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The Electrosurgical Generator (OBS-350A) is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the surgical operation area.

Device Description

The generator is enclosed in a metal and molded plastic enclosure and will have an angled front panel in the display and controls area. The front panel displays and controls will be sealed to facilitate cleaning and minimize the possibility of problems caused by accidental spills. The receptacles for the active electrosurgical accessories will be in a recessed area and will conform to IEC60601-1:2005/(R) 2012 And A1:2012.

Device components: Chassis and Cover, Front panel controls, Power supply board, Microprocessor board, Footswitch board, Interface circuits, Front panel receptacles.

Special features: Three CUT modes (Pure CUT, Blend 1, Blend 2), Three COAG modes (COAG1 (Spray), COAG2 (Forced), COAG3 (Soft)), Two Bipolar modes (Bipolar1 (Macro), Bipolar2 (Micro)), Memory (10 memory Presets), CQMS (contact quality monitoring system), Power ON self diagnostics, PPS (peak power system).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the OBS Electrosurgical Generator (model: OBS-350A), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria in this document are primarily based on achieving "substantial equivalence" to a predicate device (Valleylab Force FX). This means the OBS-350A is considered acceptable if its performance is comparable to the predicate across various parameters, particularly regarding safety and effectiveness.

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance (OBS-350A vs. Predicate)	Outcome
Intended Use	Same as predicate	Electrosurgical Generator for monopolar and bipolar functions in surgical operations.	Achieved
Technological Characteristics & Principles of Operation	Similar to predicate	HF energy, Monopolar and Bipolar output waveforms.	Achieved
Electrical Waveforms	Comparable to predicate	"The electrical waveforms of the OBS-350A were comparable to the electrical waveforms of the predicate devices. This was confirmed for all output modes (waveforms) at rated load."	Achieved
Tissue Thermal Effects	Comparable to predicate	"The tissue thermal effects test was conducted by OBS-350A and predicate devices to demonstrate the tissue thermal effects equivalence in porcine muscle, kidney and liver tissue." "Tissue thermal effects tests by OBS-350A and predicate devices demonstrate the similarity of thermal effects in three tissues."	Achieved
Safety Standards	Compliance with ES60601-1:2005/(R)2012 And A1:2012	Complies with ES60601-1:2005/(R)2012 And A1:2012	Achieved
Performance Standards	Compliance with IEC60601-2-2:2009	Complies with IEC60601-2-2:2009	Achieved
EMC Standards	Compliance with IEC60601-1-2:2007	Complies with IEC60601-1-2:2007	Achieved
Output Powers	Comparable range to predicate	See detailed power output comparison in the document (Table on Page 8). Most values for power, voltage, and frequency are similar or within acceptable ranges.	Achieved (deemed "SE")
Open Circuit Vp-p (max)	Comparable range to predicate	See detailed open circuit voltage comparison in the document (Table on Page 8). Most values are similar or within acceptable ranges.	Achieved (deemed "SE")
Accessory Compatibility	Legally marketed and compatible. Maximum electrical capacity of accessories ≥4500 Vp	Accessories are legally marketed and have a max electrical capacity ≥4500 Vp. Specific OBS accessories are recommended.	Achieved
CQMS (Contact Quality Monitoring System)	Measures resistance between ESU pad and patient; alarms if >113 ohms; stops output.	Described as functioning as designed.	Achieved
Power ON self diagnostics	All working modes/functions simulated and monitored; displays error codes and alarms if failure occurs; disables operations.	Described as functioning as designed.	Achieved
PPS (Peak Power System)	Automatically senses resistance and adjusts output voltage to maintain consistent effect.	Described as functioning in Pure CUT, Blend CUT, and Bipolar modes.	Achieved
Duty Cycle	10 seconds on, 30 seconds off for 1 hour at max power and rated load.	Described as suitable for this duty cycle.	Achieved

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" in terms of number of devices or number of tissue samples for the bench testing. It refers to "evaluations" and "tests."
Data Provenance: The testing was "bench" testing, comparing the performance of the OBS-350A against its own design specifications and against the predicate device (Valleylab Force FX). The document implicitly indicates the testing was done by the manufacturer (Baisheng Medical Co., Ltd.) as part of their submission for market clearance. No country of origin for test data is explicitly stated beyond the manufacturer's location in China. The testing is considered prospective in the sense that it was conducted directly to support this 510(k) submission.

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

The document does not mention the use of experts to establish a "ground truth" for the test set. The evaluation is focused on direct comparison of physical and electrical characteristics and compliance with recognized standards. This is typical for electrosurgical generators, where performance is objectively measured rather than subjectively interpreted (like image analysis).

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing involves objective measurements rather than subjective assessments requiring reader adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical and animal studies were not deemed necessary to support substantial equivalence." This type of study would involve human readers (e.g., surgeons) evaluating the device's performance, which was not performed or required here.

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

This question is not applicable in the context of an electrosurgical generator. A standalone "algorithm" performance is relevant for AI/software devices that make diagnostic or treatment recommendations. The OBS-350A is a physical medical device that applies energy. Its performance is measured directly, not via an algorithm operating independently to produce an outcome. The document does mention software validation for the device's embedded software, which would be a form of "standalone" software assessment, but not in the AI/human-in-the-loop sense.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:
- Design Specifications: The device's performance is compared against its own defined design specifications.
- Predicate Device Performance: Direct comparison of electrical waveforms and tissue thermal effects against a legally marketed predicate device (Valleylab Force FX).
- Recognized Standards: Compliance with international standards such as IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2.

8. The Sample Size for the Training Set

This question is not applicable. The OBS-350A is an electrosurgical generator, not an AI/machine learning device that requires a "training set" of data.

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

This question is not applicable, as there is no "training set" for this type of medical device.

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