(117 days)
Spectra Soft Tissue Biopsy Needles are indicated for obtaining biopsy samples from soft tissue in percutaneous or open surgical procedures from various tissues through a combination of cutting and/or aspirating in such a manner that the biopsy sample is retained in the orifice of the needle.
The Spectra Soft Tissue and Aspiration Biopsy Needles consist of a stainless steel needle and a translucent standard female Luer locking hub. A stylet rod assembly mates with the needle hub assembly. A depth stop is integral with each needle type to facilitate depth placement. The needle assembly is covered by a translucent removable needle guard. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need. Needles are available with an echogenic treatment to help ensure strong reflection during ultrasound procedures. Spectra Soft Tissue Biopsy Needles will be marketed as sterile, non-pyrogenic, and single use devices.
The provided document is a 510(k) Premarket Notification from the FDA for Spectra Soft Tissue Biopsy Needles. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria for device performance as would be expected for an AI/CADe device.
Therefore, the specific information requested, such as acceptance criteria table, sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training data, is not available in this document. The document describes performance testing for safety and basic functionality, not clinical performance for diagnostic accuracy.
Here's an analysis based on the information available in the document, framed against the requested items:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria that relate to diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or a clinical study proving those criteria were met for diagnostic accuracy. Instead, it details performance tests related to material safety and mechanical functionality.
| Test Type | Description / Performance | Acceptance Criteria (Explicitly stated) |
|---|---|---|
| Biocompatibility | Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993. | Device is biocompatible (passed tests). |
| Cytotoxicity | Performed | Passed |
| Sensitization | Performed | Passed |
| Irritation/Intracutaneous Reactivity | Performed | Passed |
| Systemic Toxicity | Performed | Passed |
| Hemocompatibility | Performed | Passed |
| Standard ISO Luer Hubs | Applicable luer testing used ISO 594. | Passed (met ISO 594 standards) |
| Needle Bond Strength | With hubs | Passed |
| Overall Conclusion | The Submission Devices have met all established acceptance criteria for performance testing. (General statement) | Implied safety and functionality equivalence to predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The document describes testing of the physical biopsy needles themselves (biocompatibility, mechanical performance), not an AI/CADe system evaluated on a dataset of patient images or clinical outcomes.
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)
This information is not applicable and not provided. "Ground truth" in the diagnostic sense (e.g., presence or absence of disease in an image) is not relevant to the type of device and testing described here. The "ground truth" for the performance tests would be the established safety and mechanical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for diagnostic devices to resolve discrepancies in expert interpretation, which is not the focus of this submission.
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
No MRMC study was done. This device is a physical biopsy needle, not an AI/CADe system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study, as understood for AI/CADe systems, was not conducted because this is a physical medical device. The "standalone" performance here refers to the physical and chemical characteristics of the needle itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the "ground truth" is defined by the regulatory standards and recognized biological responses to materials (e.g., no cytotoxicity, no sensitization). For mechanical tests, the "ground truth" is adherence to established engineering standards (e.g., ISO 594 for Luer hubs, bond strength specifications). No patient-level diagnostic "ground truth" (pathology, expert consensus) is involved in this documentation.
8. The sample size for the training set
This information is not applicable and not provided. There is no AI algorithm being trained.
9. How the ground truth for the training set was established
This information is not applicable and not provided because there is no AI algorithm being trained.
§ 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.