(110 days)
The Indications for Use of the Valleylab OptiMumm™ Smoke Evacuator system are for the removal of smoke and incidental fluids produced during electrosurgery and/or laser surgery. The removal of smoke from the surgical site improves visibility and reduces potential health hazards associated with surgical smoke.
The Valleylab OptiMumm™ Smoke Evacuator system includes the OptiMumm™ smoke evacuator unit, footswitch, fluid canister ring, fluid canister kit, tubing sets, filters, adapters, remote activation unit (RapidVac™ Electrosurgery Sensor), and smoke evacuator wand. A centrifugal fan provides suction, drawing the smoke into and through the system and filters. The smoke evacuator unit is designed to provide an airflow (suction) of 2.70 cfm minimum to 20.0 cfm maximum with the 7/8" tubing set. The dimensions of the evacuator are 17"D x 13-3/8"W x 9"H (without feet) and it weighs approximately 34 lbs. (without filters).
The smoke evacuator is to be used with a variety of accessories including a wand, tubing, adapters, filters, and fluid canister. These accessories will be offered both sterile and non-sterile and will be sold under separate catalog numbers.
All of the controls for the smoke evacuator unit are located on the front panel. These are:
- Mode Selector A dial control for the unit operation with four mode settings: .
Standby - powers up the unit without activating the motor or vacuum flow.
Footswitch - used to turn the smoke evacuator on or off with the optional footswitch.
Remote Flow Control (RapidVac) - used to control the vacuum flow simultaneously with activation of a Valleylab electrosurgical pencil. The mode is controlled with the optional generator Interlink or electrosurgery sensor.
Continuous - used to operate the evacuator using continuous air flow. - . Variable Speed Selector - This dial controls five variable speed settings. The user set speed setting is indicated by LED's.
- Pressure Sensor Test and Status Light Indicator A button is pressure drop across . an ULPA filter. The filter status is indicated by two LED's: green (good filter), red (replace filter), and , flashing red (filter not installed).
- RapidVac Connect Accepts the cord for the remote flow control via the current monitor. ●
- Footswitch Connect Accepts one pneumatic footswitch. .
The rear panel of the smoke evacuator incorporates the AC line receptacle, which fits a detachable line cord and contains a locking mechanism, the Rapid Vac connect which accepts the cord for remote flow control by way of the ECG blanking output of certain Valleylab generators, and, a circuit breaker. A handle is also included on the rear of the unit for carrying purposes
The OptiMumm™ Smoke Evacuator system requires the use of two filters; an ULPA filter and a disposable prefilter. The ULPA filter is a two stage filter the first stage of which is a charcoal media and the second stage, the ULPA filter. The ULPA is 99.999% efficient at 0.12 microns and will have an estimated useful life of approximately 25 hours. It is designed to trap microscopic particles and absorb odors generated by electrosurgical procedures. The disposable prefilter is a single use 0.3 micron filter and is designed to trap gross particulate matter. Its useful life is approximately 30 minutes of continuous use with heavy smoke.
Surgical smoke is collected at the surgical site by tubing or a wand which is attached by tubing to the smoke evacuator unit. It can also be collected by the Valleylab Accuvac smoke attachment which clips to the Valleylab electrosurgical pencil. Activation of the smoke evacuator unit can be controlled through a footswitch, or the unit can be placed in a continuous flow mode, or it can be activated via the remote sensor, the Valleylab Rapid Vac.
The remote flow control unit, RapidVac, allows flow control of the smoke evacuator unit on activation of the electrosurgical pencil (active). The unit is basically a current sensor through which the cord of the electrosurgical pencil is inserted. When the pencil is keyed (activated), the sensor detects current flow through the pencil cord and activates the smoke evacuator so that the operating speed increases to the speed pre-selected by the user. When the pencil is deactivated, the smoke evacuator reduces flow to a low flow purging setting.
The Valleylab OptiMumm™ Smoke Evacuator system, as described in the provided text, does not detail acceptance criteria and a study proving device performance in the manner typically expected for diagnostic AI/ML models (e.g., sensitivity, specificity, AUC, human-AI comparative studies). Instead, the document focuses on safety and performance data related to engineering specifications, regulatory compliance, and biological safety for a physical medical device (a smoke evacuator).
