(132 days)
PCH-2500 is a digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients. The device should be operated and used by dentists, x-ray technicians and other professionals licensed by the law of the state in which the device is used.
PCH-2500 is a dental digital radiographic imaging system which is available in two different image acquisition modes. Specifically designed for dental radiography of the teeth or jaws. PCH-2500 can be equipped with four dedicated sensors for two different X-ray modalities : one panoramic (Xmaru1501CF), two cephalometric scan type (Xmaru2301CF and Xmaru3001CF) and three flat panel one shot ceph sensors (1210SGA, 910SGA and 1417PGA). The proposed device is available with two X-ray generator options. PCH-2500 offers the digital panoramic and cephalometric X-ray modality for dental radiographs. The multi platforms of PCH-2500 imaging mode provides a wide range of imaging options based on the patient diagnostic needs.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes a 510(k) submission for the PCH-2500 dental digital radiographic imaging system. However, it does not explicitly list specific acceptance criteria with numerical targets that the device had to meet. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (also named PCH-2500, K122155). The core argument is that the new device is an "upgraded version of the predicate device with the same model name, the same indications for use and technical characteristics" (Section 2).
The closest equivalent to "acceptance criteria" can be inferred from the technological characteristics comparison with the predicate device and the performance tests conducted to ensure safety and effectiveness.
Table 1. Inferred Acceptance Criteria and Reported Device Performance
| Characteristic | Inferred Acceptance Criteria (from predicate device characteristics or regulatory standards) | Reported Device Performance (for new PCH-2500) | Notes |
|---|---|---|---|
| Indications for Use | Same as predicate (take panoramic and cephalometric images of oral/maxillofacial anatomy for adult and pediatric diagnostic information). | Identical to predicate device indications (Section 2, 5) | This is a primary criterion for substantial equivalence. |
| Performance Spec. | Panoramic and cephalometric imaging capability. | Panoramic and cephalometric imaging capability (Section 2) | |
| Input Voltage | AC 100-120 / 200-240 V (predicate range) | AC 100-240 V (includes predicate range) (Section 2) | The new device has a wider, "Free Input Voltage" capability, which is an improvement but still covers the predicate's range. This change was explicitly addressed (Section 5). |
| Tube Voltage | 50-90 kV (predicate range) | 50-99 kV (includes predicate range) (Section 2) | The new device has an extended tube voltage range, indicating a potential performance enhancement while still meeting or exceeding the predicate's capability. This change was explicitly addressed with safety and image evaluation (Section 5). |
| Tube Current | 4-10 mA (predicate range) | 4-16 mA (includes predicate range) (Section 2) | The new device has an extended tube current range, indicating a potential performance enhancement while still meeting or exceeding the predicate's capability. This change was explicitly addressed with safety and image evaluation (Section 5). |
| Exposure Time | Max. 20.2 s (predicate) | Max. 20.2 s (Section 2) | Identical. |
| Focal Spot Size | 0.5 mm (predicate) | 0.5 mm (Section 2) | Identical. |
| Total Filtration | Min. 2.8 mmAl (predicate) | Min. 2.8 mmAl (Section 2) | Identical. |
| Pixel Resolution | 5 lp/mm (for Xmaru series), 3.9 lp/mm (for SGA series) - (predicate) | 5 lp/mm (for Xmaru series), 3.9 lp/mm (for SGA series) (Section 2) | Maintained identical pixel resolutions, demonstrating that new detectors (Xmaru3001CF, 1417PGA) perform at comparable levels. Non-clinical performance (MTF, DQE, NPS) was specifically evaluated (Section 6). |
| Pixel Size | 100 x 100 µm (Xmaru), 127 x 127 µm (SGA) - (predicate) | 100 x 100 µm (Xmaru), 127 x 127 µm (SGA) (Section 2) | Maintained identical pixel sizes. |
| Software | DICOM 3.0 Format compatible, EasyDent for 2D Image Viewing (predicate) | DICOM 3.0 Format compatible, EasyDent (Section 2, 7) | Found to be the same as the predicate (Section 5, 7). |
| Safety Conformity | Conformity to relevant IEC/EMC (e.g., IEC 60601-1, IEC 60601-1-2) and EPRC standards. | Conformed to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, IEC 60601-1-2. Also met 21 CFR 1020.30, 31. (Section 6) | Electrical, mechanical, environmental safety, and EMC testing were explicitly performed and found satisfactory (Section 6, 7). Separate safety tests for each generator were conducted (Section 5, 6). |
