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510(k) Data Aggregation
(234 days)
aboNT SYRINGE
Indicated for intramuscular administration of Dysport® for the temporary improvement of moderate to severe glabellar lines in adults
The aboNT Syringe is a piston syringe with needle consisting of graduated barrel, plunger rod, and gasket. It is provided with a permanently attached hypodermic needle that is 31G x 5/16″. The syringe barrel is 0.3 mL in volume, with a graduated scale labeled in both volumetric (mL) and corresponding unit dosing for Dysport® (60 units/0.3mL). The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by E-beam radiation. The shelf-life has been determined to be 5 years.
The provided text describes the submission of a medical device (aboNT Syringe) for FDA clearance (K212677) and details its non-clinical testing for substantial equivalence to a predicate device. It explicitly states that no clinical testing was performed or provided, and therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisted by AI was not conducted, and a standalone algorithm performance study was not conducted.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding "reported device performance" in the format one might expect for a study evaluating an AI algorithm's diagnostic performance. Instead, it compares the subject device (aboNT Syringe) to a predicate device (UniTox® Syringe) across various technological characteristics. The "performance" in this context refers to meeting established standards for syringe manufacturing and function, rather than diagnostic accuracy.
However, we can extract some "acceptance criteria" based on the comparisons and testing outlined. The "reported device performance" is implicitly that the subject device meets these standards and is "within specification."
| Acceptance Criteria (Derived from Standards/Predicate Comparison) | Reported Device Performance (Subject Device) |
|---|---|
| Intended Use: Injection of botulinum toxin (Dysport®) | Meets (Indicated for intramuscular administration of Dysport®) |
| Syringe Type: Piston syringe with attached needle | Meets (Piston syringe with attached needle) |
| Design: Permanently attached needle, low-dead space, specific toxin dose graduation markings | Meets (Permanently attached needle, low-dead space, specific toxin dose graduation markings) |
| Operational Principles: Manual | Meets (Manual) |
| Biocompatibility: Compliant to ISO 10993-1 | Compliant to ISO 10993-1 |
| Barrel Transparency: No particle and extraneous matter | No particle and extraneous matter |
| Delivery Accuracy (Less than half nominal cap.): Within specified range (Predicate: Min: 0.0957 mL, Max: 0.1008 mL) | Min: 0.0968 mL, Max: 0.1024 mL (Within specification) |
| Delivery Accuracy (Equal to or greater than half nominal cap.): Within specified range (Predicate: Min: 0.485 mL, Max: 0.496 mL) | Min: 0.269 mL, Max: 0.300 mL (Within specification, noting volume difference) |
| Reuse Durability: NA – single use only | NA – single use only |
| Needle Cover Strength: Within specified range (Predicate: Min: 0.52 kgf, Max: 1.57 kgf) | Min: 0.32 kgf, Max: 0.51 kgf (Within specification) |
| Hub/Needle Bond Strength: Within specified range (Predicate: Min: 42.65 N) | Min: 44.72 N (Within specification) |
| Sterilization Method: E-Beam or equivalent | E-Beam (Similar, no new issues) |
| Shelf-life: 5 years | 5 years |
| Visual Inspection: Meets ISO 7886-1, ISO 7864 | Meets standards |
| Dimensional Specifications: Meets ISO 7886-1 | Meets standards |
| Mechanical & Performance Characteristics: Meets ISO 7886-1, ISO 7864, ISO 8537, ISO 11608-1 | Meets standards |
| Chemical & Biological Characteristics: Meets ISO 7886-1, ISO 8537 | Meets standards |
| Sterilization Validation: Meets ISO 11137-1, -2, -3 | Meets standards |
| Shelf-life Testing: Meets ASTM F1980-16, ASTM D4169-16 | Meets standards |
| Dye Penetration & Seal Strength: Meets ASTM F1929-15, ASTM F88/F88M-1 | Meets standards |
| Biocompatibility: Meets ISO 10993-1 methods (Cytotoxicity, Sensitization, Intracutaneous Irritation, Pyrogen, Extractables/Leachables) | Meets standards |
| Particulate Matter: Meets USP | Meets standard |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of an AI algorithm evaluation with sample sizes. The testing conducted is primarily non-clinical, involving material and performance assessments according to established standards. For these physical and chemical tests, sample sizes would typically be defined by the specific standard, but are not detailed in this summary. The data provenance is internal to the manufacturer's testing processes as required for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical evaluation of a medical device (syringe), not an AI algorithm requiring expert ground truth for diagnostic accuracy.
4. Adjudication method for the test set
Not applicable. This is a non-clinical evaluation of a medical device (syringe), not an AI algorithm requiring expert adjudication.
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 comparative effectiveness study was not conducted. The document explicitly states: "This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission." This device is a syringe, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. The device is a syringe, not an AI algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable ranges established by recognized international and national standards (e.g., ISO 7886-1, ISO 7864, ASTM F1980-16, USP , etc.). The device's performance is compared against these scientifically established benchmarks.
8. The sample size for the training set
Not applicable. This is a non-clinical evaluation of a syringe; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or corresponding ground truth establishment for an AI algorithm in this submission.
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