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510(k) Data Aggregation
(54 days)
Remedi Co., Ltd.
The device is a diagnostic X-ray system, which is intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.
The device is a diagnostic X-ray system, which is intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors.
I am sorry, but the provided text from the FDA 510(k) clearance letter for the Remex-GR100 does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it describe an AI component.
The document is a standard FDA clearance letter for an extraoral X-ray system, confirming its substantial equivalence to predicate devices and outlining the regulatory requirements for the manufacturer. It specifies the device's indications for use: "intended to be used by trained dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects."
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.
To answer your questions, I would need a different document, such as a summary of the clinical or performance testing data submitted to the FDA for the device, or a specific study report.
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(25 days)
Remedi Co. Ltd.
The KA6 is a portable X-ray system for diagnostic imaging of body extremities.
The Remex KA6 is a handheld battery-operated x-ray system intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. The subject device is designed as an x-ray source to take diagnostic x-rays as radiographic images. The x-ray tube by Canon (tube voltage 40-70kV with 0.4 mm focal spot) is located inside the handheld device. The device is used with a Flat Panel X-ray Detector(FXRD), not part of the system, which is attached to a computer with imaging software to enable image capture, display, manipulation, storage, and transmission. The device is not designed to be used with a radiographic grid.
The provided text lacks the detailed information required to fill out all the sections of the request regarding acceptance criteria and the study proving the device meets them. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general safety tests, rather than a specific clinical performance study with defined acceptance criteria for diagnostic accuracy.
Here's an attempt to extract and present the available information, with many sections marked as "Not Applicable" or "Information Not Provided" due to the nature of the given text:
Acceptance Criteria and Study for Remex KA6
The document primarily describes a substantial equivalence determination for the Remex KA6 mobile X-ray system, comparing it to the predicate device MinXray TR90BH. The focus is on demonstrating that the Remex KA6 is at least as safe and effective as the predicate, rather than meeting specific diagnostic performance acceptance criteria in a clinical study with detailed metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Software Validation | "met all requirements of the standard [ISO 14971]" | "Remex KA6 completed software validation and was determined to be a moderate level of concern software. The risk management test was performed in accordance with ISO 14971 and met all requirements." |
| Electrical Safety | "met all requirements for electrical safety" (for standards: 60601-1, 60601-1-3, 60601-1-6, 60601-2-28, 60601-2-54) | "KCTL Inc. performed tests for 60601-1, 60601-1-3, 60601-1-6, and 60601-2-28, and 60601-2-54 and met all requirements for electrical safety." |
| Electromagnetic Compatibility (EMC) | "met all requirements for safety" (for standard: 60601-1-2) | "KCTL performed tests for 60601-1-2 and met all requirements for safety." |
| Radiation Protection (Bench Testing) | "met the test requirements" | "Performance tests for radiation protection in x-ray equipment was completed by an outside laboratory, KCTL, and met the test requirements." |
| Diagnostic Quality (Clinical Evaluation) | "were approved for diagnostic quality" | "Images from the Remex KA6 were evaluated for diagnostic quality by a board certified radiologist and were approved for diagnostic quality." |
2. Sample size used for the test set and the data provenance
- Sample Size: Information not provided. The term "images" is used without a specific count.
- Data Provenance: Information not provided, but implicitly, as it's a clinical evaluation, the images would be derived from human subjects. Whether they were retrospective or prospective, or from a specific country, is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "a board certified radiologist" (singular).
- Qualifications: "board certified radiologist". No specific experience level (e.g., "10 years of experience") is provided.
4. Adjudication method for the test set
- Adjudication Method: "None" or "Not Applicable" as only one expert was used for evaluation. The document states "Images from the Remex KA6 were evaluated for diagnostic quality by a board certified radiologist and were approved for diagnostic quality." This implies a single-reader assessment.
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 explicitly mentioned or performed. The document describes an evaluation of device-generated images for diagnostic quality, not a comparative study of human readers with and without AI assistance.
- Effect Size: Not Applicable, as no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not Applicable. The Remex KA6 is a mobile X-ray system that produces images; it is not an AI algorithm. The diagnostic quality of the images generated by the device was evaluated by a human radiologist.
7. The type of ground truth used
- Ground Truth: "Expert consensus" in a very limited sense, as it was a single "board certified radiologist" who "approved for diagnostic quality." This is closer to expert opinion on image quality rather than a true ground truth established by pathology or long-term outcomes.
8. The sample size for the training set
- Training Set Sample Size: Not Applicable. The Remex KA6 is an X-ray imaging device, not an AI or machine learning algorithm that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not Applicable, as there is no training set for this type of device.
