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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.

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.

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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.

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The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic 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 handpieces.

The massager component of the Alma Lasers Accent UniForm Handpiece 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 Alma Lasers Accent Elite system similar to Accent™ RF Systems [Accent, Accent XL } is comprised of the following main components:
. Console
a Bipolar RF module
A Unipolar RF module (UniLarge)
A UniForm (RF and Massage) module
. Control panel
Footswitch. .
Modules are used to deliver radiofrequency energy to the treatment site. Each RF module consists of the following components:
. Handle - used for holding the module
. Trigger - activates the radiofrequency energy emission when pressed in Ready mode
Applicator tip establishes contact with the patient's skin .
. Thermoelectric cooler - integrated within the module, provides internal module cooling
. RF emission indicator - blue LED illuminates prior to- and during RF emission
Umbilical cable contains coolant tubes. RF-power cable and the communication . cable that controls the operation of the module
. Module connector - connects the module to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip which stores information about the module and the parameter settings.
The UniForm module additionally employs a massaging mechanism that works in conjunction with the RF energy application.
The Accent Elite is a computerized system with embedded software that controls its operation. The software also runs the graphical user interface, which enables user-friendly control of the system operation.

The provided document is a 510(k) summary for a medical device (Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite]), seeking substantial equivalence to predicate devices. It does not describe or conduct a study involving acceptance criteria and reported device performance in the way typically associated with clinical trials or AI/algorithm evaluation.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared devices based on technical characteristics and safety performance testing rather than clinical efficacy studies with specific performance metrics against a defined ground truth.

Therefore, many of the requested elements for describing an acceptance criteria study and the methodology behind it (like sample size, data provenance, expert ground-truthing, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.

However, I can extract the information that is present concerning the rationale for substantial equivalence and the listed safety performance testing.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance Study Information

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome. Instead, the "acceptance criteria" for this submission are compliance with recognized safety standards and demonstration of substantial equivalence in technical characteristics.

The results of the performance testing showed compliance with these standards. |
| Clinical Equivalence (Implicit) | Based on the above, the device is considered "safe and effective, and performs at least as safely and effectively as the predicate Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL] for the intended use and indications." (This is a conclusion drawn from the technical and safety equivalence, not from a comparative clinical efficacy study provided in this summary). |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. This document does not describe a clinical performance study with a test set of patient data. The "performance testing" refers to engineering and electrical safety standards compliance.

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 / Not Provided. No clinical ground truth was established for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. No clinical test set or adjudication method 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 / Not Provided. This device is an RF system for dermatologic/surgical procedures, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable / Not Provided. This device does not feature an algorithm for standalone performance evaluation in the context of AI or diagnostic systems.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided. The "ground truth" for this submission relates to compliance with engineering safety standards and established technical specifications, not clinical outcomes or expert consensus on a diagnostic task.

8. The sample size for the training set

• Not Applicable / Not Provided. This device is not an AI/machine learning system, so there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided. No training set exists.

Summary of the Study (as described in the 510(k) Summary):

The "study" described in this document is a regulatory submission demonstrating substantial equivalence rather than a clinical performance study measuring specific outcomes. The primary "studies" conducted were non-clinical performance testing to ensure safety and compliance:

• Type of Study: Non-clinical performance testing for electrical safety and electromagnetic compatibility.
• Purpose: To demonstrate that the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] is as safe and effective as its predicate devices, primarily through compliance with international standards (IEC 60601 series).
• Methodology: The system was tested against the requirements of IEC 60601-1-2: 2004 (electromagnetic compatibility), IEC 60601-1:1988 with amendments (general safety), and IEC 60601-2-2:2006 (particular requirements for high-frequency surgical equipment).
• Conclusion: The tests demonstrated compliance with these standards, supporting the conclusion of substantial equivalence to the predicate devices. This equivalence is based on the device sharing the same intended use, indications for use, operation principle, and similar technical and functional capabilities, alongside meeting safety criteria.

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Intended Use: The Accent UniForm Massager handpiece/module is intended to be used with the Alma Lasers Family of Accent™ RF Systems for use in dermatologic and general surgical procedures.

Indications for Use: The massage component of the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: Temporary reduction in the appearance of cellulite. Simultaneous application of RF energy and mechanical manipulation of the skin by the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: Temporary reduction in the appearance of cellulite.

The Accent UniForm Massager handpiece/module is a cleanable, reusable radiofrequency (RF) energy delivery and skin mechanical manipulation/massage device (accessory) intended for use with the Alma Lasers Family of Accent RF Systems. The Accent UniForm Massager handpiece/module is comprised of the following main components: Handpiece Tip with Massage Ring, Handpiece Body (Handle used for holding the handpiece, A RF emission indicator - blue LED illuminates prior to- and during the RF energy emission, A Thermo-electric cooler - integrated within the handpiece, provides contact cooling, A Umbilical cable - contains hot and cold water tubes (cooling system), RF-power cable and the communication cable that controls the operation of the handpiece, A Handpiece connector - connects the handpiece to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip (i-button) that stores information about the handpiece and the parameter settings. It also houses the water tube quick-connectors.)

The provided text is a 510(k) summary for the Alma Lasers Accent UniForm Massager Handpiece/Module. It establishes substantial equivalence to predicate devices and describes the intended use and indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document states:
"The review of the indications for use and technical characteristics provided demonstrates that the Accent UniForm Massager handpiece/module is substantially equivalent to the predicate devices."
And:
"The Accent UniForm Massager handpiece/module was found to be substantially equivalent to the predicate devices."

