(224 days)
The HET™ Bipolar Electrocautery Forceps and Monitor are intended to be used for grasping, manipulating and coagulating soft tissue during general surgery.
The HET™ Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids.
The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET Bipolar Electrocautery Forceps and Monitor may be used with the CONMED HYFRECATOR® 2000 or VALLEYLAB SURGISTAT II RF energy generators.
The HET™ Bipolar Electrocautery System is comprised of the HET™ Bipolar 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 cable to the bipolar output of an electrosurgical generator.
When connected to the HET™ Monitor, the HET™ Bipolar Forceps has an integrated tissue illumination feature and a temperature probe. The HET™ Monitor is an 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 temperature at the forceps-tissue interface. The HET™ Monitor does not generate RF energy.
The provided 510(k) summary for the HET™ Bipolar Electrocautery Forceps and Monitor (K121085) does not explicitly detail acceptance criteria in a quantitative table or the specific performance metrics used in the human clinical evaluations. The information focuses on establishing substantial equivalence to predicate devices rather than proving a set of pre-defined acceptance criteria with specific performance values.
However, based on the description, we can infer the intent of the acceptance criteria was to demonstrate clinical performance "substantially equivalent to clinical outcomes reported in the literature for the predicate IRC device" for the treatment of symptomatic Grade I and Grade II internal hemorrhoids, and general grasping, manipulating, and coagulating soft tissue.
Below is an attempt to structure the requested information based on the available text, with caveats regarding the missing specifics:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Inferred from substantial equivalence) | Reported Device Performance |
|---|---|---|
| Clinical Efficacy for Symptomatic Grade I & II Internal Hemorrhoids | Clinical outcomes demonstrating similar efficacy to the Redfield Infrared Coagulator (K950836) as reported in literature. | The two human clinical evaluations "demonstrated outcomes substantially equivalent to clinical outcomes reported in the literature for the predicate IRC device." |
| Tissue Coagulation (General Surgery) | Effective grasping, manipulating, and coagulating soft tissue during general surgery. | This is stated as an intended use, implicitly confirmed by substantial equivalence. |
| Safety (Biocompatibility, Electrical Safety) | Meeting established standards for biocompatibility and electrical safety. | "Biocompatibility studies, software validations, and electrical safety studies were conducted and reported in the 510(k) Notice for the predicate HET Systems device [K110143]. Because the two devices are essentially the same, the information reported for the predicate HET device is applicable." |
| In Vivo Performance | Performance comparable to the predicate device in an animal model. | "A study (in an animal model) was conducted to evaluate the in vivo performance and histological effects of the device as compared to the predicate device [K110143]." |
2. Sample Size Used for the Test Set and Data Provenance
- Human Clinical Evaluations: Two human clinical evaluations were conducted. The specific sample size for these studies is not provided in the summary.
- Data Provenance: The origin of the data (country of origin, retrospective or prospective) for the human clinical evaluations is not specified.
- Animal Model Study: One animal model study was conducted. The specific sample size (number of animals) is not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. The context of "substantially equivalent to clinical outcomes reported in the literature" suggests a comparison to published data, but it doesn't detail how ground truth for the specific clinical evaluations conducted was established or by whom.
4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary. Given the focus on substantial equivalence to literature outcomes, a formal adjudication process for the conducted human studies is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This review is for an electrosurgical device, not an AI-powered diagnostic or imaging interpretation device. Therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance was not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is an electrosurgical device with a monitor displaying temperature. It is not an algorithm-only device, and standalone algorithm performance is not applicable. The device is intended for human-in-the-loop operation.
7. Type of Ground Truth Used
- Clinical Efficacy (Human Clinical Evaluations): The ground truth for the human clinical evaluations appears to be clinical outcomes observed in patients and compared to published literature on the predicate IRC device.
- In Vivo Performance: The ground truth for the animal study involved evaluating "in vivo performance and histological effects."
8. Sample Size for the Training Set
This is an electrosurgical device, not a machine learning or AI algorithm in the context of device approval. Therefore, the concept of a "training set" for an algorithm is not applicable. The device's design and manufacturing rely on engineering principles, material science, and established medical device testing, not data-driven machine learning models.
9. How the Ground Truth for the Training Set was Established
As explained above, the concept of a "training set" and its associated ground truth is not applicable to this type of medical device for regulatory approval.
§ 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.