(138 days)
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.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Flow/Pressure Performance | Successfully completed |
| Gas Temperature Characterization | Successfully completed |
| Humidity Characterization | Successfully completed |
| Insertion/Removal Testing | Successfully completed |
| Seal Leak Integrity Testing | Successfully completed |
| Biocompatibility (ISO 10993-1) | Successfully conducted |
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.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.