(239 days)
QuickMix is indicated for use in mixing BoneSource® Hydroxyapatite Cement and sodium phosphate solution. BoneSource is indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25 cm2 per defect, and for augmentation or restoration of bony contours in the craniofacial skeleton including the frontoorbital maler and mental areas.
The DRG QuickMix mixing system consists of a syringe containing a 0.25 M sodium phosphate solution and a mixing syringes containing BoneSource® Hydroxyapatite Cement. The mixing syringe also contains a filter which allows liquid, but not the cement mixture, to pass through it. The sodium phosphate and cement mixing syringes are first connected tip to tip. The sodium phosphate solution is then injected into the mixing syringes and the cement mixture is shaken to thoroughly blend it. Excess liquid is then pulled from the mixing chamber through the filter assembly by retracting the solution plunger. The two syringes are then disconnected. The filter cap is then removed from the mixing syringe and the mixture is eiected.
The provided text describes a 510(k) premarket notification for the DRG QuickMix Mixing System for BoneSource® Hydroxyapatite Cement (HAC). This document is focused on establishing substantial equivalence to a predicate device, rather than a clinical study proving the device meets specific acceptance criteria through measured performance.
Therefore, many of the requested sections about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The 510(k) summary primarily demonstrates that the new device is as safe and effective as a legally marketed predicate device.
Here's an breakdown of what can be extracted or inferred from the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting specific performance metrics against pre-defined acceptance criteria for the QuickMix system itself. The predicate device, BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit, would have had performance data, but that is not detailed here for the QuickMix mixing system.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the 510(k) summary. A 510(k) submission for a mixing system typically relies on demonstrating that the mixing process yields a material that meets the specifications of the cement itself, which would have been established for the predicate device. It doesn't detail a separate "test set" in the context of clinical trials or algorithm performance.
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 applicable/not present. The 510(k) summary for a mixing system does not involve establishing ground truth from expert consensus in the way a diagnostic AI device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not present. As above, the nature of this submission does not involve adjudication methods related to expert consensus on clinical data.
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 applicable/not present. The device (a cement mixing system) is not an AI-powered diagnostic tool, and therefore MRMC studies or AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not present. The device is a physical mixing system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not present in the context of the QuickMix system itself. The system is a tool for preparing a medical material (BoneSource HAC). The performance validation would typically involve chemical and physical property testing of the mixed cement to ensure it meets specifications, rather than clinical ground truth as described.
8. The sample size for the training set
This information is not applicable/not present. The device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not present. As above, the device is a physical mixing system, not an AI algorithm.
Summary of what is present and its relevance:
- Acceptance Criteria & Performance: The document implicitly aims to demonstrate that the QuickMix Mixing System, when used with BoneSource HAC, produces a cement that is substantially equivalent in its properties and intended use to the predicate device (BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit distributed by Stryker Leibinger K991398). The performance would be related to the consistency and quality of the mixed cement, but specific metrics and acceptance criteria for this mixing system are not detailed in this summary. The "study" proving this would be a series of tests verifying the mixed cement's properties (e.g., setting time, strength, handling characteristics) match those of the predicate.
- Sample Sizes: Not relevant or provided for this type of submission.
- Experts/Ground Truth: Not relevant for this type of submission focused on a physical mixing device.
- Study Type: This is a 510(k) Premarket Notification document. The "study" isn't a traditional clinical trial as described in the prompt. It's a regulatory submission demonstrating substantial equivalence to a predicate device. This means showing that the QuickMix system does not raise different questions of safety and effectiveness than the previously cleared Stryker Leibinger system (K991398). This substantial equivalence is typically supported by bench testing, material characterization, and comparison of design and intended use, rather than large-scale human clinical trials or expert evaluation of outputs in the way a diagnostic device would.
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).