(86 days)
-Heat scissors generator set
The Heat scissors generator set has been designed to generate electrical energy to the Heat scissors handpiece to cut and coagulate body tissue.
-Heat scissors handpiece (XRF-940-M)
The Heat scissors handpiece has been designed to cut and coagulate body tissue in general (open) abdominal surgery.
The Heat scissors system has been designed to cut and coagulate tissue for general (open) abdominal surgery. This system consists of the Heat scissors generator, Heat scissors handpiece and foot switch. This system uses direct thermal energy and simultaneous pressure to cut and coagulate tissue. The thermal energy is generated at the Heat-generating section of the blade, on the Heat scissors handpiece. It is conveyed via a non-stick coating on the blade to the tissue.
This 510(k) summary for the Olympus Heat scissors generator set and Heat scissors handpiece does not contain the information required to populate the acceptance criteria table or describe a study proving the device meets acceptance criteria.
The document states: "When compared to the predicate devices, 'Heat scissors system' does not incorporate any significant difference for safety and efficacy to the predicate devices. Therefore, clinical data is not necessary for its evaluation of its safety and efficacy." This explicitly indicates that no clinical study was performed to establish new acceptance criteria or demonstrate performance against such criteria.
Instead, the submission relies on substantial equivalence to predicate devices. This means that Olympus is claiming their Heat Scissors system is as safe and effective as existing legally marketed devices, rather than providing new performance metrics from a dedicated study.
Here's what can be extracted from the document regarding the device's design and testing, which are not the same as acceptance criteria and a study proving performance against them in the clinical sense:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics in this document. The "acceptance criteria" here are implicitly linked to meeting the safety and efficacy profiles of the predicate devices.
- Reported Device Performance: Not reported in terms of specific clinical or measured performance metrics. The document instead states that the "Heat scissors system" has been designed, manufactured, and tested in compliance with voluntary safety standards IEC 60601-1 and IEC60601-1-2. It also notes that biocompatibility test reports show materials comply with ISO 10993-1. These are compliance statements, not performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no clinical or comparative performance study with a test set is described. The tests mentioned (IEC standards, biocompatibility) are likely bench or material tests, not clinical performance tests on humans.
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)
- Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is 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
- Not applicable. This device is a surgical cutting and coagulation tool, not an AI-assisted diagnostic tool or system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth is described as being established for a performance study.
8. The sample size for the training set
- Not applicable. This document describes a medical device, not an AI/ML algorithm that would have a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for it is described.
In summary: The provided 510(k) summary for the Olympus Heat Scissors system does not describe a study to prove acceptance criteria in the way envisioned by the prompt. It focuses on demonstrating substantial equivalence to predicate devices through compliance with safety standards and biocompatibility, negating the need for new clinical performance data.
§ 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.