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510(k) Data Aggregation
(91 days)
The Hemedex Cranial Bolt is designed to achieve cranial access and to introduce and secure one to four sensors in place for intracranial monitoring.
The QFlow 500™ Titanium Bolt Quad Lumen Kit is used to achieve cranial access and to introduce and secure up to four sensors in place for intracranial monitoring. The kit contains a cranial bolt, drill bit, scalpel, sensor introducer with stylet, Touhy Borst fittings and connectors. The cranial bolt contains four lumens with its primary materials being titanium, polyphenylsulfone, polyvinyl chloride and polycarbonate. The primary materials of the sensor introducer are polyether block amide and polycarbonate. The primary materials of the other components in the kit are stainless steel, titanium nitride, acrylonitrile butadiene styrene, polyphenylsulfone, polyvinyl chloride and polycarbonate.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This device is not an AI/ML powered device, The current response contains information derived from the provided document.
| Test | Acceptance Criteria (Predetermined Specification) | Reported Device Performance (Hemedex QFlow 500™ Titanium Bolt Kit, Quad Lumen) |
|---|---|---|
| Torque required to insert the cranial bolt | Not explicitly stated (implied to be easy) | 7 - 8 in-lbs maximum torque required. In comparative testing, required 38% to 64% less in-lbs of torque to fully insert compared to predicate/reference devices. |
| Axial tension required to pull the cranial bolt out | Greater than 40 lbf | Greater than 40 lbf. In comparative testing, the Hemedex Quad Lumen Bolt pull out force was greater than 40 lbf, whereas predicate and reference devices could not reach this threshold without incurring damage. |
| Torque required to tighten the Touhy Borst compression cap to seal the sensors | Less than 1 in-lb torque required | Less than 1 in-lb torque required. |
| Tension required to pull the sensors out of the Touhy Borst | Not explicitly stated (implied to be secure) | Approximately 1.3 lbf. |
| Leak testing | No leaking at 185 mm Hg pressure for 14 days | No leaking at 185 mm Hg pressure for 14 days. In comparative testing, the Hemedex Quad Lumen Bolts incurred less leaking at increasing intervals of insertion replicating different skull thicknesses at 185 mm Hg pressure. |
| Axial tensile strength of the "pig tails" | Not explicitly stated (implied to be strong) | 19 - 37 lbf depending on pigtail diameter. |
| Axial tensile strength of the introducer | Not explicitly stated (implied to be acceptable) | 3.7 - 4.4 lbf. |
| Axial tensile strength of the pigtail extension | Not explicitly stated (implied to be strong) | 16.6 - 20.6 lbf. |
| Drill bit dimensional and cutting functionality | Burr hole diameter 0.209" | Burr hole diameter 0.209". Easily cut through bone. Depth collars remained secure. In comparative testing, the Hemedex drill bit meets specification. Predicate (K002765) and reference device specifications are unknown for diameter. All tested drill bits easily cut through bone; depth collars remained secure. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing, which typically involves laboratory-controlled experiments rather than human or animal subjects. Therefore, the concept of "sample size used for the test set" in the context of human data or "data provenance" (country of origin, retrospective/prospective) as it relates to clinical data is not applicable here. The tests were performed on the device components themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this type of performance testing (mechanical and functional bench tests) is based on engineering specifications and physical measurements, not expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human adjudication of results; it's a series of physical and mechanical bench tests performed according to engineering protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a mechanical cranial bolt, not an AI/ML system that would involve human readers interpreting output.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI is not relevant. The performance tests described are standalone in the sense that they evaluate the device's physical properties and function without human interaction beyond operating the test equipment.
7. The Type of Ground Truth Used
The ground truth for the bench testing was based on:
- Predetermined Engineering Specifications: These are quantifiable targets for mechanical properties (e.g., torque, tension, leak rates, dimensions).
- Measurable Physical Properties: Direct measurements of the device's behavior under specific test conditions (e.g., actual torque required, actual pull-out force, actual leakage).
- Comparison to Predicate Devices: Performance was also evaluated relative to the performance of existing legally marketed predicate devices (K032337, K002765) and a reference device (K992591) to demonstrate substantial equivalence or improvement.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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