Search Results

The 40 L High Flow Insufflator F113 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application and the low flow application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F113 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.

The 40 L High Flow Insufflator F113 is a microprocessor controlled CO2 insufflator designed with a high flow application, a low flow application and a vessel harvesting application. The device incorporates the following major components and features: a housing, a world power supply, pressure reducers, a venting system, a fluid sensor, a gas heater and various setting keys and display elements. A continuous redundant pressure measurement controls the conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. In addition, a software controlled active pressure reduction ensures that the preset nominal pressure value conforms to the actual pressure that is measured in the cavity. Finally, the 40 L High Flow Insufflator F113 is designed with several alarms to inform the operator in case of an overpressure. The device may be used with a heating tube and with an optional remote control.

The provided text describes the 40 L High Flow Insufflator F113 and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or a detailed study of device performance against such criteria. The document is a 510(k) summary for a medical device and therefore focuses on establishing substantial equivalence rather than presenting an exhaustive performance study with acceptance criteria.

However, based on the information provided, we can infer some aspects related to performance and how "evidence" was presented for regulatory purposes.

Here's a breakdown of the requested information, with sections noted as "Not Provided" when the information is missing from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence, meaning the new device performs similarly and is as safe and effective as existing legally marketed devices. It does not provide specific quantitative acceptance criteria (e.g., "pressure maintained within X% of set point for Y time") or detailed results of performance testing against such criteria.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not Provided. The document mentions "performance testing" and a "clinical evaluation," but no specific sample sizes for these tests are given.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not Provided. The clinical evaluation includes a "summary of peer reviewed literature and information on questionnaire results." The origin or nature (retrospective/prospective) of this data is not specified.

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

• Not Provided. The document mentions a "clinical evaluation" and "questionnaire results," but it does not specify the number or qualifications of experts involved in establishing ground truth for any test set. Given the nature of a CO2 insufflator, "ground truth" might pertain to objective measurements of pressure regulation or flow rather than expert interpretation of images or clinical outcomes.

4. Adjudication method for the test set

• Not Provided. No mention of an adjudication method is included in the summary.

5. 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 such study was done. This device (a CO2 insufflator) is a physical medical instrument, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in a diagnostic context. Therefore, an MRMC study or AI-related effectiveness measure is not applicable.

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

• Not Applicable. This device is a hardware insufflator and does not involve algorithms for standalone diagnostic performance. Its function is to facilitate endoscopic procedures by distending cavities with gas.

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

• Not explicitly stated in detail. For a CO2 insufflator, "ground truth" would likely involve objective physical measurements like pressure, flow rate, and CO2 concentration, as well as operational safety parameters. The "performance testing" mentioned generally refers to these kinds of engineering and functional tests. The "clinical evaluation" would likely focus on the intended use and safety in a surgical context, possibly drawing upon outcomes data from the peer-reviewed literature.

8. The sample size for the training set

• Not Applicable / Not Provided. This device is a hardware product, not a machine learning model, so there is no "training set" in the conventional sense of AI/ML. For hardware, "training" might refer to testing under various conditions, but no specific "training set" size for data used to optimize hardware design is provided or relevant in this context.

9. How the ground truth for the training set was established

• Not Applicable. As there is no AI/ML training set, this question is not relevant.

Ask a specific question about this device