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The GD-P-E Enhanced Handheld Pain Relief Laser Instrument generally indicated:

• adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin;
• adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS)

The GD-P-E Enhanced Handheld Pain Relief Laser Instrument consists of a LCD, button, battery, power charger jack. Accessories include a power cords, a power adapter. It is a handheld, non-invasive, non-heating infrared cold laser instrument designed to be used as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. A key feature of the device is its ability to produce multiple laser wavelengths (808nm and 650nm).
A key feature of the device is its ability to emit dual laser wavelengths (808nm and 650nm), providing targeted low-level light therapy to the affected area. This "cold" laser therapy enables body tissue to absorb the light, facilitating a temporary reaction within the cells that promotes minor pain relief.

The provided FDA 510(k) summary (K241057) for the "Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)" does not include information about acceptance criteria and a study proving device performance in the context of AI/ML or clinical efficacy.

This document is primarily focused on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and compliance with recognized standards. It explicitly states: "No clinical study is included in this submission." and "Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA guidance 'Content of Premarket Submissions for Device Software Functions'".

Therefore, I cannot extract the requested information regarding acceptance criteria and a study that proves the device meets them from the provided text for the following reasons:

• No clinical study: The document explicitly states that no clinical study was included in the submission. This means there is no data on human patient outcomes or diagnostic performance against a ground truth.
• Focus on substantial equivalence: The primary aim of this 510(k) is to show that the new device is as safe and effective as previously cleared predicate devices through technical comparisons and non-clinical testing, not to provide novel clinical performance data.
• Device type: The device is an "Infrared Lamp" (a physical medical device), not an AI/ML imaging analysis or diagnostic software device, which would typically involve the type of acceptance criteria and studies you are asking about (e.g., sensitivity, specificity, reader studies, etc.). The software validation mentioned is likely for the control functions of the laser device, not for an AI/ML diagnostic or assistive function.

The "Performance Testing" section refers to compliance with electrical safety, EMC, and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-1-11) and verification of output parameters (wavelengths, power, energy fluence, irradiance, beam focus, and energy distribution). These are technical acceptance criteria for the device's physical and electrical characteristics, not clinical performance or AI performance.

Without a clinical study or an AI/ML component seeking to demonstrate clinical or diagnostic performance, the questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to the information provided in this 510(k) summary.

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Therapy EC and Therapy XT are non-heating infrared lamps and are indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

Therapy EC and Therapy XT are made up of ergonomic equipment that is easy to use and operate. They have one infrared laser diode (808nm). Two optical fibers conduct the laser light emitted by each emitter. The optical power emitted is controlled by the electrical current in the laser diodes. Therapy EC and Therapy XT are designed to emit infrared laser light. Additionally, they are intended to be used by health care professionals such as physicians, nurses, and physical therapists, for adjunctive use in the temporary relief of hand of wrist pain associated with Carpal Tunnel Syndrome. Therapy EC and Therapy XT are consisted of components including handpiece holder, battery charging cable, battery, spacer (3 units), safety glasses, eye protector, and transportation case. The only part that touches the patient is the spacer. This component is made of polycarbonate and has the function of creating a safe distance between the Therapy tip and the patient's skin.

The provided FDA 510(k) summary for the "Therapy EC and Therapy XT" infrared lamps does not contain information related to acceptance criteria, device performance, or human subject studies.

The document states that "Substantial equivalence of the subject device to the predicate has been established through the results of nonclinical testing." This means that the FDA cleared the device based on engineering and safety tests, and a comparison to a previously cleared predicate device, rather than explicit clinical efficacy studies for the specific device being submitted.

Therefore, I cannot provide a response to your numbered questions regarding acceptance criteria, study details, human subject data, or ground truth, as this information is not present in the provided text.

The "Non-clinical Performance Testing" section lists various IEC and ISO standards that the device complied with, focusing on laser safety, electrical safety, and software lifecycle processes. These are engineering and quality standards, not clinical performance metrics.

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The Erchonia® FX-405 laser is generally indicated:
a. while using the red and violet diodes, for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.
b. and while using the red diodes, as an adjunctive treatment of postoperative pain.