This indicates that the submission relies on demonstrating similarity to already approved devices rather than presenting a de novo study with specific performance metrics and acceptance criteria. Therefore, I cannot extract the requested information from the provided text.

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The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is intended for use in dermatologic and general surgical procedures.

The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the non-The Alma Baser Painty of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.

The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is comprised of the following main components:

• Console .
• A Bipolar RF handpieces (normal and small-tip)
• A Unipolar RF handpieces (normal and unilarge)
• Control panel .
• Footswitch. .

This document is a 510(k) summary for the Alma Lasers Family of Accent™ RF Systems and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or the methodology of an AI-powered system.

However, based on the provided text, I can infer the acceptance criteria and the study done from the perspective of a 510(k) submission, not from a clinical performance study.

Acceptance Criteria and Reported Device Performance (from a 510(k) perspective):

Based on the provided document, the following information regarding acceptance criteria and a study to prove device performance is either not applicable (for an AI diagnostic device) or not present:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a traditional medical device (RF system) rather than an AI-powered diagnostic device. The submission focuses on device equivalence, not clinical performance data in this manner.
2. 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. Ground truth as typically defined for AI diagnostic performance studies is not relevant here.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 not an AI diagnostic tool and does not involve human readers interpreting AI output.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a 510(k) submission of this nature is primarily the established performance and safety of the predicate device.
7. The sample size for the training set: Not applicable. This device does not use a training set as an AI algorithm would.
8. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" (from a 510(k) perspective):

The "study" presented here is a 510(k) premarket notification to demonstrate substantial equivalence of the Alma Lasers Family of Accent™ RF Systems (specifically Accent XL) to its predicate device, the Alma Lasers, Ltd. Accent™ (K070004).

• Type of Study: Regulatory submission (510(k) to establish substantial equivalence).
• Methodology: Comparison of the new device (Accent XL) against a legally marketed predicate device (Accent™) based on:
  • Indications for Use
  • Device Operation
  • Technical and Functional Capabilities
• Conclusion: The Accent XL™ RF device was found to be substantially equivalent to the predicate Accent™ system because it shares "the same or similar indications for use, similar design features, and functional features."

In essence, this document is a regulatory filing for a non-AI medical device; therefore, many of the requested details pertaining to AI performance studies are not relevant nor included.

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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.

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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.

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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.

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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.

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The Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. When used in conjunction with the Rapidpoint Coag and the Heparin Management Panel Cards (Heparin Management Test, Heparin Titration Test, and Protamine Response Test) Cards, its intended use is to generate information on heparin management.

The Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. The Analyzer is a point of care instrument designed to determine hemostatic parameters of blood and plasma samples. The Accent works in conjunction with the Analyzer to provide dosing information for heparin and protamine during cardiopulmonary bypass procedures. The Accent determines this information by combining test results from the Analyzer with patient data entered into the Accent by the user. During the course of a CPB procedure, the user must perform a series of tests using the Analyzer, The test cards that must be used include the Heparin Management Test (HMT™), the Heparin Titration Test (HTT™), and the Protamine Response Test (PRT™). The results of these tests provide the Accent with information on how the patient's blood will respond to the addition of Heparin and Protamine. The Accent uses this information to calculate recommended dosages of Heparin or Protamine to be given to the patient to reach a target value entered into the Accent by the user. The target value may be either a heparin concentration or a clotting time.

The Accent includes an eight-inch diagonal touch screen for user interface and a built in printer for recording test results. The case is designed with a protective front cover that doubles as a holder for the Analyzer when the system is in use. The Accent is powered by an internal power supply that also orovides power to the Analyzer. The Accent and the Analyzer communicate through a serial cable that must be plugged into the Analyzer and is permanently attached to the Accent.

The HTT card provides a method to determine the response of a patient to heparin. Before heparin administration, baseline Heparin Management Test (HMT) and HTT values are determined for the patient with the Rapidpoint" Coag (formerly TAS) Analyzer. Using these values, the Rapidpoint ACCENT will calculate the dose of heparin necessary to produce a desired concentration or effect of this drug in the patient's blood. Both citrated or noncitrated whole blood samples can be used for these tests.

The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to program the instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample is drawn into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time.

The PRT card is made for use with citrated or noncitrated blood samples containing heparin. The PRT is a modification of the HMT card and consists of a single test card that contains calcium chloride to initiate coagulation in citrated blood samples, celite as activator, stabilizers. and protamine sulfate. The test results will depend on heparin activity in the blood, which in turn depend on the levels of heparin, of coagulation factors, and of heparin inhibitors in the sample. The higher the level of heparin activity, the greater the protamine sulfate dosage required to inhibit it. The results of the PRT card are used with values produced on HMT cards with samples taken just before protamine administration, to determine the response of the individual to the agent. The values are stored by the ACCENT, which performs the calculations to determine dose recommended to neutralize the heparin present in the patient.

The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to program the instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample is drawn into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Rapidpoint Accent, Heparin Titration Test (HTT) Card, and Protamine Response Test (PRT) Card:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly state quantitative acceptance criteria in a pass/fail format. Instead, the studies aim to demonstrate "substantial equivalence" to predicate devices. For both the HTT and PRT cards, the key outcome measured was the calculated heparin/protamine dosage, and the acceptance criterion was "No significant differences (p = ≥0.05) in dosage were observed between the two systems by ANOVA testing."

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