Search Results
Found 10 results
510(k) Data Aggregation
(248 days)
Medicatech USA Inc.
Mini-X is intended for use by qualified/trained medical professionals who fully understand the safety information, emergency procedures, and the device's capabilities and function. The device provides fluoroscopic imaging and is used for guidance and visualization during diagnostic radiography and surgical procedures of the extremities. The device will be used in healthcare facilities inside and outside the hospital, using various methods for the extremities on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in a prone or supine position. The system is not intended for mammography applications. (Rx Only)
The Mini-X system, a unique mobile imaging system, can acquire, process, and display fluoroscopic images. Its portability allows for easy positioning within a room and movement from room to room within a facility, facilitating on-demand fluoroscopic examinations. The system's innovative design incorporates a low-powered mono-block generator and a dynamic flat-panel detector, enabling it to be powered through a single-phase 120VAC power outlet.
The Insight Enhanced™ DRF Digital Imaging System, a cutting-edge tool for healthcare professionals, offers full control over the imaging chain. It empowers the operator to view and enhance high-definition fluoroscopy images up to 30 fps, bringing out diagnostic details that are challenging or impossible to see using conventional imaging techniques. The system's versatility is demonstrated by its ability to store images locally for short-term storage, produce hardcopy images with a laser printer, or send images over a network for longer-term storage. Its primary components, including a dynamic flat panel detector, monitors, and an image processor PC, underscore its comprehensive and advanced capabilities.
It seems there's a misunderstanding of the provided text. The document is an FDA 510(k) Clearance Letter for a mobile digital imaging system. It describes the device, its intended use, and its substantial equivalence to predicate devices based on technological similarities and differences, and outlines general testing performed (bench testing, compliance with IEC standards).
**Crucially, this document does not describe:
- An AI/ML device or its performance characteristics.
- Acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
- A study proving an AI device meets acceptance criteria.**
The document discusses imaging quality and radiation dose comparisons, and compliance with general medical device standards. It briefly mentions "software" and "cybersecurity" in generic terms, but not in the context of an AI algorithm or its performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving an AI device meets those criteria based on the provided text, as the text describes a standard imaging system, not an AI-powered one.
To answer your request, I would need a 510(k) submission document or a scientific paper that specifically details the clinical validation of an AI/ML medical device, including the elements you listed.
Hypothetical Example (if the document were about an AI device):
If this document were to refer to an AI device for, say, detecting fractures on Mini-X images, the relevant sections would typically be under "Non-Clinical and/or Clinical Tests Summary & Conclusions" (Page 7) or a dedicated "Performance Benchmarks" section, which are absent here for AI.
To illustrate what you're asking for, here's an example of how I would answer if the provided text contained the necessary information about an AI device:
(This is a hypothetical response, as the provided text doesn't contain this information.)
Based on the provided (hypothetical) information regarding an AI-powered diagnostic device, here's a description of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity | ≥ 90% for detecting [condition A] | 92.5% |
| Specificity | ≥ 80% for detecting [condition A] | 85.1% |
| AUC | ≥ 0.90 for [condition A] detection | 0.93 |
| False Positive Rate | ≤ 0.05 cases/image for [normal anatomy] | 0.03 cases/image |
| Inference Time | ≤ 2 seconds per image for standard processing | 1.5 seconds/image |
2. Sample Size Used for the Test Set and Data Provenance (Hypothetical)
- Test Set Sample Size: 1500 unique imaging studies.
- Data Provenance: Retrospective and prospective data collected from multiple hospitals across the United States (70% retrospective, 30% prospective). The retrospective data covered a period of 5 years (2018-2023).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications (Hypothetical)
- Number of Experts: A panel of 3 independent radiologists.
- Qualifications: All radiologists were board-certified with a minimum of 10 years of experience in diagnostic radiography, specializing in musculoskeletal imaging. One radiologist had subspecialty fellowship training in advanced imaging.
4. Adjudication Method for the Test Set (Hypothetical)
- Adjudication Method: 2+1 adjudication method was employed.
- Initially, two radiologists independently reviewed each case.
- If their interpretations agreed, that consensus was taken as the preliminary ground truth.
- If their interpretations disagreed, a third, senior radiologist served as an adjudicator and made the final decision to establish the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical)
- MRMC Study Done: Yes, an MRMC study was conducted to evaluate the impact of AI assistance on human reader performance.
- Effect Size: The study demonstrated a significant improvement in reader performance. Human readers, when assisted by the AI device, showed an average 15% increase in sensitivity for detecting [condition A] and a 5% reduction in reading time per case, compared to reading without AI assistance, while maintaining specificity. The estimated Area Under the Free-Response Receiver Operating Characteristic (FROC) curve, a common metric in MRMC studies, improved from 0.78 (unaided) to 0.86 (AI-aided).
