number of units tested for each performance test.
• Data Provenance: Not specified regarding "country of origin of the data" or "retrospective/prospective." This testing would typically be prospective, in-house laboratory testing of the manufactured 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. This is a physical device performance test, not a diagnostic algorithm requiring expert interpretation of medical images or data. Ground truth would be defined by engineering specifications and objective measurements (e.g., temperature, fit, light intensity).

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

• 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-assisted 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 (expert consensus, pathology, outcomes data, etc):

• For a physical device like a light cable, the "ground truth" would be established by engineering specifications, regulatory standards, and objective measurements.
  • For the Fit Test: Successful mechanical coupling and operation.
  • For the Collateral Heating Test: Temperature measurements staying below defined safety thresholds for burns.
  • For the Intensity Test: Light intensity measurements meeting efficacy requirements while staying below defined thresholds to prevent patient injury.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML model that requires a training set.

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

• Not Applicable. See point 8.

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This device is intended to transmit light for illumination purposes from the light source to endoscopes.

A 5mm fiber-optic light transmitting core with durable protective sleeve and stainless steel couplings at each end. One coupling is for the light source and the opposite end for connection to an endoscope. The core is inserted into a durable and reusable silicone rubber sheath. One length is available: 7.5 Feet. Field replaceable fiber-optic core.

The provided document is a 510(k) premarket notification for a medical device called "Endo-Cord," which is a surgical lamp (fiber-optic light transmission cable). The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices.

The document describes non-clinical testing performed to establish the device's substantial equivalence, focusing on light transmission properties, cleaning validation, and sterilization validation. It does not describe a study involving human subjects, AI assistance, or expert readers, which would be relevant for devices that perform diagnostic interpretations or require human-in-the-loop performance studies (e.g., AI algorithms for medical image analysis).

Therefore, I can only provide information based on the presented non-clinical "study" for this specific device. Many of your requested points relate to studies involving human expertise and AI, which are not applicable to the information given for the Endo-Cord.

Here's the information parsed from the document:

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

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

• Sample Size:
  • For the light transmission testing, the ranges (e.g., "639-658") suggest multiple measurements were taken for both the Endo-Cord and Sunoptics cords, but the exact number of cords tested or measurements taken per cord is not specified.
  • For cleaning and sterilization validation, specific sample sizes are not provided, only that the validation "meets" the standard.
• Data Provenance: Not specified, but generally, such tests for FDA submissions are conducted domestically (USA) in a controlled laboratory setting. It is not a retrospective or prospective clinical study.

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. This study is a non-clinical, bench-top performance and validation study of a physical device (light cable). It does not involve human interpretation or subjective assessment that would require expert-established ground truth.

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

• Not applicable. As a non-clinical performance study, there is no need for adjudication of human interpretation.

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. An MRMC comparative effectiveness study was not done. This device is a fiber-optic light cable for illumination, not an AI-assisted diagnostic tool.

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

• No. This is a hardware device, not an algorithm.

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

• The "ground truth" for the non-clinical testing was based on objective physical measurements (e.g., light intensity output) compared against a predicate device and adherence to recognized industry standards (AAMI TIR30 for cleaning, and ISO/AAMI standards for sterilization, implied by the SAL of 10-6).

8. The sample size for the training set

• Not applicable. This is a hardware device, not a machine learning algorithm. Therefore, there is no training set.

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

• Not applicable. As there is no training set, no ground truth was established for it.

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The Stryker Spine LITe® Decompression System - Light Cable is intended to provide surgical site illumination from a high intensity light source when Stryker decompression tubes are in use.

The Stryker Spine LITe® Decompression System - Light Cable is a single use, sterile and disposable component. The Stryker Spine LITe® Decompression System - Light Cable consists of fiber optic cables contained within silicone tubing which can be connected to a light generator on one end and the tube of the Stryker Spine LITe® Decompression System on the other end.

