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The HET Bipolar System is intended to be used for the treatment of symptomatic grade I and grade II internal hemorrhoids.

The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cable to the bipolar output of an electrosurgical generator. The accessory monitor displays the temperature at the forceps-tissue interface and provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET™ Bipolar Electrocautery Forceps and Monitor do not generate RF energy themselves and may be used with any Bipolar Electrosurgical generator in the coagulation power setting with an output power set at 10 W and a maximum voltage of 1250V.

This document is a 510(k) Pre-Market Notification for the HET™ Bipolar Electrocautery Forceps and Monitor. The submission states that the device is identical to its predicate device (K140422) in terms of design, materials, software, and treatment mechanism. The purpose of this 510(k) is to limit the indications for use to symptomatic grade I and grade II internal hemorrhoids and clarify that the action is tissue ligation. Therefore, the performance data presented refers to the predicate device.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

Since the subject device is identical to the predicate device and the 510(k) is primarily for clarifying indications and the mechanism of action (tissue ligation), there are no new acceptance criteria or device performance results reported for the subject device in this document. The performance data refers to the predicate device (K140422).

Based on the information for the predicate device (K140422) as referenced in this submission:

Study Details for Predicate Device (K140422) as referenced:

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

   • Sample size: Not explicitly stated in this document. The document mentions "Performance testing was conducted" to characterize the device's performance when used with "eight FDA cleared, commercially available, bipolar electrosurgical generators." The specific number of cases, tissue samples, or treatments is not provided.
   • Data provenance: Not specified in this document. It's likely from laboratory or bench testing given the nature of evaluating thermal injury and treatment time. It's not stated whether it's retrospective or prospective.

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

   • Not applicable as the reported performance testing (zone of thermal injury, treatment time) appears to be objective, measurable parameters typically assessed through engineering and scientific methods rather than expert interpretation of images or clinical outcomes in the context of ground truth establishment.

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

   • Not applicable. The performance tests described (thermal injury, treatment time, electrical safety, biocompatibility, sterilization) are objective measurements and engineering assessments, not requiring adjudication in the context of expert case review.

4. 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:

   • No MRMC or AI-assisted study was performed or is relevant to this device. This is a medical device for electrosurgical treatment, not an AI diagnostic tool.

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

   • Not applicable. This is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For performance testing related to thermal injury and treatment time, the "ground truth" would be objective measurements (e.g., histological analysis of tissue for thermal damage depth, precise timing measurements).
   • For biocompatibility, the ground truth is established by standardized biological assays (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization).
   • For sterilization, the ground truth is the measured Sterility Assurance Level (SAL).
   • For electrical safety, the ground truth is conformance to the specified standard (IEC 60601-1-2:2014).

7. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device requiring a training set.

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

   • Not applicable.

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HET™ Bipolar Electrocautery Forceps is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.

The accessory monitor provides power for a timer, a temperature sensor and an LED light source mounted on the disposable forceps.

The HET™ Electrocautery System is comprised of the HET™ Bipolar Electrocautery Forceps and the HET™ Monitor.

The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cabel to the bipolar output of an electrosurqical generator. The HET™ Bipolar Forceps has an integrated illumination and a temperature probe. The HET™ Bipolar Forceps can be connected and used with any commercial bi-polar RF generator which is rated less than 50W.

The HET™ Monitor is an optional accessory that can be used only with the HET™ Bipolar Forceps when used in conjunction with the CONMED HYFRECATOR® 2000 or the VALLEYLAB SURGISTAT II RF generators. The monitor displays the time (in seconds) of RF energy delivery and the temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.

The provided text describes a 510(k) premarket notification for the HET™ Bipolar Electrocautery Forceps and Monitor. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing efficacy through extensive clinical trials with detailed acceptance criteria and performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert adjudication, and MRMC studies are not typically present in a 510(k) summary for a device like bipolar electrocautery forceps. The focus is on safety and performance comparable to existing devices.

Here's an analysis based on the provided text, Highlighting what is and is not available:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the summary. For a 510(k) submission, "acceptance criteria" are usually demonstrated through equivalence with predicate devices in terms of intended use, technological characteristics, safety (biocompatibility, electrical safety), and in-vivo performance. The summary states:

• "The 510(k) Notice contains summaries of a study that was conducted to evaluate the in vivo performance of the device as compared to predicate devices."
• "In addition, biocompatibility studies and electrical safety studies were conducted to demonstrate that the device was equivalent to predicate bipolar electrocautery forceps."
• "The material from which the HET Systems device is fabricated has an established history of use in medical applications; and devices produced by HET Systems have been tested in accordance with applicable guidelines and standards."

The specific performance metrics and their acceptance thresholds (e.g., coagulation time, tissue impedance ranges, ergonomic feel comparable to predicate) are not detailed.

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

• Sample Size for Test Set: Not specified. The text only mentions "a study that was conducted to evaluate the in vivo performance."
• Data Provenance: The study was "in vivo," implying animal or human subject testing, but the country of origin or whether it was retrospective/prospective is not provided.

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

This information is not provided. Given the nature of a bipolar electrocautery device, "ground truth" would likely be assessed by surgical observation of effective coagulation, minimal thermal spread, and ease of use, rather than a diagnostic 'ground truth' established by multiple expert readers.

4. Adjudication method for the test set

This information is not provided.

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

No. An MRMC study is completely irrelevant to this device. This device is a surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a manual surgical instrument. It does not operate as a standalone algorithm. The "monitor" is an accessory for displaying time and temperature, not an AI or autonomous system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "in vivo performance" study, the "ground truth" would likely be based on:

• Direct observation of surgical outcomes: Effectiveness of grasping, manipulating, and coagulating soft tissue.
• Possibly histological analysis of coagulated tissue to assess thermal damage and coagulation depth, though this is not explicitly stated.
• Comparison to predicate device performance in similar in-vivo settings.

The text does not specify one particular type of ground truth beyond "in vivo performance."

8. The sample size for the training set

This information is not applicable/provided. This device is not an AI/ML device that requires a "training set" in the computational sense. The "studies" conducted are for performance and safety validation, not machine learning model training.

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

This information is not applicable/provided for the same reason as point 8.

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