6. Standalone (Algorithm Only) Performance Study (Hypothetical)
- Standalone Study Done: Yes, a standalone performance evaluation was conducted on the full test set (1500 cases) against the established ground truth.
- Standalone Performance Metrics:
- Sensitivity: 92.5%
- Specificity: 85.1%
- F1-score: 0.88
- AUC: 0.93
7. Type of Ground Truth Used (Hypothetical)
- Type of Ground Truth: Expert consensus, established through the 2+1 adjudication process involving three qualified radiologists. In cases where available and relevant, this was supplemented or confirmed by pathology reports or follow-up outcomes data (e.g., surgical confirmation or clinical progression documented over 6 months).
8. Sample Size for the Training Set (Hypothetical)
- Training Set Sample Size: 50,000 imaging studies, collected from a diverse patient population.
9. How Ground Truth for the Training Set Was Established (Hypothetical)
- Ground Truth Establishment for Training Set: The ground truth for the training set was primarily established through a combination of:
- Radiologist Consensus: A larger team of 10 radiologists (separate from the test set readers) annotated the training data. Each image was reviewed by at least two radiologists, with disagreements resolved by an internal consensus committee.
- Clinical Records & Reports: For a subset of cases, ground truth was derived from detailed clinical reports, electronic health records, and existing radiology reports.
- Automated Labeling (with verification): For a large portion of the normal or clearly pathological cases, a pre-existing, highly accurate internal model was used for initial labeling, which was then systematically reviewed and corrected by human annotators to ensure high fidelity. All ambiguous or complex cases were subjected to full manual review by multiple radiologists.
Ask a specific question about this device
(151 days)
Medicatech USA
The MasterX 800 Series is intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the MasterX 800 Series is intended to acquire digital radiographic images on adult and pediatric patients. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.
This device represents a new combination of already cleared solid state digital x-ray acquisition panels and already cleared software. It is suitable for use with adult and pediatric populations. This is an upgrade kit for existing or new systems.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MasterX 800 Series, structured according to your request:
Based on the provided FDA 510(k) Summary, the MasterX 800 Series device is primarily an upgrade kit consisting of a new combination of already cleared digital X-ray acquisition panels and existing software. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria for novel performance claims.
Therefore, the "acceptance criteria" here are implicitly tied to demonstrating safety and effectiveness compared to the predicate, and the "study" is primarily non-clinical validation and integration testing.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for an existing technology combination, explicit quantitative acceptance criteria for new clinical performance aren't stated as they would be for a novel AI device with specific performance metrics. Instead, the "performance" shown is its equivalence to the predicate device and the compliance of its components with relevant standards.
| Acceptance Criteria (Implicit from Substantial Equivalence Goal) | Reported Device Performance | Comments |
|---|---|---|
| Indications for Use: | The MasterX 800 Series has the same Indications for Use as the predicate, with an added mention of "adult and pediatric patients" for clarity. | "Patient population added" is the only comment, implying functional equivalence. |
| Technological Characteristics: | ||
| - Configuration of Digital Panels | Exactly the same as predicate. | |
| - Power Source | Same as predicate, with some models now "AC Line only." | |
| - Digital Panel Models | 8 new models from InnoCare are used, which are "Newer models" but are individually 510(k) cleared. | This is the primary technological difference, but panels are pre-cleared. |
| - Panel Performance (DQE @ 1lp/mm, MTF @ 1lp/mm) | DQE @ 1lp/mm: 50% (same as predicate) | |
| MTF @ 1lp/mm: 63% (predicate was 60%) | "Similar" performance. The new device shows slightly better MTF, which is not a concern for equivalence. | |
| - Interface | Same as predicate. | |
| - Panel Sizes | Same sizes available as predicate. | |
| - X-ray Conversion Layer | Csl or GOS (predicate was Csl only). | GOS is described as "lower cost but has nearly comparable performance", indicating acceptable equivalence. |
| - Active Areas (pixels) | "Nearly identical" to predicate. | Minor variations in pixel counts are presented as substantially equivalent. |
| - Pixel Pitch | 140 μm (same as predicate). | |
| - A/D Conversion | 16 bits (predicate was 14 bits). | "Better" implies an improvement that does not raise new questions of safety or effectiveness. |
| - Image Acquisition Software | "Voyance" (same as predicate). | |
| - DICOM Compliance | DICOM 3 (same as predicate). | |
| Safety and Effectiveness: | Summarized through software validation, risk management, integration testing, and compliance with FDA guidances and standards. | The conclusion states the device is "as safe and effective as the predicate device" and has "insignificant technological differences." No new safety/effectiveness issues were identified. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document states: "Summary of clinical testing: Not required."
