(101 days)
The Valleylab LS10, LS Series Single Channel Vessel Sealing Generator is an electrosurgical generator containing LigaSure vessel sealing technology.
The vessel sealing function is indicated for use in sealing (fusing) vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during general surgery including, but not limited to surgical specialties such as urologic, vascular, thoracic, gynecologic, plastic and reconstructive, and colorectal.
Refer to each instrument's instructions for use (IFU) for additional indications, warnings, and specific contraindications.
The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use this function for these procedures
Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator (VLLS10GEN) is a bipolar electrosurgical generator with LigaSure™ vessel sealing output mode. The generator is an electrically isolated, microcontroller-based device, incorporating closed-loop control for LigaSure™ mode implemented in the microcontroller firmware. It incorporates tissue sensing circuitry to constantly measure the electrical resistance of the tissue and instantaneously adjust the generator output to maintain the desired power.
The generator is used with compatible LigaSure™ instruments to ligate (seal) and divide (cut) vessels up to and including 7mm, tissue bundles, and lymphatics during the general surgical procedures using radio frequency (RF) energy. When a LigaSure™ instrument is applied to a vessel or tissue bundles, and RF energy is activated by the generator, the collagen and elastin in the tissues are reformed by heat and pressure to fuse vessel walls, thereby forming a permanent seal. The microprocessor within the generator monitors the tissue properties, stops the application of energy, and allows a brief period of cooling before indicating that the seal cycle is complete.
This document is a 510(k) premarket notification for the Valleylab™ LS10, LS Series Single Channel Vessel Sealing Generator (VLLS10GEN). The purpose of this notification is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list "acceptance criteria" in a quantitative format typical for AI/ML device performance alongside reported device performance. Instead, it focuses on demonstrating that the new device (VLLS10GEN) operates "as intended" and is "substantially equivalent" to its predicate device (ForceTriad™ Electrosurgical Generator) through various bench and preclinical tests.
The performance is primarily evaluated against established medical device standards and functional objectives, rather than specific numerical thresholds for a diagnostic outcome that would have clear acceptance criteria (e.g., sensitivity > X%, specificity > Y%).
| Acceptance Criteria (Implied from testing intent) | Reported Device Performance (Summary from submission) |
|---|---|
| Compliance with Electromedical Safety Standards (IEC 60601-1, 60601-2-2) | Demonstrated compliance through testing. |
| Compliance with Electromagnetic Compatibility (EMC) Standards (IEC 60601-1-2) | Demonstrated compliance through testing. |
| Software Verification & Validation (IEC 62304) | V&V performed in accordance with standards. |
| Engineering, Mechanical, Electrical, and General Functional Testing | Device operated as intended, demonstrating proper function. |
| Vessel Sealing Performance: Up to 7mm vessel sealing (e.g., maintaining burst pressure) | Demonstrated ability to seal and divide vessels up to and including 7mm. |
| Hemostasis of tissue and tissue bundles | Demonstrated ability to achieve hemostasis. |
| Thermal Profile (e.g., max jaw temp, cool down, shaft temp) | Thermal profile characterized; device performed within safe limits. |
| Lymphatic Burst Pressure | Demonstrated sufficient lymphatic burst pressure. |
| Chronic Animal Study Outcomes | Performed to assess long-term effects and efficacy. (Specific outcomes not detailed in summary, but implied acceptable). |
| Equivalent LigaSure sealing performance to predicate | Achieved equivalent LigaSure sealing performance. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of AI/ML models (i.e., a dataset of cases used to evaluate an algorithm's performance). Instead, it refers to various bench and preclinical testing regimes. The sample sizes for these tests are not provided in this summary.
- Bench Testing: Includes renal and pulmonary burst pressure, thermal profile, and general functional/electrical/mechanical tests. The number of samples for each specific test (e.g., number of vessels tested for burst pressure) is not disclosed.
- Preclinical Testing: Includes animal studies for sealing and dividing vessels, hemostasis, thermal spread, lymphatic burst pressure, and chronic animal studies. The number of animals or vessels/tissues tested is not disclosed.
- Data Provenance: The tests were conducted by Covidien, the manufacturer. The location of these tests (e.g., country of origin) is not specified, but Covidien's address is Boulder, Colorado. The data is prospective as it was generated specifically to test the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is generally relevant for AI/ML diagnostic devices where human experts independently review cases to establish a "ground truth" diagnosis. Since this device is an electrosurgical generator, the "ground truth" is established by direct physical measurements and observations during bench and preclinical testing (e.g., direct measurement of burst pressure, visual assessment of hemostasis, pathological examination from animal studies). Therefore:
- Number of experts: Not applicable in the traditional sense of human readers reviewing cases.
- Qualifications of experts: The scientific and engineering staff conducting the testing would have the relevant qualifications (e.g., biomedical engineers, veterinarians, surgeons performing or observing preclinical studies), but specific numbers and qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable in the AI/ML diagnostic context. The results of the physical and functional tests are typically objective measurements or observations following defined protocols, not subjective interpretations requiring 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
- No, an MRMC comparative effectiveness study was not done. This type of study is specific to AI/ML diagnostic or assistive tools where human readers are involved in interpreting medical images or data, and the AI's impact on their performance is being evaluated.
- The Valleylab™ LS10 is an electrosurgical generator, not a diagnostic AI tool. Its performance is assessed through its physical operation and effect on tissue.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, standalone performance was done. The entire bench and preclinical testing described (IEC standards compliance, engineering tests, burst pressure, thermal profiles, chronic animal studies) represents the "standalone" performance of the device itself.
- The device (generator) operates autonomously to deliver energy and seal vessels, with the surgeon as the operator, not as an "interpreter" of an algorithm's output. The performance metrics listed directly assess the device's functional integrity and its intended biological effects.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Direct physical measurements: Pressure readings for burst pressure, temperature measurements for thermal profiles, electrical output measurements.
- Pathological assessment: Tissue analysis (e.g., from preclinical animal studies) to confirm seal integrity, thermal spread, and absence of adverse effects.
- Functional observation: Direct observation of device operation and its effects during preclinical procedures (e.g., visual confirmation of hemostasis).
- Compliance with validated standards: Meeting predefined safety and performance requirements outlined in IEC standards.
8. The Sample Size for the Training Set
- Not applicable. This device is hardware (an electrosurgical generator) with embedded firmware/software for control. It is not an AI/ML system that learns from a "training set" of data in the conventional sense (e.g., images for classification).
- The device's algorithms (e.g., for tissue sensing and energy adjustment) are programmed based on engineering principles and extensive prior knowledge of electrosurgical physics and biology, not "trained" on a dataset in the way a neural network is.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" for an AI/ML algorithm in this context, there is no ground truth to be established for it. The underlying principles of the device's operation are based on validated scientific and engineering models.
§ 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.