(30 days)
The modified Laparoshield Conditioned Insufflation Set ("Laparoshield") is intended to be used as an accessory to an insufflator to heat, humidify and filter a gas stream used for insufflation during laparoscopic surgery. It is indicated for use with CO2.
The modified Laparoshield consists of a length of silicon coated heating wire coiled in the insufflation tubing. Heating control is performed by a constant voltage/voltage limited power supply. The patient end of the heater wire is encased in a hydrating wick. Gas flows through the annulus created by the wick and outer tubing. The proximity of the heating wire and hydrated wick produce warms and humidifies CO2 from the insufflator. A temperature strip indicates under, normal, and over temperature conditions. The set has a universal connector for compatibility with insufflation machines with Luer, 15mm/22mm ISO 5356-1 and hose-barb gas ports and a trocar.
The Pall Medical Laparoshield Conditioned Insufflation Set is described as an accessory to an insufflator designed to heat, humidify, and filter a CO2 gas stream for laparoscopic surgery. The document provides information regarding its technological characteristics and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Temperature and Humidity Output: No specific numerical acceptance criteria are provided in the document. The general acceptance criterion implied is that the device must meet its internally defined "performance specifications" for temperature and humidity output. | "In all instances, the modified Laparoshield met its performance specifications." The device demonstrated the ability to warm and humidify CO2. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Testing was performed to evaluate the temperature and humidity output at two different per minute average CO2 flow rates." No specific sample size (i.e., number of units tested) for the test set is provided. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it is implied to be bench testing conducted by Pall Medical as part of their premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The performance testing described is bench testing of physical parameters (temperature and humidity output), not a clinical study involving expert assessment of images or patient outcomes. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this was bench testing of physical characteristics, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes bench testing of a medical device, not a comparative effectiveness study involving human readers or AI assistance.
6. Standalone Performance Study (Algorithm Only)
Yes, a standalone performance study was conducted in the form of bench testing. The document states: "Testing was performed to evaluate the temperature and humidity output at two different per minute average CO2 flow rates. In all instances, the modified Laparoshield met its performance specifications." This directly assesses the device's performance without human interaction in its function.
7. Type of Ground Truth Used
The ground truth used was the predefined performance specifications for temperature and humidity output established by Pall Medical for the device. This is based on physical measurements against engineering design requirements, not clinical ground truth like pathology or expert consensus.
8. Sample Size for the Training Set
Not applicable. This device is a hardware accessory with heating and humidifying functions; it is not software or an AI algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.