The Reprocessed HARMONIC 1100 Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.
The Reprocessed HARMONIC 1100 Shears instrument is a sterile, single patient used for dissection, grasping, coagulation, and cutting between the blade and clamp arm. It consists of an ergonomic handle with an integrated hand piece and two energy delivery buttons. 1) Energy button for power levels 1-5, and 2) Energy with Advanced Hemostasis button for large vessel sealing. The instrument is available in two shaft lengths (20 cm and 36 cm). An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instrument has a clamp and coated curved blade that are designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated continuously to facilitate visualization and access to targeted tissue. The instrument are intended to represent relative vessel size. The Energy button is in diameter. When the Energy button is used, cutting speed is the fastest. The energy button with Advanced Hemostasis is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy button with Advanced Hemostasis is reduced and hemostasis is maximized. The instrument utilizes Adaptive Tissue Technology. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. The HARMONC 1100 Shears instrument is designed for use exclusively with the Generator 11 (GEN11) software version 2018-1 or later.
The provided text is a 510(k) summary for reprocessed HARMONIC 1100 Shears. It describes the device, its intended use, and a study comparing it to predicate devices. However, it does not contain detailed information about specific acceptance criteria or the study design and results in a format that allows for the extraction of all the requested information.
Here's an analysis of what can be extracted and what is missing:
The submission is for Stryker Sustainability Solutions' Reprocessed HARMONIC 1100 Shears (HAR1120 and HAR1136). The focus of the provided document is the expansion of the indications for use to include coagulation of veins up to and including 7 mm in diameter.
1. A table of acceptance criteria and the reported device performance
- The document states: "Supplemental chronic 21-day survival studies were completed to assess the long-term seal quality of veins up to and including 7 mm in diameter. The data supports the expansion of the include coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis."
- Missing from the text: Specific quantitative acceptance criteria (e.g., minimum seal burst pressure, failure rates) and the precise reported device performance metrics against those criteria are not detailed. The phrase "long-term seal quality" is qualitative without acceptance thresholds.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The study is described as "Supplemental chronic 21-day survival studies." This implies a prospective animal study.
- Missing from the text: The number of animals or vessels tested (sample size) for this study is not provided. The country of origin for the data is also not specified, though it's implied to be a pre-clinical study.
3. 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)
- This question is not applicable to this type of device and study. The "ground truth" for vessel sealing devices in pre-clinical studies is typically based on physiological measurements (e.g., burst pressure, histological analysis) rather than expert interpretation of images. The study involved "animal study data," which suggests direct observation and measurement in live subjects.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As noted above, this study is not interpreting images or clinical outcomes that would require an adjudication method by human readers. It's a technical performance study.
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 document describes a medical device (surgical shears), not an AI-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth in this context would be the directly measured "long-term seal quality of veins" in the animal model. This would likely involve physiological parameters like burst pressure, histological examination of the sealed vessels for integrity, and potentially observation of complications over the 21-day survival period.
- Missing from the text: The specific metrics and methods used to define "long-term seal quality" are not detailed.
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. This is not an AI/ML device that requires a training set.
Summary of available information regarding the device's performance study:
Device: Reprocessed HARMONIC 1100 Shears (HAR1120, HAR1136)
Purpose of Study: To support the expansion of indications for use to include coagulation of veins up to and including 7 mm in diameter.
Study Type: Supplemental chronic 21-day survival studies in an animal model.
Evaluation Focus: Assessment of "long-term seal quality" of veins up to and including 7 mm in diameter.
Conclusion stated: "The data supports the expansion of the include coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis."
Missing Critical Information from the provided text:
- Detailed quantitative acceptance criteria.
- Specific numerical results of the "long-term seal quality" assessment.
- The exact sample size (number of animals or vessels) used in the study.
- Specific ground truth metrics (e.g., burst pressure values, histological findings).
- Details of the study protocol.
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