(35 days)
The MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (STATIONARY). (Digital Diagnostic X-Ray Systems) are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
The MAK 1500 employs a ceiling mounted tubehead/collimator combination made by Suinsa, the NOVA . The system has one digital panel inside the universal bucky in the chest stand. It employs the Suinsa NBS-2100 Universal Bucky. The MAK 2000 uses a conventional vertical column mount and adds a Suinsa NET-4100 table. The MAK 3000, like the MAK 1500, employs a ceiling mount and universal bucky in the chest stand and adds the Suinsa NET-4100 table with a digital panel mounted inside. The digital pancl is the same one we supplied in K080582, manufactured by DRTcch Corporation (K080064) and the software is also unchanged.
The provided text is a 510(k) summary for a Digital Diagnostic X-Ray System (MAK 1500, MAK 2000, MAK 3000) and an FDA clearance letter. It describes the device, its intended use, and its equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics.
The 510(k) summary primarily focuses on:
- Identification of the Device: Proprietary-Trade Name, Classification Name, Product Codes, Common/Usual Name.
- Equivalent legally marketed devices: Stating it's a modified device based on K080582.
- Indications for Use: What the device is intended to be used for (diagnostic radiographic exposures of various body parts in adults and pediatrics).
- Description of the Devices: Details about the components (tubehead, bucky, digital panel, software).
- Safety and Effectiveness, comparison to predicate device: A general statement that "The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices."
The FDA letter confirms the substantial equivalence determination but does not delve into specific performance data or acceptance criteria.
Therefore, based solely on the provided text, I cannot complete the requested tables and sections related to acceptance criteria, detailed study information, sample sizes, expert qualifications, or ground truth establishment. The document does not contain this level of detail regarding performance studies.
Here's what I can extract and state based on the provided text, noting the missing information:
Description of Device and General Regulatory Context:
- Device Name: Model MAK 1500, MAK 2000, MAK 3000 Digital Diagnostic X-Ray System (Stationary).
- Manufacturer: MedicaTech USA
- 510(k) Number: K082798
- Indications for Use: Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
- Predicate Device: K080582 (The current device represents a variation of the tubehead mounting method described in this 510(k)).
Missing Information from the Provided Text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided in the document. The document states "The results of bench and standards testing indicates that the new device is as safe and effective as the predicate devices," but no specific performance metrics, acceptance criteria, or comparative data are listed.
2. Sample size used for the test set and the data provenance:
- Not provided in the document. No information on a specific "test set" for performance evaluation (e.g., number of images, patient demographics, country, retrospective/prospective nature) is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided in the document. There is no mention of expert reviews or ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided in the document. No adjudication method is mentioned as there is no described test set evaluation.
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/Not provided. This is a diagnostic imaging system (X-ray machine), not an AI-assisted diagnostic software. Therefore, an MRMC study comparing human readers with/without AI assistance would not be relevant to this specific device's clearance. The document does not describe any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. As stated above, this is an X-ray system, not an algorithm, so a standalone algorithm performance evaluation is not relevant or described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided in the document. No ground truth type is mentioned as no specific performance study is detailed.
8. The sample size for the training set:
- Not applicable/Not provided. As this is a hardware X-ray system and not an AI/machine learning algorithm, there is no "training set" in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. (See point 8).
Conclusion:
The provided 510(k) summary and FDA letter pertain to the substantial equivalence of a general-purpose digital X-ray system. The documentation focuses on hardware specifications, intended use, and comparison to a predicate device based on bench and standards testing for safety and effectiveness. It does not provide the detailed performance study information, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods typically found for software algorithms or devices requiring specific diagnostic accuracy claims. For an X-ray system, "safety and effectiveness" often refers to image quality (resolution, contrast, dose), electrical safety, mechanical safety, and compliance with performance standards, rather than diagnostic accuracy metrics of a distinct algorithm.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.