- Therefore, there is no clinical test set, sample size, or data provenance from a clinical study. The evaluation relies on non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable as no clinical test set or ground truth established by experts was used for performance evaluation in a clinical context. The evaluation was primarily engineering and regulatory in nature, comparing an assembled system to a predicate device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable as no clinical test set requiring adjudication was used.
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 MRMC comparative effectiveness study was done. This device is an X-ray acquisition system, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable as this is an X-ray acquisition system, not an algorithm being evaluated for standalone performance. The "software" referred to is image acquisition software, which is part of the system operation, not an AI for interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- No clinical ground truth (expert consensus, pathology, outcomes data) was used, as no clinical study was performed. The "ground truth" for the non-clinical testing was defined by engineering specifications, regulatory standards compliance, and comparison to the predicate device's established performance parameters (e.g., DQE, MTF).
8. The sample size for the training set
- No training set is mentioned or applicable, as this device is an X-ray acquisition system and not an AI/machine learning algorithm that requires training data.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set mentioned or used.
Ask a specific question about this device
(48 days)
MedicaTech USA
The MasteRad MX30 is 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, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
This device represents a new combination of already cleared solid state digital x-ray acquisition panels (plus one NEW panel) and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list: Varex PaxScan 2530Wv4, Varex PaxScan 4336Wv4, Varex PaxScan 4343R, Varex PaxScan 4343RC, Varex XRpad 4343F, Varex XRpad 3025, Varex XRpad 4336, Toshiba* FDXA4343R. As compared to our predicate system, the tube stand is floor mounted instead of ceiling mounted. The collimator is different. Instead of the Ralco collimator, a Collimare model is supplied. The purchaser selects one of the following FDA certified models: CML-150-0001-C; CTL-150-0001-C; CML-125-0001-C. The x-ray tube and the high voltage generator remains the same as our predicate. The x-ray tube is a Toshiba model and the generator is the CPI CMP 200DR. The image acquisition software is a newer version of our Voyance software originally cleared in K130377.
The MasteRad MX30 is an X-ray system, and the provided text describes its substantial equivalence to a predicate device (K143257). The acceptance criteria and supporting studies are based on demonstrating that the new device, particularly a new digital X-ray receptor panel, maintains diagnostic quality and safety.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly tied to demonstrating that the new Toshiba FDXA4343R digital panel (and the overall MasteRad MX30 system) performs at least as well as, or equivalently to, the predicate device and the previously cleared Toshiba FDX4343R panel. The primary performance criterion is diagnostic quality of images.
| Acceptance Criteria Category | Specific Metric (Implicit) | Acceptance Standard (Implicit, based on predicate/previous panel) | Reported Device Performance (Toshiba FDXA4343R) |
|---|---|---|---|
| Image Quality | Limiting Resolution | 3.5 Lp/mm typ (from predicate's Toshiba FDX4343R) | 3.7 Lp/mm Max. (Slightly better) |
| MTF (2.0 Lp/mm, 70 kVp, 1x1) | 36 % Typ (from predicate's Toshiba FDX4343R) | 50 % typ (Slightly better) | |
| DQE (0), Quantum-Limited | > 70 % (from predicate's Toshiba FDX4343R) | > 56 % (Typ.) (Not a meaningful difference, found to be of diagnostic quality) | |
| A/D Conversion | 14 bit (from predicate's Toshiba FDX4343R) | 16 bit (Slightly better) | |
| Functional Equivalence | Cycle Time | Shot to Shot 6 sec (from predicate's Toshiba FDX4343R) | Shot to Shot 6 sec (No difference) |
| Clinical Diagnostic Value | Diagnostic image quality | Images found to be of diagnostic quality (for predicate's panel) | Images found to be of excellent diagnostic quality |
| System Safety | Compliance with standards | US Performance Standards, UL 60601-1, IEC 60601-1, IEC 60601-1-2 (for predicate) | Conforms to US Performance Standards and hardware UL Listed to US Standards for safety for medical devices (UL 60601-1). Complies with IEC 60601-1 and IEC 60601-1-2. |
| Software Functionality | Software Validation & Risk Management | Demonstrated for predicate/previous software versions. | Software validation and risk management performed for updated software version. Complies with NEMA PS 3.1 - 3.18 (2009) DICOM. |
2. Sample sized used for the test set and the data provenance
- Sample Size: The document does not specify a numerical sample size for the clinical images beyond stating "Clinical images were acquired from the new Toshiba panel." It implies a sufficient number were obtained for review, but no specific count is given.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the images were "acquired from the new Toshiba panel" for the purpose of this submission, which suggests a prospective acquisition for evaluation, specifically for a new panel not previously cleared by the FDA.
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.
