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510(k) Data Aggregation
(277 days)
ScalpelCric
Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.
Surgical Cricothyrotomy set for securing the airway in case of upper airway obstruction, respectively as "Ultima Ratio" if all other attempts to ventilate the patient failed. The set consists of scalpel, bougie, tube, extension tube with swivel connector, syringe and necktape.
The provided text is a 510(k) Premarket Notification for the ScalpelCric device, a cricothyrotomy set. It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.
However, this document does not contain information about a study that assesses the device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop system, or a multi-reader multi-case (MRMC) study. The document focuses on the physical and biological characteristics of the medical device itself, its sterilization, biocompatibility, and bench testing, rather than a performance study involving diagnostic accuracy, expert review, or AI assistance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them in the context of an AI-assisted diagnostic system, as that information is not present in the provided text.
The closest information related to "acceptance criteria" is under section 9.4 Bench Testing, which lists features to be tested and the result (all "Passed"). This refers to the physical and functional performance of the device components, not a diagnostic or AI-related performance.
Here's what I can extract from the provided text regarding device testing, but it's important to note this is not a study proving AI performance as requested:
1. A table of acceptance criteria and the reported device performance:
The document provides a table under "9.4 Bench Testing" (page 10), which lists various tests performed on the components of the ScalpelCric set. The "Features to be tested" can be considered the acceptance criteria for those specific physical/functional aspects, and the "Result" indicates "Passed" for all.
| Object under Test | Features to be tested (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Bonding Connector | Bonding between connector and tube | Passed |
| Bonding Inflation Line | Bonding between inflation line and tube | Passed |
| 15mm Connector | Dimensions of 15mm Connector | Passed |
| Luer Pilot Balloon | Dimensions of the female luer connector in the pilot balloon | Passed |
| Cuff | Function of the Cuff | Passed |
| Scalpel | Function and design of the scalpel | Passed |
| Bougie | Bougie which shall fulfill all relevant specification according [DI] and [MS_Bougie]. | Passed |
| Tube | Function and dimensions of the tube | Passed |
| Tube | Tube is recognizable in X-Ray images | Passed |
| Extension Tube | Function and dimension of the extension tube | Passed |
| Neck Tape | Neck tape which shall fulfill all relevant specification according [DI] and [MS_NT] after 4 times sterilization | Passed |
| Syringe | Function of the syringe | Passed |
| Tube with inflation line and cuff, | Function and features of the tube with attached inflation line and pilot balloon and with cuff | Passed |
| ScalpelCric | Biological compatibility | Passed |
| Material | Function and ingredient of the ScalpelCric materials | Passed |
| Tube and extension Tube | Oxygen resistance of Tube and Extension tube | Passed |
| Label | Device Label | Passed |
| Bougie | Device Label Bougie | Passed |
| IFU | IFU which shall contain all relevant information regarding [DI] and [ER]. | Passed |
| ScalpelCric | ScalpelCric Set can be used in Operating condition | Passed |
| ScalpelCric | Functionality after simulated transport | Passed |
| Transport Validation | Functionality after simulated transport | Passed |
| Safety | Verify implementation and effectiveness of all Risk Control Measures defined in the Risk Analysis | Passed |
| Suction Cap | Connecting tube with open suction cap during ventilation | Passed |
| User Needs | User Needs for ScalpelCric, defined in [SoP] | Passed |
| ScalpelCric | Usability | Passed |
| Headerbag | Requirements of DIN EN ISO 11607-1 and DIN EN ISO 11607-2. | Passed |
| Sterilization | Sterilization Requirements for ScalpelCric | Passed |
| Business Needs | Business Needs for ScalpelCric | Passed |
| Label Sterile Packaging | Sterile packaging label which shall contain all relevant information regarding the [SFL], [DI] and [ER]. | Passed |
| Label Outer Packaging | Outer packaging label which shall contain all relevant information regarding the [SFL], [DL] and [ER] | Passed |
| Packaging | Packaging Requirements for ScalpelCric | Passed |
| Accelerated Aging Syringe | Quality of the syringe after 5 years accelerated aging | Passed |
| Accelerated aging of Pouch | Function of the sterile packaging after 5 years accelerated aging | Passed |
| Bougie | Bougie shall fulfill all relevant specifications after 1 year accelerated aging | Passed |
| Scalpel | Function of the scalpel after accelerated aging 1 year | Passed |
| ScalpelCric | Scalpel Cric Set application oxygen resistance after 1 year accelerated aging | Passed |
| Surgicric | Function and dimension after 5 years accelerated aging of the Surgicric and the function of the sterile packaging. | Passed |
| Surgicric | are identical to the devices in ScalpelCric. | Passed |
| Surgicric | Function and dimension after 3 years real time aging of the Surgicric including Tubus and the function of the sterile packaging. The tested tube and sterile packaging are identical to the devices in ScalpelCric. | Passed |
| Syringe | Quality of the syringe after 3 years real time aging | Passed |
| Bougie | Bougie shall fulfill all relevant specifications after 5 years accelerated aging | Passed |
| Scalpel | Function of the scalpel after 5 years accelerated aging | Passed |
| ScalpelCric Set | Application oxygen resistance after 5 years accelerated aging | Passed |
| Cuff Tube Collapse included in the ScalpelCric after 5 years of accelerated aging. | Test required by DIN EN ISO 5361:2013-03, Annex C: Resistance of the VBM tracheal tube ventilation lumen collapse with cuff inflated inside a cylinder. | Passed |
The remaining requested information (sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set details) is NOT available in the provided document, as it pertains to a different type of device evaluation (e.g., AI/diagnostic performance) than what is described here. This document is focused on the substantial equivalence of a physical medical device (a cricothyrotomy set) to a predicate device.
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