Search Results
Found 7 results
510(k) Data Aggregation
(216 days)
The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures.
The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces.
The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.
The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.
The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Ultrasound Module provides ultrasonic diathermy intended for:
- Relief of pain
- Muscle spasms
- · Joint contractures
- · NOT for the treatment of malignancies
The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].
The Alma Lasers Accent XL is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.
The provided document describes the Accent XL with the Alma Ultra hand piece and its substantial equivalence to predicate devices, primarily for its ultrasonic diathermy function. The document does not contain information on clinical studies involving human patients, human readers, or a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance. The focus is on technical performance bench testing and regulatory equivalence.
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 are derived from the performance bench testing conducted and comparison to predicate devices, ensuring it meets similar specifications and safety standards.
| Acceptance Criterion | Reported Device Performance (K160075 Accent XL with Alma Ultra handpiece) |
|---|---|
| Ultrasonic Performance (Compared to Predicate K091615 MC1 General Project) | - |
| Ultrasound Frequency | 1MHz (± 20%) |
| Ultrasonic Intensity | 3W/cm² |
| Max treatment time | 30 minutes |
| BNR (Maximum Beam Non-uniformity Ratio) | 6:1 (within range of predicate K952536 Zimmer Sono 5 which is 6:1, and K091615 MC1 General Project which is 4:1) |
| ERA (Effective Radiating Area) | 1.2 cm² (different from predicates (4.9cm² and 5.0cm²), but deemed not to present new safety/effectiveness concerns as parameters are within ranges used by predicate devices) |
| Electrical Safety & EMC | - |
| IEC 60601-1:05+CORR.1(2006)+CORR.2(2007)+A1:12 | Testing performed in accordance with this standard. |
| IEC 60601-1-2:2007 (edition 3.0) | Testing performed in accordance with this standard. |
| IEC 60601-2-5:2009 | Testing performed in accordance with this standard. |
| Biocompatibility | - |
| ISO 10993-5:1999 | Testing performed in accordance with this standard. Patient contacting material previously cleared in K042000 and K141237. |
| ISO 10993-10:1999 | Testing performed in accordance with this standard. Patient contacting material previously cleared in K042000 and K141237. |
| Performance Bench Testing (Temperature) | - |
| Raise skin temperature to 40-45°C | Achieved in less than 15 minutes. |
| Maintain skin temperature at 40-45°C | Maintained for a minimum of 10 minutes. |
| Treat for 30 minutes with no adverse effects | Device capable of this. |
2. Sample size used for the test set and data provenance
The document describes bench testing, not a clinical study on a patient test set. The sample size for the bench tests is not specified, but it refers to physical testing of the device's electrical, thermal, and mechanical properties. The data provenance is from bench laboratory testing conducted by the manufacturer, not from human subjects or retrospective/prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was regulatory submission based on technical compliance and substantial equivalence, not a study requiring expert-established ground truth for a clinical dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was bench testing against predefined technical standards and predicate device specifications, not a study requiring adjudication of clinical findings.
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, an MRMC comparative effectiveness study was not done. This document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical device (ultrasonic diathermy) and does not involve AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance bench testing, the "ground truth" was established by engineering and safety standards (e.g., IEC standards for electrical safety, EMC, and ultrasonic physiotherapy equipment) and comparison to the specifications of legally marketed predicate devices. For the temperature performance, the criteria (e.g., raising skin temperature to 40-45°C in less than 15 minutes) served as the ground truth.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
Ask a specific question about this device
(84 days)
The ACCENTO single laser system is indicated for the following:
755 nm Long pulsed Alexandrite laser
Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions ( such as port of wine stains, hemangiomas, telangiectasias)
Permanent hair reduction is defined as the long term, stable reduction in the number of hairs re-growing when measured at 6, 9,and 12 months after the completion of a treatment regime.
The ACCENTO combined laser system is indicated for the following:
755 nm Long pulsed Alexandrite laser
Temporary hair reduction, Stable long-term or permanent reduction through selective targeting of melanin in hair follicles.
