(40 days)
SiteRite Needle Guide Kits and SiteRite Probe Cover Kits are intended to be used with Site~Rite Ultrasound Systems. The probe cover sheathes the transducer and isolates a site of surgical penetration from microbial and other contamination. The needle guide provides guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.
Site~Rite Needle Guide Kits - Single use sterile disposable needle guide kit available in 18 GA., 20 GA. and 21 GA. configurations. Each kit contains; 1 set of needle guides, conductive gel, elastic bands and a polyethylene sheath.
Site~Rite Probe Cover Kit – Single use sterile disposable sheath kit. Each kit contains; conductive gel, elastic bands and a polyethylene sheath.
The provided text is a 510(k) summary for the "SiteRite® Needle Guide Kits and SiteRite® Probe Cover Kit," which primarily discusses substantial equivalence to predicate devices and provides details about the device's description and intended use. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document states:
- "Testing was carried out to address the requirements associated with the required 510(k) information Based on March 12, 2000 Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers."
- "There are no changes made that affect the technological characteristics of the device."
- "The characteristics of the components within the predicate device are the same as the predicate device."
This suggests that the testing focused on meeting regulatory requirements related to safety and functionality (like sterility, biocompatibility, or material integrity) as per the referenced guidance, rather than a performance study with specific metrics (e.g., accuracy, sensitivity, specificity) against defined acceptance criteria. The claim is for "substantial equivalence," meaning it's as safe and effective as a legally marketed device, not necessarily that it has met new, specific performance benchmarks for, say, needle guidance accuracy.
Therefore, most of the requested information cannot be extracted from this document as it's not present.
Here's a breakdown of what can be gathered, and what is absent:
Acceptance Criteria and Study Details
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The document refers to testing "to address the requirements associated with the required 510(k) information" based on a guidance document, but it does not specify quantitative acceptance criteria or the results against them.
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Sample size used for the test set and the data provenance: This information is not provided. The document mentions general "testing" but gives no details about sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As there's no described performance study involving clinical data and ground truth establishment, this detail is absent.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided as no such study 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: This is not applicable/provided. The device is an ultrasound needle guide and probe cover, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable/provided. The device is a physical accessory, not an algorithm. Its function inherently involves human interaction (guiding a needle).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided as no performance study requiring ground truth establishment is detailed.
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The sample size for the training set: This is not applicable/provided. The device is a physical accessory, 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: This is not applicable/provided for the same reason as above.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence based on device description, intended use, and similar technological characteristics to predicate devices, along with general regulatory testing (e.g., for sterility, materials) rather than a detailed performance study with quantifiable acceptance criteria and clinical data analysis.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.