(58 days)
Remington Medical, Inc. Automatic Cutting Needle (NAC) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
The Remington Medical Inc. Automatic Cutting Needle (NAC) is a device used for obtaining biopsies from soft tissues such as liver, kidnev, prostate, spleen, lymph nodes and various soft tissue tumors in combination with compatible commercial biopsy instrument(s)/gun(s) which are FDA cleared and distributed in the US Market. The Automatic Cutting Needles (NAC) are available in five qauges (differentiated by color) and seven needle lengths. The Automatic Cutting Needle (NAC) is advanced via the compatible commercial biopsy instrument/gun into the desired tissue to obtain a sample for histological examination. The Automatic Cutting Needle (NAC) is a sterile, single patient use and non-pyrogenic device.
The provided text describes a 510(k) premarket notification for the Remington Medical, Inc. Automatic Cutting Needle (NAC). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study or AI model evaluation.
Therefore, many of the requested details, such as those related to AI algorithm performance, training/test set data, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this type of regulatory submission. This is a traditional medical device, not an AI/ML enabled device.
Based on the provided information, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
There isn't a table of specific performance acceptance criteria in the sense of accuracy, sensitivity, or specificity metrics typical for AI/ML devices. Instead, the "acceptance criteria" are implied by the non-clinical testing performed to establish substantial equivalence. The "reported device performance" are the results of these non-clinical tests demonstrating the device's physical and functional properties are comparable to the predicate.
| Acceptance Criteria (Implied by Study Type) | Reported Device Performance (Summary) |
|---|---|
| Dimensional Requirements | Met (results demonstrated equivalence to predicate) |
| Stylet / Cannula to Hub Tensile Strength | Met (results demonstrated equivalence to predicate) |
| Equipment Interface | Met (results demonstrated equivalence to predicate) |
| Integrity of the Sterile Barrier | Met (results demonstrated equivalence to predicate) |
| Biocompatibility | Met (results demonstrated equivalence to predicate) |
| Pyrogenicity | Met (results demonstrated equivalence to predicate) |
| Sterility Assurance | Met (results demonstrated equivalence to predicate) |
| Distribution Simulation | Met (results demonstrated equivalence to predicate) |
| Simulated Use Soft Tissue Sampling (Ex Vivo) | Met (results demonstrated equivalence to predicate for obtaining biopsies) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" like in an AI study. The tests listed are non-clinical (e.g., mechanical, material, engineering tests) performed on samples of the device itself.
- Data Provenance: The tests are ex-vivo (meaning, performed outside of a living organism, likely in a lab setting using tissue phantoms or excised animal tissue for the "Simulated Use Soft Tissue Sampling"). The document does not specify a country of origin for the data beyond being conducted by Remington Medical, Inc. for their 510(k) submission. It is by definition "prospective" testing of manufactured devices for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of clinical or AI studies (e.g., disease presence) is not relevant here. The "ground truth" for these engineering tests would be the established specifications and performance of the predicate device, against which the subject device's non-clinical performance is compared. This is a comparison of physical device characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are for resolving discrepancies in expert interpretations of medical data (e.g., radiologist reads), which is not part of this 510(k) submission's non-clinical testing.
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. An MRMC study was not done, as this is for a traditional biopsy needle, not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the AI/clinical sense. The "ground truth" for the non-clinical tests is based on engineering specifications, material properties, and the established performance characteristics of the predicate device. For the "Simulated Use Soft Tissue Sampling," the ground truth would be the ability to successfully obtain a biopsy sample comparable to that obtained by the predicate.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or "ground truth" for it in the context of an AI/ML device.
§ 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.