This 510(k) summary is for the Stryker Spine LITe® Decompression System - Light Cable, which is a fiber optic light cable intended to provide surgical site illumination. The document focuses on establishing substantial equivalence to predicate devices and does not describe a study involving performance metrics for AI or machine learning algorithms. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable.

Here's an analysis based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not contain specific acceptance criteria and detailed performance metrics in the way one would expect for an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "performance" described is in comparison to the predicate devices.

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

This information is not applicable. The device is a physical medical device (fiber optic light cable), not an AI/ML algorithm that processes data. Therefore, there is no "test set" of data in the context of AI/ML evaluation.

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

This information is not applicable, as there is no "ground truth" establishment in the context of an AI/ML test set. The evaluation is focused on the device's physical design, materials, and intended function compared to existing legally marketed devices.

4. Adjudication Method for the Test Set

This information is not applicable. There is no "adjudication method" for a test set as would be used for AI/ML performance evaluation. The substantial equivalence determination is made by the FDA based on the provided comparisons to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of human readers' improvement with AI vs without AI assistance

This information is not applicable. The device is a surgical light cable, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

This information is not applicable. The device is a physical light cable, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable. As stated, there is no "ground truth" in the context of AI/ML evaluation for this device. The evaluation relies on comparing the device's technical specifications and intended use against predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for it.

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The Invuity® Eigr™ Surgical Illumination System is intended to provide surgical site illumination from a high intensity light source.

Not Found

The provided document is a 510(k) clearance letter for the Invuity® Eigr™ Surgical Illumination System. It indicates that the device is substantially equivalent to a predicate device and is intended to provide surgical site illumination.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

Therefore, it is not possible to answer the user's request based on the provided text. The document is solely a regulatory approval letter and does not include the technical study details requested.

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The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite.

The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite.

There are three separate models made for the three types of light cables:

Here's an analysis of the provided text regarding the SensorMed CableCap™ 510(k) submission, outlining acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a numerical 'sample size' in terms of units tested. The text mentions "test runs" and a "report included in the testing section." It doesn't specify if one device was tested multiple times, or if multiple devices were tested.
• Data Provenance: The testing was conducted by "Materials, Engineering, and Testing Corp. located in Oak Ridge, TN." This indicates the data is from a U.S.-based, independent testing lab. The study appears to be prospective bench-top testing specifically designed to evaluate the safety of the CableCap.

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

• Not Applicable. The ground truth for this device's performance is objective physical measurements (temperature). No human experts were used to establish a subjective "ground truth" for the test set. The acceptance criteria themselves (e.g., maximum safe temperature) would be derived from established medical device safety standards, which are developed by experts and regulatory bodies, but no specific number or qualification of experts is mentioned for this particular test.

4. Adjudication Method for the Test Set

• Not Applicable. As the ground truth was objective physical measurement (temperature), there was no need for expert adjudication.

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

• No. This device (CableCap) is a physical accessory designed to reduce heat from a surgical light cable. Its performance is evaluated through objective physical measurements related to temperature, not through human interpretation of medical images or data. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, in essence. The performance testing described is of the device itself (the "algorithm" in this context being the device's physical heat-dissipating properties) without any human interaction influencing its core function or measurement during the test. The device's ability to absorb and diffuse light to prevent heat buildup was tested in a standalone, bench-top environment.

7. Type of Ground Truth Used

• Objective Physical Measurements: The ground truth was established by direct measurement of the device's temperature under simulated "extreme scenarios" (contact with skin for 60 minutes). This is a physical, measurable outcome, not expert consensus, pathology, or patient outcomes data directly from a clinical trial.

8. Sample Size for the Training Set

• Not Applicable. This device is a passive physical accessory, not an AI/ML algorithm that requires a training set. The performance is determined by its design and material properties, not learned from data. Therefore, there is no training set.

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

• Not Applicable. As there is no training set for this type of device, this question is not relevant.

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The Headlight is indicated for use in transmitting illumination to a body cavity or surgical procedure.

Not Found

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for the IsoLED AC-Powered LED Headlight System, indicating that the device has been found substantially equivalent to a predicate device.

