(29 days)
Hasla is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
The product (Dental CBCT X-ray System, Model: Hasla) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube, Collimator), Image receptor and Image processing system (including Computer, Monitor, and Software workstation).
The provided FDA 510(k) clearance letter and summary for the Yian Medical Technology (Haining) Co., Ltd. Dental CBCT X-ray System (Model: Hasla) indicate that this is a Special 510(k) for a device modification. This means the company is asserting that the modified device is substantially equivalent to their own previously cleared predicate device (Dental Cone-beam Computed Tomography, Model: iDT901X1, K232710) and that the modifications do not raise any new safety or effectiveness concerns.
Therefore, the submission relies on the previous clearance and asserts that the current device meets the same acceptance criteria as the predicate without requiring new comprehensive studies to prove that from scratch. Instead, it demonstrates that the modifications themselves do not negatively impact the performance, safety, or efficacy previously established.
Given this context, here's a breakdown of the information requested. It's important to understand that the document does not report on a new study for the current device to explicitly prove it meets acceptance criteria with new data. Instead, it leverages the prior clearance through a demonstration of equivalence.
Acceptance Criteria and Device Performance (as related to the predicate device and the claim of equivalence)
The document states: "The subject device and the predicate device are equivalent in the model name, same in the indications for use, patient population, use environment, software functions, and software level of documentation, performance characteristics and technical specification." It further specifies that "Any difference between the predicate device and the subject device have no impact on safety or efficacy of the subject device and do not raise any new potential or increased safety risks."
Therefore, the "acceptance criteria" for the current device are implicitly met by demonstrating that its performance and safety characteristics are unchanged from the predicate device, which had previously met its own acceptance criteria during its clearance process (K232710).
The summary provides a detailed comparison table (Table 1) between the subject device (Hasla) and the predicate device (iDT901X1). Essentially, all listed specifications and performance characteristics are presented as identical between the two.
Table 1: Acceptance Criteria (Implied from Predicate Equivalence) and Reported Device Performance
| Feature/Acceptance Criteria Category (Implied) | Reported Performance (Subject Device is equivalent to Predicate) |
|---|---|
| Indications for Use | "Hasla is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height..." |
| Target Population | For patients 6 years and older |
| Anatomical Site | The dental, oral, maxillofacial region |
| Users | Health care professionals |
| Patient Contact Material | Meet ISO 10993 series standard (Non-sterile) |
| Tube Voltage | 60kV~120kV |
| Tube Current | 1 mA～20 mA |
| Nominal Focal Spot Size | 0.5 |
| Pulse Exposure function | Yes |
| Power | Frequency: 50/60Hz, Voltage: 110-120VAC, Power: 3.0KVA |
| Detector | FPD（TFT）, material: CsI |
| Pixel Size | 200µm x 200µm (With binning) (CT, Cephalometric); 100µm x 100µm（Without binning）(CT, Panoramic) |
| Pixel Number | 15041248 (With binning) (CT, Cephalometric); 8002496 (Without binning) (CT); 300865 (Without binning) (Panoramic); 15041248 (With binning) (Cephalometric) |
| Size of Area Receiving X-ray | 300.8mm x 249.6mm (CT, CEPH); 80mm x 249.6mm (CT); 300.8mm x 6.5mm (PANO) |
| Spatial Resolution | 5lp/mm |
| Number of Bits | 16bits |
| SID/SOD | SID: 750mm/490mm |
| Dimension (WxDxH) | Max.overall dimension 1300mm1272mm2365mm |
| Weight | 233kg±5kg |
| Imaging Mode | CBCT, PANO, CEPH |
| Panoramic Scan Performance (Scan Time) | 15sec |
| Cephalometric Radiography (Scan Time) | 2.3sec |
| CT Scan Time | 22sec |
| CT FOV (Voxel Size) | Diameter 230 mm x 180mm (0.45mm); Diameter 150 mm x 120mm (0.29mm); Diameter 80 mm x 80mm (0.15mm); Diameter 50 mm x 50mm (0.097mm); Diameter 50 mm x 50mm (0.071mm) |
| Software functions | Image acquisition, data management, image display, image processing, System Settings |
| Software level of documentation | Basic Documentation Level |
| Compliance with Electrical Safety Standards | ANSI/AAMI ES60601-1, IEC 60601-1, IEC60601-1 Edition 3.2 2020-08, ANSI/AAMI ES: 60601-1:2005/A2:2010/AMD2:2021 |
| Compliance with Electromagnetic Compatibility Standards | IEC 60601-1-2 |
| Compliance with Radiation Safety Standards | IEC 60601-1-3 |
| Compliance with Electrical Equipment Usability Safety | IEC 60601-1-6 |
| Compliance with Usability Engineering Standard | IEC 62366 |
| Compliance with Software Lifecycle Process Standard | IEC 62304 |
| Compliance with Essential performance of dental extra-oral X-ray equipment Standard | IEC 60601-2-63 |
| Compliance with Acceptance tests of Imaging performance of computed tomography X-ray equipment Standard | IEC 61223-3-4; IEC 61223-3-7 |
| Compliance with Laser Safety standard | IEC 60825-1 |
| Compliance with Risk Management Standard | ISO 14971 |
| Compliance with DICOM Standard | ISO 12052:2017 |
| Compliance with Biocompatibility Standard | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 |
Study Details (Based on the provided document for the current 510(k) submission)
It's crucial to reiterate that this is a Special 510(k). The document explicitly states: "The modifications of the device have no impact on the product's design, working principle, software function, software documentation level, performance characteristic and technical specification indication for use, patient population, environment of use, user needs, thus no impact on the previously conducted Bench Testing and validation. No new bench testing or validation was needed. The previously conducted and submitted verification and validation test results are still valid for the modified device..."
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable/Not specified as new data. The submission relies on the testing of the predicate device (K232710) and general compliance with standards.
- Data Provenance: Not applicable/Not specified, as no new clinical or standalone performance studies were explicitly conducted for this submission beyond bench testing to confirm compliance with recognized standards. The submitter is Yian Medical Technology (Haining) Co., Ltd. in China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission does not detail a study involving expert readers or ground truth establishment, as it's a Special 510(k) relying on equivalence to a previously cleared device.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No such study or adjudication method is described.
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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 Dental CBCT X-ray System, which is an imaging acquisition device, not an AI-based diagnostic tool for human reader interpretation improvement. The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is an imaging system, not a standalone algorithm. The clearance is based on the device's ability to produce images compliant with established standards, not on an algorithm's diagnostic performance. The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." The bench testing cited ("Bench Testing Summary") confirms the physical and technical specifications against standards (e.g., spatial resolution, focal spot size, etc.), which are standalone performance characteristics of the device (hardware/software combined for image generation), but not a "standalone algorithm" in the typical sense of AI performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No new clinical studies requiring external ground truth were conducted for this Special 510(k). The evaluation revolves around compliance with engineering and radiation safety standards, and performance characteristics (like spatial resolution, scan time) derived from bench testing using phantoms or calibrated equipment.
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The sample size for the training set:
- Not applicable. This is not an AI algorithm requiring a training set in the conventional sense. The "software functions" mentioned are for image acquisition, data management, display, processing, and system settings, which are intrinsic to the operation of the imaging device itself.
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How the ground truth for the training set was established:
- Not applicable, as there is no specific training set described for an algorithm in this context.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.