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The MiSeal Reposable Thermal Ligating Shears are intended for the simultaneous cutting and cauterization of soft tissue during surgery, and cutting of natural or synthetic, nonmetallic sutures during surgery.

The MiSeal Reposable Thermal Ligating Shears system consists of the following: MiScal Reusable Handpiece, MiScal Thermal Ligating Shears Kit, Universal Power Supply 200-006R. The MiSeal Reposable Thermal Ligating Shears are designed to provide thermal ligation and division in various surgical procedures. The MiSeal Reposable Thermal Ligating Shears consist of a reusable handpiece with heating elements at the distal tip which are activated by a finger switch located on the handpiece of the device. The MiSeal Reposable Thermal Ligating Shears are designed to allow the surgeon control of the heating element power of the device in order to accommodate the individual patient anatomy. An instrument cord connects the handpiece to the dedicated Microline Surgical Universal Power Supply K070871. The MiSeal Reposable Handpiece is supplied non-sterile in a foam cavity placed in a fiberboard carton and is for multiple patient uses following cleaning and steam sterilization procedures performed per the provided Instructions for Use. The handpiece can be used multiple times if cleaning and sterilization procedures are followed. The MiSeal Disposable Kit (the functional instrument Tip and power cable portion of the applied part of the system) is supplied sterile in a die-cut chipboard Packaging Insert and Tyvek/Mylar pouch and is labeled for single use only. The tip is intended to be used by a trained physician for a single patient use in open general surgery, open vascular surgery, and laparoscopic surgical procedures. The MiSeal single use power cable is connected to the instrument handpiece and terminates at the electrical connection of the Universal Power Supply. The system power supply is supplied non-sterile for reusable use outside the sterile field. The MiSeal device incorporates Hi and Low heating modes that are used to coagulate and cut soft tissue. The heating elements in the disposable tip are activated by a physician controlled finger switch located on the handpiece of the device. The MiSeal device is intended to provide general purpose dissection, spreading, and grasping of soft tissue during minimally invasive or open surgical procedures.

Here's an analysis of the provided text regarding the MiSeal Reposable Thermal Ligating Shears, focusing on acceptance criteria and the study proving it:

Based on the provided document (K122086 510(k) Summary), the information is primarily about establishing substantial equivalence to a predicate device, as required for a 510(k) submission to the FDA. This type of submission generally does not include detailed acceptance criteria or extensive clinical study results in the same way a PMA (Pre-Market Approval) or de novo submission might.

The document states: "Preclinical and performance tests were performed to assure the MiSeal Reposable Thermal Ligating Shears functioned as intended and met all product specifications. Sufficient data was generated and analyzed to prove that the MiSeal Reposable Thermal Ligating Shears was substantially equivalent to the predicate device."

This indicates that internal performance specifications were met, and the key acceptance criterion for the FDA submission was demonstrating substantial equivalence to the predicate device (Starion Instruments Thermal Ligating Shears, K062257). However, the specific details of these internal "product specifications" and the data generated are not provided in this summary.

Therefore, I cannot populate all the requested fields with specific details. Here's what can be inferred or stated as "Not Provided" based on the document:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not provided. The document mentions "Preclinical and performance tests" but does not specify sample sizes for these tests (e.g., number of tissue samples, number of devices tested).
• Data Provenance: Not provided specific details. The tests were likely conducted internally by Microline Surgical or by a contracted lab. The document does not mention country of origin of data or whether it was retrospective or prospective. Given the nature of a 510(k), these would primarily be laboratory/bench tests or, at most, animal studies, rather than human clinical data in the traditional sense.

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

• Not applicable/Not provided. The summary describes "Preclinical and performance tests" which are typically laboratory-based engineering evaluations (e.g., tensile strength, burst pressure, temperature profiles). Ground truth in this context would be objective physical measurements rather than expert human interpretation.

4. Adjudication method for the test set:

• Not applicable/Not provided. This concept of "adjudication" (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation or clinical endpoints that require consensus among experts, such as in diagnostic imaging or pathology. For device performance testing described, direct measurements against specifications would be the primary evaluation.

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:

• No. This device is an electrosurgical system, not an AI software/diagnostic device. MRMC studies are not relevant for this type of product.

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

• Not applicable. This is a surgical instrument, not an algorithm or AI system. Its performance is inherent in its physical and electrical properties when operated by a surgeon.

7. The type of ground truth used:

• Laboratory/Bench Test Results (Objective Measures): Likely based on defined physical and electrical property measurements (e.g., tissue sealing strength, burst pressure, cutting time, temperature, power output, device integrity under stress) as per specified testing protocols.
• Substantial Equivalence: The ultimate "ground truth" for the FDA submission is a comparison against the performance and characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not a machine learning or AI model that requires a "training set." Device design and development typically involve iterative testing and refinement, but not in the sense of a machine learning training set.

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

• Not applicable. (See #8).

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