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510(k) Data Aggregation
(130 days)
When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.
The ConchaSmart Column is an accessory to the Neptune Heated Humidifier (K063758 and K131912). It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the Neptune Heated Humidifier.
The provided document is a 510(k) summary for the ConchaSmart Column, a respiratory gas humidifier. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.
Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are largely not applicable to this type of regulatory submission. This document describes a medical device, but not an AI-powered one that would typically undergo the kind of performance evaluation requested.
However, I can extract the information that is present and indicate where the requested information is not applicable (N/A) or not provided in this document.
1. A table of acceptance criteria and the reported device performance
The document presents a comparison to a predicate device based on technological characteristics and performance specifications rather than explicit acceptance criteria and a study proving device performance against those criteria in the way an AI device would be evaluated. The "reported device performance" in this context refers to its specifications alongside those of the predicate.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (ConchaSmart Column) |
|---|---|---|
| Intended Use | Same as predicate (Fisher & Paykel MR290) | When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, provides heated humidification for patients with and without an artificial airway in place. |
| Patient Population | Neonatal, Infant, Pediatric, Adult | Neonatal, Infant, Pediatric, Adult |
| Humidification Therapies | Invasive, Non-Invasive, High Flow Nasal Cannula Therapy | Invasive, Non-Invasive, High Flow Nasal Cannula Therapy |
| Humidity Output | ISO 8185:2007 | ISO 8185:2007 |
| - Subglottic mode | ≥33mg H2O /L | ≥33mg H2O /L |
| - Supraglottic mode | ≥10mg H2O /L | ≥10mg H2O /L |
| Enthalpy Limit | < 194 kJ/kg dry gas | < 194 kJ/kg dry gas |
| Leakage | < 100 ml/min | ≤ 29 ml/min |
| Compressible Volume | 280 ml | 190 ml |
| Compliance | 0.4ml/cmH2O | 0.25ml/cmH2O |
| Connectors | ISO 5356-1:2004 compliant 22 mm connectors | ISO 5356-1:2004 compliant 22 mm connectors |
| Sterilization | Non-Sterile | Non-Sterile |
| Shelf Life | No Shelf Life (implied) | 3 year |
| Materials | Cleared as having met ISO 10993 and G-95-1 requirements | Cleared as having met ISO 10993 and G-95-1 requirements |
Study Proving Device Meets Acceptance Criteria:
The document states: "The data presented demonstrate that the device is as safe and as effective as the predicate device and therefore substantially equivalent." The comparison table and the statement "The primary differences relate to performance specifications in which the ConchaSmart Column contains less dead space, less compliance, and more stringent leak specifications" implicitly serve as the proof of meeting comparable or improved "acceptance criteria" by comparing it to an already approved device. For the ConchaSmart Column, the leakage, compressible volume, and compliance values are improvements over the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A. This is a 510(k) submission for a non-AI physical medical device. The "test set" concept as it applies to AI/algorithm evaluation is not present. The document refers to "Performance Data" but explicitly states "The change in sterility does not impact the performance characteristic of the device; therefore, no performance testing was required." This implies that the performance data for the mechanical characteristics are likely based on design specifications and engineering evaluations, not a clinical trial or a test set as understood in AI.
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)
N/A. No test set requiring expert ground truth was mentioned for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. No test set requiring adjudication was mentioned.
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
N/A. This is not an AI device, so no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. The "ground truth" for this physical device's performance relies on engineering specifications, adherence to ISO standards (e.g., ISO 8185:2007 for humidity output, ISO 5356-1:2004 for connectors), and biocompatibility testing (ISO 10993, G-95-1).
8. The sample size for the training set
N/A. This is not an AI device, so there is no training set.
9. How the ground truth for the training set was established
N/A. This is not an AI device, so there is no training set or ground truth in that context.
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