Erchonia® FX-405 is low level laser system that uses three semi-conductor diodes (visible light) 630nm to 650nm with a mean power output of 17.25mW per diode and one semi-conductor diode 400nm to 410nm with a mean power output of 23.00mW. The Erchonia®FX-405 is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 has been classified by the FDA/EC as a Class II device and a Class 2 Laser. The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The device has an adjustable main arm that is attached to the mobile baser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered utilizes internal mechanics that collects the light emitted from each of the four (4) laser diodes and processes each through a proprietary patented lens which redirects the beam with a line refracted light is then bent into a spiraling circle pattern that is totally random and independent of the other diodes. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the four (4) laser output heads to be rotated, titled, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended. The exterior materials consist of 6061 T6 AL, Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish.

The provided text does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria. Instead, it describes a 510(k) premarket notification for the Erchonia FX-405, where substantial equivalence to predicate devices is established.

The document highlights the device's characteristics and compares them to existing cleared devices (Erchonia FX-405, K212595 as primary predicate, and Erchonia XLR8, K211186 as secondary predicate) to demonstrate that the new device is as safe and effective.

Here's an analysis of the information that is not present in the provided text, based on your request:

1. Table of acceptance criteria and reported device performance: This is not present. The document focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific performance metrics against pre-defined acceptance criteria.

2. Sample size used for the test set and data provenance: No clinical test set data is presented in this 510(k) summary, as stated in the "Performance Testing-Clinical" section: "No clinical data was used to establish Substantial Equivalence."

3. Number of experts used to establish ground truth and qualifications: Not applicable, as no clinical test set with ground truth was used for this submission.

4. Adjudication method for the test set: Not applicable, as no clinical test set with ground truth was used.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned and not performed, as no clinical data was used for substantial equivalence.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable. The Erchonia FX-405 is a physical laser device, not an AI algorithm.

7. Type of ground truth used: Not applicable, as no clinical test set requiring ground truth was used.

8. Sample size for the training set: Not applicable, as this is a physical device and not an AI/machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as this is a physical device and not an AI/machine learning algorithm.

Summary of available information related to performance and equivalence:

The document states that "No clinical data was used to establish Substantial Equivalence." Instead, the submission relies on a comparison of technological characteristics with predicate devices and compliance with voluntary and performance standards.

The device is substantially equivalent to the primary predicate device (Erchonia FX-405, K212595) because it is described as the "exact same model." For the secondary predicate (Erchonia XLR8, K211186), equivalence is established by comparing technical specifications:

• Wavelength, Energy Source, Mechanism of Action: Identical to the secondary predicate (Erchonia XLR8).
• Number of Diodes, Power, Total Joules Per Minute: Differences are deemed "negligible" and not affecting safety or effectiveness when applied over the treatment area.
• Recommended Treatment Duration: Same for the Indications for Use (IFU) regarding postoperative pain.
• Energy Delivery & Target Size: Differences in floor model vs. handheld, and electronically scanned vs. manually scanned, are stated not to change the physiological mechanism or affect safety/effectiveness.
• Indications for Use: The subject device's indication for adjunctive treatment of postoperative pain (using red diodes) is identical to one of the XLR8's indications. The added indication for nociceptive musculoskeletal pain (red and violet diodes) is covered by the primary predicate.

Performance Data (General Compliance, not specific acceptance criteria):

• Compliance with Voluntary Standards: IEC 60601-1-2:2014 Edition 4.0, IEC 60601-1:2005 Edition 3.1, IEC 60825-1:2014 Edition 3.0.
• Performance Standards: Complies with FDA's performance standards for light-emitting products (21CFR 1040.11 by Laser Notice #50).
• Software: Software verification and validation testing conducted, classified as "minor" level of concern. No patient data storage, no cybersecurity risk of safety or effectiveness, no wireless interfaces.
• Biocompatibility: Not applicable, as the device does not contact patient skin or tissue.
• Sterilization and Shelf-Life: Not provided sterile; device is electro-mechanical, components will not degrade during storage.

Therefore, the "study" referred to in the prompt is essentially the technical comparison and compliance with standards presented in the 510(k) summary, rather than a clinical trial or performance study against specific acceptance criteria.

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The FibroLux is indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia.

Not Found

This is a 510(k) clearance letter for a medical device called FibroLux, an infrared lamp indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia. This document does not contain the kind of detailed performance study information typically provided for AI/ML-based medical devices or diagnostic tools.

Therefore, I cannot provide answers to most of your requested points because the information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on a detailed performance study with acceptance criteria and ground truth analysis.

Here's what I can extract and state based on the provided text, and where I must indicate that the information is "Not Available in the provided text":

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

   • Acceptance Criteria: Not Available in the provided text.
   • Reported Device Performance: Not Available in the provided text. The device received 510(k) clearance based on substantial equivalence to a predicate device, not on specific performance metrics outlined in this document.

