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The SurBlate™ Ablation System is intended for coagulation (thermoablation) of soft tissues. Not for use in cardiac procedures.

The SurBlate™ Ablation System is an integrated system for interstitial thermoablation of soft tissues through controlled emission of microwaves. The system is composed by four interactive devices (and one optional device), namely: a) SurBlate™-GEN: a digitally controlled microwave power source, operating at 2450 MHz, and delivering up to 100 Watts CW (continuous wave). SurBlate™-GEN features a single output channel. b) SurBlate™-APPLICATOR: an interstitial single-use coaxial microwave applicator, activated by the SurBlate™-GEN and connected to SurBlate™-GEN via the SurBlate™-COAX. c) SurBlate™-PUMP: a peristaltic pump for convective applicator cooling through continuous circulation of liquid coolant, fully controlled by and attached to SurBlate™-GEN. d) SurBlate™-COAX: a microwave coaxial cable serving as a medical grade microwave transmission line used for transmitting microwave energy. Its characteristic impedance is 50 ohm. In the system, it is used to transmit microwave energy from SurBlate™-GEN to the SurBlate™ APPLICATOR. e) SurBlate™-FOOT (Optional): a foot pedal supplied with SurBlate™-GEN for remote control of energy delivery activation.

The provided text is a 510(k) summary for the SurBlate™ Ablation System. It details the device, its intended use, comparison to a predicate device, and various performance and safety tests conducted to demonstrate substantial equivalence. However, it does not explicitly describe a study where the device "meets acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or improvement over human readers.

Instead, the submission focuses on engineering and bench performance tests to demonstrate that the SurBlate™ Ablation System is as safe and effective as its predicate device (HS AMICA). The "acceptance criteria" here relate to compliance with international standards and successful operation within predefined technical specifications, rather than clinical efficacy metrics.

Therefore, many of the requested points regarding clinical testing, expert adjudication, MRMC studies, and ground truth for clinical outcomes cannot be extracted from this document, as those types of studies were not required for this 510(k) clearance for this type of device (an electrosurgical cutting and coagulation device). The document explicitly states: "Animal Study and Human Clinical performance testing were not required to demonstrate safety and effectiveness of SurBlate™ Ablation System."

However, I can extract information related to the technical performance tests that were conducted.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and reported device performance:

The document describes several performance tests with implied acceptance criteria being successful compliance with the stated ranges and conditions. It doesn't present these in a formal "acceptance criteria vs. reported performance" table for each specific parameter, but rather states successful completion of tests.

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

• Test Set Sample Size:
  • Ex-vivo tissue ablation: Not explicitly stated as a number of samples or tissues, but mentions testing in "liver, kidney and muscle" (porcine) in "worst-case scenario" (20 degrees C). This implies multiple tissue samples were used.
  • For other tests (electrical, software, etc.), the sample size would be related to the number of devices or components tested, but this is not specified.
• Data Provenance: Not specified for the ex-vivo testing. The manufacturer is Mima-Pro (Nan Tong) Scientific Inc., located in Nantong City, Jiangsu Province, PRC. This suggests the testing may have been conducted there or by a contract research organization.
• Retrospective or Prospective: These were primarily bench and ex-vivo engineering performance tests, not clinical studies in humans or animals in a retrospective/prospective clinical trial context.

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

This information is not applicable/not provided in this type of submission. The ground truth for the ex-vivo ablation study was the measurement of the non-stained (coagulated) area using the triphenyltetrazolium chloride (TTC) dye technique, a laboratory method, not expert consensus on pathology or outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable/not provided as there were no clinical image evaluations or similar assessments requiring expert human readers and 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:

This is not applicable. The device is an ablation system, not an AI imaging analysis tool for diagnostic assistance. No MRMC study was mentioned or required.

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

This is not applicable as it's a physical device (ablation system), not an AI algorithm. Its "performance" is its ability to coagulate tissue as designed, not to interpret images or classify data.

7. The type of ground truth used:

• For Ex-vivo Ablation: Laboratory measurement of the non-stained (coagulated) area using the triphenyltetrazolium chloride (TTC) dye technique. This acts as the "ground truth" for the extent of coagulation.
• Not expert consensus, pathology, or outcomes data in the clinical sense, as human clinical studies were not required.

8. The sample size for the training set:

This is not applicable. The device is not an AI/ML model that requires a training set.

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

This is not applicable as there is no training set for an AI/ML model.

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