Treatment of benign pigmented lesions. Treatment of Winkles. The photocoagulation of dermatological vascular lesions (such as port of wine stains, hemangiomas, telangiectasias)
1064nm Long pulsed Nd: YAG laser
the removal of un-wanted hair reduction, for stable long term or permanent hair reduction and for treatment of PFB to all skin type Fitzpatrick I-VI including tanned skin. Treatment of Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stain, hemangiomna, warts, telangiectasia, rosacea, venus lake, legveins and spider veins. Coagulation and hemostasis of soft tissue, Benign pigmented lesions such as lentigos (age spot) Solar lentigos ( sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae skin tags, keratoses, tattoo reduction (dart color) and plaques. Pigmented lesions to reduce lesion size and patients with lesions, reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of scar, Treatment of wrinkle.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, 12, months after the completion of a treatment regime
The ACCENTO Dual device are contained two separate laser heads 755nm long pulsed Alexandrite and 1065nm Nd: YAG laser. The output of each laser head is optically combined on the laser rail to delivery same beams path. This single delivery system can obtain either 755nm or 1064nm wavelengths.
The LED touch screen equipped in Control panel to adjust parameters easily Each laser heads has self contained circulation water system to cool system and laser head fully using distilled water at a controlled temperature. The ACCENTO laser system delivers laser energy with various pulse durations from 0.2ms to 350ms. The output of this laser is delivered to the area of treatment by means of lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end.
A trigger switch( Finger or Foots pedal) is used to control the delivery of laser pulse. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be deliver repetitively as long as the switch is depressed at repetition rates up to 10 pulses per second depending on the chosen pulse duration Energy from the laser is directed to the target area via optical fiber handpiece.
The Dynamic Cooling system provides a short burst of Cryogen spray prior to firing the laser pulse. The Energy is delivered via optical fiber to handpiece with a spot size 2, 3, 5, 8,10,12,18, 20mm diameter circular beam on the skin. Operator may select parameters as desired fluence and repetition rate, and operated using touch screen and display panel
This device consist of
Power supply and modulator system Optical laser Hand pieces and delivery system Circulator system Software control system, Dynamic cooling system, LED control panel
ACCENTO single device are contained 750nm Alexandrite laser only, and provided it optionally to treat related indication.
This device also equipped with safety interlock systems to protect patients and user
The provided document is a 510(k) premarket notification letter from the FDA to Bison Medical Co Ltd regarding their ACCENTO Dual/single Laser. This document is a regulatory approval and does not contain the results of a study proving the device meets specific acceptance criteria in the way a clinical trial report would.
Here's why and what information can be extracted:
- No Acceptance Criteria or Performance Study: The letter explicitly states: "Clinical and Non-Clinical performance test data was not provided in this submission." (Page 5, Section 6). This means there is no study described within this document showing the device's measured performance against a set of acceptance criteria.
- Basis for Clearance: The device received clearance based on substantial equivalence to a predicate device (K130199 CLARITY LPC Lutronic Corp). Substantial equivalence means the new device is as safe and effective as a legally marketed device. This often relies on design, technological characteristics, and intended use being similar, along with adherence to recognized safety standards.
- Mentioned Standards: The document lists several standards the device was manufactured in accordance with (IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1). These are safety and electromagnetic compatibility standards, not performance criteria for therapeutic efficacy.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document because that information is not present.
However, I can provide information relevant to your other points by indicating what is not present or by describing the basis for clearance:
1. Table of Acceptance Criteria and Reported Device Performance
- Not provided in this document. The submission explicitly stated that "Clinical and Non-Clinical performance test data was not provided in this submission." The device was cleared based on substantial equivalence to a predicate device, not on direct performance data against specific acceptance criteria presented here.
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable/Not provided: No test set data or sample size information is available in this document as performance data was not submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable/Not provided: No test set was detailed in this filing.
