(58 days)
The Boston Surgical Products, Inc. Model 50 Coagulator General purposes solid state bipolar generator to supply the RF signal to electrosurycal handpieces used to coagulate soft body tissues where a wide range of tissue types, patient conditions, and load impediances are encountered.
A 0-50 digital display power setting indicator provides the operator a parallax free reading of the power setting (+/- Swatts, full scale (@ 100 ohms).
A bar graph display output current monitor provides the operator a relative measure of the output current amplitude and to denote the presence of output energy during activation.
The handswitch is powered by an independent low voltage (7 Vdc) isolated power supply.
Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.
RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) bipolar coagulators.
This device is identical to an existing approved device.
The provided documents describe a 510(k) submission for the Model 50 Coagulation Generator. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving effectiveness through clinical studies with acceptance criteria based on human or algorithm performance.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving the effectiveness of AI/ML-based diagnostic devices, is not applicable to this submission.
The document states: "This device is identical to an existing approved device." and the FDA's letter confirms: "we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976..."
Instead of clinical studies, the submission focuses on demonstrating that the new device meets established performance and safety standards, and that its design and specifications are identical or substantially similar to a legally marketed predicate device.
Here's why each of your points is not directly addressed or required for this 510(k) submission:
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A table of acceptance criteria and the reported device performance: Not applicable. The "performance" described relates to technical specifications and safety standards, not diagnostic accuracy or clinical outcomes.
- Digital display power setting indicator: +/- 5 watts, full scale (@ 100 ohms). This is a technical specification, not a clinical acceptance criterion.
- Bar graph display output current monitor: Provides relative measure and denotes output energy. This is a functional description.
- Handswitch power: Independent low voltage (7 Vdc) isolated power supply. Safety feature.
- Audio and Visual monitors: In accord with IEC 601-1-2 and ANSI HF-18 guidelines. Safety and functional compliance.
- RF and Low Frequency leakages: Well within IEC 601-1-2 and ANSI HF-18 safety guidelines. Safety compliance.
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Sample sized used for the test set and the data provenance: Not applicable. There's no "test set" in the context of diagnostic performance evaluation. Testing would involve engineering verification and validation against technical specifications and safety standards, not patient data sets.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in a diagnostic sense is mentioned.
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Adjudication method for the test set: Not applicable. No diagnostic test set requiring adjudication.
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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: Not applicable. This device is a surgical generator, not a diagnostic imaging or AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a surgical instrument, not an algorithm.
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The type of ground truth used: Not applicable. No diagnostic ground truth is established or required for this type of device.
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The sample size for the training set: Not applicable. This device does not involve machine learning or a training set.
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How the ground truth for the training set was established: Not applicable.
In conclusion, the provided documents pertain to a traditional medical device (an electrosurgical generator) undergoing a 510(k) clearance process based on substantial equivalence. The criteria and studies you've outlined are relevant for devices with diagnostic functions, particularly those leveraging AI/ML, which this device is not.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.