(33 days)
The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general and endoscopic ENT surgical procedures.
The Karl Storz Unimat Plus and accessories is a membrane type irrigation pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mm Hg.
The provided text describes a 510(k) summary for the Karl Storz Unimat Plus, a suction/irrigation pump. This document focuses on establishing substantial equivalence to predicate devices and does not contain the detailed performance study information typically associated with AI/ML-driven medical devices that would have acceptance criteria and a structured study demonstrating its fulfillment. The device is a "membrane type irrigation pump" and not an AI/ML diagnostic tool.
Therefore, I cannot provide the requested information as it is not present in the given text. The provided text does not contain:
- A table of acceptance criteria and reported device performance: The document states "The minor differences between the Karl Storz Unimat Plus and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This is a claim of equivalence, not a presentation of performance data against specific acceptance criteria.
- Sample size used for the test set and data provenance: No test set is mentioned.
- Number of experts used to establish ground truth and their qualifications: No ground truth establishment process is mentioned.
- Adjudication method for the test set: No test set or adjudication process is mentioned.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is not relevant for a mechanical pump.
- Standalone (algorithm only) performance: This device is a pump, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The 510(k) summary for the Karl Storz Unimat Plus focuses on establishing substantial equivalence by comparing its basic features and intended use to predicate devices, asserting that any minor differences do not raise new safety or effectiveness concerns. It does not detail specific performance studies with acceptance criteria in the manner requested, which is more typical for software or AI/ML-based diagnostic devices.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.