- Qualifications: "A board certified radiologist." No specific years of experience are mentioned.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/None explicitly stated as an adjudication method. The evaluation was performed by a single board-certified radiologist who "reviewed" the images and "found them to be of excellent diagnostic quality." There is no mention of multiple reviewers or a consensus process.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
- AI Improvement Effect Size: Not applicable. This submission is for an X-ray system and its digital detector, not an AI-powered diagnostic tool for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is an X-ray acquisition system, not a standalone algorithm. The "performance" described relates to the imaging capabilities of the hardware component (the digital detector) rather than an interpretive algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type: Expert opinion/evaluation. The ground truth for image quality was established by a single board-certified radiologist's assessment of "diagnostic quality." This is based on the expert's interpretation of whether the images are suitable for clinical diagnosis.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. The document describes the validation of a hardware system and its updated software, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable, as there was no training set for a machine learning model.
Ask a specific question about this device
(85 days)
MEDICATECH USA
The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are intended for use by a qualified/ trained doctor or technician on both adult and pediatic 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. Not for mammography.
This device represents a new combination of already cleared solid state digital x-ray acquisition panels and software with the diagnostic x-ray compnents required to make a complete system. The purchaser may select their digital panel from this list:
- Toshiba wireless flat panel detector (FDX-3543RP, FDX-3543RPW, 14 in. x 17 in.) or Toshiba wired flat panel detector (FDX-4343R, 17 in x 17in). (K130883)
- Vieworks all series: (FXRD-1717SA/SB, or FXRD-1417SA/SB or FXRD-1417WA/WB. (K130337, Medicatech "New Series.")
- PerkinElmer XRpad™ 4336 MED, (K140551).
The purchaser can select either a "C" arm configuration (KrystalRad 1100) or an overhead tube crane configuration (KrystalRad 3000). The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Toshiba (E7252X Series), and the collimator is the Ralco R302A. An IBA kerma meter model 120-131 is supplied.
The provided text describes the KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems. However, it does not contain detailed information regarding the acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods typically found in a clinical study report for AI-powered devices.
This document is a 510(k) premarket notification for a traditional medical device (an X-ray system), not an AI/ML-powered device that requires extensive clinical performance evaluation against specific acceptance criteria. The approval is based on substantial equivalence to a predicate device, meaning it has the same intended use and similar technological characteristics, and that its components have been previously cleared.
Here's a breakdown of the available information based on your request, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical acceptance criteria for a clinical study. The document focuses on demonstrating substantial equivalence to a predicate device. | "The images were found to be of excellent diagnostic quality." (Based on radiologist review) |
Missing: Specific quantitative performance metrics (e.g., sensitivity, specificity, AUC) or defined acceptance thresholds for diagnostic accuracy that would be typical for an AI device.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document states "Clinical images were acquired from each panel".
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: One
- Qualifications of Experts: "a board certified radiologist."
4. Adjudication Method for the Test Set
- Adjudication Method: Implicitly "none," as only one radiologist reviewed the images. There was no consensus or arbitration process mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is more common for assessing the impact of AI on human reader performance.
- Effect size of improvement with AI vs. without AI: Not applicable, as this is not an AI-powered device.
6. Standalone Performance Study (Algorithm Only)
- Was a standalone study done? No. This device is a radiographic system, and its performance is evaluated as an integrated system producing images for human interpretation.
7. Type of Ground Truth Used
- Ground Truth Type: Expert opinion/review ("clinical images... reviewed by a board certified radiologist").
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a traditional X-ray system, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for an AI/ML model.
Summary of Device and Study Context:
The KrystalRad 1100 and KrystalRad 3000 Digital Stationary Radiographic Systems are conventional X-ray machines. Their FDA clearance (K143257) is based on demonstrating substantial equivalence to an existing legally marketed device (Sedecal Nova FA DR System, K133782). The "study" described is a non-clinical bench testing and review of clinical images to ensure the system functions correctly and produces diagnostically acceptable images. It is not a clinical trial designed to establish specific performance metrics against a medical condition, nor does it involve an AI algorithm with training and test sets. The focus is on the safety and effectiveness of the hardware and integrated software for image acquisition, primarily through demonstrating that its components (cleared digital panels, generator, collimator) work together to produce images of "excellent diagnostic quality" as judged by a single radiologist.
Ask a specific question about this device
(92 days)
MEDICATECH USA
Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad "New Series" is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care or trauma work, excluding fluoroscopy, angiography and mammography.
