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The Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps (Catalog No. 20-0XXX) is a single use product sold sterile and is intended for use in electrosurgery for coagulation and irrigation of tissue. This device is intended for use with the OLSEN MEDICAL Integrated Irrigation Tubing and Bipolar Cord Set or similar design of Bipolar Cord and Irrigation Tubing.

OLSEN MEDICAL Single Use Bayonet Bipolar Irrigating Forceps is packaged sterile with a nonpyrogenic fluid pathway. It consists of an inlet pathway running into a transparent rigid PVC tube attached to the right hand prong of the bayonet forceps. This gives the surgeon a visual of the fluid pathway which facilitates the local fluid irrigation through the forceps. The device is for Single Use Only and is designed for use with bipolar electrosurgical units.

The provided text describes a 510(k) summary for the Olsen Medical Single Use Bayonet Bipolar Irrigating Forceps. This is a medical device submission, and the document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study involving experts, algorithms, or ground truth as would be done for an AI/ML device.

Therefore, many of the requested points are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document

• states the device "meet[s] or exceed[s] the minimum qualification criteria for the predicate device."
• "conforms to applicable ASTM and ISO Standards."
• "Tests will meet the applicable requirements of ANSI/AAMI HF18:2001 and IEC 60601-2-2 3rd Edition."

However, specific numerical acceptance criteria (e.g., "coagulation time < X seconds") and corresponding reported performance values for those criteria are not provided in this summary. The assessment of performance is based on demonstrating substantial equivalence to predicate devices, which implies the predicate devices already met established performance standards.

2. Sample size used for the test set and the data provenance:

• Not applicable. This submission focuses on demonstrating substantial equivalence through comparison of design, materials, and intended use, along with conformity to industry standards. It does not describe a "test set" for performance evaluation in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no mention of "ground truth" or "experts" in the context of establishing performance for this device as it's not an AI/ML diagnostic or predictive tool.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication process is described in this submission.

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 is not an AI/ML device, and no MRMC study is mentioned.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Not applicable. There is no "ground truth" discussed in the context of this device being a medical instrument for surgery. Performance is evaluated against engineering and safety standards, and equivalence to existing devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

9. How the ground truth for the training set was established:

• Not applicable. As above, there is no AI/ML component or training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The "study" to prove the device meets criteria (or rather, is safe and effective) is a substantial equivalence assessment against two predicate devices:

• Q2 Medical's Bayonet Forceps Bipolar Irrigating (K002752)
• Dermacare's Disposable Bipolar Cord and Bipolar Forceps (K884656)

The document states:

• "The new device is technologically the same as the predicate device."
• "Device qualification criteria meet or exceed the minimum qualification criteria for the predicate device."
• "The device conforms to applicable ASTM and ISO Standards."
• "Tests will meet the applicable requirements of ANSI/AAMI HF18:2001 and IEC 60601-2-2 3rd Edition."
• A "Device Comparison Table" and "Device Comparison Photographs" were provided to the FDA to "supports our claim of substantial equivalence," highlighting the similarities and differences in intended use, materials, design, and functionality.

The FDA's letter of clearance (K080187) confirms that based on this information, the device was found to be "substantially equivalent" to the legally marketed predicate devices, thereby allowing it to proceed to market. This type of submission relies on the established safety and efficacy of the predicate devices.

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