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Electro-Light Therapy System is used to provide topical heating for:

• Temporary increases in local blood flow and circulation .
• . Temporary relief of minor muscle and joint aches
• . Temporary relief of pain and stiffness
• . Relaxation of muscles
• . Temporary relief (or relaxation) of muscle spasms
• . Temporary relief of minor pain and stiffness associated with arthritis

The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.

The Electro-Light Therapy offers similar infrared therapy to the K072256 predicate device. The IR Light covered by K072256 allowed the operation of only one light head. The Electro-Light Therapy can support up to 4 light heads each with a similar intensity to the predicate K072256. The Electro-Light Therapy device can shine its IR light through the optional transparent gel electrodes. The Electro-Light Therapy is intended be used with any legally marketed TENS, interferential, or powered muscle stimulator. The IR and visible light will pass through a clear gel electrode. The gel electrode was cleared under K072256. Like the predicate devices, the Electro-Light Therapy is intended to be used only by a qualified therapist. Both the predicate devices and the new device are intended to be used on a cart. The new device has a maximum time setting of 99 minutes.

1. Table of acceptance criteria and the reported device performance

This 510(k) summary does not provide specific acceptance criteria or quantitative performance metrics in the format of a table. Instead, it relies on demonstrating substantial equivalence to predicate devices, particularly K072256 (HF 54 with Optional Hands-free operation) and K071445 (Terraquant Mq2000 V.5 With The Tq-1 Tens).

The primary performance aspects discussed the document relate to safety and intended use:

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

The document does not describe a formal study with a "test set" in the context of clinical performance or diagnostic accuracy. The evaluation appears to be based on:

• Engineering/Bench Testing: The "Measurement" for tissue temperature (maximum temperature was 45 ℃) strongly suggests bench testing. There is no specified sample size for this test.
• Comparison to Predicate Devices: The primary method of demonstrating substantial equivalence is by comparing the technological characteristics, performance capabilities (like light intensity and compatibility with electrodes), and safety features to legally marketed predicate devices.

Data Provenance: Not applicable as it's not a clinical study with patient data. The safety assessment relies on engineering measurements and a comparison of features.

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

Not applicable. This device is an infrared therapy lamp. The 510(k) summary does not involve a "ground truth" derived from expert interpretation (e.g., radiologists interpreting images) for a test set. The evaluation focuses on physical characteristics, safety, and equivalence to existing devices.

4. Adjudication method for the test set

Not applicable. As there are no expert interpretations or clinical data in a formal test set described, there is no adjudication method mentioned.

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 is an infrared therapy lamp, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant to this submission.

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

Not applicable. This device is an infrared therapy lamp, not an algorithm or AI system.

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

For the "Temperatures in Tissues" section, the "ground truth" is established through physical measurement of temperature, likely using thermal sensors or similar instrumentation during testing. This is an objective physical measurement, not an expert consensus, pathology, or outcomes data.

For other aspects, substantial equivalence relies on:

• Engineering specifications and design comparisons.
• Compliance with recognized standards (e.g., IEC 60601-1).
• Functional comparison to predicate devices, demonstrating similar intended use and performance.

8. The sample size for the training set

Not applicable. This device is an infrared therapy lamp and not an AI/ML device that requires a training set.

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

Not applicable. This device is an infrared therapy lamp and does not have a training set.

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The Aklarus Blue (420nm +/-10nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Aklarus combination of Red (628nm +/-10nm) and Blue (420nm +/-10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

The Aklarus Anti-Aging Red (628nm +/-10nm) and Anti-Aging Infrared (880nm +/- 10nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Alarus Infrared (880nm +/-10nm) is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Not Found

The provided text is a 510(k) summary for the Aklarus Phototherapy System. It outlines the device's details, indications for use, and a comparison to predicate devices, concluding that it is substantially equivalent. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance studies.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with defined acceptance criteria for novel performance claims. While the Indications for Use mention treating conditions like acne vulgaris, periorbital wrinkles, and pain relief, the document explicitly states: "The proposed Aklarus Phototherapy System when used as directed in the operator's manual presents no new safety or effectiveness concerns and is Substantially Equivalent to the predicate devices listed in this section." This suggests that the substantial equivalence was likely based on comparison of technological characteristics and intended use to existing devices, rather than a new standalone clinical study with acceptance criteria.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided 510(k) summary.