This device represents the combination of already cleared software and already cleared digital receptor panels. This device is a functional replacement for radiographic film. It serves as an upgrade to film based or older digital panel diagnostic x-ray systems. Digital radiography uses digital X-ray sensors instead of traditional photographic film. Advantages include time efficiency through bypassing chemical processing and the ability to digitally transfer and enhance images. Also less radiation can be used to produce an image of similar contrast to conventional radiography. This gives advantages of immediate image preview and availability; elimination of costly film processing steps; a wider dynamic range, which makes it more forgiving for over- and under-exposure; as well as the ability to apply special image processing techniques that enhance overall display of the image.
This document describes the premarket notification (510(k)) for the KrystalRad "New Series" Digital Radiographic Portable Retrofit System. The device is intended as an upgrade for radiographic film-based or older digital panel diagnostic x-ray systems.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly define "acceptance criteria" in a quantitative manner for performance metrics like sensitivity, specificity, or image quality scores. Instead, the demonstration of safety and effectiveness relies on establishing substantial equivalence to a predicate device (KrystalRad 660, K112132). The "acceptance criteria" in this context are primarily the absence of significant differences in technical characteristics and diagnostic quality, and compliance with relevant safety and performance standards.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (KrystalRad "New Series") |
|---|---|
| Intended Use: Acquire digital radiographic images for routine exams, intensive care, trauma (excluding fluoroscopy, angiography, mammography). | SAME as KrystalRad 660, unchanged. (i.e., meets this criterion) |
| Technological Characteristics: Functionality, image acquisition panel specifications (resolution, bit depth), communication, DICOM compliance, electrical safety. | * Functionality: Functionally identical to predicate. |
| * Image Acquisition Panel: Wired panels: 2,560 x 3,072 pixels / 3,072 x 3,072 pixels; Wireless panel: 2,560 x 3,072 pixels; Pitch: 140 µm; Bit depth 14 bit. (Comparable to predicate's 2,400 x 3,000 pixels, 144 µm pitch, 14 bit, with minor improvements in resolution and pitch). | |
| * Communication Standard: IEEE 802.11n (2.4 GHz) or hardwire Ethernet. (SAME as predicate). | |
| * DICOM: DICOM 3. (SAME as predicate). | |
| * Electrical Safety: Electrical Safety per IEC-60601, UL listed. (SAME as predicate). | |
| Image Quality: Diagnostic quality comparable to predicate. | Clinical images were found to be of excellent diagnostic quality and had no significant differences when compared to predicate images. |
| Safety and Effectiveness: No new questions of safety or effectiveness. | Integration testing, bench testing, safety testing, and software validation indicate the new device is as safe and effective as the predicate device. Conforms to US Performance Standards. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document states that "Clinical images were acquired and compared to our predicate images by a board certified radiologist." However, it does not specify the number of clinical images or cases used in this comparison.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely that the images would have been collected in a manner compliant with US regulations, potentially from a US healthcare setting. The term "acquired" suggests prospective collection for the purpose of the comparison, but this is not definitively stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: One (1) board certified radiologist.
- Qualifications of Experts: Board certified radiologist. No further details on years of experience or specific sub-specialty are provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Only one radiologist was used for comparison, so there was no need for an adjudication method. The radiologist directly compared the images from the new device to those from the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improvement with AI vs Without AI Assistance:
- MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not performed, nor was it applicable. This device is a digital X-ray panel and software system, not an AI-assisted diagnostic tool. Its purpose is to acquire and display images, not to interpret them or provide AI assistance to readers. Therefore, there is no AI component for human readers to improve with, and no effect size on human reader performance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Standalone Performance Study: No, a standalone performance study in the context of an "algorithm only" or AI performance was not done, nor was it applicable. The device is a hardware and software system for image acquisition and display, not an AI algorithm. Its performance is assessed through its ability to produce diagnostically acceptable images, not through an independent algorithm's diagnostic accuracy.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" for the clinical image comparison was established by the expert opinion (board certified radiologist), who assessed the "diagnostic quality" and "significant differences" of the images from the new device compared to the predicate device. This is a form of expert consensus, although with only one expert, it's essentially a single expert's opinion. There is no mention of pathology, outcomes data, or other objective measures for ground truth.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: The document does not mention a training set in the context of machine learning or AI development. This device is a digital X-ray system, and its development process, as described, involves engineering and integration of already cleared components. No AI model training is indicated.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set or AI model development.
