(129 days)
The Hemostatix Model 2400Z Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
The Hemostatix Model 2400Z Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance. This document primarily focuses on establishing substantial equivalence to a predicate device and outlining basic device characteristics and regulatory compliance.
Here's an breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document states that "The Hemostatix Model 2400Z Thermal Scalpel System is designed to meet UL 2601-1 including Australian deviations, CSA 22.2 No. 601, IEC 601-1-1 (EN 60601-1), IEC 601-1-2 (EN 60601-1-2), IEC 601-1-4 (EN 60601-1-2), IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 529, ISO 10993-1, EN 55011, Class B."
This lists a set of international and national standards that the device is designed to meet. However, it does not provide specific performance metrics or acceptance criteria tables as they would typically be presented (e.g., minimum cutting efficiency, maximum tissue damage, etc.). It also does not report detailed performance results against these standards, only a general statement of compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given text. There is no mention of any specific test sets, sample sizes, or data provenance from a device performance 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 information is not provided. The document does not describe any studies involving experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. As there's no mention of a test set or ground truth establishment, there's no adjudication method described.
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 is not applicable. The device is a "Thermal Scalpel System," not an AI-assisted diagnostic or imaging system that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a surgical instrument. There is no mention of an algorithm in the context of performance studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided. No specific performance study with ground truth is described. The approval is based on "substantial equivalence" to a predicate device and compliance with general safety and performance standards.
8. The sample size for the training set:
This information is not provided. No training set for an algorithm is mentioned or relevant to this type of device and submission.
9. How the ground truth for the training set was established:
This information is not provided. No training set for an algorithm is mentioned or relevant to this type of device and submission.
Summary based on available information:
The provided document, a 510(k) summary, focuses on establishing the substantial equivalence of the "Hemostatix Model 2400Z Thermal Scalpel System" to a predicate device (Oximetrix Shaw Hemostatic Surgical System) and its intended compliance with various technical and safety standards. It does not present a detailed study with specific acceptance criteria, performance metrics, or clinical data in the format you requested. The regulatory approval is based on demonstrating that the new device has "the same technological characteristics, power modality and mode of operation as the predicate device" and meets a list of recognized safety and performance standards, rather than a specific comparative effectiveness study with ground truth and expert evaluation.
§ 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.