2. Sample size used for the test set and the data provenance: Not Available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Available in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Available in the provided text.

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 Available in the provided text. This is not an AI-based device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not Available in the provided text. This is not an AI-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not Available in the provided text.

8. The sample size for the training set: Not Available in the provided text.

9. How the ground truth for the training set was established: Not Available in the provided text.

Summary of what is available:

• Device Name: FibroLux
• Indication for Use: "The FibroLux is indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia."
• Regulatory Clearance: 510(k) clearance (K212189) based on substantial equivalence to a predicate device.
• Device Type: Infrared Lamp (Product Code: NHN)
• Regulatory Class: Class II
• Type of Use: Prescription Use

The provided document is a regulatory communication, not a clinical study report. To get the requested information, you would need to consult detailed clinical study reports or 510(k) summary documents if they contain such information. However, for a device cleared via substantial equivalence, often detailed performance studies with explicit acceptance criteria and ground truth establishment in the manner described are not a primary component of the 510(k) submission itself, but rather rely on the safety and effectiveness of the predicate device.

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The Erchonia® GVL laser is generally indicated:

a. while using the green and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,

b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

The Erchonia® GVL (Model# GVL) is a low-level laser system that uses two semi-conductor diodes (visible green and violet light), green: 520 nm and violet: 405 nm ± 10. The Erchonia® GVL (Model# GVL) is a variable hertz device. The variable hertz feature of the Erchonia® GVL (Model# GVL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® GVL (Model# GVL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.

The components of the device consist of:

An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 520 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.

The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW green and <5mW violet non-convergent beam and is classified as a Class 2 laser in accordance IEC 60825-1 (Complies with 21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50). The separate inductive charging base runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.

A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The Erchonia® GVL (Model# GVL) as designed contains user protocols. The user protocols are defined and saved by the user in one of ten memory locations and can be changed at any time. User instructions are provided in the Erchonia® GVL Operation & Maintenance Manual for proper touchscreen interface operation for the user to set laser diode variable hertz and length of treatment time. There is no interface that allows the end user the laser power output (milliwatts) or the laser wavelength (nanometers).

The Acne protocol is factory set and cannot be altered by the end user.

The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons, work in conjunction with the component platform to ensure the device operates as intended.

The associated accessories include:

• Charging Base .
• Power Supply
• . Patient protective eyewear

This document describes the Erchonia® GVL device, which is an infrared lamp cleared for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin (using green and violet diodes simultaneously) and to treat moderate inflammatory Acne Vulgaris (using the violet diode). The device's substantial equivalency is based on a comparison to the Erchonia® EVRL (predicate device).

Here's the information about the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

For temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin:

Individual subject success was pre-established as a 30% or greater decrease in Visual Analog Scale (VAS) rating at endpoint relative to baseline.

2. Sample Size Used for the Test Set and Data Provenance

The study was a single-group non-inferiority design.

• Test Set Sample Size: 43 subjects completed the study for the Erchonia® GVL device.
• Data Provenance: The document does not explicitly state the country of origin. The study was prospective, as it involved administering the Erchonia® GVL to new subjects. The comparative data for the predicate device (Erchonia® EVRL) was attained from a 2019 trial, which would also be considered prospective at the time it was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the test set was based on self-reported Visual Analog Scale (VAS) pain ratings from subjects, not expert medical assessment for individual cases. Therefore, this section is not applicable in the traditional sense of medical image or diagnostic device evaluation.

4. Adjudication Method for the Test Set

The adjudication method for the test set (regarding pain relief) was based on individual subject self-reporting of VAS pain ratings, with success defined as a 30% or greater decrease from baseline. There was no mention of an expert adjudication panel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study was a non-inferiority clinical study comparing the device to a previously established predicate device's clinical trial results. The outcome measure (VAS pain rating) is a subjective patient-reported outcome, not an interpretation by multiple readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is a physical medical device (laser system), not an algorithm or AI system for diagnosis or interpretation. Therefore, a standalone (algorithm only) performance study is not applicable. The performance evaluated was the direct effect of the device on patients.

7. The Type of Ground Truth Used

The ground truth used for the pain indication was patient-reported outcomes, specifically the change in Visual Analog Scale (VAS) neck and shoulder pain ratings.

