(245 days)
Phasor EVAC™ is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The EVAC system is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.
Phasor EVAC™ subdural evacuation system is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the EVAC system components are designed to promote gradual brain re-expansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir.
This 510(k) clearance letter for the EVAC device (K243205) indicates that it is a central nervous system fluid shunt and components and it's regulated under 21 CFR 882.5550. While the letter confirms the device's substantial equivalence to predicate devices and states that various tests were conducted, it does not provide detailed information about specific acceptance criteria, study methodologies (like sample size, ground truth establishment, expert qualifications, or MRMC studies), or actual performance data in the format requested.
The document primarily focuses on explaining why the device is considered substantially equivalent to existing devices based on its intended use, indications for use, and technological characteristics. It mentions that "Various tests including for biocompatibility, packaging, sterility, safety, and performance were conducted and passed successfully," and that "testing for a closed system with firm purchase into bone was established and verified by testing." However, it does not disclose the specific data or criteria for these tests. It explicitly states, "No clinical testing was needed or performed otherwise."
Therefore, based on the provided FDA 510(k) clearance letter, I cannot populate the detailed table and answer all the specific questions about acceptance criteria and study proving device performance as requested, because this information is typically contained in the actual 510(k) submission, not the clearance letter itself. The clearance letter summarizes the FDA's decision, but not the detailed technical data from the submission.
Here's what can be inferred or explicitly stated from the provided document, with notes where information is not present:
Acceptance Criteria and Device Performance (Based on Inferred Safety and Effectiveness)
The acceptance criteria for a 510(k) cleared device are implicitly that it demonstrates substantial equivalence to a predicate device, meaning it is as safe and effective while having the same intended use. For this device, the "performance" described is its ability to meet the design intent and demonstrate equivalence through bench testing, rather than clinical efficacy.
Table 1: Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from 510(k) Basis) | Reported Device Performance (from document) |
|---|---|
| Biocompatibility | "Various tests including for biocompatibility... were conducted and passed successfully." (Specific criteria and results not provided) |
| Packaging Integrity | "Various tests including for... packaging... were conducted and passed successfully." (Specific criteria and results not provided) |
| Sterility | "Various tests including for... sterility... were conducted and passed successfully." (Specific criteria and results not provided) |
| Safety | "Various tests including for... safety... were conducted and passed successfully." (Specific criteria and results not provided) |
| Performance (Functional Equivalence) | "Various tests including for... performance were conducted and passed successfully." |
| "Specifically, testing for a closed system with firm purchase into bone was established and verified by testing." | |
| "The performance and design validation testing conducted on the EVAC™ device on the bench demonstrated that it performs equivalent to the stated predicates..." (Specific criteria and results not provided) | |
| Manufacturing Quality Systems | Compliance with Quality System (QS) regulation (21 CFR Part 820) and other general controls is required for marketing. (No specific test results provided in letter) |
Study Details (Based on Available Information)
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Sample size used for the test set and the data provenance:
- The document states "No clinical testing was needed or performed otherwise." This indicates that the "test set" for demonstrating substantial equivalence was primarily based on bench testing and engineering evaluations of the device components and system.
- Specific sample sizes for these bench tests are not provided in the clearance letter.
- Data provenance (country of origin, retrospective/prospective): Not applicable or specified for bench testing.
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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):
- Given that "No clinical testing was needed or performed," there's no mention of expert panels establishing ground truth in a clinical context. The "ground truth" for the engineering tests would be derived from accepted engineering standards and specifications.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical study or human reader evaluation requiring adjudication was performed.
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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 comparative effectiveness study was not done. The device is a surgical system (shunt and components), not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is more pertinent to software/AI devices. The EVAC system is a mechanical device. Its "performance" refers to its physical functioning (e.g., maintaining a closed system, firm purchase into bone), not an algorithmic output. The "Phasor Drill" component is explicitly stated to have been previously cleared (K161704), indicating its standalone performance was established previously.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" for its functional performance was based on engineering specifications, material science standards, and mechanical testing requirements (e.g., ability to form a "closed system with firm purchase into bone"). There's no mention of clinical ground truth (like pathology or outcomes data) because no clinical study was performed.
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The sample size for the training set:
- Not applicable. This is a hardware device, not an AI/machine learning algorithm requiring a "training set."
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).