Search Results

Insuflow Synergy™ Port (5 mm) and Insylow® Synergy™ XL Port (8 mm, 10mm and 12mm) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

The Insuflow® Synergy™ and Insuflow® Synergy™ XL Port devices are gas conditioning devices that attach to the outlet port of an insufflator or other regulated CO2 source and are design and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow® Synergy™ XL Port consist of a sterile, disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the system.

The Insuflow® Synergy™ and Synergy™ XL Port devices and their modifications involve design changes to existing gas conditioning and path of entry devices used in minimally invasive surgery.

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with specific performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the modified devices perform in accordance with specifications and applicable standards, and are "substantially equivalent" to predicate devices. The performance testing focuses on ensuring that the changes do not negatively impact the established functionalities of the original devices.

Study Details

The provided text describes a submission for a Special 510(k), which is typically used for modifications to a legally marketed device that do not significantly affect its safety or effectiveness. As such, the "study" is primarily a performance testing regimen to validate the design changes rather than a large-scale clinical trial or comparative effectiveness study.

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

   • Sample Size: Not explicitly stated as a number of units. The testing was conducted for "the modified Insuflow® Synergy™ (5 mm) and Synergy™ XL (8 mm, 10 mm and 12 mm) Port dual lumen models." This implies that representative samples of each modified size/configuration were tested.
   • Data Provenance: The testing was conducted by the manufacturer, LEXION Medical, LLC, as part of their risk analysis and product development. This would be retrospective in the sense that it's laboratory/bench testing performed after the design changes were implemented, but before market introduction of the modified device. The country of origin for the data is not specified, but the submitter is based in St. Paul, MN, USA.

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

   • Not Applicable. This type of device modification and performance testing (bench testing for flow, pressure, and mechanical integrity) does not typically involve human expert "ground truth" establishment in the way an imaging AI algorithm would. The "ground truth" is defined by engineering specifications and physical measurements.

3. Adjudication method for the test set:

   • None. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments, such as interpreting medical images. For physical device performance testing, objective measurements against engineering specifications are used, removing the need for expert adjudication in this context.

4. 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 study is not applicable as this device is a surgical instrument (gas conditioner and port) and not an AI-powered diagnostic or assistive tool for image interpretation.

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

   • Partially Yes (in a different context). The device itself is a standalone medical device that performs its function without a human "in the loop" for its primary operation (gas conditioning, port access). It's not an AI algorithm. The performance tests described (flow/pressure, insertion/removal) are standalone tests of the device's physical and functional properties.

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

   • The ground truth for the performance testing is based on engineering specifications and measurable physical properties. For example, the "ground truth" for flow/pressure performance would be the required flow rates and pressure tolerances as defined by the device design and relevant industry standards. For insertion/removal, it would relate to acceptable forces, ease of use, and lack of damage.

7. The sample size for the training set:

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

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

   • Not Applicable. As there is no training set, there is no ground truth established for it in this context.

Ask a specific question about this device

Insuflow® Synergy™ Port has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

The Insuflow Synergy™ Port (Dual and Single Lumen) is a gas conditioning device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow Synergy™ Port consists of a disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the svstem. Regulated CO2 gas flows into the Insuflow® Synergy™ Port, through the in-line filter, continues along the tubing to enter the path of entry access device that contains the heating element and humidification media, and through the path of entry access device lumen for delivery into the patient's surgical cavity. The integral path of entry access device is designed and constructed similarly to the predicate trocar device with a sealed instrument access lumen. The Insuflow® Synergy™ Port (Dual and Single Lumen) has a dual-lumen or single-lumen path of entry access device configuration for conditioned gas delivery. Both configurations have a working channel with duckbill and tool seals for instrument entry into the surgical cavity. The single lumen device delivers conditioned insufflation gas through the working channel while the dual lumen configuration has a second outer lumen channel for conditioned gas delivery.

The provided text is a 510(k) summary for the Insuflow® Synergy™ Port, a medical device. This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

This document focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study demonstrating the device's meeting specific, quantitative acceptance criteria via a performance study with a test set, ground truth and human readers.

Therefore, I cannot fully complete all sections of your request as the information is not present in the provided text. However, I can extract what is available.

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The Insuflow® Synergy™ Port is a gas conditioning insufflator accessory device designed to warm, humidify, and filter CO2 gas for insufflation during minimally invasive surgeries, and to establish a path of entry for endoscopic instruments. The regulatory pathway for this device was a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than a direct clinical performance study with specific acceptance criteria in the format you've requested.

The "acceptance criteria" in this context are implicitly related to demonstrating that the Insuflow® Synergy™ Port performs safely and effectively in a manner substantially equivalent to its predicate devices. The study proving this involved extensive performance testing and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for a clinical performance study (e.g., sensitivity, specificity thresholds) are not explicitly stated in this 510(k) summary, I can only infer what was tested and that the device "successfully completed" these tests, implying they met internal or standard-based criteria.

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

This information is not provided in the summary. The document mentions "extensive performance testing" but does not detail the sample sizes for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective). It is likely these were bench/laboratory tests rather than tests on patient data.

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

This information is not provided. Given the nature of the device (a gas conditioning insufflator and access port) and the type of testing described (flow/pressure, temperature, humidity, insertion/removal, seal leak, biocompatibility), it's highly improbable that "experts to establish ground truth" in the context of diagnostic performance (e.g., radiologists interpreting images) would be relevant or used. The "ground truth" for the performance tests would be instrument measurements and standardized test procedures.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for the type of testing described in this 510(k) summary. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of data where consensus is needed for ground truth (e.g., image interpretation).

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, a MRMC comparative effectiveness study was not performed. This device is a surgical instrument accessory, not an AI-powered diagnostic tool, so such a study would not be applicable or relevant to its regulatory approval.

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

This question is not applicable. The Insuflow® Synergy™ Port is a physical medical device, not an algorithm, so a "standalone" algorithmic performance study without human-in-the-loop would not be relevant.

7. The Type of Ground Truth Used

For the performance tests mentioned (Flow/Pressure, Gas Temperature, Humidity, Insertion/Removal, Seal Leak Integrity), the "ground truth" would be established by objective physical measurements using calibrated instruments and adherence to established engineering and medical device standards. For biocompatibility, it would be established by laboratory testing results against ISO 10993-1. Pathology or outcomes data would not directly serve as ground truth for these types of tests.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a physical hardware product, not a software algorithm that requires a "training set."

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

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

Ask a specific question about this device