(59 days)
The Stryker Stiletto Electrosurgical Probe is indicated for use in laparoscopic surgical procedures, including laparoscopic general surgery, thoracic surgery, laparoscopic thoracic surgery, gynecological surgery, general surgery and urological surgery. The device allows for suction and irrigation of sterile irrigant solution, In addition, the device is intended to be used for electrosurqical cutting/coagulation during laparoscopic procedures.
The Stryker Stiletto Electrosurgical Probe is a suction/irrigation probe with electrosurgical capability, composed of stainless steel, thermoplastic polymers (such as polyimide and PTFE) and thermoset polymers (like silicone rubber).
The provided document is a 510(k) summary for the Stryker Stiletto Electrosurgical Probe. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a new AI/software device. Therefore, much of the requested information regarding an "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI device cannot be directly extracted from this document.
However, I can extract the information relevant to the device's characteristics and the regulatory process, and explain why other requested details are not present.
Acceptance Criteria and Device Performance (as inferable from a 510(k) submission):
For a 510(k) submission like this, the "acceptance criteria" is typically centered around demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate. The "study" (or rather, the justification) involves showing that the new device does not raise new questions of safety or effectiveness and performs comparably to the predicate.
Given this context, here's what can be provided:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria (Inferred from 510(k) Substantial Equivalence) Reported Device Performance (as stated in 510(k)) Safety: Conforms to relevant safety standards for electrosurgical equipment and biological evaluation. Conforms to: IEC 60601-2-2, ANSI/AAMI HF-18, ISO 10993, EN 552. No new safety questions raised compared to predicate. Effectiveness/Performance: Operates as intended for electrosurgical cutting/coagulation and suction/irrigation, comparable to predicate. Indicated for same laparoscopic surgical procedures (general, thoracic, gynecological, urological surgery). Allows for suction/irrigation and electrosurgical cutting/coagulation. No significant technological or performance differences from predicate. Materials: Biocompatible and suitable for medical use. Composed of stainless steel, thermoplastic polymers (polyimide, PTFE), and thermoset polymers (silicone rubber). Conforms to ISO 10993. Intended Use: Similar indications for use as a legally marketed predicate device. Identical Indications for Use to predicate (Stryker StrykeFlow Electrocautery Probes, K963765). -
Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a "test set" in the context of an AI/software device. The demonstration of substantial equivalence relies on conformance to standards and comparison of device characteristics to a predicate, not performance on a dataset.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of "ground truth" or expert review in this 510(k) submission, as it's not a study evaluating an AI/software device against expert interpretations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication method is described.
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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 is for a manual surgical instrument, not an AI-assisted diagnostic or interpretative device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no ground truth data used in the context of evaluating an AI algorithm presented in this document. The "truth" for this device's regulatory pathway is its adherence to performance standards and its similarity to a predicate.
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The sample size for the training set: Not applicable. The device is a physical electrosurgical probe, not a machine learning model, so there is no training set.
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How the ground truth for the training set was established: Not applicable. There is no training set for this device.
Summary of Regulatory Finding:
The FDA determined that the Stryker Stiletto Electrosurgical Probe is substantially equivalent to the Strykeflow Electrocautery Probes (K963765). This determination is based on the new device having similar indications for use, technological characteristics, and conformance to recognized safety and performance standards, without raising new questions of safety or effectiveness.
§ 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.