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The Stryker AIM Light Source is intended to trans-illuminate anatomical structures during open or laparoscopic surgical procedures.

The Stryker® AIM Light Source and SafeLight Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The Stryker® AIM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near infrared imaging.

Fluorescence imaging of biliary ducts with the Stryker® AIM Light Source and SafeLight Cable are intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

The Stryker IRIS Ureteral Kit when used with compatible Stryker is intended to trans-illuminate the ureter during surgical procedures. The catheter accepts up to 0.038" guide wire. The kit can be used for either open surgical or laparoscopic procedures.

The Stryker® Infrared Illuminating System (IRIS) is used to trans-illuminate the ureter during laparoscopic or open surgical procedures. Trans-illumination is intended to help the surgeon identify the ureter(s) during open or laparoscopic surgical procedure of lower abdomen or pelvic areas. The Stryker® Infrared Illuminating System (IRIS) consists of the following main components (herein referred to as 'proposed devices'):

• A light source console.
• A Ureteral Kit that consists of two catheters, one fiber assembly containing two light emitting fibers, one catheter dispenser, one light emitting fiber dispenser, two luer connectors, and two drape clips.

This document is a 510(k) premarket notification for the Stryker® Infrared Illuminating System (IRIS). It's a regulatory submission to the FDA, demonstrating substantial equivalence to previously cleared devices. It does not contain a study that proves the device meets acceptance criteria in the format you requested, typically found in clinical trial reports or detailed performance studies.

The document primarily focuses on demonstrating that the new device, IRIS, is substantially equivalent to existing predicate devices (Stryker Ureteral Illumination System IV and Stryker® Infrared Fluorescence Imaging System) in terms of its indications for use, design technology, and performance specifications.

Here's an analysis based on the provided text, addressing your questions where information is available, and noting when it's not:

1. Table of acceptance criteria and reported device performance:

The document mentions "Bench performance testing was conducted to ensure that the devices functioned as intended and met design specifications and acceptance criteria." and "Cadaver testing validated the ureteral trans-illumination capability of the Stryker Infrared Illuminating System (IRIS)." However, it does not provide specific acceptance criteria or detailed reported device performance in a quantitative table format. It only states that the device "met design specifications and acceptance criteria" and "validated the ureteral trans-illumination capability."

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

• Bench Testing: The document does not specify the sample size for bench testing.
• Cadaver Testing: The document does not specify the sample size (number of cadavers or ureters) used for "cadaver testing."
• Data Provenance: Not specified, but generally, such testing for a 510(k) submission would be conducted by the manufacturer (Stryker) or
  contracted labs within the U.S. or other regulated regions. The document implies this data is prospective, generated specifically for this submission.

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

Not applicable or not provided. This type of regulatory submission for a device without a diagnostic claim typically relies on engineering specifications and direct physical performance assessment, not expert interpretation of outputs against a ground truth from an expert consensus. The "validation" of trans-illumination in cadavers would be a direct observation, likely by the engineers and potentially surgeons involved in the study.

4. Adjudication method for the test set:

Not applicable or not provided. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need to be resolved. The tests described (bench and cadaver) are more focused on direct physical performance and engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No, an MRMC comparative effectiveness study was not done or reported in this document. MRMC studies are typically used to compare the performance of human readers with and without AI assistance for diagnostic tasks. This device is an illumination system, not a diagnostic algorithm that would be evaluated in such a study.

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

This question is not directly applicable. The device is a physical illumination system (light source and ureteral kit), not a standalone algorithm. Its function is to provide illumination for human surgeons. The "standalone" performance would be its ability to emit light and trans-illuminate, which was assessed through bench and cadaver testing.

7. The type of ground truth used:

• For bench testing, the "ground truth" would be the device's design specifications and established engineering parameters.
• For cadaver testing, the "ground truth" for "ureteral trans-illumination capability" would be the direct visual confirmation of the ureter being illuminated by the device in the cadaveric model. This is a direct physical observation, not an expert consensus or pathology report.

8. The sample size for the training set:

Not applicable. This device is a hardware system, not an AI/ML algorithm that requires a "training set" of data.

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

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

In summary:

This 510(k) submission details the regulatory pathway for a medical device (an infrared illuminating system) by establishing its substantial equivalence to previously cleared devices. It describes that performance testing (bench and cadaver) was conducted to ensure the device met design specifications and validated its intended function. However, it does not provide detailed quantitative acceptance criteria, specific performance metrics, sample sizes for testing, or information relevant to AI algorithm studies (like MRMC, training sets, or expert consensus on ground truth) which are not applicable to this type of device.

