(153 days)
Indications for Use: The Domain Surgical System is indicated for cutting and coagulation of soft tissue.
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 (21 CFR §878.4400). It is classified as a Class II (510(k)) device.
The Domain Surgical System is a soft tissue cutting and coagulation device that consists of a generator that is electrically connected to a sterile, single-use handpiece and an optional footswitch. Like the predicate devices, the handpiece includes an actuation button that can be used to activate heating in the handpiece tip. Also like the predicate devices, an optional footswitch can be used to activate the handpiece.
Here's an analysis of the provided text regarding the Domain Surgical System, focusing on acceptance criteria and supporting studies:
The provided document, K110439, is a 510(k) Summary for the Domain Surgical System, dated July 18, 2011. This summary focuses on demonstrating substantial equivalence to predicate devices, rather than detailing specific acceptance criteria and a comprehensive study showing performance against those criteria. As such, information regarding quantitative performance metrics, ground truth establishment, expert qualifications, and specific sample sizes for particular studies is largely absent.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state a table of quantitative acceptance criteria for device performance. Instead, it relies on demonstrating that the device functions as intended and is as safe and effective as predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Generator output within specification | "Bench tests verified that the generator output was within specification" |
| Thermal output of handpiece tip corresponds to target values | "Bench tests verified... that the thermal output of the handpiece tip corresponds to the target values." |
| Compliance with electrical safety standards | "Tested by an accredited independent testing laboratory to assure that it complies with the applicable electrical safety standards for medical electrosurgical devices, including the applicable sections of IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2." |
| Software meets design requirements and operates safely/effectively | "The software... has undergone proper design verification and validation to assure that it meets design requirements and operates safely and effectively... including controlling output power and providing audio and visual information during use." |
| Biocompatibility | "Successful biocompatibility testing of applicable parts of the system was completed by accredited independent testing laboratories according to ISO 10993-1 and 510(k) Memorandum G95-1." |
| Effectiveness at cutting and coagulating soft tissue | "Live animal testing was performed that demonstrates that the Domain Surgical System is as effective at cutting and coagulating soft tissue as other legally marketed electrosurgical devices." |
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "Bench tests" and "Live animal testing" as the primary studies. However, it does not provide specific sample sizes for these tests.
- Provenance: Not explicitly stated, but "Live animal testing" suggests live subjects (animals). Bench tests are typically laboratory-based. The country of origin for the studies is not mentioned.
- Retrospective/Prospective: Not specified. Animal testing is typically prospective, but without details, this cannot be confirmed.
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 in the document. The "ground truth" for electrosurgical device performance is typically objective physical measurements and observed physiological outcomes in an animal model, rather than expert consensus on images or diagnoses.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of electrosurgical device testing (bench and animal), an adjudication method in the context of human readers/experts is not directly applicable. Performance is evaluated based on physical measurements and observed physiological effects.
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 to this device. The Domain Surgical System is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers/clinicians interpreting data. Therefore, an MRMC study and effects on human reader improvement are outside the scope of this device's function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable in the AI sense. However, the bench tests and animal testing can be considered "standalone" in that they assess the device's inherent physical and functional performance independently of human interaction for interpretation (unlike an AI algorithm that provides outputs for human review). The device's operation, however, does involve a human operator (surgeon).
7. The Type of Ground Truth Used
- For bench tests: The ground truth was objective measurements against engineered specifications (e.g., generator output values, handpiece thermal output).
- For biocompatibility: The ground truth was "Successful biocompatibility testing" against established standards (ISO 10993-1 and 510(k) Memorandum G95-1), likely involving in-vitro and in-vivo tests to assess material safety.
- For live animal testing: The ground truth was direct observation of the device's effectiveness in "cutting and coagulating soft tissue" compared to legally marketed electrosurgical devices (predicates). This would involve macroscopic and potentially microscopic assessment of tissue effects.
8. The Sample Size for the Training Set
This is not applicable as the Domain Surgical System is a hardware medical device with software control, but it does not employ a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves engineering design, development, and validation against known physical principles and performance requirements.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8. The device's functionality is based on its design and manufacturing specifications, verified through various tests, not through learning from a labeled dataset.
§ 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.