(184 days)
Insuflow is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.
The Insuflow device is a single use 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 into the cardiothoracic, vascular or abdominal surgical cavity. The Insuflow device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Insuflow® device, through the in-line filter, continues along the tube to enter the Insuflow® device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to anno a insufflation needle/trocar and finally flows into the patient's surgical cayity over and finally
The provided text is a 510(k) summary for the Insuflow device. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. However, this document does not contain any information about specific acceptance criteria, device performance metrics, or the details of a study (test set, training set, ground truth, expert involvement, or MRMC studies) that proves the device meets acceptance criteria.
Instead, it states that:
- "Extensive performance testing has been conducted to assure that the Insuflow performs in accordance with its specifications and applicable standards."
- "Details of that testing were provided in 510(k) K063546 and are summarized in Section 5."
To answer your request, the full 510(k) K063546 document, or specifically its Section 5, would be needed. The current document only makes a general declaration of testing.
Therefore, I cannot populate the table or provide detailed answers to points 2 through 9 based solely on the provided text.
Summary of what can be extracted from the provided text:
-
A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states "Extensive performance testing has been conducted to assure that the Insuflow performs in accordance with its specifications and applicable standards," but it does not specify what those specifications or standards are, nor does it report any performance metrics against them. It refers to a previous 510(k) (K063546) for these details.
-
Sample size used for the test set and the data provenance:
- Cannot be provided. No information on a "test set" or specific study details is available.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. No information on ground truth establishment or expert involvement in a test set is available.
-
Adjudication method for the test set:
- Cannot be provided. No information on a test set or adjudication method is available.
-
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:
- Cannot be provided. This device is a medical device (gas conditioner), not an AI/software device. Therefore, an MRMC study with AI assistance is not applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This is not an algorithm/AI device.
-
The type of ground truth used:
- Cannot be provided. No information on ground truth for any testing is available.
-
The sample size for the training set:
- Cannot be provided. No information on a "training set" is available. This is not an AI/software device.
-
How the ground truth for the training set was established:
- Cannot be provided. No information on a "training set" or its ground truth establishment is available.
In conclusion, the provided document is a regulatory summary focusing on substantial equivalence, and it explicitly defers details of performance testing to a prior submission (K063546). Without that prior submission, the requested information cannot be extracted.
§ 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.