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The InLine™ Bi-Polar RF Linear Coagulation Device is a single use, sterile, bipolar, hand-held Radiofrequency (RF) Device that is used to coagulate/ablate tissue. The device is designed for use in intraoperative surgical procedures or used through a non-conductive hand-port during laparoscopic surgical procedures.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the InLine™ Bi-Polar RF Linear Coagulation Device:

It's important to note that this document is a 510(k) summary for a medical device submitted to the FDA. As such, the level of detail regarding specific "acceptance criteria" and "device performance" in clinical study format (as you might see for a diagnostic AI device) is often different for electrosurgical devices. For these types of devices, the demonstration of substantial equivalence and safety/efficacy often relies heavily on bench testing and comparison to a predicate device, rather than extensive clinical efficacy trials with patient outcomes.

Acceptance Criteria and Study Details for InLine™ Bi-Polar RF Linear Coagulation Device

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance metrics against a predefined acceptance criterion in a clinical study. The "acceptance criteria" for this submission are implicitly tied to proving that the device performs as well as or similarly to the predicate device and does not raise new questions of safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criterion: The device must demonstrate substantial equivalence to the predicate device in terms of intended use, materials, and principle of operation, and not raise new questions of safety and efficacy.	Bench testing/functional testing was performed on the InLine™ Bi-Polar RF Linear Coagulation Device to ensure that the product is substantially equivalent to the predicate device and to ensure that the new device does not raise new questions of safety and efficacy.
Implicit Acceptance Criterion: The device must be safe and effective for its intended use (coagulating tissue during laparoscopic and intraoperative surgical procedures).	The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls. This implies the FDA found sufficient evidence of safety and effectiveness based on the provided data.

Explanation: The document does not explicitly state numerical performance metrics (e.g., accuracy, sensitivity, specificity) with corresponding acceptance thresholds. Instead, the "acceptance criteria" are met by demonstrating that the device is substantially equivalent to a previously cleared predicate device (Radionics Cool-tip RF Electrode, K984552) through bench and functional testing.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Bench testing/functional testing was performed on the InLine™ Bi-Polar RF Linear Coagulation Device".

Sample Size: Not specified. It typically refers to the number of devices or components tested in a laboratory setting.
Data Provenance: The testing was "performed on the InLine™ Bi-Polar RF Linear Coagulation Device," implying prospective testing conducted by the manufacturer for the purpose of this 510(k) submission. The country of origin of the data is not specified beyond the applicant's address in Fremont, CA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. For a device like an electrosurgical tool, "ground truth" is typically established through engineering specifications, validated test methods, and direct physical measurement of device performance (e.g., temperature output, power delivery, coagulation effect on tissue models) rather than expert consensus on interpretation. There would not be "experts" establishing a ground truth in the sense of reviewing medical images or patient data for this type of submission.

4. Adjudication Method for the Test Set

Not applicable. As described above, the testing involved bench and functional assessments, not human interpretation or a test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study is typically relevant for diagnostic devices, especially those involving image interpretation by human readers, often comparing human performance with and without AI assistance. This device is an electrosurgical tool, not a diagnostic AI device, so such a study would not be applicable or expected.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical electrosurgical tool, not an algorithm, and inherently requires human operation. The concept of "standalone performance" without human-in-the-loop is not relevant here.

7. The Type of Ground Truth Used

The "ground truth" for this device would be based on engineering specifications and validated test methods to assess parameters such as:

RF energy output
Temperature profiles
Coagulation depth/width on tissue surrogates (e.g., ex vivo animal tissue)
Integrity of materials
Electrical safety standards

It is not based on expert consensus, pathology, or outcomes data in the context of this 510(k) summary, as it's primarily a performance and equivalence submission.

8. The Sample Size for the Training Set

Not applicable. This device is an electrosurgical tool, not a machine learning or AI algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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