(90 days)
The Boston Surgical Products, Inc. Model 20 Coagulation Generator is a solid state bipolar generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where low impedance or wetfield conditions exist.
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 technically identical to an existing approved device (Kirwan Model 25 1000, 510k K880863) but repackaged in e new style enclosure and relabeled Boston Surgical Products Model 20.
The provided documentation is a 510(k) submission for a medical device (Model 20 Bipolar Coagulator) and a related FDA clearance letter. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of the device's performance against specific acceptance criteria in the manner typically seen for novel AI/machine learning devices.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement is not available in the provided text, as it describes a different type of regulatory submission primarily based on technical similarity to an existing device.
However, I can extract the relevant information that is present:
Here's the information that can be extracted or deduced from the provided documents:
| Category | Information Provided |
|---|---|
| 1. Acceptance Criteria and Device Performance | Acceptance Criteria (Implied by Predicate Device Equivalence): The device is considered to have met acceptance criteria because it is deemed "technically identical" to an existing approved device (Kirwan Model 25 1000, 510k K880863) in terms of its core functionality as a solid-state bipolar generator for RF signal to electrosurgical handpieces. |
Specific Performance Statements:
- Handswitch Power: Powered by an independent low voltage (7 Vdc) isolated power supply.
- Monitors: Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.
- Leakage: RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guidelines for isolated (body floating) bipolar coagulators.
Reported Device Performance: The document states that the observed performance meets the mentioned guidelines, implying compliance with these technical standards, which serve as direct, stated performance criteria. |
| 2. Sample size and data provenance (test set) | Not applicable. This submission doesn't describe a clinical or performance study with a test set of data samples. The demonstration of equivalence is based on technical specifications and regulatory standards. |
| 3. Number of experts and qualifications (ground truth) | Not applicable. Ground truth as typically understood in AI/machine learning studies is not relevant here. The evaluation is against engineering standards and a predicate device. |
| 4. Adjudication method (test set) | Not applicable. No test set requiring expert adjudication is involved. |
| 5. MRMC comparative effectiveness study | No. This is not an AI/machine learning device, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described. |
| 6. Standalone performance | The device's performance is inherently standalone in its function as a bipolar coagulator generator. The document describes compliance with specific technical and safety standards (IEC 601-1-2, ANSI HF-18) for its operation, implying standalone performance evaluation against these standards. |
| 7. Type of ground truth | The "ground truth" for this submission is regulatory compliance and technical equivalence to a predicate device. This is established by demonstrating adherence to international and national safety standards (IEC 601-1-2, ANSI HF-18) for electrical medical equipment, and by asserting "technical identity" to a previously approved device. |
| 8. Sample size for training set | Not applicable. This device is not an AI/machine learning device and does not involve a training set. |
| 9. How ground truth for training set established | Not applicable. |
Summary of the Study:
The "study" in this context is a 510(k) Pre-market Notification which aims to demonstrate Substantial Equivalence (SE) to a legally marketed predicate device.
- Study Design: Not a traditional clinical or performance study. It's a regulatory submission where the applicant asserts and provides documentation to support that their new device (Boston Surgical Products Model 20) is "technically identical" to an already approved predicate device (Kirwan Model 25 1000, 510k K880863), with only cosmetic changes (repackaged enclosure and relabeling).
- Proof of Meeting Acceptance Criteria: The proof relies on:
- Assertion of technical identity: The submission explicitly states the device is "technically identical" to the predicate, implying it performs to the same standards.
- Compliance with recognized standards: The document highlights adherence to specific safety and performance standards for electrical medical equipment:
- IEC 601-1-2 (likely referring to the general requirements for safety and electromagnetic compatibility for medical electrical equipment).
- ANSI HF-18 (likely referring to a standard for high-frequency electrical equipment).
- Specific technical specifications: Statements about the isolated power supply for the handswitch (7 Vdc) and the leakage levels within safety guidelines act as specific performance claims that presumably align with the predicate device and the referenced standards.
In essence, the "study" is a regulatory comparison, not an experimental one, focusing on technical specifications and safety standards rather than a performance evaluation against a dataset.
§ 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.