(64 days)
K5 is intended to supply power to and serve as a base for dental devices and accessories. This product is intended for use by dentist and dental assistance to assist dental treatment of patients for adjusting the position of the patient seat, operating the instruments, and supplying water into the oral cavity through a water line in dental clinical environments.
The K5 Cart, K5 Mount and K5 Swing are designed for dental treatment and are intended for dental use only and are intended for use by trained medical personnel only.
These devices consist of a foot controller, headrest, backrest, seat, armrest, doctor table, unit, dental light, auxiliary table and doctor stool.
These are an AC-powered dental operative unit with accessories, intended to supply power to and serve as a base for other dental devices. It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water unit functions.
The provided FDA 510(k) clearance letter and summary for the K5 Cart, K5 Mount, K5 Swing devices (K251491) indicate that these devices are Class I Dental Operative Units and Accessories. Class I devices are generally considered to be low-risk and often demonstrate substantial equivalence through non-clinical testing rather than extensive clinical studies.
The document extensively compares the proposed devices to a predicate device (K5, K233805) to establish substantial equivalence. It does not describe specific acceptance criteria in terms of performance metrics with numerical thresholds for the device's function as a whole. Instead, it relies on compliance with recognized consensus standards and a detailed comparison of technological characteristics.
Therefore, many of the requested details about acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, or improvement over human readers) are not applicable or not explicitly stated in this type of 510(k) submission for a Class I mechanical device. The "acceptance criteria" here are primarily met by demonstrating compliance with safety and performance standards relevant to dental operative units and showing that any differences from the predicate device do not raise new questions of safety or effectiveness.
Here's an analysis based on the provided document, addressing the points where information is available and noting where it's not applicable for this type of device and submission.
Acceptance Criteria and Device Performance
As a Class I dental operative unit, the "acceptance criteria" are primarily established by compliance with recognized electrical safety, electromagnetic compatibility, and performance standards for dental equipment, along with demonstrating that any differences from a predicate device do not introduce new safety or effectiveness concerns. The performance is assessed qualitatively through compliance with these standards and by direct comparison of functionalities and specifications with the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit via Standards Compliance) | Reported Device Performance (as demonstrated by compliance/comparison) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Verified according to IEC 60601-1; electrical safety is equivalent to predicate device. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Verified according to IEC 60601-1-2; EMC is equivalent to predicate device. |
| Performance (General Dental Unit) | Compliance with ISO 7494-1 (dental units), ISO 7494-2 (dental chairs) | Verified according to ISO 7494-1, ISO 7494-2; performance is equivalent to predicate device. |
| Software Verification & Validation | Compliance with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions" | Updated software verified according to IEC 62304 and FDA Guidance; deemed substantially equivalent despite different software versions, as major functions are identical. |
| Air Pressure Parameters | Min/Max Operating Air Pressure Range | Proposed: 550(min), 600kPa(max) (Different from Predicate: 550(min), 750kPa(max). No explicit "acceptance criteria" stated on this difference other than it does not raise new concerns.) |
| Water Pressure Parameters | Min/Max Operating Water Pressure Range | Proposed: 250(min), 600kPa(max) (Same as Predicate) |
| Patient Load Capacity | Maximum patient weight | Max. 150kg (Same as Predicate) |
| Chair Height Adjustment | Min/Max Chair Height | Proposed: Max. 850±30mm, Min. 450±30mm (Different from Predicate: Max. 840±30mm, Min. 440±30mm. No explicit "acceptance criteria" stated.) |
| Back Rest Angle | Range of backrest articulation | 0°±5° to 70°±5° (Same as Predicate) |
| Head Rest Angle | Range of headrest articulation | Proposed: -90° to 75° (Different from Predicate: -90° to 70°. No explicit "acceptance criteria" stated.) |
Study Details
It's important to differentiate that this 510(k) submission is for a mechanical/electrical dental operative unit, not an AI/software as a medical device (SaMD). Therefore, many of the questions related to AI performance metrics, clinical study design for accuracy/sensitivity, expert readers, and ground truth establishment (common for imaging AI) do not apply to this clearance. The "study" here is primarily a series of non-clinical tests and a detailed comparison to a predicate device.
1. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of typical AI/imaging studies. Performance was demonstrated through compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 60601-1-6, ISO 7494-1, ISO 7494-2) and direct engineering measurements and comparisons. This involved testing the physical device(s).
- Data Provenance: Not applicable in the sense of patient data. The testing involves engineering and safety evaluations of the manufactured devices.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The device is a dental operative unit, not an AI diagnostic tool requiring expert-established ground truth from medical images. Compliance with engineering standards and functional specifications constitutes the "ground truth" for this device type.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader adjudication of diagnostic outputs.
4. 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 not an AI diagnostic or assistive device for human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as it's not an algorithm-based device in the diagnostic sense. The device performs its intended functions independently (e.g., moving chair, supplying water/air, powering instruments).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" is established by:
- Compliance with recognized consensus standards: e.g., IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), ISO 7494-1 (Dental Units), ISO 7494-2 (Dental Chairs).
- Engineering specifications and measurements: Verifying that the device meets its design specifications for things like air pressure, water pressure, chair movement ranges, and patient load.
7. The sample size for the training set:
- Not applicable. This is not a machine learning/AI device requiring a training set.
8. How the ground truth for the training set was established:
- Not applicable. No training set is used.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.