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510(k) Data Aggregation
(267 days)
V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.
V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.
V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.
V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.
V80 Anesthetic Vaporizer is used to provide desflurane vapour with controllable concentration.
The provided text is a 510(k) Summary for the Mindray V80 Anesthetic Vaporizer. It focuses on demonstrating substantial equivalence to a predicate device (D-Vapor Anesthetic Vaporizer) by comparing technical characteristics and performance data, mainly through bench testing and compliance with various standards.
Crucially, this document does not describe a study that uses a test set, ground truth established by experts, or measures human reader performance with or without AI assistance. The device in question is an anesthetic vaporizer, which is a piece of hardware, not an AI/software device that interprets medical images or diagnoses conditions. Therefore, many of the requested elements of your query (e.g., sample size for test set, number of experts, MRMC study, standalone performance for an algorithm, training set details) are not applicable to this type of medical device submission.
However, I can extract the relevant information from the document regarding its acceptance criteria and the type of studies conducted to prove it meets those criteria, specifically concerning its performance and other safety/effectiveness aspects.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table between the subject device (V80 Anesthetic Vaporizer) and the primary predicate device (D-Vapor Anesthetic Vaporizer), essentially demonstrating that the acceptance criteria for the subject device are met by matching or exceeding the performance and specifications of the predicate.
| Technical Characteristics (Acceptance Criteria Based on Predicate) | Subject device V80 Anesthetic Vaporizer (Reported Performance) | Primary predicate D-Vapor Anesthetic Vaporizer (Benchmark/Acceptance Target) |
|---|---|---|
| Performance | ||
| Concentration setting range | 2vol.% to 18 vol.% | 2vol.% to 18 vol.% |
| Calibrated setting concentration | ±0.5vol.% or ±15%rel, the larger value applies in each case | ±0.5vol.% or ±15%rel, the larger value applies in each case |
| Other setting concentration (0.2-2 L/min) | ±0.9Vol.% or ±30% rel, which is greater | ±0.9Vol.% or ±30% rel, which is greater |
| Other setting concentration (2-8 L/min) | ±0.9Vol.% or ±20% rel, which is greater | ±0.9Vol.% or ±20% rel, which is greater |
| Other setting concentration (8-15 L/min) | ±0.9Vol.% or ±30% rel, which is greater | ±0.9Vol.% or ±30% rel, which is greater |
| Flow range | 0.2 to 15L/min | 0.2 to 15L/min |
| Maximum tilt angle during working | 10° | 10° |
| Warm-up time at 22 °C | within 6 min | within 6 min |
| User Interface Indicators | ||
| Display Panel Indicators | Operational, No Output, Delivery Low, Fill Up, Battery | Operational, No Output, Delivery Low, Fill Up, Battery |
| Glass tube liquid level indicator | A sight glass on the front to visually indicate the level of agent | A sight glass on the front to visually indicate the level of agent |
| Audio Paused | 120s | 120s |
| Connection to anesthesia delivery system | Selectatec®-compatible plug-in connectors | Selectatec®-compatible plug-in connectors |
| Filling system | Saf-T-Fill™ | Saf-T-Fill™ |
| Filling volume | Total: 320 mL | Total: 300 mL |
| Anesthetic agent loss (24 hours in storage, 22°C) | ≤0.5mL | ≤0.5mL |
| Anesthetic agent loss (24 hours in work, 22°C) | ≤2.5mL | ≤2.5mL |
| Filling time for 240 mL Desflurane (22°C, not warmed up) | < 1 minute | < 1 minute |
| Filling time for 240 mL Desflurane (22°C, warmed up) | < 2 minutes | < 2 minutes |
| Internal Battery | ||
| Battery type | Li-ion (sealed) battery | Nickel/metal hydride (NiMH) |
| Bridging time when mains power supply absent (6 Vol.%, 4 L/min, fully charged) | 6 minutes | maximum of 5 minutes |
Note: The differences in battery type and bridging time are addressed by stating, "The differences in technological characteristics do not raise new questions of safety and effectiveness," implying these differences meet safety and effectiveness criteria.
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not applicable as this is a hardware device where performance is evaluated through bench testing and compliance with standards rather than a test set of data samples. The functional and system level testing was conducted on the "subject device" (V80 Anesthetic Vaporizer). The exact number of units or test cycles for the bench testing is not specified in the summary, but it implies a sufficient number to validate performance.
- Data Provenance: The testing was conducted by "Mindray" (Shenzhen Mindray Bio-Medical Electronics Co., LTD. which is based in China). The document does not specify if these were retrospective or prospective tests, but for bench testing of hardware, it would inherently be prospective (testing a new device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/imaging devices (e.g., expert radiologist annotations) is not relevant for an anesthetic vaporizer's performance which is measured by objective physical parameters (e.g., concentration output, flow rate, warm-up time). The "ground truth" for these tests are the established specifications and consensus standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert consensus or adjudication method for medical interpretations is involved. Performance is measured against predefined engineering specifications and international standards.
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
Not applicable. This is a hardware device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the context of an algorithm. However, the performance data presented is "standalone" in the sense that it measures the device's intrinsic performance characteristics (e.g., concentration delivery, flow rate) against engineering specifications, independent of human interaction other than setting up and operating the test itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance evaluation is based on:
- Engineering Specifications: The design specifications the device is intended to meet.
- Predicate Device Performance: The established performance characteristics of the legally marketed predicate device (K042276 – D-Vapor Anesthetic Vaporizer).
- Consensus Standards: Compliance with recognized international standards (e.g., ISO 80601-2-13, ISO 5360, IEC 60601 series, ISO 10993 series, ISO 18562 series) which define acceptable performance and safety limits for medical devices.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable.
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