(146 days)
The device is indicated for the injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedures.
KI works' Anesthesia Injection Tool Set (KIW-1000) is a device for injecting local anesthetic for anesthesia prior to, or in conjunction with, dental procedures. This device consists of Main body, Hand-piece, Battery pack and Adapter. All operating displays and the majority of the operator controls are located on front panel of the control unit.
The provided text describes the KI works' Anesthesia Injection Tool Set (KIW-1000) and its submission for 510(k) clearance, asserting substantial equivalence to a predicate device. However, the document does not contain explicit "acceptance criteria" presented as quantitative thresholds or specific performance metrics that the device had to achieve. Instead, the document focuses on demonstrating that the KIW-1000 is "substantially equivalent" to a legally marketed predicate device (Comfort Control Syringe System) based on intended use, technological characteristics, and safety/effectiveness considerations, primarily relying on non-clinical performance and electrical testing.
The study presented is a non-clinical performance test, not a clinical trial evaluating effectiveness against specific acceptance criteria.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating similarity to a predicate device and adherence to safety standards. The performance aspects discussed are comparative and qualitative/descriptive, rather than explicitly defined acceptance thresholds.
| Performance Aspect | Acceptance Criteria (Explicitly stated) | Reported Device Performance (KIW-1000) |
|---|---|---|
| Intended Use | For the injection of local anesthetics for anesthesia prior to, or in conjunction with, dental procedures. | For the injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedures. (Matches predicate and intended use) |
| Indications for Use | To administer consistent and comfortable injections. | To deliver anesthetics in dental procedure safely and effectively without pain for patient. (Similar to predicate's intent) |
| Sterility | Not specified as an acceptance criterion; described as not contacting human body directly, used with disposable syringe/needle. | All the system is not contact with human body. Using in conjunction with disposable, one time use, standard syringe and needle. (Matches predicate's approach) |
| Control of anesthesia-time | Free control (High/Low speed) | Free control (High/Low speed) (Matches predicate functionality) |
| Anesthesia time (dose) | Small doses, Short time | Small doses, Short time (Matches predicate functionality) |
| Electric power source | Internal | Internal Battery (Similar to predicate, internal) |
| Operation | Automatic/Manual (5-step speed control) | Automatic/Manual (6-step speed control) (Similar to predicate, slight difference in steps) |
| Injection Mode | 5 mode button (-Block, -Infiltration, -Palate, -PDL, -intraosseous) | 3 Mode (Auto1, Auto2, Manual 6 phases) (Different from predicate, but described as an electronic pre-programmed anesthetic delivery device) |
| Initial Slow Injection Time | Not explicitly stated as an acceptance criterion beyond being "similar" to the predicate. | "First slow injection time of Auto 1, KIW-1000 is similar to Predicate device's first 10 seconds. Auto 1 is designed for adult and Auto 2 is for children. For the children the first slow injection time is 22 second." |
| Safety Standards Adherence | Adherence to EN60601-1, EN60601-1-2, EN55011:2007. | Testing conducted in accordance with EN60601-1, EN60601-1-2, EN55011:2007. "None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of devices or injections. The "performance test" mentions evaluating "initial slow injection time" for Auto 1 (adult) and Auto 2 (children) settings of the KIW-1000 and comparing it to the predicate device's "first 10 seconds." It implies direct comparison, but the number of tests performed is not quantified.
- Data Provenance: The testing was "non-clinical" (bench testing) performed by KIWORKS Co., Ltd. (Korea). The data is retrospective in the sense that it's reported after the testing, but it's not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. This was a non-clinical bench test. There were no human experts establishing ground truth for performance. The comparison was to a predicate device's known characteristics and general engineering principles.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No human adjudication was involved in this non-clinical bench testing.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an anesthetic delivery tool, not an AI-assisted diagnostic or interpretation system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable in the context of AI. This device is a physical, automated-assist medical tool, not an algorithm for diagnosis or interpretation. The device's "standalone" performance was assessed via bench testing, as described in point 2.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the performance test, the "ground truth" was the performance characteristics of the predicate device (Comfort Control Syringe System) and engineering standards/specifications (e.g., EN60601-1) for safety. There was no clinical ground truth (like pathology or outcomes data) established.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning system that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there was 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.