4. Adjudication Method for the Test Set
- Not applicable/Not provided: No test set was detailed in this filing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: A MRMC study was not described or required for this 510(k) clearance, as clinical performance data was not provided.
6. Standalone (Algorithm Only) Performance Study
- No: This device is a laser surgical instrument, which does not involve an algorithm for standalone performance evaluation in the typical sense (e.g., AI diagnostics). Performance data, generally, was not provided.
7. Type of Ground Truth Used
- Not applicable/Not provided: As performance data was not submitted, no ground truth was established or used in this filing. The clearance hinged on substantial equivalence to a predicate device.
8. Sample Size for the Training Set
- Not applicable/Not provided: This document relates to a physical laser device and its regulatory clearance; it does not involve training sets as would be used for AI/machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided: This document does not describe a training set or its ground truth establishment.
Ask a specific question about this device
(110 days)
The Accent™ device is intended for use in dermatologic and general surgical procedures.
The Accent™ device is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids using combined treatment with UniPolar and BiPolar.
The Alma Lasers Accent™ device is comprised of the following main components:
- Main console containing the major electrical components, including the: .
- Control Panel; A
- Radiofrequency (RF) Module; A
- a Power Supply Module;
- Service Panel; A
- A Cooling Module;
- A Handpiece holders;
- A Emergency stop push button;
- A Key switch;
- A RF energy emission visual and audio indicators;
- A Connector ports for the handpieces and power cord:
- A Main circuit breaker; and
- UniPolar (i.e., monopolar) and Bipolar Handpieces incorporating:
- Treatment tip with thermoelectric cooling (TEC) for cooling the treatment ア site during use for patient comfort;
- A Handpiece trigger;
-
Umbilical connection to the main console; and
- Accessories:
- A Cart:
- Water Filling Kit;
- 0 Non-contact thermometer.
The Alma Lasers Accent™ is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.
This document is a 510(k) premarket notification for the Alma Lasers Accent™ device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or the details of a study demonstrating the device meets such criteria in terms of quantitative performance metrics.
The provided text states:
- "Clinical information was provided to demonstrate safety and effectiveness."
- "Clinical information demonstrating the safety and effectiveness of the Alma Lasers Accent™ device for the non-invasive treatment of wrinkles and rhytids was provided."
This suggests a clinical study was performed, but the details of that study, including acceptance criteria and reported performance, are not present in this 510(k) summary. FDA 510(k) summaries often only provide a high-level overview.
Therefore, I cannot populate the table or answer the specific questions below with the provided information.
Based on the provided text, the following information is NOT available:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on establishing "substantial equivalence" to existing predicate devices for regulatory clearance, rather than presenting a detailed performance study with quantitative acceptance criteria.
Ask a specific question about this device
(37 days)
The LAR Manufacturing, LLC Orthodontic Ceramic Brackets are indicated for orthodontic movement of teeth.
LAR Manufacturing, LLC Ceramic Brackets are available if the following prescriptions: Exceed Series Brackets Roth .018" & .022" Slot Sizes Accent Series Roth .018" & .022" Slot Sizes; Edgewise .018" & .022" Slot Sizes; Ricketts .018" Slot Size; Bio-Progressive/Hilgers .018" & .022" Slot Sizes The Exceed Series and Accent Series Ceramic Brackets are produced using Al2O3, translucent polycrystalline aluminum oxide (99.9%). These Ceramic Brackets are bonded to the teeth with commercially available materials and linked together by "archwire" that applies steady, gentle pressure to produce desired tooth movement.
This 510(k) premarket notification is for orthodontic ceramic brackets and does not describe software or AI. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies related to AI performance.
The submission focuses on demonstrating "substantial equivalence" to a predicate device (Mystic Orthodontic Ceramic Brackets, K042178), primarily through material composition and intended use.
Here's why the requested information cannot be extracted from this document:
- No AI/Software Component: The device is a physical, non-digital orthodontic bracket. The concepts of acceptance criteria for AI performance (like sensitivity, specificity, AUC), training/test sets, ground truth, or multi-reader studies are not applicable.