8. The Sample Size for the Training Set

The document describes a clinical study for the Erchonia® GVL device. This study is a non-inferiority clinical trial to demonstrate effectiveness, not a study for training an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical data from the Erchonia® EVRL 2019 trial (n=44) and the Erchonia® PL2000/EVRL (K012580, K152196) (n=43) serve as comparative effectiveness data from prior studies, not training data for the subject device's approval.

9. How the Ground Truth for the Training Set Was Established

As noted above, there is no "training set" in the machine learning sense for this device. The comparative data (from previous trials for the Erchonia® EVRL and PL2000) also used patient-reported outcomes (VAS pain ratings) as their ground truth for establishing effectiveness.

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Pain TB and Pain TJ Laser systems are indicated for adjunctive use in the temporary relief of low-back pain and wrist pain associated with Carpal Tunnel Syndrome.

PainTB and PainTJ can be used repeatedly and uses semiconductor lasers to generate three wavelengths of light at 670nm, 830nm and 910nm. In general, this device irradiates to the pain area with a laser beam to relieve pain. It can also be controlled via a dedicated app on your smartphone, allowing you to monitor when and how much you have used it.

The information provided describes the PainTB/PainTJ Laser systems. Here's a breakdown of the acceptance criteria and study details based on the input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific numerical acceptance criteria for performance like a certain percentage reduction in pain score with a corresponding confidence interval. Instead, it relies on demonstrating statistical significance in pain reduction compared to a mock device and claiming substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: 60 adult patients
• Data Provenance: Single-center study conducted in South Korea. The study was prospective and randomized.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not explicitly state the number of experts or their qualifications for establishing ground truth regarding the patients' pain levels. It mentions "VAS measurement has used as pain level scale," which is a subjective patient-reported outcome. The study was "rater blind," meaning the individuals assessing the VAS scores were unaware of the treatment group, but it doesn't specify if these "raters" were experts.

4. Adjudication method for the test set:

Not explicitly mentioned. The study likely relied on patient-reported VAS scores as the primary outcome.

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:

This is not applicable to the described device. PainTB/PainTJ is a therapeutic laser system, not an AI-powered diagnostic imaging tool involving human readers.

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

Not applicable. The PainTB/PainTJ is a medical device that delivers laser therapy; it is not an algorithm that performs a task autonomously. Its performance is evaluated through patient outcomes and safety.

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

The primary ground truth for effectiveness was outcomes data, specifically:

• Patient-reported Visual Analog Scale (VAS) scores for pain relief.
• Observation for adverse effects.

8. The sample size for the training set:

Not applicable. The PainTB/PainTJ device is a physical laser therapy system and does not involve AI or machine learning models that require a "training set."

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

Not applicable, as there is no training set for this type of device.

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The Erchonia® FX-405 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

The Erchonia® FX-405 (Model#: MLS-AC) is low level laser system that uses three semi-conductor diodes (visible light) 630nm to 650nm with a mean power output of 17.25mW per diode and one semi-conductor diode 395nm to 415nm with a mean power output of 23.00mW. The Erchonia® FX-405 (Model#: MLS-AC) is a variable hertz device. The variable hertz feature of the Erchonia® FX-405 (Model#: MLS-AC) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX-405 (Model#: MLS-AC) has been classified by the FDA/EC as a Class II device and a Class 2 Laser.

The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes can only be on or off; there is no user interface that allows the end user to alter the laserdiode output. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered utilizes internal mechanics that collects the light emitted from each of the four (4) laser diodes and processes each through a proprietary patented lens which redirects the beam with a line refracted light is then bent into a spiraling circle pattern that is totally random and independent of the other diodes. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the four (4) laser output heads to be rotated, tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended. The exterior materials consist of 6061 T6 AL, Kydex 430 and Copolymer Acetal with powder coating and carbon fiber finish. The associated accessories include: (1) Hospital grade power cord, (1) Patient protective eyewear (sufficiently and effectively block the laser light spectrum at OD 2+ @ 635nm, OD 0.75 @ 405nm VLT60), (2) Power safety lockout keys.

The provided text describes an FDA 510(k) premarket notification for the Erchonia® FX-405 device, a low-level laser system indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

Crucially, the document states: "No new clinical study results are being submitted as part of this [submission]. Clinical data previously reviewed in 510(k) submissions of the predicate device, the Erchonia® FX-635 Laser K190572, as well as the reference device, the Erchonia® EVRL Laser K191257 were provided to demonstrate safety of using the red and violet diodes simultaneously."

