(151 days)
The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.
The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.
The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.
The subject device ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. The front panel features a touch screen GUI that displays current settings, connection status, and allows access to menus for editing settings, procedures, and preferences. Compatible accessories include previously cleared footswitches.
The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm. The POWERSEAL devices are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics. The jaws are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism opens and closes the jaws. A second control initiates bipolar energy delivery for sealing. A separate control activates a blade for tissue division.
The provided text details the 510(k) submission for the Olympus Electrosurgical Generator ESG-400 and Accessories, and the POWERSEAL Curved Jaw Sealer and Divider, Double Action. The study described focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving direct performance against them in a traditional sense. The performance data provided is primarily in the context of comparative testing to established predicate devices.
Here's an attempt to extract the information requested, with indications where the information is not explicitly available in the provided document:
1. Table of acceptance criteria and the reported device performance
The document doesn't explicitly state specific numerical acceptance criteria for performance metrics (e.g., burst pressure in mmHG, or a specific range for coagulation time). Instead, it states that the device "met all acceptance criteria" for biocompatibility and that "performance requirements defined in the User Requirements Specification and Design Specification were met for both subject devices, and that they exhibit comparable performance characteristics to the predicate device and reference devices."
The performance is described qualitatively as being "comparable" or having "equivalent technology and performance" to predicate/reference devices. For example, for vessel sealing, the key performance indicator mentioned is "vessel burst pressure testing."
Therefore, a table of acceptance criteria and reported numerical performance values cannot be fully constructed from the provided text in the typical quantitative manner.
Table 1: Acceptance Criteria and Reported Device Performance (as inferred and stated qualitatively)
| Performance Aspect | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Qualitative Statement) |
|---|---|---|
| Biocompatibility | Met all criteria of ISO 10993 | Met all acceptance criteria for Cytotoxicity, Material Mediate Pyrogen, ISO Acute Systemic Injection Test, ISO Intracutaneous Irritation Test, ISO Guinea Pig Maximization Sensitization |
| Electrical Safety & EMC | Compliance with IEC standards | Design of subject devices comply with recognized standards (AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-2) |
| Thermal Safety | Compliance with recognized standards | Design of subject devices comply with recognized standards (referencing Table 11, which includes IEC 60601-1, IEC 60601-2-2) |
| Software Validation | Compliance with FDA Guidance for "Major Level of Concern" | Software validation activities performed; existing functionalities not influenced by new mode; electrical waveforms of "predicate modes" verified. |
| Vessel Sealing Performance | Comparable to predicate devices in animal and bench tests | Demonstrated substantial equivalence to predicate device in chronic and acute animal studies. Performance requirements met, comparable to predicate and reference devices in ex-vivo vessel burst pressure testing. |
| Shelf Life and Sterilization | Compliance with ISO 11607-1, ASTM F1980-16, ISO 11135 | Stability evaluation supports three-year shelf life; accelerated aging test conducted as required. |
| Risk Management | Acceptable residual risk per ISO 14971 | Risk analysis carried out, residual risk evaluated as acceptable. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify exact sample sizes for the "test set" in terms of number of cases or samples for the animal studies or bench testing (e.g., how many vessels were sealed for burst pressure testing). It only states that "ex-vivo Vessel Burst Pressure testing was conducted."
- Data Provenance (Country of Origin, Retrospective/Prospective): Not explicitly stated. The studies were likely conducted in a controlled lab or animal facility. The document refers to FDA guidance documents, which are for U.S. regulatory submissions, but doesn't specify where the actual testing took place. It also doesn't specify if the animal studies or bench tests were retrospective or prospective, though performance testing is generally prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information (number of experts, their qualifications, and their role in establishing ground truth) is typically related to clinical studies involving human interpretation or pathology. The reported studies are primarily bench (ex-vivo) and animal studies. Therefore, this information is not applicable in the context of the provided document. The "ground truth" for these studies would be objective measurements (e.g., burst pressure from instrumentation) rather than expert consensus on clinical findings.
4. Adjudication method for the test set
This is also typically relevant for clinical studies with human interpretation. For bench and animal studies (e.g., measuring vessel burst pressure), the "adjudication" is typically through objective measurements and statistical analysis, not a consensus process among experts as described by methods like 2+1 or 3+1. Therefore, this information is not applicable in the context of the provided document.
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
- MRMC Study Done: No. This study is for an electrosurgical device, not an AI-assisted diagnostic tool involving human readers.
- Effect Size of Human Readers: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable to this type of device. The device itself is an electrosurgical tool, not an algorithm, and it is used by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing, the ground truth was established through objective physical measurements in bench and animal studies:
- Biocompatibility: In vitro and in vivo (animal tissue/systems) tests following ISO 10993 standards.
- Electrical/Thermal Safety & EMC: Measurements against IEC standards.
- Vessel Sealing Performance: Chronic and acute animal studies demonstrating seal performance, and ex-vivo vessel burst pressure testing. The "ground truth" here would be the measured burst pressure values and observed tissue effects.
8. The sample size for the training set
The document describes an electrosurgical device, not a machine learning or AI algorithm in the context of diagnostic imaging. Therefore, the concept of a "training set" in this context is not applicable. The "training" for such a device involves engineering design, prototyping, and testing against specifications and regulatory standards.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm being developed.
§ 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.