- Substantial Equivalence Pathway: 510(k) submissions, especially for devices like this, typically rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics (materials, dimensions, manufacturing processes) and intended use, rather than conducting new clinical performance studies that would generate the kind of data you're asking for.
If this were a 510(k) for a medical device software with an AI component, the document would contain sections detailing performance metrics, validation studies, and possibly human-in-the-loop evaluations. This particular document however, does not.
Ask a specific question about this device
(70 days)
The Accent Sensor is a digital x-ray sensor system for human and non human use in dental, medical and veterinary applications. It is used to provide instant Xray images, typically of teeth, bone and surrounding tissues. Accent replaces standard X-ray film and/or phosphor plate technology.
The X-ray tube (not part of this product) is pointed at the sensor and activated. The X-ray energy is detected by the sensor and transmitted as data to the computer to which it is connected. The software (not part of this product) interprets the image as a gray scale image and displays it on the computer monitor for diagnosis.
This document is a 510(k) premarket notification letter from the FDA for a device named "Accent," an extraoral source x-ray system. The letter discusses the substantial equivalence of the device to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, device performance, sample sizes used in studies, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth sources, or training set details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory approval letter, not a study report or a summary of performance data.
Ask a specific question about this device
(78 days)
ACCENT™ is a computerized tissue segmentation device intended for use in conjunction with magnetic resonance (MRI) imaging data to identify similar tissue types. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. ACCENT can also be used to provide accurate and reproducible measurements of the longest diameter and volume of identified tissue. Patient management decisions should not be made based solely on the results of ACCENT analysis.
The ACCENT device relies on the assumption that pixels having similar MR signal intensities represent similar tissues. The ACCENT software simultaneously analyzes the pixel signal intensities from multiple MR sequences and applies multivariate pattern recognition methods to perform tissue segmentation and classification.
The ACCENT system consists of proprietary software developed by Confirma installed on an off-the-shelf personal computer and a monitor configured as an ACCENT display station.
This is a 510(k) premarket notification for the ACCENT device, which means the device is seeking substantial equivalence to existing predicate devices rather than proving de novo safety and effectiveness. As such, the submission primarily focuses on comparing the new device's intended use, design, function, and performance characteristics to those of predicate devices already on the market.
Therefore, the provided text does not contain information about a dedicated study proving that the device meets specific acceptance criteria. The document states that the software has been designed, developed, tested, and validated according to internal procedures, and a hazard analysis was performed. However, it does not explicitly detail a clinical or performance study with defined acceptance criteria and corresponding results.
Here's a breakdown of the information that is present, and what is missing, based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission is a 510(k) aiming for substantial equivalence to predicate devices, not a demonstration of meeting predefined performance acceptance criteria through a specific study in the detailed manner you've requested.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. No specific test set or data provenance is mentioned.
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)
This information is not provided in the document. Since no specific test set is detailed, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is mentioned as there is no detailed test set described.
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
There is no mention of an MRMC comparative effectiveness study in the provided text. The device's intended use states it "provides information that may be useful in screening and diagnosis" and "Patient management decisions should not be made based solely on the results of ACCENT analysis," implying it's an assistive tool, but no study on human reader improvement is presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly stated as a formal standalone performance study with specific metrics. The device is described as "computerized tissue segmentation device" that "simultaneously analyzes the pixel signal intensities... and applies multivariate pattern recognition methods to perform tissue segmentation and classification." While this describes the algorithm's function, there's no dedicated study or reported performance metrics for its standalone accuracy without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. No specific ground truth methodology is described.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
In summary: The provided 510(k) submission for the ACCENT device focuses on establishing substantial equivalence to predicate devices rather than detailing a specific performance study with acceptance criteria, expert adjudication, or ground truth establishment. Therefore, most of the requested information regarding experimental design, sample sizes, and performance metrics is absent from this document.
