(49 days)
Indications for use are identical for the predicate products cited, and also more than 20 others sold in the US market, i.e., to remove obstructing secretions, blood or vomits from a patient's airway, to keep air passages to lungs open to allow ventilation.
The 1999 device (LSU4000) is a new more modern, unique solid design witch added benefits of more user-friendly controls, a batery level indicator, and a built in AC adapter. LSU performance is virtually the same as for its predicate designs and configurations.
Components: The subject LSU consists of a high-speed piston pump powered directly by an electric motor, an internal 12 V sealed lead-acid rechargeable battery, an electronic circuit board with controls and signalling light-emitting diodes. All components are assembled into a custom plastic cabinet. The 12 V battery and 8,4 V motor make it possible to both operate and charge the unit from any 12 - 28 VDC, 4 Amp source. Charging may also take place utilizing the internal 110-230 VAC power adapter.
Here's an analysis of the provided text to fulfill your request, broken down by each point. It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed performance metrics. As such, some of your requested information (especially on MRMC studies, specific expert qualifications, and detailed ground truth generation for training data) will not be present.
Acceptance Criteria and Device Performance Study
The Laerdal Suction Unit (LSU4000) aims to be substantially equivalent to its predicate devices concerning construction, indications for use, operating characteristics, and performance. The document outlines key performance criteria based on industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Criterion | Acceptance Criteria (Industry Standard Protocols) | Reported Device Performance |
|---|---|---|
| Vacuum Levels | 300 - 500 millimeters of mercury (mmHg) | "LSU performance is virtually the same as for its predicate designs and configurations." The device offers settable levels of 80, 120, 200, 350, or 500+ mmHg. |
| Airflow | 20 – 30 litres per minute (LPM) | "LSU performance is virtually the same as for its predicate designs and configurations." |
| Continuous Operation from Internal Battery | Ability to function for twenty continuous minutes of operation | "LSU performance is virtually the same as for its predicate designs and configurations." |
| Safety and Effectiveness | Relevant tests to ensure safety and effectiveness (not explicitly quantified) | Tests performed "simultaneously" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a dataset for an AI/ML device. Instead, it refers to internal product testing against industry standards. Therefore:
- Sample Size for Test Set: Not applicable in the context of a dataset. Tests are performed on units of the device itself. The number of physical units tested is not specified.
- Data Provenance: Not applicable in the context of a dataset. The testing is described as internal validation against industry standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not an AI/ML device that relies on expert-labeled data for "ground truth" establishment in a dataset. The "ground truth" for performance is defined by established industry standards and specifications (e.g., ISO, IEC, ASTM, Federal Specifications).
4. Adjudication Method for the Test Set
Not applicable. There is no expert review or adjudication process described for the performance testing. The product's compliance is assessed against predefined numerical and functional standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This document describes a medical device (portable suction unit), not an AI/ML-based diagnostic or assistive technology that would typically undergo an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device. The "performance" is inherently standalone, as it refers to the device's functional capabilities (vacuum, airflow, battery life) independent of human assistance for its operation.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by industry standard protocols and performance criteria for medical suction equipment. These include:
- ISO 10079-1: Medical Suction Equipment - Part 1 Electrically powered suction...
- IEC 601-1: Medical Electrical Equipment – Part 1 Gen. requirements for safety
- General Services Administration KKK-A-1822C, Federal Specification for Ambulance, para. 3.12.4
- ASTM F-29 Standard F 960, Medical and Surgical Suction and Drainage Systems, paras 5.8.1 and 5.8.2
The device claims to meet these criteria, implying adherence to their specified requirements for vacuum, airflow, and battery operation time.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set" of data. The device's design is based on engineering principles and improvements over predicate devices, not machine learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set." The design and engineering process for this device would rely on established scientific principles, previous device designs, user feedback, and industrial standards.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.