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The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function intended to permit the safe removal of scalpel blades from most currently available scalpel handles and contain the blade immediately upon removal to eliminate the need for further handling prior to be disposed as medical waste while allowing the user to monitor its use to see when it is becoming full and will need changing. Scalpel handles compatible with the Qlicksmart BladeFlask PLUS include:

Swann Morton sizes 3. 4. 5. 6. 7. 8. and 9
Lawton size 4
Martin sizes 3, 4, and 7
Aesculap sizes 3. 4. 6. and 7
Sayco sizes 3, 4, and 5
Smic sizes 3 and 4
Nopa sizes 3 and 4
AB Stainless size 4
Lance sizes 3 and 4
Pro-Med sizes 3 and 4
Paragon sizes 3 and 4
Rocket size 5
Conqueror size 3
Feather sizes 3. 4. and 7
LRI sizes 3 and 4
Generic handle size 4
L-dent
Medesy size 5
Jakobi size 4
CS size 5
Helmut Zepf

Scalpel handles known to be incompatible with the Qlicksmart BladeFlask PLUS include:

Beaver type handles
Disposable handles

Device Description

The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function that is used under non-sterile conditions. The Qlicksmart BladeFlask PLUS removes scalpel blades from scalpel handles in a single-handed action and then immediately contains the used scalpel blade inside the Qlicksmart BladeFlask PLUS. The handle is intended to be used to dispose the entire container as hazardous waste when full (100 removed blades and shut-off system is activated) and the device is not intended to be reprocessed.

The Qlicksmart BladeFlask PLUS combines a hard plastic sharps container with an internal blade remover mechanism made of hard plastic and hardened steel parts.

It is approximately (13.5 cm) tall by (9.1 cm) wide by (12.3 cm) deep. It weighs less than 250gm per unit when empty. It is red in color. It is labelled as shown on the samples provided with this application.

AI/ML Overview

This document is a 510(k) Summary for the Qlicksmart BladeFlask PLUS, a medical device intended for safe scalpel blade removal and containment. The summary outlines the device's characteristics, intended use, and most importantly, the performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided information, structured to answer your questions regarding acceptance criteria and study proving device performance:

1. A table of acceptance criteria and the reported device performance

The document provides a detailed table within the "TECHNOLOGICAL CHARACTERISTICS COMPARISON OF WITH THE VI. PREDICATE DEVICE" section under "Performance Specifications." This table, along with the "Mechanical and Functional Tests" and "Transportation Tests" sections, outlines the acceptance criteria and corresponding results.

