(30 days)
The Easy Core Biopsy System is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs/tumors or masses for histological analysis. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate.
The Easy Core Biopsy System is a sterile, single-use biopsy needle.
The provided document describes a 510(k) premarket notification for the "Easy Core™ Biopsy System." It highlights the device's intended use and substantial equivalence to predicate devices but does not contain information regarding specific acceptance criteria, performance metrics, or a study that would demonstrate the device meets those criteria.
Therefore, most of the requested information cannot be extracted from the given text. The document is primarily a regulatory approval letter and a summary of the device's classification, intended use, and substantial equivalence, not a detailed study report.
Here's what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The document states "All data gathered demonstrate this device as substantially equivalent" to predicate devices, but it does not specify what performance metrics were measured or what success criteria were set.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (only a general statement of "substantially equivalent" is provided) |
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 available in the provided document. The document refers to "data gathered" but does not detail the specifics of any test set, sample size, or data provenance.
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 available in the provided document. As no specific test set or ground truth establishment process is described, this detail cannot be provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided document.
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:
This information is not available in the provided document. The device is a biopsy system, not an AI-assisted diagnostic tool, so an MRMC study in this context is unlikely and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not available in the provided document. The device is a physical biopsy system, not an algorithm, so "standalone performance" in that context is not relevant or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not available in the provided document. While the device is used for "histological analysis," the method for establishing ground truth for any potential comparative study is not discussed.
8. The sample size for the training set:
This information is not available in the provided document. The document does not describe a training set for an algorithmic device.
9. How the ground truth for the training set was established:
This information is not available in the provided document.
§ 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.