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(23 days)
Remedi Co. Ltd.
R-Sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.
The R-Sensor dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.
The subject R-Sensor is an intraoral digital x-ray system comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Management Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
R-Sensor, Size 1 is also known as factory code S11684-12; R-Sensor, Size 2 is also known as factory code S116845-12.
The provided text describes the "R-Sensor," an intraoral digital x-ray sensor, and its substantial equivalence to a predicate device, the "QuickRay HD." The document primarily focuses on demonstrating that the R-Sensor is identical to the predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the R-Sensor itself.
Therefore, the information below is derived from the comparison to the predicate and the general statements about the device's characteristics, as the document states the two devices are identical in all aspects.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission argues for substantial equivalence based on the R-Sensor being identical to the predicate device (QuickRay HD), the "acceptance criteria" are implicitly met by matching the predicate's specifications and performance where specified. The document does not explicitly state unique acceptance criteria for the R-Sensor but rather focuses on demonstrating its identical characteristics to the cleared predicate.
| Characteristic | Acceptance Criteria (Implied from Predicate & Standards) | Reported Device Performance (R-Sensor) |
|---|---|---|
| Resolution | Real ≥ 20 lp/mm (from predicate) | Real ≥ 20 lp/mm |
| Pixel size | 20 x 20μm (from predicate) | 20 x 20μm |
| Grey levels | 14 bits (from predicate) | 14 bits |
| Lifespan CMOS | Min. 100,000 cycles (from predicate) | Min. 100,000 cycles |
| Electrical Safety | Conforms to IEC 60601-1 | Conforms to IEC 60601-1 |
| EMC | Conforms to IEC 60601-1-2 | Conforms to IEC 60601-1-2 |
| Image Quality / DQE | Conforms to IEC 62220-1 | Bench tests performed in conformance with IEC 62220-1 |
| Ingress Protection (IP Code) | Conforms to IEC 60529 | Bench tests performed in conformance with IEC 60529 |
| Biocompatibility | No direct/indirect patient-contacting components (addressed by single-use barrier) | Biocompatible testing not warranted due to single-use protective barrier. |
| Diagnostic Relevance | Images diagnostically relevant and reliable (based on clinical images of the "complete system" - likely the predicate or very similar system) | Clinical images found to be diagnostically relevant and reliable. |
2. Sample size used for the test set and the data provenance
The document mentions "Clinical images were provided" for the R-Sensor to demonstrate that "the complete system works as intended." However, it explicitly states these images "were not necessary to establish substantial equivalence based on the modifications to the predicate device but they provide further evidence in addition to bench testing data." This suggests the primary "test set" for equivalence relies on the established performance of the predicate device and bench testing of the R-Sensor's components.
- Sample size for clinical images: Not specified.
- Data provenance: Not specified, but a qualified practitioner in Ormond Beach, FL reviewed them. It's unclear if these were retrospective or prospective, or from what country of origin beyond the U.S. location of the reviewing practitioner.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: One expert is explicitly mentioned.
- Qualifications of experts: Dr. Parham, a "qualified practitioner in Ormond Beach, FL." Specific specialty (e.g., dentist, radiologist) or years of experience are not provided.
4. Adjudication method for the test set
Not applicable/Not specified. The clinical images were "examined by Dr. Parham" and "found to be diagnostically relevant and reliable," suggesting a single-reader assessment rather than an adjudication process involving multiple experts.
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
No. This document does not mention an MRMC comparative effectiveness study or any AI component. The R-Sensor is described as a hardware device (intraoral sensor) with associated image management software, performing as a receiver of X-rays to capture images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance assessment of the R-Sensor hardware was performed through bench testing conforming to IEC 62220-1 (for DQE, influencing image quality) and other standards (IEC 60601-1, IEC 60601-1-2, IEC 60529). The "algorithm" here refers to firmware and driver, which are part of the sensor's electronics, and image management software. The entire system's performance, including software, is presented as being identical to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "clinical images" section, the ground truth was established by the assessment of a single "qualified practitioner" who deemed them "diagnostically relevant and reliable." For the direct comparison, the "ground truth" for substantial equivalence is the previously cleared predicate device, QuickRay HD, and its established performance and adherence to standards.
8. The sample size for the training set
Not applicable. The document describes a medical device seeking 510(k) clearance based on substantial equivalence to an existing predicate. It does not describe an AI/ML device that requires a training set. The firmware and drivers were provided by Hamamatsu, and the image management software (Xray Vision) is an off-the-shelf package cleared previously (K983111).
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
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