| Imaging Performance | Non-clinical & clinical considerations per FDA Guidance & acceptance test per IEC 61223-3-4. Not explicitly quantified as a specific numerical benchmark but implies maintenance of image quality. | Satisfactory non-clinical performance (MTF, DQE, NPS) and clinical consideration reports for new image receptors. Separate clinical image evaluation performed for each X-ray generator. Acceptance test per IEC 61223-3-4 performed. (Section 6) | The non-clinical performance (MTF, DQE, NPS) and clinical consideration reports for the new image receptors (Xmaru3001CF and 1417PGA) were provided. The outcome of an expert review of image comparisons was also relied upon for substantial equivalence (Section 6). "All test results were satisfactory" (Section 7). |
Study that Proves the Device Meets the Acceptance Criteria:
The submission describes a set of tests to demonstrate substantial equivalence to the predicate device, rather than a single, large clinical study with specific acceptance criteria. The primary "study" is a compilation of various engineering tests, performance validations, and comparisons.
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Sample size used for the test set and the data provenance:
- Test Set: Not explicitly stated as a "test set" in the traditional sense of a clinical trial. The evaluation primarily involved device characteristics and performance metrics.
- Data Provenance: The studies are laboratory and engineering tests conducted by the sponsor's qualified individuals, likely at the manufacturing facility in Gyeonggi-Do, Republic of Korea, as indicated by the submitter's address. The data is retrospective in the sense that it relies on comparisons to an already cleared predicate device and established standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "an expert review of image comparisons for both devices" (Section 6).
- The number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text. It only states "qualified individuals employed by the sponsor" conducted laboratory and clinical performance testing (Section 5).
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Adjudication method for the test set:
- The document mentions "outcome of an expert review of image comparisons" (Section 6), but the specific adjudication method (e.g., 2+1, 3+1, none) is not 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 MRMC comparative effectiveness study was done or reported. This device is a digital X-ray imaging system, not an AI-powered diagnostic tool. The focus is on the image acquisition system itself.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is an image acquisition system, not an algorithm. Its performance is evaluated based on image quality metrics and compliance with technical specifications and safety standards.
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The type of ground truth used:
- For technical performance: The "ground truth" was based on established industry standards (e.g., IEC standards for safety, ISO/NEMA standards for image quality metrics like MTF, DQE, NPS), and comparison to the performance characteristics of the legally marketed predicate device.
- For clinical image evaluation: The "ground truth" was based on expert review of images produced by the device, likely assessing diagnostic utility and quality against established clinical imaging benchmarks, but the exact nature of this "ground truth" is not detailed (e.g., if it involved pathology confirmation or outcomes data).
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The sample size for the training set:
- Not applicable. This device is an X-ray imaging system, not a machine learning algorithm that requires a "training set" in the AI sense.
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How the ground truth for the training set was established:
- Not applicable. As the device is not an AI algorithm, no training set or its associated ground truth establishment mechanism is relevant to this submission.
In essence, the "study" demonstrating the device meets acceptance criteria is a comprehensive set of engineering, electrical, mechanical, and image quality tests, along with a direct comparison of all technical specifications to a pre-existing cleared predicate device (K122155). The conclusion of substantial equivalence is drawn from the satisfactory results of these tests and the identified similarities and acceptable changes from the predicate.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.