This means there is no new performance data or a new clinical study specifically conducted to establish acceptance criteria or prove device performance for the Erchonia® FX-405 in this submission. Instead, the submission relies on the substantial equivalence to previously cleared devices (predicate and reference devices) and data from their respective clinical trials.

Therefore, many of the requested details regarding acceptance criteria, study design, sample size, ground truth, and expert involvement for a new study are not applicable to this specific submission. The information provided relates to the comparison justifying substantial equivalence based on the technological characteristics and previously collected clinical data.

Based on the available information, here's a breakdown of what can and cannot be answered:

Acceptance Criteria and Reported Device Performance

There are no explicit "acceptance criteria" presented for a new clinical study of the FX-405 device in this document, as no new clinical study was performed. The "performance" being demonstrated is the substantial equivalence to the predicate and reference devices, implying that the FX-405 would achieve similar results as those demonstrated by the previous devices.

The table below summarizes the comparison of shared characteristics between the subject device (FX-405) and the predicate device (FX-635), which is used to argue substantial equivalence, rather than a direct performance outcome table for the FX-405 itself.

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

As stated above, no new clinical study was conducted for the FX-405. The "performance" is implicitly tied to the performance of the predicate and reference devices. The document does not provide a table of performance outcomes for the FX-405, but rather a comparison of its technical specifications to the predicate device leading to the conclusion of substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable for a new study of the FX-405. The submission refers to clinical data from previous 510(k) clearances (K190572 for FX-635 and K191257 for EVRL). The sample sizes for those studies are not detailed in this document.
• Data Provenance: Not specified in this document for the previously conducted studies (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: No new study with a "test set" and "ground truth" establishment was conducted for this specific submission of the FX-405. These details would pertain to the clinical trials supporting the predicate and reference devices, but are not provided here.

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

• Not Applicable: Similar to point 3, no details on adjudication methods for establishing ground truth are provided.

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: The device is a low-level laser system for pain relief, not an AI-assisted diagnostic device involving human readers or image interpretation. Therefore, an MRMC study and AI assistance are not relevant.

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

• Not Applicable: This is a physical therapy device, not a diagnostic algorithm.

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

• Relevant to previous studies: For the previous clinical studies that supported the predicate and reference devices, the "ground truth" for the device's efficacy would have been outcomes data related to nociceptive musculoskeletal pain relief (e.g., pain scores, functional improvement). The specifics are not detailed in this document.

8. The sample size for the training set

• Not Applicable: This is not an AI/machine learning device with a "training set." The term "training set" is typically used in the context of data used to train AI models.

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

• Not Applicable: See point 8. No training set for an algorithm is discussed. The "ground truth" for previous clinical studies (on which this submission relies) would have been established through clinical assessments and patient-reported outcomes for pain relief, but the methodology details are not included in this document.

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The Erchonia® XLR8 is generally indicated:
a. as adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process
c. for the temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery
d. as an adjunctive treatment of postoperative pain

The Erchonia® XLR8 (Model# HLS) is a low-level laser system that uses two semi-conductor diodes (visible red light), red: 640nm ±10. The Erchonia® XLR8 (Model# HLS) is a variable hertz device. The variable hertz feature of the Erchonia® XLR8 (Model# HLS) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® XLR8 (Model# HLS) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser. The Erchonia® Laser is applied externally and has proven through clinical trials to treat post-surgical pain associated with liposuction and breast augmentation surgery. The Erchonia ® XLR8 laser emits a 640-nanometer wavelength with a tolerance of ±10 nanometer, from each of the two laser are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power. The internal battery powers the two specially created and patented electronic diodes with an output of <10mW red laser beam.

The document provided describes an FDA 510(k) premarket notification for the Erchonia® XLR8 laser, primarily focusing on expanding its indications for use. It states that the subject device (Erchonia® XLR8 Laser, Model# HLS) is identical to its predicate device (also Erchonia® XLR8 Laser, Model# HLS) previously cleared under K130996. Therefore, no new performance testing (bench, animal, or clinical) was conducted for this specific submission to demonstrate compliance with acceptance criteria for the expanded indication.

Instead, the submission relies on:

1. The substantial equivalence to the previously cleared predicate device, which itself had previously demonstrated substantial equivalence to another predicate (Erchonia EML Laser, K041139, K072206).
2. Supportive published literature on low-level laser therapy (LLLT) to justify the expanded indication for "adjunctive treatment of postoperative pain."