Here's an analysis based on the information provided, framed to address your requested points where applicable, and noting where information is absent for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Engineering Specifications | Airflow (suction) range for 7/8" tubing set | 2.70 cfm minimum to 20.0 cfm maximum |
| Physical Dimensions | Dimensions and Weight | 17"D x 13-3/8"W x 9"H (without feet), approx. 34 lbs. (without filters) |
| Filter Efficiency | ULPA filter efficiency | 99.999% efficient at 0.12 microns |
| Filter Lifespan | ULPA filter estimated useful life | Approximately 25 hours |
| Filter Lifespan | Disposable prefilter useful life (with heavy smoke) | Approximately 30 minutes of continuous use |
| Standards Conformance | UL2601 Medical Electrical Equipment, Part 1: General requirements for Safety | Conforms to standards |
| Standards Conformance | EN55011 - Specification for Limits/methods of measurement of radio disturbance characteristics of industrial, scientific and medical radio frequency Equipment | Conforms to standards |
| Biocompatibility | Tubing sets, adapters, wands materials tested to USP Class III minimum and ISO Standard 10993-1, Part 1 (where applicable) | Assured through selection of materials demonstrating appropriate levels of biocompatibility. |
| Functionality | Activation modes (Standby, Footswitch, Remote Flow Control, Continuous) | Unit designed with these modes |
| Functionality | Variable speed control (5 settings) | Unit designed with this control |
| Functionality | Filter status indication (Green: good, Red: replace, Flashing Red: not installed) | Unit designed with this indicator |
| Functionality | Remote sensing activation (RapidVac) | Unit designed with this capability |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of this device's evaluation. The evaluation described is for a physical medical device, not a diagnostic AI/ML model requiring a test set of data samples (e.g., images, patient records). The testing refers to bench testing and validation/verification of the device's physical and electrical properties, and material biocompatibility.
- Data Provenance: Not applicable. The "data" here are engineering measurements, material test results, and compliance checks, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the AI/ML context, refers to expert-annotated labels for data. For this smoke evacuator, the "ground truth" is based on established engineering principles, regulatory standards (UL, EN, ISO, USP), and documented material properties. The experts involved would be engineers, materials scientists, and regulatory compliance officers, but their roles are not defined as "establishing ground truth for a test set" in the AI/ML sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used to resolve discrepancies in expert labeling of data for AI/ML models. This is a physical device evaluation.
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
- No. An MRMC study is relevant for evaluating the impact of AI assistance on human performance (e.g., diagnostic accuracy). This document describes a physical device, not an AI diagnostic tool, so such a study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm. The device performance (e.g., airflow, filter efficiency) is a standalone measurement of the device's physical capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance relies on established engineering specifications, adherence to recognized industry standards (UL, EN, ISO, USP), and validated bench testing results. For example, filter efficiency is a quantifiable physical property, not subject to expert consensus in the diagnostic sense. Biocompatibility relies on material testing protocols vs. established biological safety criteria.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model is involved.
Summary of the Study Proving the Device Meets Acceptance Criteria:
The document states that the safety and performance of the Valleylab OptiMumm™ Smoke Evacuator and its accessories have been "evaluated and verified through validation/verification and bench testing."
Specifically, the study proving the device meets its "acceptance criteria" (which are primarily engineering specifications and regulatory compliance) consists of:
- Bench Testing: This involved directly measuring the device's physical properties, such as airflow (reported as 2.70 cfm minimum to 20.0 cfm maximum for the 7/8" tubing set) and verifying the functionality of controls and indicators.
- Conformance to Standards: Testing was conducted to ensure compliance with specific electrical and electromagnetic standards (UL2601, EN55011). The document explicitly states, "Product testing showed conformance to design specifications and also to the above standards."
- Biocompatibility Testing: Materials used for components like tubing sets, adapters, and wands were tested according to USP Class III minimum and ISO Standard 10993-1, Part 1. This ensures that the device's components are safe for biological interaction.
- Filter Efficiency and Lifespan Evaluation: The characteristics of the ULPA filter (99.999% efficient at 0.12 microns, ~25 hours lifespan) and prefilter (~30 minutes lifespan) were determined, presumably through laboratory testing under specified conditions.
The overall "study" demonstrating the device meets its criteria is a comprehensive set of engineering tests, material evaluations, and regulatory compliance checks, as opposed to a clinical study with patient data or an AI/ML model evaluation.
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.