(34 days)
To inject local anesthetic agents subcutaneously or intramuscularly for dental applications.
The CompuDent STA™ Syringe is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device provides audible and visible status indicators of injection rate, amount of anesthetic remaining in the carpule, and pressure at the tip of the needle. It is substantially equivalent to the company's currently marketed CompuDent™ computer controlled syringe.
This 510(k) summary for the CompuDent STA™ Syringe indicates that it is substantially equivalent to a previously marketed device (CompuDent™ computer controlled syringe). As such, it relies on the predicate device's performance and does not describe a new study with acceptance criteria and device performance. Device performance for substantial equivalence is often established through detailed comparisons to the predicate device's specifications and existing performance data, rather than new, stand-alone clinical trials with explicitly stated acceptance criteria.
Therefore, many of the requested elements (like sample size, number of experts, ground truth, MRMC study, and training set details) are not explicitly present in the provided text because the submission is for substantial equivalence to an existing device rather than a de novo approval requiring extensive new clinical validation.
However, based on the provided text, I can infer what would typically be considered "acceptance criteria" for a device of this nature and the "study" demonstrating performance, which in this case is the substantial equivalence comparison.
Here's an attempt to answer your questions based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the primary "acceptance criterion" is that the new device performs as intended and is substantially equivalent to the predicate device. Performance is demonstrated by showing that the design, materials, principle of operation, and intended use are the same as the predicate. The document doesn't quantify specific performance metrics with numerical acceptance criteria (e.g., "flow rate must be within X% of target").
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (from text) |
|---|---|
| Intended Use: Device performs its intended function effectively and safely. | "To inject local anesthetic agents subcutaneously or intramuscularly for dental applications." (Same as predicate) |
| Principle of Operation: Device operates on the same scientific principles. | "The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes." (Implies same as predicate) |
| Material Equivalence: Materials used are safe and comparable to predicate. | "The materials... are the same as other marketed piston and cartridge syringes." (Implies same as predicate) |
| Safety: Device presents no new safety concerns. | No new safety concerns identified; substantial equivalence implies comparable safety. |
| Performance Features: Device provides similar functionality and user feedback. | "The device provides audible and visible status indicators of injection rate, amount of anesthetic remaining in the carpule, and pressure at the tip of the needle." (Comparable to predicate functionality) |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable or not specified. Substantial equivalence typically relies on design verification/validation and comparison to the predicate's established performance, rather than a new clinical "test set" in the traditional sense for a novel device.
- Data provenance: Not explicitly stated. The comparison is against the "company's currently marketed CompuDent™ computer controlled syringe," which implies internal company data and existing market performance data for the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As this is not a study requiring medical image interpretation or complex diagnostic outcome assessment, there isn't a "ground truth" established by experts in this context. The "truth" is established by demonstrating that the device functions according to its design and industry standards, and is equivalent to the predicate.
4. Adjudication method for the test set
- Not applicable. There was no "test set" in the clinical trial sense that would require 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. This device is a mechanical syringe, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not a software algorithm, and it always functions with human-in-the-loop operation (a dentist or other medical professional).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on the established performance and safety of the legally marketed predicate device (CompuDent™ computer controlled syringe), combined with design verification and validation testing to ensure the new device meets its specifications and performs as intended. There isn't a specific "ground truth" from a medical outcome perspective for a substantial equivalence submission of this type of device.
8. The sample size for the training set
- Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.