Given this context, the request for specific acceptance criteria and a study demonstrating the device meets those criteria for the current submission cannot be fully answered with new data from this document. The document explicitly states: "No new clinical data is being submitted in this 510(k) submission." and "No clinical study results are being submitted as part of this submission."

However, I can extract the information provided about the device and how the expanded indication is justified.

1. Table of Acceptance Criteria and Reported Device Performance

Since no new performance criteria or clinical study results are provided for this submission for the expanded indication, I will present the key performance characteristics that define the device and how its substantial equivalence to the predicate (which previously met acceptance criteria for its indications) is established. The "acceptance criteria" here implicitly refer to the proven safety and effectiveness of the identical predicate device and the general principles of LLLT supported by literature.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable for this specific 510(k) submission, as no new clinical studies were conducted or submitted. The justification for the expanded indication relies on a review of published literature on low-level laser therapy (LLLT).
• Data Provenance: The document states that "Seven randomized controlled clinical trials published in scientific peer-reviewed journal publications were identified wherein low-level laser therapy (LLLT) was evaluated for its therapeutic ability to reduce post-operative pain following surgical procedures." The specific countries of origin for these studies are not mentioned, nor is whether they were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable for this submission. The ground truth for the efficacy of LLLT in reducing postoperative pain, if inferred from the cited literature review, would have been established by the authors, reviewers, and editors of the scientific journals in which those studies were published. No specific experts are mentioned as being involved in establishing a ground truth for a new test set in this 510(k).

4. Adjudication Method for the Test Set

• Not applicable for this submission, as no new clinical test set was used requiring adjudication.

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 therapeutic laser, not an AI-assisted diagnostic or interpretive system.

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

• Not applicable. This device is a therapeutic laser.

7. The Type of Ground Truth Used

• For the expanded indication, the "ground truth" is asserted based on outcomes data (reduction in postoperative pain) reported in seven randomized controlled clinical trials of low-level laser therapy (LLLT) published in scientific peer-reviewed journals. This is a general ground truth for the category of therapy, not a specific ground truth for the Erchonia® XLR8 in a new clinical study.

8. The Sample Size for the Training Set

• Not applicable for this submission. There is no mention of a training set as this is a medical device submission based on substantial equivalence and literature review, not a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

• Not applicable. (See #8).

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a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,

b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

The Erchonia® EVRL (Model# EVRL) is a low-level laser system that uses two semi-conductor diodes (visible red and violet light), red: 630-650 nm and violet: 380-450 nm. The Erchonia® EVRL (Model# EVRL) is a variable hertz device. The variable hertz feature of the Erchonia® EVRL (Model# EVRL) is a pulsed wave, defined as containing a selected series of breaks, variances. The Erchonia® EVRL (Model# EVRL) has been classified by the FDA/EC as a Class II/IIa device and a Class II/2 laser.

The Erchonia® EVRL (Model# EVRL) is indicated for use:

a. while using the red and violet diode simultaneously, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,

b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

The Erchonia® Laser is applied externally and has proven through clinical trials to treat neck and shoulder pain with the red diode.

The components of the device consist of:

An ultra-slim hand-held battery-operated control device with a docking station providing two laser diodes a 640 nanometer and a 405 nanometer. Each laser diode emits its wavelength with a tolerance of ±10 nanometer. The lasers are powered by an internal battery that is recharged using a separate inductive charging base powered by an external class II medical power supply. This configuration offers portability as well as consistency of power.

The internal battery powers the two specially created and patented electronic diodes with an output of 7.5mW ± 1mW red and <5mW violet non-convergent beam and is classified as a Class 2 laser in accordance IEC 60825-1 (Complies with 21CFR 1040.10 and 21 CFR 1040.11 by Laser Notice #50).

The separate inductive charging base runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.

A touch screen that functions as a display screen and inout panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off, there is no user interface that allows the end user to alter the laser diode output. The Erchonia® EVRL (Model# EVRL) as designed contains user protocols. The user protocols are defined and saved by the user in one of ten memory locations and can be changed at any time. The protocols consist of activating the lasers to emit predefined frequencies for a predetermined length of time.

The Acne protocol is factory set and cannot be altered by the end user.

The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons, work in conjunction with the component platform to ensure the device operates as intended.

The associated accessories include:

• Charging Base
• Power Supply
• Patient protective eyewear .

