(29 days)
For control of vacuum flow in a gas scavenging apparatus, used as an accessory in Porter Instrument Company's Nitrous Oxide Sedation Systems with Dental Analgesia Gas Machines (flowmeters).
The intended use of the AVS accessory is to control the vacuum flow in a gas scavenging apparatus.
The intended use of the modified device, as described in our labeling, has not changed as a result of the modifications.
The automatic interlock switch (AVS) is a device intended to assure that analgesic gases cannot be turned on unless an activated scavenging system is present.
This 510(k) summary describes a traditional medical device (Automatic Vacuum Switch - AVS), not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device testing are not applicable. I will address the applicable criteria based on the provided document.
Acceptance Criteria and Device Performance Study for the Automatic Vacuum Switch (AVS)
This document describes the validation of the Automatic Vacuum Switch (AVS) for use as an accessory in Nitrous Oxide Sedation Systems with Dental Analgesia Gas Machines. The primary purpose of the AVS is to interlock with the analgesic gas supply, ensuring that these gases cannot be activated unless an activated scavenging system is present.
The study aimed to demonstrate the device's safety and effectiveness and its substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Assessment Method |
|---|---|---|
| Functional Performance | Device must ensure analgesic gases cannot be turned on unless an activated scavenging system is present. | Functional Test: All finished products undergo a functional test defined in Porter's manufacturing procedure, conforming to product design specifications, prior to release. |
| Control of vacuum flow in a gas scavenging apparatus. | Functional Test: Confirmed as per manufacturing procedures. Specific Testing: Included tests for delivery and vacuum flow. | |
| Safety | No new questions of safety raised compared to predicate devices. Device is as safe as legally marketed predicate devices. | Risk Assessment: Detailed risk assessment conducted, including Failure Mode Effects Analysis (FMEA) and Hazard Analysis. Specific Testing: Backpressure, internal and external leak testing, and complete system testing. Simulated Use Testing: Performed to confirm safe operation in use scenarios. |
| Effectiveness | Device is as effective as legally marketed predicate devices. | Functional Test: Confirmed as per manufacturing procedures. Specific Testing: Delivery and vacuum flow, complete system testing, and simulated use testing. |
| Visual Inspection | Device must meet visual inspection requirements. | Visual Inspection: Conducted both in-process and on finished products, as defined in Porter's inspection procedure and conforming to product design specifications. |
| Compliance | Adherence to Porter Instrument Company's Document & Data Control procedure (QSP 5-1) for all procedures and records, including approvals, releases, and revisions. | All procedures and records for this product are approved, released, distributed, and revised according to QSP 5-1. (Implies compliance was met as a quality system process). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size in terms of a number of devices or data points from an independent clinical study. The testing described appears to be primarily verification and validation (V&V) testing performed during the device development and manufacturing process on production units. This includes:
- Manufacturing Functional Tests: Applied to "All finished products." This implies 100% inspection during manufacturing.
- Design Validation Testing: Risk assessment, backpressure, delivery and vacuum flow, leak testing, system testing, and simulated use testing would have been performed on a representative sample during the design validation phase. The exact number of units or test iterations is not specified in this summary.
- Data Provenance: The data is generated internally by Porter Instrument Company, Inc. and is prospective in nature (i.e., created specifically for the device's validation and ongoing manufacturing quality control). No country of origin for a clinical dataset is applicable as a clinical study is not described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
N/A. This medical device is a mechanical accessory; its "ground truth" is based on its physical functionality and adherence to engineering specifications and safety standards rather than expert-labeled diagnostic data. Technical experts (engineers, quality assurance personnel) within Porter Instrument Co. Inc. would have defined and assessed these criteria.
4. Adjudication Method for the Test Set
N/A. Not applicable for a mechanical device undergoing V&V testing. Results would be pass/fail based on pre-defined specifications, not expert adjudication of subjective outcomes.
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/ML device, and no MRMC study or human reader improvement analysis was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a traditional mechanical device; there is no "algorithm only" performance to evaluate. The device functions as intended when installed and operated correctly.
7. The type of ground truth used
The "ground truth" for the AVS is based on engineering specifications and functional requirements. This includes:
- Design Specifications: Detailed parameters for backpressure, flow rates, leak tolerances, and activation logic.
- Safety Standards: Compliance with relevant medical device safety standards and risk assessment outcomes (FMEA, Hazard Analysis).
- Intended Use Definition: The device successfully performs its specific function as an interlock for gas scavenging systems.
8. The Sample Size for the Training Set
N/A. This is not an AI/ML device; therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
N/A. Not applicable for a non-AI/ML device.
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).