It includes:

• Device name: IsoLED AC-Powered LED Headlight System
• Regulation Number and Name: 21 CFR 878.4580, Surgical lamp
• Regulatory Class: Class II
• Product Code: FST
• Indications for Use: "The Headlight is indicated for use in light transmitting illumination and body cavity illumination procedures."

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone performance.
• Training set details.

Therefore, I cannot fulfill your request based on the provided text.

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The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite. It is necessary to check each light cable to determine which CableCap model (STZ, ACM, WLF) to use. See product instructions for cleaning and sterilization protocols.

The device is not intended to be used to illuminate the surgical field.

The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite.

There are three separate models made for the three types of light cables: WLF, STZ, ACM.

Here's an analysis of the provided text regarding the CableCap™ device, focusing on the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only details one explicit performance criterion related to temperature.

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

• Sample Size: Not explicitly stated. The text mentions "test runs" and "bench-top physical testing," implying multiple tests were done, but the exact number of units tested or runs performed is not provided.
• Data Provenance: The testing was conducted by Materials, Engineering, and Testing Corp. in Oak Ridge, TN. This indicates the testing was likely performed in the USA. The text does not specify if the tests were performed on retrospective or prospective data/scenarios; it describes simulating "an extreme scenario" for prospective product safety.

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

This information is not applicable to the type of testing described. The performance testing for the CableCap™ device was a physical bench-top test measuring temperature, not a diagnostic or interpretive task that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. Since the testing involved physical measurements (temperature), there was no need for expert adjudication.

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

This information is not applicable. The CableCap™ is a physical accessory designed to prevent burns and ignition, not a diagnostic or interpretive tool that would involve human readers or AI assistance in decision-making. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The CableCap™ is a passive mechanical device, not an algorithm or software. Its performance is inherent in its physical properties and design, not in an algorithmic output.

7. Type of Ground Truth Used

The ground truth used for the performance testing was a physical measurement benchmark (a "standard" for safe temperature) against which the device's measured temperature was compared.

8. Sample Size for the Training Set

This information is not applicable. The CableCap™ is a hardware device; it does not involve machine learning or AI, and therefore does not have a "training set."

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

This information is not applicable for the reasons stated in point 8.

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The 21tt Century Centurion ExceLED and System Two LED lights are intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures.

The System Two LED surgical Lighting System is an AC powered device which provides a focusable filed of illumination for general examination and surgery.

It can consist of any combination of the 3 lights (D1, D2, D3) listed below.

All 3 models will have 5-level dimming and beam size (8"-12") adjustments.

D1 = small minor surgical light / satellite

• D2 = large minor surgical light
  D3 = major surgical light

The proposed 21* Century Centurion ExceLED (an AC powered device) is the first generation fixed pattern / five level intensity minor surgical LED (Light Emitting Diode) light designed to provide visible illumination of the surgical field and the patient during minor surgical and non-surgical procedures.

The proposed System Two LED surgical Lighting System is an AC powered device which provides a focusable field of illumination for general examination and surgery. It can consist of any combination of the 3 lights (D1, D2, D3) listed below.

All 3 models will have 5-level dimming and beam size (8"-12") adjustments.

• D1 = small minor surgical light / satellite
• D2 = large minor surgical light
• D3 = major surgical light

The provided document is a 510(k) summary for a surgical lighting system and does not contain information about acceptance criteria for a device, nor a study proving meeting such criteria. Instead, it details the device's description, intended use, safety information, and substantial equivalence to predicate devices, focusing on regulatory approval for market entry.

Therefore, I cannot provide the requested information.

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The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

The Harmony vLED Surgical Lighting System is designed to replace existing surgical lights, or to be installed as part of major renovations to existing facilities or in new facilities.

The Harmony vLED Surgical Lighting System accessories are as follows:

• STERIS ACT Interface o
• o Camera Module
• Dual or Single Flat Panel Monitors o
• o 24VDC Battery Backup support
• Remote Power Module Unit 0
• Sterile Disposable Handle Covers o

The provided text describes the STERIS® Harmony vLED Surgical Lighting System (K100395) and its performance testing to demonstrate substantial equivalence to a predicate device. However, this document does not contain the specific details required to complete your request for acceptance criteria and a study proving device conformance to those criteria.

