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510(k) Data Aggregation
(56 days)
CytoCore
The CytoCore is a device to hold a syringe for performing a biopsy of an identified mass with one hand.
The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor oscillates the needle to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells.
The Praxis Medical CytoCore is a biopsy instrument intended to hold a syringe for performing a biopsy of an identified mass with one hand. Below is a summary of its acceptance criteria and the study conducted to demonstrate that the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-life & Durability | 1-year shelf-life (accelerated aging). Pre and post-aging performance maintained. | Samples subjected to accelerated aging equivalent to 12 months. Performance maintained. |
| Drop Testing | Withstand 6 drops from 1m height onto a hard surface without damage affecting function. | Samples removed from shipping box, dropped twice from each of three orientations (total 6 drops) from 1m onto a 50mm ± 5mm thick hardwood board (hardwood > 600 kg/m3) on a concrete/rigid base. All samples passed. |
| Biocompatibility | No patient contact; therefore, ISO 10993 testing not required. | The subject device has no patient contact. (The user supplies the needle, which contacts the patient). |
| Cellular Harvest Ability (Equivalence) | Ability to harvest or collect cellular materials equivalent to or better than the predicate device. | Comparative cellular harvesting study showed the subject device (CytoCore) averaged 2.59, compared to the predicate's 1.85. The discussion states, "The results demonstrate that the subject device was able to harvest or collect an equivalent to more cellular materials than the predicate. We are making no claim of better performance only equivalence." |
| Electrical Safety & EMC | Compliance with applicable electrical safety and EMC standards. | The system complies with AAMI ANSI ES 60601-1: 2005 + A1: 2012 and IEC 60601-2-22 Edition 3.1 2012-10 standards for safety and IEC 60601-1-2: 2014 for EMC. |
| Needle Compatibility | Compatible with 22-25 gauge needles. | Performance testing included a 22-25-gauge needle with both the subject and predicate devices. (Implied successful compatibility during testing.) |
2. Sample size used for the test set and the data provenance:
- Cellular Harvest Ability (Comparative Performance Testing): Fifteen licensed physicians utilized the subject device and the predicate. The number of samples (e.g., biopsy procedures, tissue samples) each physician performed is not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective. Given the nature of a comparative performance study with physicians actively using the device, it is most likely a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the cellular harvest ability study, fifteen licensed physicians were used.
- Their specific qualifications beyond "licensed physicians" (e.g., years of experience, specialization) are not detailed in the provided document.
4. Adjudication method for the test set:
- The document states that comparative cellular harvesting was "evaluated and scored." The specific adjudication method (e.g., 2+1, 3+1, independent review) for scoring the cellular harvest quantity/quality is not described.
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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. The study described is a comparative cellular harvest ability study between two devices (Praxis Medical CytoCore vs. TAO Aspirator and Plastic Finger), not an AI-assisted diagnostic study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the Praxis Medical CytoCore is a physical medical device (a syringe-holding device with an internal motor for needle oscillation), not an algorithm or AI system.
7. The type of ground truth used:
- For the comparative cellular harvest ability study, the ground truth appears to be established through the "evaluation and scoring" of the harvested cellular material, likely by the licensed physicians themselves or by an independent pathologist/cytologist assessing the quality and quantity of the biopsy samples. The exact nature of this "scoring" is not detailed, but it relates to the biological outcome of the biopsy procedure (i.e., how much and how well cellular material was collected).
8. The sample size for the training set:
- This question is not applicable as the Praxis Medical CytoCore is a physical medical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as #8.
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