Ask a specific question about this device
(115 days)
MEDICATECH USA
Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad 660 is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
This device is simply the combination of two cleared devices, the same Wireless Portable Detector as used in the FD-W I (K90062) marketed by Philips Medical Systems and the image processing software cleared in our K080522 DDR MAK Series. Alternately the image processing software is the same as in Omil'ision, K. 100403 made by Modern Module Inc. The Wireless Portable Detector consists of three main parts: Portable in radiography detector (x-ray sensitive part); Docking station which is directly connected to the radiographic workshow and a backup cable which can connect the decector to the docking station if the wireless connection cable which can connect the detector to the docking if the wireless connection cannot be used. Detector size: 35 x 43 cm (14 x 17") Image matrix size: 3000 pixels x 2400 pixels. Pixel size 144 um Image matrix size: 3000 pixels x 2400 pixels. Pixel size: 144 µm, 1mage resolution up to 3.5 LP/mm. The device is intended as an upgrade to existing film x-ray systems. It should be installed by a qualifics trained by a qualifics trained
The KrystalRad 660 Digital Radiographic Portable Retrofit System's acceptance criteria and study details are provided below based on the 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state acceptance criteria in quantitative terms (e.g., minimum sensitivity, fidelity metrics). Instead, it focuses on demonstrating substantial equivalence to predicate devices. The primary performance metric is the qualitative comparison of clinical images and integration testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Clinical images are not significantly different from predicate. | Clinical images acquired were compared to predicate images; no significant differences. |
| Integration testing successfully completed. | Integration testing was performed. |
| Device is as safe and effective as predicate devices. | The new device is as safe and effective as the predicate device. |
| Conforms to US Performance Standards. | The modified device conforms to US Performance Standards. |
| Hardware is UL Listed to US Standards for medical device safety. | The hardware is UL Listed to US Standards for safety for medical devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Clinical images were acquired and compared to our predicate images." However, it does not specify the sample size for the test set (number of images or patients).
The data provenance is not explicitly stated regarding its country of origin or whether it was retrospective or prospective. It only mentions "clinical images were acquired," which could imply prospective acquisition, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the clinical images. The comparison is described simply as "compared to our predicate images," suggesting an internal comparison rather than a formal expert review process for ground truth.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method for the test set. The statement "no significant differences between them" suggests a qualitative assessment without detailing a specific process like 2+1 or 3+1 consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this submission. The study focuses on demonstrating equivalence to predicate devices, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a hardware combination (digital X-ray panel and image processing software). The "performance" being evaluated is the image quality and functionality of this combined system itself. Therefore, the "standalone" performance in this context refers to the system acquiring images, which was done by collecting and comparing clinical images. It's not an "algorithm-only" performance in the sense of an AI diagnostic aid.
7. The Type of Ground Truth Used
The ground truth for the comparison was based on "our predicate images." This implies comparing images from the KrystalRad 660 system to images produced by the previously cleared predicate devices (Philips Wireless Portable Detector FD-W17 K090625 and the image processing software from K080582 DDR MAK Series or K100403 OmniVision). The "ground truth" is therefore the established image quality and clinical utility of the predicate devices.
8. The Sample Size for the Training Set
The device is a combination of two already cleared predicate devices. The "study" described is a comparison and integration test of this combination, not the development or training of a new algorithm. Therefore, there is no specific "training set" mentioned for the KrystalRad 660 as it's not a de novo AI algorithm requiring training. The image processing software itself (cleared under K080582 or K110040) would have had its own validation/training, but details are not provided here for KrystalRad 660.
9. How the Ground Truth for the Training Set was Established
As stated in point 8, there isn't a "training set" for the KrystalRad 660 as a new device. The ground truth for the predicate image processing software or detector would have been established during their original clearance, likely involving various methods (e.g., expert review, physical phantoms for image quality metrics), but these details are not provided in this submission for K112132. The KrystalRad 660 leverages the already established "ground truth" (i.e., safety and effectiveness) of its predicate components.
Ask a specific question about this device
(144 days)
MEDICATECH USA
The KrystalRad 560 (FLAATZ 560) Digital X-Ray System is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).
The KrystalRad 560 (FLAATZ 560) System is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The KrystalRad 560 (FLAATZ 560) device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector Panel is used to capture the image in electronic form.
Once the system captures a radiographic image and subsequently displaying and storing an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a work station. The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network. Hardcopy images can also be made from digital printers, optimizing for the user's preference. The system can have DICOM-compliant output to ensure compatibility with existing imaging network infrastructure.
Here's a breakdown of the acceptance criteria and study information for the KrystalRad 560 (FLAATZ 560) System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes the KrystalRad 560 (FLAATZ 560) as "substantially equivalent" to a predicate device (DRTech FLAATZ 750 system). Acceptance criteria are not explicitly stated as pass/fail thresholds for clinical performance but rather by demonstrating that the new device's performance characteristics (technical specifications) are comparable to or better than the predicate device. The study presented is a comparison to the predicate device, not a standalone clinical trial with specific performance metrics for disease detection.
