(86 days)
The Laparoshield Conditioned Insufflation Set is intended for use as an accessory to an insufflator to heat, humidify, and filter a gas stream used for insufflation during laparoscopic surgery. The device is indicated for use with CO2
The Laparoshield Conditioned Insufflation Set consists of a length of silicon coated heating wire coiled in the insufflation tubing. Heating control is performed by a temperature control unit integrated into the power supply component of the device. 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.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed clinical study report with explicit quantitative acceptance criteria. Therefore, the "acceptance criteria" here are implied by the performance characteristics of the predicate device, and the "device performance" is stated in qualitative terms.
| Acceptance Criterion (Implied by Predicate Performance) | Reported Device Performance (Laparoshield Conditioned Insufflation Set) |
|---|---|
| Ability to heat a gas stream | Functions as intended (implies heating capability) |
| Ability to humidify a gas stream | Functions as intended (implies humidifying capability) |
| Ability to filter a gas stream | Functions as intended (implies filtering capability) |
| Maintain specified flow rates | Testing performed includes flow rate evaluation |
| Maintain specified temperature | Testing performed includes temperature evaluation |
| Maintain specified humidity | Testing performed includes humidity evaluation |
| Compatibility with CO2 gas | Indicated for use with CO2 |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of devices or experimental runs. The text mentions "Testing was performed to evaluate the flow rate, temperature and humidity at two different per minute average CO2 flow rates." This indicates at least two flow rate conditions were tested, but not the number of units tested or repetitions.
- Data Provenance: The document does not specify the country of origin of the data. The testing appears to be internal to Pall Medical, the manufacturer. The study is retrospective in the sense that it's a verification and validation study conducted by the manufacturer before submission for market clearance, rather than a prospective clinical trial on human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable. This type of device (a gas conditioning set) does not typically involve expert review for "ground truth" in the same way an imaging AI algorithm might. The performance criteria (flow, temperature, humidity) are objectively measurable physical properties.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The "ground truth" for the performance metrics (flow rate, temperature, humidity) is established by direct physical measurement using calibrated equipment, not by subjective expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the device aims to assist or improve their performance. The Laparoshield Conditioned Insufflation Set is a device accessory that performs physical conditioning of gas, not a diagnostic tool for human interpretation.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Standalone Performance: Not applicable in the context of an "algorithm only" device. This device is a mechanical/electrical accessory that operates independently to condition gas. Its performance is inherent to its design and function, not dependent on an algorithm interpreting data. The performance testing described (flow rate, temperature, humidity) is its standalone performance without human intervention in the conditioning process itself.
7. Type of Ground Truth Used:
- Ground Truth Type: The ground truth for this device's performance is based on objective physical measurements of flow rate, temperature, and humidity, presumably against established engineering specifications or industry standards for optimal insufflation gas conditioning.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set." It's a hardware device with defined physical characteristics.
9. How Ground Truth for Training Set was Established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of 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.