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510(k) Data Aggregation
(63 days)
Miltex N-Tralig Intraligamentary Syringe
Integra® Miltex® N-Tralig® Intraligamentary Syringe is indicated to be used in conjunction with anesthetic needles and cartridges for injection of anesthetic into the periodontal ligament.
The Integra® Miltex® N-Traligamentary Syringe is a cartridge syringe intended to inject anesthetic agents into the intraligamentary space (i.e., periodontal ligament). The device consists of a stainless steel syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the barrel cap, the device is used to administer an injection to the patient. The Integra® Miltex® N-Tralig® Intraligamentary Syringe delivers 0.2cc of anesthetic with each ratchet. The ratchet action of the syringe allows for the slow infiltration of anesthetic during the Periodontal Ligament Injection (PDL injection) to help minimize patient discomfort. The 30° adapter helps provide a better angle with difficult-to-reach injections. The syringe comes with a solid barrel and a window barrel.
Here's an analysis of the provided text, focusing on acceptance criteria and study details.
Based on the provided text, the device is the Integra® Miltex® N-Tralig® Intraligamentary Syringe. This document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed performance metrics and acceptance criteria as might be found in a De Novo or PMA submission.
Therefore, the "acceptance criteria" discussed here are primarily related to meeting recognized standards and validating specific processes, rather than performance metrics of an AI algorithm or a clinical effectiveness study.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for a medical device like a syringe, the "acceptance criteria" are typically related to standards compliance and validation of operational aspects (like cleaning and sterilization) rather than clinical performance metrics in the way one might evaluate an AI algorithm's diagnostic accuracy.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Results) |
|---|---|
| AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devices for reprocessing | Compliant (implied by "Pass" results) |
| AAMI TIR30:2011 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices | Compliant (implied by "Pass" results) |
| ANSI/AAMI/ISO 17665-1:2006/(R)2013 (EN ISO 17665-1:2006) – Sterilization of health care products - Moist heat | Compliant (implied by "Pass" results) |
| ANSI/AAMI ST79:2010/A1:2010/A2:2011/A3:2012/A4:2013 Comprehensive guide to steam sterilization and sterility assurance | Compliant (implied by "Pass" results) |
| ANSI/AAMI ST81:2004/(R)2010 – Sterilization of medical devices - Information to be provided by the manufacturer | Compliant (implied by "Pass" results) |
| ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the manufacturer | Compliant (implied by "Pass" results) |
| ISO 14971 - Medical devices - Application of risk management to medical devices | Compliant (implied by "Pass" results) |
| ISO 7153-1 – Surgical instruments -- Metallic materials -- Part 1: Stainless steel | Compliant (Material selection) |
| ISO 7405 - Dentistry - Evaluation of biocompatibility of medical devices used in dentistry | Compliant (Material selection) |
| Manual Cleaning Validation | Pass |
| Pulse pre-vacuum sterilization validation at 132°C for 4 minutes | Pass |
| Pulse pre-vacuum sterilization validation at 134°C for 3 minutes | Pass |
| Gravity Displacement Steam Sterilization Validation at 132°C for 15 minutes | Pass |
2. Sample size used for the test set and the data provenance
The document describes non-clinical technical testing (cleaning, sterilization validation). It does not mention a "test set" in the context of patient data or clinical performance. Therefore, there is no information provided regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical syringe, not an AI diagnostic tool. Ground truth in the context described (cleaning and sterilization validation) would be established by the adherence to specified quality and safety standards and documented validation protocols, likely involving lab technicians and engineers, not clinical experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no clinical "test set" or diagnostic evaluation that would require an adjudication method.
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 is a medical device (syringe), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (syringe), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the technical tests (cleaning and sterilization validation), the "ground truth" is adherence to established, recognized international and national standards (e.g., ISO, AAMI). For biocompatibility, the ground truth is based on the long-standing safety record and material specifications of stainless steel.
8. The sample size for the training set
Not applicable. This is a medical device (syringe), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm.
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