(246 days)
These devices are intended for use by dental professionals only. The devices are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Hu-Friedy dental cartridge syringes are made from chrome-plated brass and stainless steel. Syringes are reusable, sterilizable and packaged non-sterile.
Here's an analysis of the acceptance criteria and study information for the Hu-Friedy Dental Cartridge Syringes, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative or objective pass/fail manner with corresponding numerical results. Instead, it describes performance characteristics that were demonstrated to be "within recommended specifications" of various ISO standards. Therefore, I will derive the acceptance criteria from the mentioned ISO standards and summarize the finding as "Conforms to applicable clauses."
| Acceptance Criteria (Derived from ISO Standards) | Reported Device Performance |
|---|---|
| Pertaining to ISO 9997:1999 (Dental Cartridge Syringes): | |
| Loading of cartridges (compatibility with 1.8ml anesthetic vial) | Conforms to applicable clauses |
| Plunger rod testing | Conforms to applicable clauses |
| Plunger movement testing | Conforms to applicable clauses |
| Aspiration testing | Conforms to applicable clauses |
| Corrosion testing | Conforms to applicable clauses |
| Pertaining to ISO 11499:2007 (Dental Cartridges for Local Anesthetics): | |
| General compatibility and performance related to anesthetic cartridges | Conforms to applicable clauses |
| Pertaining to ISO 13402:1995 (Surgical and Dental Hand Instruments): | |
| General instrument characteristics and performance | Conforms to applicable clauses |
| Reprocessing and sterilization: | |
| Successful steam sterilization cycles per ANSI/AAMI ST79 | Conforms to ANSI/AAMI ST79 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size (number of syringes) used for the in-house performance testing. It also does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given it was "in-house testing," it's prospective testing conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the device described. The "test set" here refers to the physical dental syringes undergoing engineering and performance testing against established international standards (ISO standards). The "ground truth" is determined by measurements and observations as per the test methodologies outlined in those standards, not by expert consensus on clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. Testing against ISO standards typically involves objective measurements and predefined pass/fail criteria, not consensus-based adjudication from multiple human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of data/images (e.g., radiologists reading scans), which is not relevant to a dental cartridge syringe.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance testing described is a standalone evaluation of the device's physical and functional characteristics against established standards. There is no "algorithm" involved, and the human role is in conducting the tests and verifying compliance, not in interpreting the device's output within a clinical context.
7. The Type of Ground Truth Used
The ground truth used for establishing the performance of the device comprises:
- International Standards: Specifically, ISO 9997:1999, ISO 11499:2007, and ISO 13402:1995 provide the "truth" or benchmark for acceptable performance.
- ANSI/AAMI ST79: This standard serves as the ground truth for establishing successful steam sterilization cycles.
- Manufacturer's Recommended Specifications: The document states that performance was "within recommended specifications of the applicable clauses," implying that the manufacturer's internal specifications, aligned with the ISO standards, were used as the benchmark for "ground truth."
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
§ 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.