(178 days)
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The Sure-Core Biopsy Electrode Kit consists of four components: a locator needle, a locator wire, a soft tissue dillator, and the Sure-Core electrosurgical core cutting electrode. The Sure Core Biopsy Electrode is both a manual core cutting device and a monopolar electrosurgical device that is used to cut soft tissue for the purpose of obtain a biopsy sample. The distal tip is a sharp stainless steel cutting blade which cores the tissue distal to the end of the dilator. The most difficult aspect of obtaining a true core biopsy is the detachment of the core from the remaining tissue. The Sure-Core Biopey Electrode overcomes this obstacle by means of a monopolar electrosurgical wire. The electrosurgical wire cuts the tissue perpendicular to the distal blade.
The provided text describes a medical device, the Sure-Core Biopsy Electrode, and argues for its substantial equivalence to other marketed devices. However, it does not contain any information about acceptance criteria, performance studies, or associated data for the Sure-Core Biopsy Electrode itself.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria or study details.
The document is a 510(k) Safety and Effectiveness Summary for a device cleared in 1997. At that time, the regulatory requirements for demonstrating "substantial equivalence" primarily focused on comparing the new device's features and intended use to legally marketed predicate devices, rather than requiring extensive performance studies as might be expected for novel AI-based devices today.
To answer your prompt with the information provided, I would state:
This 510(k) summary does not contain acceptance criteria or study results for the Sure-Core Biopsy Electrode. The submission relies on demonstrating "substantial equivalence" to predicate devices based on design features and intended use.
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set or ground truth establishment is described.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not conducted or described.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable as this is a manual, non-AI device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.