(140 days)
The Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider is a bipolar electrosurgical instrument intended for use with the ForceTriad™ Energy Platform in general and gynecologic laparoscopic surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue.
Indications for use include general laparoscopic procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, colectorny, adhesiolysis, oophorectomy, etc. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider can be used on vessels and lymphatics up to and including 7mm and tissue bundles as large as will fit in the jaws of the instrument.
The Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider is a multifunctional electrosurgical instrument for use in performing laparoscopic surgical procedures using the ForceTriad™ Energy Platform.
The outer diameter of the instrument shaft is 5 mm, with a working length of 37 cm. The following controls are located on the instrument handle:
- A lever for opening and closing the instrument jaws. The mechanism incorporates a . latch to hold the jaws in the closed position during vessel sealing and cutting.
- An activation button for generator power to initiate vessel sealing. .
- A trigger for actuating the cutter. The cutter can only be actuated when the jaws are . closed and latched.
- . A knob to rotate the instrument jaws.
All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator.
The instrument attaches to the generator via a ten-foot cable with a Smart™ connector that identifies the instrument type to the generator. The instrument is supplied sterile for single use.
The scope of this submission only includes the reprocessed Covidien 100 sealer/divider device and not the ForceTriad™ Energy Platform. Stryker Sustainability Solutions does not reprocess or market the generator.
The provided document is a 510(k) summary for the Reprocessed LigaSure™ Blunt Tip Laparoscopic Sealer/Divider. It describes the device and its intended use, but it does not contain the level of detail requested for acceptance criteria and study methodology that would typically be found in a clinical trial report or a more extensive validation study summary.
Specifically, the document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed LigaSure 1 Blunt Tip Laparoscopic Sealer/Dividers. This included the following tests: Biocompatibility, Validation of Reprocessing, Sterilization Validation, Functional Performance Tests, Packaging Validation. Performance testing demonstrates that reprocessed devices perform as originally intended."
However, it does not provide quantitative acceptance criteria or detailed results for these tests, nor does it describe a study with a test set, ground truth experts, adjudication methods, or sample sizes in the manner requested.
Therefore, I cannot fill out all parts of your request based on the provided text. I will, however, extract what is explicitly stated in the document.
Acceptance Criteria and Device Performance
The document states that reprocessed devices perform "as originally intended" and are "at least as safe and effective to the predicate device." While this implies that the performance matches the predicate, specific quantitative acceptance criteria and detailed reported device performance are not provided. The testing categories are listed, but not the specific metrics or thresholds.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility requirements met | Device is biocompatible |
| Reprocessing validated | Reprocessing is validated |
| Sterilization validated | Sterilization is validated |
| Functional performance equivalent to predicate | Device functions as originally intended; "at least as safe and effective to the predicate device" |
| Packaging validated | Packaging is validated |
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The studies are described as "Bench and laboratory testing," implying a controlled laboratory environment rather than patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The described testing refers to bench and laboratory tests, not studies relying on expert interpretation for ground truth.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The described testing refers to bench and laboratory tests, not studies requiring expert adjudication.
4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument, not an AI diagnostic tool that would involve human readers.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable in the context of an algorithm. However, the "Functional Performance Tests" could be considered a form of standalone testing for the device itself, demonstrating its physical and electrical properties. The document states: "Performance testing demonstrates that reprocessed devices perform as originally intended."
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "Functional Performance Tests" and other bench tests, the ground truth would be based on predefined engineering specifications, established scientific standards, and comparison to the performance of new (unreprocessed) predicate devices. This is not explicitly detailed but is inferred from the nature of the device and testing.
7. The sample size for the training set
- Not applicable. The document describes the reprocessing and validation of a surgical instrument. There is no mention of a "training set" in the context of machine learning or AI.
8. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned, there is no ground truth establishment for it.
§ 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.