(164 days)
The Surgical Drive System (Model: ES70, ES90, E8) is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery
The Surgical Drive System is an electrical drive unit, including a motor, power console, foot control, connection cables, and other accessories. It is intended for use in surgical procedures involving incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone. The basic function of the Surgical Drive System is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation of the motor and changing parameters e.g. program, pump state, and motor direction. The motor's function is to provide power for handpieces with the gear ratio (1:1, 1:4.2, 1:5, 3.2:1, 3.4:1, 40:1), the Max. speed of the motor is 40000 min-1, and it is designed with an ISO 3964 Type 3 connector.
This FDA 510(k) summary (K240340) for the Surgical Drive System (Model: ES70, ES90, E8) describes a device that is not an AI/ML-driven medical device. The document focuses on establishing substantial equivalence to a predicate device based on technical design, intended use, and conventional performance and safety testing.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, cannot be extracted from this document because it does not involve AI/ML.
However, I can provide a summary of the non-clinical performance testing that was conducted to support the substantial equivalence claim for this medical device, which addresses the "study that proves the device meets the acceptance criteria" in a general sense, but not for AI/ML specific criteria.
Non-AI/ML Related Acceptance Criteria and Study Summary (Based on Provided Document):
The acceptance criteria for this non-AI/ML device are primarily related to safety, electromagnetic compatibility, and reprocessing effectiveness, demonstrated through adherence to recognized international standards.
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML):
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Electrical Safety: IEC 60601-1 and IEC 8060-2-60 | Test results in compliance with safety standards |
| Electromagnetic Compatibility: IEC 60601-1-2 and IEC/TR 60061-4-2 | Test results in compliance with safety standards |
| Reprocessing (Effectiveness & Max Number): ISO 17665-1; FDA Guidance (Reprocessing Medical Devices) | Validation performed, effectiveness confirmed |
| Software Verification & Validation: IEC 62304 and FDA Guidance (Software in Medical Devices) | Verification and validation performed, requirements met |
| Motor Coupling Systems Classification (ISO 3964): Type 3 (proper specifications as per ISO 3964 or equivalent) | Test results show performance meets standards, no accidental disconnection |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of devices / units. Testing would typically involve a statistically relevant sample of devices or components to demonstrate compliance with standards.
- Data Provenance: Not explicitly stated, but testing is implied to be conducted by the manufacturer (Guangdong Jinme Medical Technology Co., Ltd.) or a contracted testing facility. The nature of these tests (safety, EMC, reprocessing validation) implies prospective testing on manufactured devices to meet specific engineering and regulatory requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable as this is a non-AI/ML device. "Ground truth" established by expert consensus is typically relevant for evaluating the diagnostic or classification performance of AI/ML algorithms. For this device, compliance is measured against engineering specifications, industry standards, and regulatory requirements, which do not rely on expert "ground truth" in the same way.
4. Adjudication method for the test set:
- Not applicable for a non-AI/ML device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or performance evaluations for diagnostic devices to resolve discrepancies in expert interpretations, particularly for establishing ground truth for AI model training or 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:
- Not applicable as this is a surgical drive system, not an AI-driven diagnostic or assistive imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a hardware-based surgical drive system, not an AI algorithm.
7. The type of ground truth used:
- For this device, "ground truth" is established by:
- Engineering Specifications: The device is designed to meet specific performance parameters (e.g., motor speed, power output, operating mode).
- International Standards: Compliance with established safety (e.g., IEC 60601-1), EMC (e.g., IEC 60601-1-2), and reprocessing (e.g., ISO 17665-1) standards, where the standard itself defines the acceptable criteria and test methods.
- Software Design Requirements: For the device's control software, compliance is against its own validated design requirements and IEC 62304.
8. The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.