If such a study had been conducted and included in the submission, significant details on its methodology, results against acceptance criteria, and statistical analysis would typically be found in a separate section of the 510(k) submission, often titled "Clinical Studies" or "Performance Data." This document only provides a summary demonstrating substantial equivalence based on predicates.

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The HF54 interferential therapy and premodulated therapy is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain.

Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain joint contractures This can be done using One or two ultrasound applicators. The second ultrasound applicator is optional. Ultrasound therapy, either alone or in combination with interferential therapy or premodulated therapy can be used in a scanned manner (where the therapist moves the applicator) or for specific treatment areas identified in the operator's manual, the applicator can be used in a hands-free manner (where the applicator remains stationary).

An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for: Temporary increases in local blood flow and circulation. Temporary relief of minor muscle and joint aches Temporary relief of pain and stiffness Relaxation of muscles. Temporary relief (or relaxation) of muscle spasms. Temporary relief of minor pain and stiffness associated with arthritis

The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation is a device that provides ultrasonic diathermy, interferential current therapy, and infrared lamp therapy. It can be used with one or two ultrasound applicators, and the ultrasound therapy can be applied in a scanned or hands-free manner. An optional infrared light probe is also available.

The provided 510(k) summary for the Hill Laboratories HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with optional hands-free operation (K072256) does not describe a study involving a test set, expert adjudication, MRMC comparative effectiveness, or stand-alone algorithm performance in the typical sense of a clinical trial or algorithm validation study for diagnostic devices.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K062256) by affirming compliance with mandatory and consensus standards, and by performing risk analysis for the expanded indication of "hands-free" operation for ultrasound. The "acceptance criteria" here refer to safety thresholds and compliance with established performance standards for similar medical devices.

Here's an breakdown based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a "test set" in the context of clinical data or images. The "tests" mentioned are primarily engineering and electrical safety measurements (e.g., thermal measurements, pulsed output analysis) for the device itself.

• Sample Size: Not applicable in the context of a clinical test set. The measurements were likely performed on a single or a small number of device units.
• Data Provenance: The measurements related to thermal output and standing waves were conducted internally by Hill Laboratories, likely in a laboratory setting. This is a technical validation, not clinical data from patients.

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

Not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, is not described as part of this submission. The "ground truth" for the engineering performance aspects would be the physical laws and measurement standards.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This submission is for an expanded indication for a physical therapy device, focusing on safety and technical equivalence rather than a diagnostic or screening efficacy study involving human readers.

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

Not applicable. This device is a physical therapy equipment, not an AI algorithm for diagnosis or image analysis. Its operation inherently involves a human operator (therapist). The "hands-free" aspect refers to the applicator staying stationary on the patient, but the therapist still monitors the patient.

7. The Type of Ground Truth Used

The "ground truth" here is based on:

• Engineering and physical measurements: For thermal output, acoustic properties (standing waves), and electrical safety.
• Compliance with established standards: Mandatory (21 CFR 1050.10) and consensus standards (IEC 60601 series, UL 60601-1).
• Risk analysis: Identifying potential hazards and mitigation strategies (e.g., operator manual instructions).

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI algorithms described in this submission.

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

Not applicable. As there is no training set, there's no ground truth established for one.