TEST METHOD or STANDARD	TEST PURPOSE	ACCEPTANCE CRITERIA	REPORTED DEVICE PERFORMANCE (RESULTS)
ISO 23907-1	Test Container Stability	The container shall not topple over when tested.	PASS
ISO 23907-1	Test Strength of Handle	The handle shall not break or detach during testing.	PASS
ISO 23907-1	Test Resistance to Penetration	The force needed to penetrate test specimens shall be minimum of 16N and an average of 18N or greater.	PASS
ISO 23907-1	Test Resistance to Damage and Leakage after Dropping	No evidence of leakage and no breach of the sharp's containment area.	PASS
ISO 23907-1	Test Resistance to Spillage by Toppling	No evidence that the performance or function of the container has been compromised, closure remains intact.	PASS
Qlicksmart In-house Testing	Test Blade Removal Performance	If one scalpel blade is not removed from a particular combination, that particular handle and blade combination will be not approved for being used with the BladeFlask PLUS and declared as incompatible.	The results show that all the different combinations of known handles and blades were removed in a safe and effective manner using only one hand. Except for Beaver and disposable handles (which were explicitly listed as incompatible).
Qlicksmart In-house Testing	Test Counting Accuracy	The counter should read to an accuracy of 100±5 scalpel blades to be inserted before the full sign appears.	PASS
Qlicksmart In-house Testing	Test Performance of Automatic shut-off mechanism activation	The counter should activate with an accuracy of 100± 5 scalpel blades to be inserted before the automatic shut-off mechanism is activated.	PASS
Qlicksmart In-house Testing	Test of Bracket Functional Performance	The force required to install or remove the container from the bracket must be more than the force in Newtons to insert or retrieve the scalpel handles into the container and less than 90 Newtons which will be a safety amount of force for the user to install or remove the container.	Force required to install and remove the container 75.30 Newtons (This value is within the acceptance range as it's > force to insert/retrieve scalpel handles [22.50N/23.75N] and < 90N).
Qlicksmart In-house Testing	Test of Scalpel Removal Functional Performance	The force required to insert or retrieve the scalpel handle into or from the container must be less than the force in Newtons to remove the container from the bracket.	Force required to insert the scalpel handle is 22.50 Newtons and to remove the scalpel handle is 23.75 Newtons (These values are less than 75.30N, which is the force to remove the container from the bracket).
Qlicksmart In-house Testing	Test of Scalpel Insertion Functional Performance	The device is not jammed, and the device is not become non-functional should the scalpel handle be inserted incorrectly.	PASS
The United Nations Recommendations on the Transport of Dangerous Goods 21st Edition 6.1.5.3	Test of Product Functional Performance (Drop Test)	No rupture is permitted in packaging which would be permit the spillage of loose explosive substances or articles from the outer packaging.	PASS
The United Nations Recommendations on the Transport of Dangerous Goods 21st Edition 6.1.5.3	Test of Product Functional Performance (Stacking Test)	No test sample may leak. No test sample may show any deterioration which could adversely affect transport safety or any distortion liable to reduce its strength or cause instability in stacks of packages.	PASS

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: The document does not explicitly state the specific sample number for each test (e.g., how many units were subjected to the drop test or how many blades were removed for the blade removal performance test). It mentions that the volume is sufficient to hold "100 of the largest scalpel blades tested," indicating a capacity, but not a test sample size.
Data Provenance: The tests were conducted by Falcon Test Engineers, which is "a NATA (National Association of Testing Authorities) approved laboratory." This suggests the testing was likely done in Australia, where Qlicksmart Pty Ltd is based (Brisbane, Queensland, Australia). The data appears to be prospective as it's performance testing for a new device to support a 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of device (a sharps container/blade remover) relies on mechanical and functional performance testing, not expert interpretation of medical images or patient outcomes. Therefore, the concept of "experts establishing ground truth for a test set" as it applies to, for example, a diagnostic AI device, is not applicable here. The ground truth is defined by the physical/mechanical specifications and performance standards (e.g., ISO 23907-1, AS 4031-1992, and in-house protocols). The "experts" would be the engineers and technicians at Falcon Test Engineers who conducted the tests according to these established standards. Their qualifications are implied by the NATA accreditation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests are objective, quantifiable mechanical and functional evaluations.

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 device is a physical medical instrument, not an AI or diagnostic tool that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable, as this is not an algorithm or AI device. The "standalone" performance here refers to the device's functional integrity as a physical product meeting its specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device's performance is based on:

Established mechanical and safety standards:
- AS 4031-1992 "Non-reusable containers for the collection of sharp medical items used in health care areas" (for impact resistance, integrity of closure and leakage, handle integrity, toppling resistance, resistance to penetration).
- ISO 23907-1:2019 "Sharps injury protection – Requirements and test methods – Sharps containers" (for container stability, strength of handle, resistance to penetration, resistance to damage and leakage after dropping, resistance to spillage by toppling).
- United Nations Recommendations on the Transport of Dangerous Goods 21st Edition 6.1.5.3 and 6.1.5.6 (for drop and stacking tests).
In-house derived functional specifications: For aspects like blade removal performance with specific handle types, counting mechanism accuracy, automatic shut-off activation, and bracket/scalpel insertion/removal forces. These were "specifically designed in collaboration with Qlicksmart for this type of devices," suggesting engineering specifications.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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