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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 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, bariatio, vascular, thoracic, 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 jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and is provided in shaft lengths of 23, 37, and 44 cm.

The 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 radiofrequency (RF) energy, otherwise known as 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 the 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 separate control to activate a blade, which divides the tissue along the seal line.

The provided text is a 510(k) summary for the POWERSEAL Sealer and Divider, a medical device. It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, this document does not contain the information necessary to answer the specific questions about acceptance criteria and a study proving the device meets those criteria, as typically found in clinical trials or performance studies for AI/software-based devices.

The device in question (POWERSEAL Sealer and Divider) is an electrosurgical device, not an AI/software-based device. Therefore, questions 3, 4, 5, 8, and 9 are not applicable as they relate specifically to AI/ML model development and validation, ground truth establishment, and multi-reader studies.

The document discusses "performance requirements" and "acceptance criteria" in a general sense within the context of bench testing, preclinical (simulated use) evaluation, and animal studies, but it does not present a table of specific quantitative acceptance criteria and corresponding reported device performance with numerical results that would be expected for an AI/software product.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not present for an electrosurgical device submission of this type:

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

• Not explicitly provided in a quantitative table format. The document states: "System testing demonstrated that the performance requirements defined in the User Requirements Specification and Design Specification were met for the subject devices, and that they exhibit comparable performance characteristics to the predicate device."
• It also mentions: "Ex-vivo Vessel Burst Pressure testing was conducted on both the subject and predicate devices to demonstrate vessel sealing performance," and "Performance testing demonstrated that the device is as effective, and performs as well as the predicate devices."
• "Risk analysis was carried out in accordance with established internal acceptance criteria based on ISO 14971."
• While these statements indicate that acceptance criteria were defined and met for various tests (electrical, mechanical, functional, biocompatibility, sterilization, vessel burst pressure), the specific numerical criteria and the quantitative results are not included in this 510(k) summary. This type of detailed data is typically found in the full 510(k) submission, not the public summary.

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated with numerical values. The text mentions "Ex-vivo Vessel Burst Pressure testing" which implies a sample of vessels, and "Acute Animal Study" and "Chronic Animal Study," also implying animal subjects. However, the specific number of vessels or animals is not provided.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not applicable in the traditional sense for these types of bench and animal studies. These are experimental studies designed to prospectively test the device's performance.

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

• Not Applicable. This device is an electrosurgical tool, not an AI/software system requiring expert interpretation for ground truth establishment for a test set. The "ground truth" for this device's performance would be objective measurements (e.g., burst pressure, thermal spread, mechanical force) and pathological/clinical outcomes from animal studies, not expert annotations of images.

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

• Not Applicable. See explanation for #3. Adjudication methods like 2+1 are used for establishing consensus among human readers for AI/software ground truth, which is not relevant here.

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

• Not Applicable. This is an electrosurgical device, not an AI assistance tool for human readers. MRMC studies are for evaluating diagnostic imaging AI.

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

• Not Applicable. This is electrosurgical hardware. There is no "algorithm only" performance concept for this device.

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

• The "ground truth" for this device's performance is established through objective measurements from bench testing (e.g., electrical, mechanical, functional tests), ex-vivo vessel burst pressure testing, and pathological/outcomes data from the acute and chronic animal studies (e.g., seal performance, safety, tissue effects, thermal margin).

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. See explanation for #8.

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