Search Results

The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, 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, bariatic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, 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 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 subject POWERSEAL devices will be provided as 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 of the POWERSEAL 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 allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing is complete, the user operates a third control to activate a blade, which divides the tissue along the seal line.

The provided text is a 510(k) Summary for the Olympus POWERSEAL Curved Jaw Sealer and Divider, Double Action (K212643). It states that this submission is a modification to a previously cleared device (K203682) to add compatibility with an additional Olympus generator (ESG-410).

Crucially, the document explicitly states: "The POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, and PS-0544CJDA) is unchanged from the predicate device as cleared under K203682 in terms of intended use, design, performance, and technological characteristics. The only difference is in the labeling that identifies an additional compatible Olympus generator."

Therefore, the study described in this document is not a de novo study proving the initial performance of the device, but rather a bridge study to demonstrate that the device's performance, when connected to a new, compatible generator, remains equivalent to its previously cleared performance. The focus is on demonstrating that the modification (new generator compatibility) does not adversely affect the device's established safety and effectiveness.

Because of this, the document does not contain the detailed information necessary to answer all aspects of your request, particularly regarding clinical studies, human-in-the-loop performance, and the specifics of generating ground truth for a completely new device evaluation. The information provided heavily relies on the previous clearance (K203682) and focuses on non-clinical testing to confirm continued equivalence.

However, I can extract the relevant information that is available from the document regarding the acceptance criteria and the study that proves the device meets them for this specific modification.

Here's a breakdown based on the provided text, addressing your points where information is available:

1. A table of acceptance criteria and the reported device performance:

The document states: "Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate device and ensure that the performance criteria was met when used with the additional compatible generator. A risk analysis was completed to identify any new risks associated with the modification to the POWERSEAL Curved Jaw Sealer and Divider, Double Action. The following tests associated with the device modification were performed on the subject device according to the methods and acceptance criteria established in the original clearance K203682:

• Non-clinical (electrical, mechanical, functional)
• Preclinical (simulated use) evaluation and testing of tissue effects and thermal safety and vessel burst pressure testing and vessel thermal margin"

The specific acceptance criteria (e.g., minimum burst pressure, maximum thermal spread) and the reported quantitative performance data for these tests are not detailed in this 510(k) Summary. The document relies on the fact that these tests were "performed on the subject device according to the methods and acceptance criteria established in the original clearance K203682" and that the results "met" those criteria, implying the performance is equivalent to the predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for specific tests. The tests mentioned are "non-clinical" and "preclinical (simulated use)", which would involve a certain number of devices or simulated tissue samples, but the exact quantities are not provided.
• Data Provenance: The tests were conducted by the manufacturer, Gyrus ACMI, Inc., with some testing performed by Intertek (Fridely, MN, USA) and WuXi AppTec (St. Paul, MN, USA) for compliance to voluntary standards (e.g., biocompatibility). These are laboratory/bench tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable to this type of submission. This document describes non-clinical and preclinical testing of a surgical device's physical and functional properties, not an AI or imaging device requiring expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This question is not applicable. Adjudication is typically associated with human-read studies or clinical trials involving subjective interpretation, which is not what this document describes. Test results for electrosurgical devices are typically quantitative measurements against defined engineering specifications.

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 question is not applicable. This submission is for a electrosurgical sealing and cutting device, not an AI-assisted diagnostic or imaging tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This question is not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical and preclinical tests, the "ground truth" would be established by the engineering specifications and scientific principles governing device performance. For example, for "vessel burst pressure testing," the ground truth is the actual measured burst pressure, and the acceptance criterion would be a predefined minimum required pressure. For "tissue effects and thermal safety," the ground truth is the measured extent of tissue damage or thermal spread, compared against a safe operating range. These are objective measures, not subjective interpretations.

8. The sample size for the training set:

• This question is not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established:

• This question is not applicable. This is not an AI/machine learning device.

In summary, as per the provided text, the study proving the device meets acceptance criteria for this specific 510(k) (K212643) was primarily a non-clinical and preclinical validation that the addition of compatibility with a new generator did not alter the power seal device's performance characteristics established in its prior clearance (K203682). The detailed acceptance criteria and quantitative performance results for those tests are not provided in this summary, but the document states they were met.

Ask a specific question about this device

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)

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.

Ask a specific question about this device