(123 days)
The Pajunk BrainPro biopsy cannula for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The BrainPro is provided in a set.
The Pajunk BrainPro Biopsy Needle is a dual cannula device made from stainless steel or titanium. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue.
The Pajunk BrainPro Access is an optional single-use anchoring and guidance instrument for Pajunks BrainPro biopsy cannula with cutting titanium thread for drill holes. It is used in brain biopsy procedures. The BrainPro Access is provided sterile.
The Paiunk BrainPro biopsy cannula is a single-use device intended for use in navigational guided biopsy of brain tumors.
The Pajunk BrainPro Biopsy Needle is a singel use dual cannula device made from stainless steel or titanium. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated to cut the tissue.
The Pajunk BrainPro Access is a single-use anchoring and guidance instrument for Pajunks BrainPro biopsy cannula with cutting titanium thread for drill holes.
The provided document is a 510(k) Premarket Notification Submission for the BrainPro and BrainPro Access devices. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found for novel technologies or PMA submissions.
Therefore, the document does not contain the detailed information required for direct answers to all your questions, specifically regarding specific acceptance criteria with numerical targets and the study data proving the device meets them in the format requested.
However, I can extract the information that is available and explain why some parts are not present based on the nature of the submission.
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) submission. A 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics, intended use, and safety/effectiveness profiles, rather than presenting a performance study against predefined numerical acceptance criteria.
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 provided. The submission does not detail a specific clinical "test set" or clinical study with patient samples. The basis of the submission is substantial equivalence to legally marketed predicate devices, meaning the focus is on comparing the device's design, materials, and intended use to existing devices.
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 provided. As there's no clinical test set described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Again, without a described clinical test set, adjudication methods are not applicable here.
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 provided. The BrainPro and BrainPro Access are physical medical devices (cannulas for brain biopsy), not AI-powered diagnostic tools. Therefore, an MRMC study related to AI assistance is not relevant or included in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The devices are physical instruments, not algorithms. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Since there's no clinical study described with a "test set" requiring ground truth for performance evaluation, this is not applicable. The devices are used to obtain tissue for pathology, which then serves as diagnostic ground truth in clinical practice, but this submission does not evaluate the device against such an outcome.
8. The sample size for the training set
This information is not provided. As the devices are not AI-driven, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not provided. Not applicable for physical medical devices.
Summary of Device and Evidence Presented:
The 510(k) submission for BrainPro and BrainPro Access relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The arguments revolve around:
- Device Description: The BrainPro biopsy cannula is a single-use device for navigational guided biopsy of brain tumors, made of stainless steel or titanium, using vacuum suction and a rotating inner cannula to cut tissue. The BrainPro Access is an optional anchoring and guidance instrument.
- Predicate Devices:
- Sterilization: The sterilization process (Sterigenics) is the same as that used for other Pajunk devices already cleared for market, suggesting established safety and efficacy in this regard.
- Technology Characteristics: Highlighted features include the special cutting construction for sufficient biopsy material and proven equipment compatibility with the BrainLab Image guided surgery system VectorVision Cranial (K020631).
- Conclusion of Submission: "The comparison between the predicate devices and the proposed devices in section 12 of this submission demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices."
In essence, the "study" proving the device meets "acceptance criteria" in a 510(k) context is the comparison to predicates, which implicitly means the device performs at least as safely and effectively as those already deemed acceptable by the FDA. The acceptance doesn't come from meeting specific numerical benchmarks in a clinical trial but from demonstrating similar characteristics and performance as devices already on the market.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).