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The HF54 is indicated for: Pain relief for: Symptomatic relief of chronic intractable pain and/or management of traumatic or post surgical pain. Ultrasound therapy is available from the HF54 and indicated for: Applying therapeutic deep heat within body tissues for the treatment of selected chronic and sub-chronic medical conditions such as: Relief of pain Muscle Spasms Joint contractures The combination ultrasound & electrotherapy modes offer deep heat for pain management (ultrasound therapy) at the same time that electrical stimulation for either pain management or muscle stimulation is being delivered. Two electrotherapy modes utilizing Premodulated IFC can be utilized at a time in conjunction with the ultrasound mode. These are using One or two ultrasound applicators. The second ultrasound applicator is optional. An Infrared Therapy Probe is available as an optional accessory (HF023) for use with the Hill Laboratories HF54 Combination Ultrasound Interferential and premodulated stimulation system or for stand-alone use with an optional external medical grade, isolated power supply. It is used to provide topical heating for: . Temporary increases in local blood flow and circulation . Temporary relief of minor muscle and joint aches Temporary relief of pain and stiffness Relaxation of muscles . Temporary relief (or relaxation) of muscle spasms . Temporary relief of minor pain and stiffness associated with arthritis

The HF54 Combination Ultrasound Interferential and Premodulated Stimulation System is a device that offers electrical stimulation, ultrasonic therapy and/or combination of the two. It also has an optional Infrared light probe accessory (HF023).

Here's an analysis of the provided text regarding the Hill Laboratories HF54 Combination Ultrasound Interferential and Premodulated Stimulation System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on presenting a comprehensive study of the new device's performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested categories, especially those related to clinical study design, will likely be absent or inferable rather than explicitly stated.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a substantial equivalence determination, the "acceptance criteria" here primarily refers to the device meeting the same fundamental characteristics and performance safety standards as the predicate device, as well as adherence to relevant consensus standards. There isn't a table of clinical performance metrics (e.g., sensitivity, specificity) because this type of device is not typically evaluated in that manner for 510(k) clearance.

Study Details (Based on available information)

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

• Sample Size: Not applicable. This 510(k) summary does not describe a clinical "test set" in the sense of patient data. The evaluation for substantial equivalence is based on engineering specifications, compliance with standards, and comparison to the predicate device's design and indications for use.
• Data Provenance: Not applicable. No clinical data or patient data is mentioned.

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

• Not applicable. No ground truth based on expert review of clinical data is described.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a physical therapy apparatus, not an AI-assisted diagnostic or interpretative tool. No MRMC study was performed.

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

• The device is a physical therapy system requiring direct human application (qualified therapist). It does not involve an algorithm for standalone performance evaluation in the context of diagnostic or interpretive AI. Its standalone performance would relate to its electrical/ultrasound/infrared output characteristics, which are checked against standards.

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

• The concept of "ground truth" as typically used in diagnostic study evaluations (e.g., pathology for cancer detection) is not directly applicable here. For this device, the "truth" is established by:
  • Compliance with published standards: Mandatory (21 CFR 1050.10) and Consensus (IEC 60601 series, UL 60601-1).
  • Consistency with FDA guidance and international standards for ultrasound and electrical stimulation outputs.
  • Direct functional and performance comparison to the legally marketed predicate device (Dynatronics Solaris Model 708 and 709).

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI algorithms requiring a training set.

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

• Not applicable. No training set is used.

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The Air-Flex is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction, powered flexion and muscle relaxation therapy.

The AIR-FLEX with AUTO-DISTRACTION is a modification of the AIR-FLEX table originally cleared under K932810 on 02/17/1995. This new platform will replace the model originally cleared under K932810.

The device is a Hi-Lo multi-function physical therapy table as defined under 21 CFR 890.5880. Neither the proposed device nor the predicate device provides heat.

The proposed device differs from the predicate device in that it utilizes precision pneumatic actuators for distraction force and positioning rather than electric motors that were used on the predicate. The height adjustment of the proposed device is performed using the same electric motor as the predicate.

The proposed device has a new, optional automatic cycling mode intended to provide intermittent distraction and flexion.