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The InfraVision Ureteral Kit with the InfraVision IR Illuminator is intended to transilluminate the ureter during surgical procedures. The Catheter accepts up to a 0.038"-guidewire. The Kit can be used for either open surgical (with the InfraVision Detector Probe) or laparoscopic (with the InfraVision Camera) access.

The Stryker Ureteral IIIumination System IV consists of an open-ended ureteral catheter, which allows the use of a guidewire (up to 0.038" dia), is composed of Pellethane™ with a hydrophilic coating to ease insertion into the ureters and incorporates a fiberoptic light guide that is used with the InfraVision IR llluminator to transluminate the ureter during surgical procedures. It can be used for either open surgical or laparoscopic access and is distributed as a sterile, single use disposable product. The device is validated for EtO sterilization to a SAL of 10°.

The provided text is a 510(k) summary for the Stryker Ureteral Illumination System IV. It describes the device's intended use and claims substantial equivalence to a predicate device, the Stryker Ureteral Illuminator System III (K982542).

However, the document does NOT contain any information regarding specific acceptance criteria for performance, a study detailing device performance against those criteria, sample sizes, expert ground truth establishment, or any of the other detailed study parameters requested in your prompt.

The 510(k) summary primarily focuses on:

• Device Name and Classification: Identifying the device and its regulatory classification.
• Intended Use: Stating what the device is for (transilluminating the ureter during surgical procedures).
• Technological Characteristics: Describing the components (catheter, guidewire compatibility, materials, hydrophilic coating, fiberoptic light guide) and sterilization method.
• Substantial Equivalence Claim: Asserting that the device is as safe and effective as the predicate device and that technological differences do not affect safety or efficacy.
• Standards Conformance: Listing general safety and performance standards the device will conform to (e.g., ISO, AAMI, ASTM).

Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text, as this information is not present. The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting de novo clinical performance data against specific acceptance criteria for a novel device.

Summary of available information from the text:

• Acceptance Criteria & Reported Device Performance: Not explicitly stated or detailed. The submission relies on claiming substantial equivalence to a predicate device.
• Sample Size (test set) & Data Provenance: Not mentioned. No specific "test set" or performance study is described.
• Number of experts and qualifications for ground truth: Not applicable, as no ground truth establishment for a performance study is described.
• Adjudication method for test set: Not applicable.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance: Not applicable; this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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The Stryker Ureteral Illuminator System III is an ureteral transillumination device with a reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The Stryker Ureteral Illuminator System III is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures. Transillumination is intended to help the ureter(s) during open or laparossopic surgical procedures of the lower abdomen or pelvic areas. As a general surgery transillumination device, the Stryker Ureteral Illuminator System III replaces and is substantially equivalent to existing predicate fiberoptic light ureteral catheter transillumination devices.

The Stryker Ureteral Illuminator System III is an ureteral transillumination device with a reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The Stryker Ureteral Illuminator System III is intended to transilluminate the ureter during laparoscopic and open surgical procedures. Transillumination is intended to help the ureter(s) during open or laparoscopic surgical procedures of the lower abdomen or pelvic areas. The Stryker Ureteral Illuminator System III illumination source will comply with UL 544 Standard for Medical and Dental Equipment and 21 CFR 1040.10 Performance Standards for Lasers. The Stryker Ureteral Illuminator System III fiberoptic light ureteral catheter kit will be constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. The Stryker Ureteral Illuminator System III EtO sterilization processes are validated per AAMI/ANSI/ISO 11135, to a SAL of 10-6.

The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding AI integration for the Stryker Ureteral Illuminator System III. The submission is a 510(k) for a medical device that predates the widespread use of sophisticated AI in medical devices, and focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide answers to the requested points, as the information is not present in the given document. The document primarily discusses:

• Device Name and Classification: Stryker Ureteral Illuminator System III, classified under 21 CFR 876.4020 for fiberoptic light ureteral catheters.
• Intended Use: To transilluminate the ureter during laparoscopic and open surgical procedures to help locate the ureters.
• Safety and Effectiveness: Stated to be equivalent to existing marketed devices (specifically Gabriel Ureteral Illuminator System II - K945088).
• Compliance: Mentions compliance with UL 544, 21 CFR 1040.10, ISO 10993 for biocompatibility, and AAMI/ANSI/ISO 11135 for sterilization validation.
• FDA Determination: A letter from the FDA stating the device is substantially equivalent to predicate devices marketed before May 28, 1976.

The traditional 510(k) process for a device like this relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a detailed performance study against specific acceptance criteria in the manner you've described for AI/algorithm-driven devices. Performance is often inferred from the predicate device's established safety and effectiveness.

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