(22 days)
Clearview Plus Bone and Vertebral Body Biopsy Needles are intended for use by a physician performing bone or vertebral body biopsy using a coring (cutting) or aspiration technique.
The Clearview Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly in 11 and 13 gauge configurations. The needles have a useable length of 4.565 in (11.6 cm).
The modified Clearview Plus Bone and Vertebral Body Biopsy Needles consist of a cannula/stylet assembly and are available in an 11 gauge configuration. The additional components include:
- . 10cc VacLok syringe
- Luer cap .
- 13.5 gauge inner cannula (useable length 5.355 in, 13.6 cm) .
The needles useable length of 4.565 in (11.6 cm) is the same for the original design and for the modified design. The modified product and the original product are both provided sterile and for single use only.
This is a 510(k) summary for a medical device (Clearview Plus Bone and Vertebral Body Biopsy Needles), not a study demonstrating algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for AI/ML devices is not applicable.
The document describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Clearview Bone and Vertebral Body Biopsy Needles, K011206). Substantial equivalence means the device is as safe and effective as a legally marketed device that does not require premarket approval. The "acceptance criteria" here refers to the regulatory criteria for demonstrating substantial equivalence, not performance metrics of an algorithm.
Here's a breakdown of what information can be extracted or inferred based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain quantitative acceptance criteria or performance data in the way one would expect for an AI/ML device. For a 510(k) submission like this, "acceptance criteria" would primarily relate to demonstrating that the new device shares the same intended use, technological characteristics, and safety/effectiveness profiles as a legally marketed predicate device. The "reported device performance" is essentially the finding of "substantial equivalence."
Acceptance Criteria for 510(k) (Inferred for this type of submission):
| Acceptance Criteria Category | "Reported Device Performance" for Substantial Equivalence |
|---|---|
| Intended Use | The device's intended use is identical to the predicate. |
| Design | The device has similar design features to the predicate (cannula/stylet assembly, gauge configuration, usable length). |
| Technological Characteristics | The device uses similar technology as the predicate (e.g., coring or aspiration technique). |
| Safety and Effectiveness | The device is as safe and effective as the predicate. The submission implies this through equivalence in design and technology, and the 510(k) clearance confirms the FDA's agreement. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a physical medical device, not an AI/ML algorithm that would undergo a test set evaluation. The decision of substantial equivalence is based on comparing the device and its documentation to a predicate, not on clinical performance data from a test set in the context of an algorithm.
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)
Not applicable. No "ground truth" establishment in the context of an algorithm's performance on a test set is discussed. The "experts" involved would be the FDA reviewers and the manufacturer's regulatory team.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set for algorithm performance.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical biopsy needle.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the context of an algorithm's performance. The "ground truth" for this submission is that the predicate device is already legally marketed and considered safe and effective.
8. The sample size for the training set
Not applicable. No training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm.
In summary, the provided document describes a regulatory submission (510(k)) for a physical medical device. It is not an AI/ML device and therefore the questions pertaining to acceptance criteria and study designs relevant to AI/ML algorithms are not applicable to this text. The "study" here is essentially the comparison and justification provided by the manufacturer (Parallax Medical, Inc.) to the FDA for demonstrating substantial equivalence to a predicate 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.