Additionally, the AIR-FLEX with AUTO-DISTRACTION can be configured with up to four pneumatically dropped sections including cervical (straight down and forward motion), thoracic, lumbar and pelvic. Each drop is activated by pressing a clearly marked button and is executed via a foot pedal.

An Air-thoracic Breakaway (with release) allows for a thoracic recoil movement and features an adjustable air tension spring controlled by a foot pedal allowing the spring to lock at any point down to 5.5 inches. This allows the use of the table with patients with large abdominal areas. The Air-Breakaway can be combined with thoracic and lumbar drop.

The proposed device can be fitted with an elevation headpiece. This raises up to 5 inches and is fitted with a tilting section. Manual or Air-activated drops can be added as options.

The activation of the selected drop can be made by footswitches or optional cocking foot strips. The AIR-FLEX with AUTO-DISTRACTION table is configured to match the owner's preferences.

The optional Auto-Flex allows the therapist to treat patients manually (for which the AIR-FLEX table is already cleared) or easily switch to AUTO-FLEX for motorized flexion. The stroke (controls the amount of flexion) can be adjusted.

The patient lies prone on the treatment surface and the patent is secured around the waist using a seat-belt type strap with quick release buckle to the stationary part of the table. The ankles are secured using straps to the movable part of the table. Once the therapist is sure that the patient is properly secured, the therapist unlocks the movable section and sets the distraction force, which is read on a gauge on the table. The therapist has the option to perform manual cycling and, where the table is configured with the automatic cycling module, can now set the overall treatment time, relax level, the rate to increase, time to hold (Pull Time) and the time to rest (Rest Time).

This 510(k) premarket notification for the "Air-Flex with Auto-Distraction" device is a submission for a modification of an already cleared device (K932810). For such modifications, the primary focus of the submission is to demonstrate substantial equivalence to the predicate device, rather than proving efficacy from scratch with a new clinical study.

Therefore, the document does not contain a typical study that would "prove the device meets acceptance criteria" in the way a new device submission or a premarket approval (PMA) would. Instead, the "acceptance criteria" are implicitly met by demonstrating that the new features do not introduce new safety or effectiveness concerns and perform similarly to features on the predicate or well-understood mechanisms.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a modified device proving substantial equivalence, formal "acceptance criteria" in the sense of performance targets from an efficacy study are not explicitly stated in this document. The "performance" is primarily assessed by comparing technological characteristics and safety features to the predicate device and relevant consensus standards.

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

No test set or clinical data is mentioned in this submission. The demonstration of substantial equivalence relies on technological comparison and compliance with standards, not on a new clinical study with a test set of patients.

• Sample Size: Not applicable.
• Data Provenance: Not applicable.

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

Not applicable, as no external "test set" and corresponding ground truth establishment is described for a clinical study. The "ground truth" for the device's technical specifications and safety would be based on engineering specifications, testing against standards, and comparison with the predicate device.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

Not applicable. This is a physical therapy table, not an AI-assisted diagnostic or therapeutic device that involves "human readers" or AI assistance in interpretation.

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

Not applicable. This device is not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The type of "ground truth" implicitly used for this 510(k) submission is:

• Engineering Specifications and Design Verification: The device's components and functionalities (e.g., distraction force, automatic cycling, safety cut-out) are verified against their design specifications, which are themselves derived from safety standards and the performance of the predicate device.
• Compliance with Standards: Verification that the device design and manufacturing processes comply with recognized consensus standards (e.g., IEC 60601-1).
• Predicate Device Performance: The "ground truth" for what constitutes acceptable overall performance and safety is largely established by the performance and safety record of the legally marketed predicate device (Air-Flex K932810). The submission argues that the new device's changes do not negatively impact this established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable, as this device does not involve machine learning or AI models that require training sets.

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

Not applicable, as this device does not involve machine learning or AI models.