| Criteria (Technical Specification) | Predicate Device (DRTech FLAATZ 750) Performance | KrystalRad 560 (FLAATZ 560) Performance (Reported Device Performance) |
|---|---|---|
| Panel Shape | Square | Rectangle |
| Detector Size | 42.9 x 42.9 (cm) | 35x43 cm |
| Dimensions (W x L x H) | 482 x 482 x 35 (mm) | 383 X 460 X15mm |
| Pixel Pitch | 168 (um) | 139 um |
| Image Size | 3072 x 3072 (pixels) | 3072 x 2560 pixels |
| Selenium Thickness | 500 (µm) | 500 (µm) |
| Weight (Detector) | 6.2 (kg) | 3.8kg |
| DQE @ 0.5lp/mm | 48.5% | 52.5% |
| MTF @ 3.5lp/mm | 78% | 77% |
| Resolution | 3.6lp/mm | 3.5lp/mm |
| Ghosting @ RQA5 Condition |
Ask a specific question about this device
(144 days)
MEDICATECH USA
The KrystalRAD (ATAL8) Digital X-Ray System is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).
The KrystalRAD (ATAL8) System is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The KrystalRAD (ATAL8) device differs from traditional Xray systems in that, instead of exposing a film and chemically processing it to create a hard convenial 71 a device called a Detector Panel is used to capture the image in electronic form.
Once the system captures a radiographic image and subsequently displaying and storing an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a work station.
The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network.
Hardcopy images can also be made from digital printers, optimizing for the user's preference. The system can have DICOM-compliant output to ensure compatibility with existing imaging network infrastructure.
The provided text describes the KrystalRAD (ATAL8) System, a flat-panel digital X-ray detector, and its 510(k) submission (K102285) for market clearance. The submission relies on demonstrating substantial equivalence to a predicate device, the DRTech FLAATZ 750 (K080064). The acceptance criteria and supporting study are primarily focused on this comparison and general safety/effectiveness rather than a detailed clinical performance study with specific acceptance criteria for a diagnostic task.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly or explicitly based on comparing the KrystalRAD (ATAL8) System's technical specifications and performance metrics directly against its predicate device, the DRTech FLAATZ 750 (K080064). The goal is to demonstrate "substantial equivalence," meaning that the new device is as safe and effective as the legally marketed predicate.
| Metric / Characteristic | Acceptance Criteria (from predicate K080064) | Reported Device Performance (KrystalRAD (ATAL8) System) |
|---|---|---|
| Indication for Use | General radiographic images of human anatomy; replaces film/screen in general diagnostic procedures (excluding fluoroscopic, angiographic, mammographic) | Same as predicate. |
| User Interface | Software Driven Touch Panel LCD + remote control unit + remote console | Same as predicate. |
| Software | ECOM OmniVue | OmniVision |
| Panel Shape | Square | Square Panel |
| Detector Size | 42.9 x 42.9 cm | 43 x 43 cm |
| Dimensions (W x L x H) | 482 x 482 x 35 mm | 500 x 500 x 40 mm |
| Pixel Pitch | 168 µm | 143 µm |
| Image Size | 3072 x 3072 pixels | 3072 x 3072 pixels |
| Selenium Thickness | 500 µm | no selenium |
| Weight (Detector) | 6.2 kg | 12.7 kg |
| Materials | Amorphous Selenium (a-Se) Detector | Amorphous Silicon (a-Si) |
| DQE | 48.5% @ 0.5 lp/mm | 68% @ 0.5 lp/mm |
| MTF | 78% @ 3.5 lp/mm | 52.5% @ 3.5 lp/mm |
| Resolution | 3.6 lp/mm | 3.5 lp/mm |
| Ghosting |
Ask a specific question about this device
(35 days)
MEDICATECH USA
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.
Ask a specific question about this device
(73 days)
MEDICATECH USA
The DDR Digital 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 DDR MAK-800 is the digital panel available alone for upgrading current systems. The DDR MAK-1000 FS is a complete system with a straight tube stand/detector combination. The DDR MAK-1100FA is a complete system with a "C-arm" shaped tube stand/detector combination which permits lateral positioning. These systems have been designed as a direct digital imaging system for use in hospital emergency rooms, imaging centers and all general radiology applications. The C-arm design maintains constant alignment between the x-ray tube and image receptor, regardless of C-arm tilt positions or image receptor angle. Its extraordinary flexibility makes the system ideal for all patients in standing, sitting or laying position, including those who are disabled or physically restricted. The DDR MAK-1100 digital flat panel detector provides advanced technology to capture radiographic images in a digital format almost instantly. The nearly 17 x 17 inch imaging area allows for the capture of chest and abdominal images without having to rotate the detector unit.
The provided text describes a 510(k) submission for a new X-ray system (DDR MAK-800, MAK-1000 FS, and MAK-1100 FA) that combines two previously cleared devices. The submission asserts "substantial equivalence" to predicate devices, focusing on the system's technical specifications and intended use rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a clinical or analytical performance study.
Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes, expert ground truth, adjudication methods, and MRMC studies are not explicitly addressed or applicable in the provided document, as the FDA cleared the device based on substantial equivalence, which primarily relies on technical comparison to predicate devices, and bench, user, and standards testing.
Here's a breakdown of the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as quantitative thresholds for performance metrics. Instead, the acceptance criterion for the submission appears to be demonstrating substantial equivalence to predicate devices in terms of technical characteristics and safety/effectiveness. The "reported device performance" is essentially a comparison of its technical specifications to those of the predicate devices.
| Characteristic | Predicate Devices (K042876 & K062335) | DDR MAK-800/1000 FS/1100 FA (This Submission) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|---|
| Intended Use | General purpose diagnostic X-ray unit | SAME | Same intended use as predicate devices | General purpose diagnostic X-ray unit for skull, spine, chest, abdomen, extremities, and other body parts; adult and pediatric. |
| Image Acquisition | Digital (CANON CXDI-50G, K031447) OR Film | Digital (DRTech Portable Digital Radiographic Detector, K080064) | Digital acquisition equivalent to or better than predicate | Digital acquisition using DRTech Portable Digital Radiographic Detector K080064. |
| Digital Panel Size | Up to 14" x 17" active area (for digital predicate) | 17" x 17" or 14" x 17" | Panel size comparable or larger than predicate | Larger option (17"x17") available, allowing capture of chest and abdominal images without rotating. |
| Digital Resolution | 160 x 160 microns pixel pitch, with approximately 6 million pixels (for digital predicate) | 139 x 139 OR 160 x 160 micron pixel pitch, either 6.8 or 7.8 million pixels. | Resolution comparable or better than predicate | Improved resolution (139x139 micron pixel pitch) and higher pixel count (6.8 or 7.8 million pixels) available. |
| Safety & Effectiveness | As safe and effective as other marketed devices | As safe and effective as predicate devices (based on bench, user, and standards testing) | Demonstrates equivalent safety and effectiveness to predicate | Bench, user, and standards testing indicates the new device is as safe and effective as predicate devices. |
| Technological Differences | None or minor, not raising new safety/effectiveness questions | Few technological differences, no new indications for use | No significant technological differences that raise new safety/effectiveness questions | System combines two cleared devices (K062335 and K080064), resulting in functionally identical performance to K042876. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a performance study with a defined sample size for image analysis or clinical outcomes. The evaluation was based on bench, user, and standards testing, which typically involves testing the physical device, its components, and its adherence to relevant technical standards (e.g., electrical safety, radiation output). Details on the number of units tested, the specific tests performed, or the number of "users" in user testing are not provided.
The data provenance is not specified in terms of country of origin or retrospective/prospective nature, as it's not a clinical study yielding patient data. It's focused on engineering and regulatory compliance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided. The evaluation was not based on expert-adjudicated ground truth image sets for diagnostic accuracy.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable and not provided, as there was no test set requiring expert adjudication for ground truth.
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
An MRMC comparative effectiveness study was not done. This device is a general-purpose diagnostic X-ray unit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an X-ray imaging system, not an AI algorithm. Its performance is tied to image acquisition, not interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically used in diagnostic algorithm evaluation is not applicable here. The ground truth for this submission was the demonstration of the device's technical specifications, safety, and effectiveness through engineering tests and comparison to already-cleared predicate devices and applicable industry standards.
8. The Sample Size for the Training Set
This is not applicable. The device is a hardware system, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set.
Summary of the Study and Conclusion:
The "study" in this context refers to the comprehensive evaluation performed by Medicatech USA to demonstrate substantial equivalence for the 510(k) submission. This evaluation included:
- Bench Testing: Engineering tests to verify technical specifications, safety, and performance of the hardware components.
- User Testing: Likely to ensure the system's usability and interface design met expectations for operators.
- Standards Testing: Verification that the device complies with relevant medical device standards (e.g., electrical safety, radiation emission).
- Comparison to Predicate Devices: A detailed comparison of the new device's technical characteristics (intended use, user interface, maximum output, image acquisition method, digital panel size, digital resolution, method of control, collimator) against two existing legally marketed devices (SEDECAL X PLUS LP PLUS Universal Radiographic Systems K062335 and a version of the DRtech Digital Panel, K080064, which combined functionally result in a device equivalent to Sedecal URS LP X-Ray Units with Digital Detector, K.042876).
The conclusion of this "study" was that the DDR MAK-800/1000 FS/1100 FA Radiographic Systems with Digital Detectors are as safe and effective as the predicate devices, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent. The FDA concurred with this assessment.
Ask a specific question about this device
Page 1 of 1