The provided text describes a 510(k) premarket notification for the Erchonia® EVRL device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (the same model, K152196) and presents clinical data to support the device's expanded indication for use in relieving neck and shoulder pain.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission appear to be centered around demonstrating non-inferiority or superiority of the Erchonia® EVRL when using both red and violet diodes simultaneously for neck and shoulder pain, compared to the previously cleared red diode only application.

Study Details:

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

2. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 44 subjects completed the study for the investigational device arm. Data from 43 subjects from a previous 2001 trial served as the comparative "active control" (red diode only).
   • Data Provenance: The document does not explicitly state the country of origin. The study was conducted at "the investigator's test site." Given the FDA context and the company's address in Florida, USA, it's reasonable to infer a US-based study, but this is not explicitly stated. The present study was prospective, comparing its results to a retrospective re-analysis of a prior clinical trial (the 2001 trial).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The clinical study used patient-reported outcomes (Visual Analog Scale for pain, and satisfaction ratings) and objective physical measurements (Range of Motion) as its primary and secondary endpoints.

   • No external "experts" were used to establish ground truth in the sense of image annotation or disease diagnosis for a test set. The ground truth for this study was the patient's own perception of pain (VAS score) and measured physical range of motion.
   • The "investigator" is mentioned as administering the procedure, but their qualifications are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   The study design involved direct measurement of patient pain (VAS) and range of motion. There was no "adjudication" in the sense of multiple readers or experts reviewing data for consensus, as would be common in image-based diagnostic studies. The "ground truth" was directly reported by the patient or measured.

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 study was done. This study is not an AI-assisted diagnostic study involving human readers. It is a clinical trial assessing the effectiveness of a physical therapy device (low-level laser). Therefore, this question is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No, this is not applicable. This device is a physical therapy laser, not an algorithm. Its performance is directly tied to its physical application by a user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth was based on patient-reported outcomes data (Visual Analog Scale for pain, satisfaction ratings) and objective physical measurements (range of motion). The study criteria for "success" were a 30% or greater decrease in VAS rating.

8. The sample size for the training set:
   Not applicable. This document describes a clinical study for a medical device (laser), not a machine learning model; therefore, there is no "training set" in the AI/ML sense. The "training" for the device's effectiveness occurred through its design and empirical testing in clinical trials.

9. How the ground truth for the training set was established:
   Not applicable. See point 8.

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The Erchonia® FX-635 laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.

The Erchonia® FX-635 (Model#: HPS) is low level laser system that uses three semi-conductor diodes (visible red-light) 630nm to 650mm. The Erchonia® FX-635 (Model#: HPS) is a variable hertz device. The variable hertz feature of the Erchonia® FX-635 (Model#: HPS) is a pulsed wave, defined as containing a selected series of breaks, variances that are preprogrammed. The Erchonia® FX 635 (Model#: HPS) has been classified by the FDA/EC as a Class II/Ila device and a Class II/2 Laser.

The Erchonia® FX 635, model: HPS laser is indicated for the adjunctive use in providing temporary relief of nociceptive musculoskeletal pain. The Erchonia® Laser is applied externally and has proven through clinical trials to treat the neck, shoulder, low back and plantar fasciitis.

The components of the device include a mobile base which plugs into the wall, using a hospital grade power cord, equipped with a medical grade transformer. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power. Four (4) antistatic wheels that enable ease for maneuverability. A touch screen that functions as a display screen and input panel. The touch screen communicates with the PCB to initiate, stop or pause the energy flow to the laser diodes. The laser diodes can only be on or off; there is no user interface that allows the end user to alter the laser diode output. The low back protocol and heel pain protocol is factory set and cannot be altered by the end user. The device has an adjustable main arm that is attached to the mobile base with the laser head assembly located at the end. The adjustable main arm is capable to collapse into the mobile base for storage and transporting or extends to position the laser heads above the area of involvement. The laser head assembly that is attached to the adjustable main arm that is manually raised and lowered, utilizes internal mechanics that collects the light emitted from each of the three (3) laser diodes that rotate in a spiraling circle pattern that is totally random and independent of the other diodes. The laser head assembly is positioned 3-4 inches from the patient's skin to deliver treatment for pain. This assembly can be rotated 120 degrees for proper positioning to patient for accurate treatment. The laser head assembly includes arms and pivots that allow the three (3) laser output heads to be rotated, tilted, and raised / lowered independently. The device contains software that is loaded into the PCB drivers. This data includes the touch screen images (GUI) and the command prompts that activate the screen icons; work in conjunction with the component platform to ensure the device operates as intended.