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The Healthstar Elite machine administers genuine intervertebral decompression. Each treatment session consists of a physician prescribed treatment period on the Healthstar Elite. A treatment is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. The machine can be used to relieve sciatica pain and pain associated with: bulging or herniated discs, degenerative disc disease, and posterior facet syndrome. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

This device is for prescription use only.

The Healthstar Elite is a multifunction elevation table designed to apply distraction forces to a patient's spine. The powered elevation adjustments of the table's surface height are designed to provide easier loading and unloading of the patient on and off the table.

The patient lies in a supine position on the table with either the knees bent or legs supported on an adjustable height stool creating a 90-degree bend between the calves and hamstrings. This position helps to provide comfort during distraction and to provide relaxation to the Para spine tissue during distraction.

The upper body is restrained through a chest harness, which is attached underneath the rib cage. The harness is attached to a metal spreader bar and web strap, then attached through a cam-type buckle assembly. The lower body is restrained to the moveable lower section of the table through a flexible pelvic restraint is fixed to the table's lower moveable section. Each side of the restraint can be moved in and out width wise by pushing a lever and having a stud engage into one of three numbered holes, depending on the size of the patient. The flexible restraint is designed to capture and secure the patients iliac crest.

The Healthstar Elite consists of two components:

• 1. The elevation table with traction capabilities.
• 2. An attachable control panel, which can be inserted into either side of the table.

The elevation table is controlled by a 24-volt actuator and is elevated by pushing a hand control with built in arrows indications (no label required).

The control panel allows the operator to select one of eight predetermined programs of distraction, time of treatment, pounds of distraction, and pelvic tilt angle.

The provided text is a 510(k) premarket notification for the Healthstar Elite, a powered traction equipment device. The document primarily describes the device's function, its similarities to predicate devices, and the FDA's determination of substantial equivalence.

However, the document does not contain information regarding detailed acceptance criteria, specific study designs, or performance metrics in a way that would allow for the completion of the requested table and accompanying details.

Here's a breakdown of what is not present in the provided text:

• Acceptance Criteria Table: There is no table outlining specific performance targets (e.g., accuracy, precision, safety thresholds) for the device. The document focuses on regulatory equivalence rather than quantitative performance.
• Reported Device Performance: No specific quantitative performance data (e.g., measurement accuracy of distraction force, reliability over time, patient outcome statistics) is reported.
• Study Details:
  • Sample Size (Test Set): Not mentioned.
  • Data Provenance: Not mentioned.
  • Number of Experts/Qualifications (Ground Truth): Not mentioned.
  • Adjudication Method: Not mentioned.
  • MRMC Comparative Effectiveness Study: Not mentioned. The document primarily compares the device's "principles and working characteristics" to predicate devices, not a rigorous comparative effectiveness study with human readers/operators.
  • Standalone Performance: Not explicitly stated as a separate study. The document implies the device works as intended but doesn't detail a standalone performance evaluation with specific metrics.
  • Type of Ground Truth: Not applicable, as no specific performance study is detailed with ground truth.
  • Sample Size (Training Set): Not mentioned.
  • Ground Truth Establishment (Training Set): Not applicable.

Summary of available information related to effectiveness and safety:

The "Summary of Safety and Effectiveness" section states:
"The operating principles of the Healthstar Elite permit the safe application of effective distraction tensions of the lumbar spine."
It further describes safety features like a patient handheld cut-off switch and a quick release for power failure.

Conclusion:

The provided 510(k) notification for the Healthstar Elite focuses on demonstrating substantial equivalence to predicate devices (SpineMED, DRS System, SPINA System) for regulatory approval, rather than providing a detailed performance study with quantifiable acceptance criteria and results. Therefore, it is impossible to complete the requested table and answer the study-specific questions based on the given text.

The FDA's letter states that they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the evaluation was against existing known devices in terms of intended use, technological characteristics, and safety/effectiveness principles, rather than requiring a new, comprehensive clinical performance study with specific metrics as would be expected for a novel device or a device requiring a PMA.

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