(135 days)
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.
§ 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.