The associated accessories include:

• Hospital grade power cord
• Patient protective eyewear
• Power safety lockout keys

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

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 refers to three pivotal clinical studies. These studies were prospective, multi-center, randomized, double-blinded, and placebo-controlled multi-arm studies.

• Pivotal Study 1 (K012580 - TUCO Erchonia PL2000 for Neck/Shoulder Pain):

  • Test Set Sample Size: 86 subjects available for primary endpoint analysis (43 in investigational device arm, 43 in control arm). 100 subjects were initially enrolled.
  • Data Provenance: Prospective, multi-center, randomized, double-blinded, and placebo-controlled. Conducted at 3 sites, all in the United States.

• Pivotal Study 2 (K132940 - Erchonia Allay™ for Heel Pain):

  • Test Set Sample Size: 69 subjects available for primary endpoint analysis (37 in investigational device arm, 32 in control arm). All 69 enrolled subjects were available for primary endpoint analysis.
  • Data Provenance: Prospective, multi-center, randomized, double-blinded, and placebo-controlled. Conducted at 2 sites, both in the United States.

• Pivotal Study 3 (K180197 - Erchonia® FX-635™ for Low Back Pain):

  • Test Set Sample Size: 58 subjects available for primary endpoint analysis (29 in investigational device arm, 29 in control arm). All 58 enrolled subjects were available for primary endpoint analysis.
  • Data Provenance: Prospective, multi-center, randomized, double-blinded, and placebo-controlled. Conducted at 3 sites, all in the United States.

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)

The device is a low-level laser system for pain relief, and the acceptance criteria are based on patient-reported pain scores (Visual Analog Scale - VAS) and clinical safety. The "ground truth" in this context is the patient's subjective experience of pain reduction and the absence of adverse events.

Therefore:

• No external "experts" (like radiologists interpreting images) were used to establish ground truth.
• The ground truth was established directly by the subjects/patients through their self-assessment of pain using the VAS scale.
• Clinical investigators (physicians, study coordinators) would have been involved in patient selection, treatment administration, and data collection, but their role was not to "adjudicate" pain scores as experts.

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

The document states that all three pivotal studies were "double-blinded." This means:

• Neither the subjects receiving the treatment nor the treatment providers/assessors knew whether the subject was receiving the active device or the placebo. This blinding serves as a form of "adjudication" or bias mitigation by preventing knowledge of treatment assignment from influencing outcome assessment.
• The primary outcome measure (VAS pain rating) is a subjective patient-reported outcome. There is no mention of an independent expert adjudication panel for these subjective pain scores as the outcome is directly reported by the patient.

So, the adjudication method was: Double-blinding of subjects and treatment providers/assessors for the patient-reported outcome (VAS pain score). No external "adjudication panel" (like 2+1 or 3+1) was used for the primary endpoints.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

This device is a therapeutic laser for pain relief, not an diagnostic imaging or AI-assisted interpretation device. The studies described are clinical trials comparing the device's efficacy against a placebo for pain reduction, not studies involving human readers and AI assistance. Therefore, there is no effect size related to human reader improvement with AI assistance.

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

No, a standalone algorithm-only performance study was not done.

The device is a physical therapeutic device (laser) operated by a clinician on a patient. It is not an algorithm, and its performance is inherently linked to its application by a human healthcare professional in a clinical setting (human-in-the-loop performance). The studies evaluated the device's effect on patients when used as intended.

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

The ground truth used was patient-reported outcomes data, specifically:

• Visual Analog Scale (VAS) pain ratings: Subjects self-reported their pain levels on a 0-100 scale.
• Clinical Safety Data: Absence of treatment-related adverse events, collected through patient observation and reporting.

8. The sample size for the training set

The document describes clinical studies that are designed to demonstrate safety and effectiveness for regulatory clearance, typically done after significant development. It does not mention a "training set" in the context of machine learning or AI.

The studies described are the pivotal clinical trials used to demonstrate the device's efficacy and safety. The subjects in these trials (ranging from 58 to 86 for primary endpoint analysis per study) constitute the data upon which the claims of effectiveness were based. They are not a "training set" for an AI model.

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

As there is no "training set" in the context of an AI/ML model for this device:

• This question is not applicable. The clinical trials are designed to test the device's effectiveness against a placebo, and the "ground truth" (patient pain scores and safety) for these trials was established by the patients themselves and observed safety data, as described in point 7.

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