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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:

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.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method for the test set: Not applicable. No diagnostic test set requiring adjudication.

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: Not applicable. This device is a surgical generator, not a diagnostic imaging or AI-assisted device.

6. 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.

7. The type of ground truth used: Not applicable. No diagnostic ground truth is established or required for this type of device.

8. The sample size for the training set: Not applicable. This device does not involve machine learning or a training set.

9. 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.

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