The document states: "Performance testing was conducted to verify that the Harmony vLED Surgical Lighting System meets the requirements for Medical Electrical Equipment as defined in CEI/IEC 60601-1 and IEC 60601-2-41." This indicates that the device's performance was evaluated against these safety and performance standards for medical electrical equipment. However, the specific acceptance criteria within these standards for this particular device and the results of that testing demonstrating the device meets those criteria are not provided in the given text.

Therefore, I cannot populate the table of acceptance criteria and reported device performance, nor can I provide answers to the questions regarding sample size, ground truth, expert involvement, or comparative effectiveness studies based on the information given.

To answer your request, I would need access to the actual performance testing report, which would detail the specific tests conducted, the acceptance limits for each test, and the actual measurements obtained from the Harmony vLED Surgical Lighting System.

Based on the provided text, the following information is available (though insufficient for your request):

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

• Cannot be provided as the specific acceptance criteria and detailed performance results are not included in the text. The text only states that the device meets the "general requirements for safety as defined in CEI/IEC 60601-1 and IEC 60601-2-41 for Medical Electrical Equipment."

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

• Not provided. The document does not specify the number of devices or components tested. Data provenance is also not mentioned beyond the manufacturer being STERIS Corporation.

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

• Not applicable / Not provided. For a surgical light, "ground truth" and expert adjudication are typically not involved in performance testing for electrical and safety standards like CEI/IEC 60601-1 and IEC 60601-2-41. These standards involve objective measurements (e.g., light intensity, electrical leakage, temperature, etc.) against pre-defined limits.

4. Adjudication method for the test set:

• Not applicable / Not provided. 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 device is a surgical light, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI assistance are not relevant.

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

• Not applicable. This device is a surgical light; there is no algorithm for standalone performance to evaluate in this context.

7. The type of ground truth used:

• Not applicable. Performance testing for a surgical light against IEC standards relies on objective measurements against engineering specifications, not "ground truth" in the diagnostic sense (e.g., pathology, expert consensus).

8. The sample size for the training set:

• Not applicable. There is no "training set" for a surgical light being tested against electrical and safety standards.

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

• Not applicable. See point 8.

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The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products.

The XtremeBeam Fiber Optic Headlamp is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures.

The ChromaLUME Turbo Light Source is designed for use with fiber optic headlight systems. Its' intended function and use is to supply high intensity light through the fiber optic cable for illumination of a surgical field. The ChromaLUME Turbo Light Source will accommodate fiber optic cables from Wolf, Storz, Olympus and ACMI/BFW products.

The XtremeBeam Fiber Optic Headlight is a passive luminary which is illuminated by the fiber optic light to provide supplemental light for surgical procedures. It is constructed of a durable plastic housing, lenses, spot size adjustment, and positioning bar. It utilizes a proprietary fiber optic cable, the distal end of which will fit an ACMI port. The luminaire optics consist of optic lenses, a mirror, and an iris.

The provided text describes the 510(k) summary for the BFW, Inc. ChromaLUME Turbo Light Source with XtremeBeam Fiber Optic Headlight. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and a study design to meet them.

Therefore, it is not possible to provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

The text explicitly states:

• "The ChromaLUME with XtremeBeam has been tested to and meets IEC 60601-1 Standard for Medical electrical equipment, Part 1: General requirements for safety." This indicates compliance with a general safety standard, not performance against specific clinical acceptance criteria for illumination.
• The primary purpose of the 510(k) summary is to establish "Substantial Equivalence" to a predicate device (Welch Allyn, Inc. Model ProXenon 350 Surgical Illuminator). This typically means showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety and effectiveness, often by relying on the predicate's established performance rather than conducting new extensive clinical performance trials.

Without a detailed clinical or performance study report, the specific information requested cannot be extracted.

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