(191 days)
The EnSeal LCJ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures. It is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open, general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments. The EnSeal Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
The Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer is a sterile, single patient use device. The functionality is the same as the predicate devices.
The provided document, K101520, is a 510(k) summary for the Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer. It claims substantial equivalence to a predicate device based on performance testing and functional similarities. However, the document does not contain the specific details required to fully address your request in terms of acceptance criteria, study design, and ground truth establishment, as the performance data section is very brief.
Here's an analysis based on the information available in the document and the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) | Notes on Sufficiency |
|---|---|---|---|
| Overall Functionality | Function as intended | "Bench and animal testing was performed to ensure the devices function as intended and meet design specifications." | Lacks specific metrics or thresholds. "Function as intended" is a general statement. |
| Design Specifications | Meet design specifications | "Bench and animal testing was performed to ensure the devices function as intended and meet design specifications." | Lacks specific design specs and how performance met them. |
| Equivalence to Predicate | Substantially equivalent to predicate device | "Based on performance testing and functional similarities to the predicate devices, the Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer devices are substantially equivalent to the predicate devices." | This is a conclusion, not specific performance data against equivalence criteria. |
Missing Information:
The document does not explicitly state specific, quantifiable acceptance criteria (e.g., minimum seal burst pressure, maximum thermal spread, specific transection time, etc.). It only provides a general statement that "Bench and animal testing was performed to ensure the devices function as intended and meet design specifications." Without these specific criteria, it's impossible to create a comprehensive table of acceptance criteria and reported performance with detailed metrics.
2. Sample Size for the Test Set and Data Provenance
Missing Information: The document does not specify the sample size used for either bench or animal testing. It also does not mention the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Missing Information: The document does not describe the establishment of a "ground truth" using experts. Performance testing for medical devices, especially electrosurgical ones, typically involves objective measurements (e.g., burst pressure, thermal spread, histological analysis) rather than expert consensus on subjective findings.
4. Adjudication Method for the Test Set
Missing Information: Since the document does not describe expert involvement for ground truth, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable: The device is an electrosurgical tissue sealer, not an imaging or diagnostic device that would typically involve human readers interpreting results. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not relevant or mentioned in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not Applicable: The device is a physical electrosurgical instrument, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
Based on the nature of the device (electrosurgical tissue sealer) and the mention of "bench and animal testing," the ground truth for performance would likely be established through:
- Objective physical measurements: Such as burst pressure of sealed vessels, impedance measurements, thermal spread measurements.
- Histological analysis: Examination of tissue samples after sealing to assess cellular damage and seal integrity.
- Physiological outcomes in animal models: Such as hemostasis, healing, absence of complications.
Missing Information: The document does not explicitly detail the specific type of ground truth used for each aspect of testing or how it was established.
8. Sample Size for the Training Set
Not Applicable: This device is a traditional electrosurgical instrument, not a machine learning or AI-driven system that would typically require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.
Summary of Conclusions from the Document:
- Study Performed: Bench and animal testing.
- Purpose of Study: To ensure the devices function as intended and meet design specifications.
- Conclusion of Study: Based on this testing, and functional similarities to predicate devices (SurgRx EnSeal Tissue Sealers, K072177), the Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer devices are considered substantially equivalent to the predicate devices.
- Modifications: Differences include an improved ergonomic handle, larger shaft, jaw diameter, and jaw length/shape compared to the predicate device.
Overall, the provided 510(k) summary is very high-level regarding performance data. It states that testing was done to ensure functionality and design specifications were met, and that this supports substantial equivalence. However, it lacks detailed quantitative acceptance criteria and specific results that would typically be found in a more comprehensive study report.
§ 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.