Search Results
Found 1 results
510(k) Data Aggregation
(298 days)
The Branchpoint AURA™ ICP Monitoring System is intended for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in intraparenchymal applications.
The Branchpoint AURA™ ICP Monitoring System is a device intended for monitoring intracranial pressure (ICP). The Branchpoint AURA™ ICP Monitoring System is composed of the following three packages:
Package 1) AURA™ Sensor Tray (Model SP101-A)
- AURA™ Sensor (Model 10025G)
- Disposable Scalp Retractor (Model OS0001B)
- Disposable Drill Bit with Collar (Model 10008C)
- Disposable Torque Wrench (Model OS0004C)
- Disposable Antenna Holster (Model 10007A)
Package 2) AURA™ Monitor Pack (Model TK101-A) - AURA™ Monitor (Model T0011B)
- AURA™ Antenna (Model T0010A)
- 2x Lithium-Ion 11v Rechargeable Batteries (Model T0032A)
- Two-bay battery charger (Model T0014A)
Package 3) AURA™ Data Receiver Pack (Model DG101-A) - AURA™ Data Receiver (Model D0004B)
Here's a breakdown of the acceptance criteria and the study information for the AURA™ ICP Monitoring System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provides a list of non-clinical bench tests performed to support substantial equivalence and demonstrate device performance. For the direct ICP measurement, the relevant standard is ANSI/AAMI NS28:1988(r)2010. While specific numerical acceptance criteria and precise reported device performance values for ICP measurement itself are not detailed in the provided text beyond meeting the standard, the document states:
| Acceptance Criterion (Test Name) | Reported Device Performance |
|---|---|
| ICP Monitor performance testing (ANSI/AAMI NS28:1988(r)2010) | Meets pre-defined acceptance criteria (implied compliance with standard) |
| Pressure measurement resolution testing | Meets pre-defined acceptance criteria (implied satisfactory resolution) |
| Barometric pressure compensation testing | Meets pre-defined acceptance criteria (implied satisfactory compensation) |
| System response time testing | Meets pre-defined acceptance criteria (implied satisfactory response time) |
For Biocompatibility, specific results are provided:
| Test (ISO 10993 Series) | Acceptance Criterion (implicitly, "non-cytotoxic," "non-sensitizer," etc.) | Reported Device Performance |
|---|---|---|
| MEM Elution (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic: score of 0. |
| Sensitization Maximization Extract (ISO 10993-10) | Non-sensitizer | Non-sensitizer: No irritation was found on any of the negative control or test animals. |
| Intracutaneous Reactivity (ISO 10993-10) | Non-Irritant | Non-Irritant: The test device score for both extracts was 0. |
| Acute Systemic Injection (ISO 10993-11) | No systemic toxicity | No systemic toxicity: No test or control animals exhibited signs of toxicity. |
| Subacute and Subchronic Toxicity (IV) (ISO 10993-11) | No systemic toxicity | No systemic toxicity: No systemic toxic effects were observed. |
| Subacute and Subchronic Toxicity (IP) (ISO 10993-11) | No systemic toxicity | No systemic toxicity: No systemic toxic effects were observed. |
| Genotoxicity - Ames (ISO 10993-3) | Non-mutagenic | Non-mutagenic: The test article did not cause an increase in revertant colonies for any strain greater than two-fold over negative control values. |
| Genotoxicity - Mutagenicity (ISO 10993-3) | Non-clastogenic & non-genotoxic | Non-clastogenic & non-genotoxic: No statistical significant differences (p ≥ 0.05) were noted between the test and control extracts. |
| Genotoxicity - Mouse Lymphoma (ISO 10993-3) | Non-mutagenic & non-clastogenic | Non-mutagenic & non-clastogenic: RTG was > 10%. |
| Subcutaneous Implantation (ISO 10993-6) | Acceptable tissue reaction | Macroscopic reaction not significant compared to control; microscopically, slight irritant. |
| Brain Tissue Implantation (ISO 10993-6) | Acceptable tissue reaction | Neurobehavioral, gross pathological, clinical reactions not significant; histologically, minimal or no reaction. |
| Mediated Material Pyrogenicity (ISO 10993-11) | Non pyrogenic | Non pyrogenic: Temperature increase was < 0.5 °C for all animals. |
| Indirect (extract) Hemolysis (ISO 10993-4, ASTM F756-17) | Non hemolytic | Non hemolytic: Test article hemolytic index was 0.00%. |
| For Disposable Antenna Holster (Adhesive layer): | ||
| MEM Extraction Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic: score of 0. |
| Skin Irritation (ISO 10993-10) | No irritation | No irritation: irritation index was 0. |
| Closed Patch Sensitization (ISO 10993-10) | No sensitization | No sensitization: no contact sensitization observed. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only discusses "non-clinical bench tests" and "biocompatibility testing." It does not describe any clinical studies involving human patient data, nor does it mention machine learning algorithms that would typically involve test sets of data from a specific country or collected retrospectively/prospectively. The testing described is primarily focused on hardware and material performance, as well as adherence to recognized standards. Therefore, information about test set sample size or data provenance in the context of AI/ML is not available in this document.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This document describes a medical device clearance based on substantial equivalence through non-clinical bench testing and biocompatibility. It does not involve diagnostic image analysis or other applications where expert ground truth establishment for a test set would be relevant.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring expert adjudication is described in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention any MRMC study. The device is an ICP monitoring system, not a diagnostic imaging AI tool that would typically be evaluated with MRMC studies comparing human reader performance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The AURA™ ICP Monitoring System is a hardware device for direct physiological measurement, not an algorithm being deployed in a standalone capacity without human interaction for interpretation or diagnosis.
7. Type of Ground Truth Used
The "ground truth" for the tests described is the established scientific and engineering principles, and the specific pass/fail criteria outlined in the referenced national and international standards (e.g., ANSI/AAMI NS28 for ICP performance, ISO 10993 series for biocompatibility). For example, a score of 0 for cytotoxicity or a temperature increase < 0.5 °C for pyrogenicity constitutes the ground truth for those specific tests.
8. Sample Size for the Training Set
Not applicable. This document describes the clearance of a hardware medical device based on non-clinical testing and substantial equivalence, not an AI/ML algorithm that would typically involve a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is described in the provided document.
Ask a specific question about this device
Page 1 of 1