Ask a specific question about this device
(87 days)
The ACCENT systems are mobile image-intensified fluoroscopic x-ray systems, intended for use in general surgical procedures such as orthopedics, traumatology, visceral surgery, pacemaker implants, urology, etc. or other interventional procedures.
The ACCENT system is composed of: a mobile C-Arm that includes: an image intensifier with CCD video camera, an x-ray generator and controller, an x-ray tube mounted in the same housing as the x-ray generator, a beam-limiting device, optional: a Laser beam alignment device, optional: a dose area product meter and display. and a monitor cart that includes: TV monitors, an image digital processing and storage system, may be of different models, optional: VCR and video printers.
The provided text is a 510(k) summary for the ACCENT Mobile X-ray System, which is a premarket notification to demonstrate substantial equivalence to legally marketed predicate devices. It does not describe a study to prove the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity for a particular clinical task. Instead, it focuses on demonstrating that the device is safe and effective by complying with established standards and being substantially equivalent to existing devices.
Therefore, many of the requested sections about acceptance criteria, study design, and ground truth establishment are not applicable to the information contained in this 510(k) summary.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a new algorithm or diagnostic aid. Instead, it refers to compliance with safety and performance standards relevant to X-ray systems.
| Acceptance Criteria (Compliance/Safety Standards) | Reported Device Performance/Compliance |
|---|---|
| All construction and materials compliant with UL 2601-1, and IEC 601-1 equipment standards. | Compliant: "All construction and materials are compliant with UL 2601-1, and IEC 601-1 equipment standards." |
| Design meets or exceeds standards set forth in UL 2601-1 and IEC 601-1. | Meets/Exceeds Standards: "The design meets or exceeds standards set forth in UL 2601-1 and IEC 601-1." Additionally, includes "hardware redundancies to prevent single point failures (such as x-ray emission and C-Arm motion)". |
| Exposure levels comply with 21CFR 1020.30 - 31 - 32. | Compliant: "Systems comply with the requirements of 21CFR 1020.30 - 31 - 32." Specifics include: Maximum rated peak tube potential: 110 kV, Fluoroscopic Entrance Exposure Rate (EER): less than 10 R/min., Radiography: 160 mAs maximum, manual setting. |
| Controls for potential hazards (x-ray, mechanical, electrical). | Controlled: "The potential hazards (x-ray, mechanical and electrical) are controlled by compliance with the federal x-ray standard, adherence to industry standards (UL 2601-1) and with the recommendations of other industry experts as described in the labeling." |
| Substantial Equivalence to Predicate Devices (STENOSCOP 2, Model 6000 and 9000). | Substantially Equivalent: "The ACCENT systems are substantially equivalent to the above listed devices. The energy source, exposure levels and principles of operation are very similar." The device performs the same functions and replaces the listed units. (This is the primary "acceptance criterion" for a 510(k) pathway, rather than a clinical performance study). |
2. Sample size used for the test set and the data provenance:
- Not Applicable: This document does not describe a performance study with a test set of patient data. The evaluation is based on engineering compliance and substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: No ground truth was established from clinical experts for this type of submission.
4. Adjudication method for the test set:
- Not Applicable: No test set or adjudication process for clinical outcomes is described.
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: This device is a mobile X-ray system, not an AI-powered diagnostic aid. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This device is hardware (X-ray system), not an algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable (in the context of clinical ground truth): The "ground truth" for this submission would be regulatory standards and the specifications of predicate devices, against which the ACCENT system's design and operating parameters were compared.
8. The sample size for the training set:
- Not Applicable: There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable: No training set was used.
In summary: The provided text is a regulatory submission demonstrating the safety and effectiveness of a mobile X-ray system through compliance with established engineering and radiation safety standards, and by demonstrating substantial equivalence to legally marketed predicate devices. It does not contain information about a clinical performance study with defined acceptance criteria, test sets, or ground truth as would be associated with a new diagnostic algorithm or AI-enabled device.
Ask a specific question about this device
Page 1 of 1