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The BIOFLEX LD-R100 Treatment head device is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

The BIOFLEX LD-R100 Treatment head device is to be used with the Low Intensity Laser Therapy System, BioFlex Professional System & the Prescription Unit and Related Treatment Heads. These systems were cleared under 510(k) submission K023621 & K051875 respectively. The treatment head device is a Class II Low Level Laser treatment head that apply energy, which penetrates the surface to the underlying tissues, and triggers normal cellular functions.

This document describes a 510(k) premarket notification for the BIOFLEX LD-R100 Treatment Head. The submission demonstrates substantial equivalence to predicate devices rather than providing a study specifically proving the device meets individual acceptance criteria through performance metrics.

Therefore, many of the requested categories (acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth types related to a study proving specific performance) are not applicable or cannot be extracted from this type of regulatory document.

However, based on the provided text, here's what can be answered:

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

This document does not present a table of acceptance criteria with reported device performance in the way a clinical study would for efficacy targets. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" in this context are the regulatory requirements for substantial equivalence, which include similar indications for use, technological characteristics (power density, wavelength, optical power, power source), and similar size and weight.

The reported "performance" is that the device meets these general equivalence criteria and is considered "safe and effective" based on its similarity to the predicate devices.

Table of Equivalence Claims (extracted from the document):

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

Not applicable. This is a 510(k) submission based on substantial equivalence to existing devices, not a clinical study with a test set of patient data. There is no information regarding sample sizes or data provenance in the context of a performance study.

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. No ground truth establishment for a patient test set is described or required for this type of submission.

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

Not applicable. No 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 not an AI/software device and no MRMC study was performed.

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

Not applicable. This is a physical medical device (treatment head for laser therapy), not a standalone algorithm.

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

Not applicable. The ground truth for this submission is the regulatory precedent set by the legally marketed predicate devices. The device is deemed safe and effective because its characteristics and intended use are substantially equivalent to devices that have already been cleared by the FDA.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable. No training set is mentioned.

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The BioFlex® is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, failed previous fusion (pseudoarthrosis).

In addition, the BioFlex® is indicated for use in patients:

• . Who are receiving fusions with autogenous graft only;
• . Who are having the device fixed or attached to the lumbar or sacral spine:
• t Who are having the device removed after the development of a solid fusion mass.

The BioFlex® is comprised spring-like rods and pedicle screws. All components are manufactured from medical grade titanium alloy (Ti6Al4V).

This is a 510(k) premarket notification for a medical device called BioFlex®, a pedicle screw spinal system. This document package does not contain a study with acceptance criteria or performance data as typically seen in AI/ML performance studies. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, function, materials, and intended use.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets) are not applicable to the information provided in this 510(k) submission.

Here's the information that can be extracted or deduced from the provided text:

1. Table of acceptance criteria and the reported device performance:

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

• Not Applicable. This submission does not describe a "test set" in the context of an algorithmic performance study. The "testing performed" refers to verification and validation activities (likely mechanical and material testing) to demonstrate substantial equivalence, not a clinical performance validation against a ground truth.

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. No ground truth establishment by experts for a test set is described.

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

• Not Applicable. No 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. This is a hardware device (pedicle screw system), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or is relevant.

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

• Not Applicable. This is a hardware device.

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

• Not Applicable. For this hardware device submission, "ground truth" isn't established in the context of diagnostic accuracy. Substantial equivalence is established through engineering and material testing, and comparison to legally marketed predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a hardware device, not an AI/ML product requiring a training set.

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

• Not Applicable. This is a hardware device, not an AI/ML product.

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The BioFlex™ Prescription Unit and related Treatment Heads is used by trained health care professionals and is indicated for the use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue.

The BioFlex™ Prescription Unit and related Treatment Heads are designed for clinical applications to provide low level light therapy and and display system parameters as part of the treatment session. This device does NOT store patient data. As such, this device is a Class II device, having Regulation Number: 21 CFR part 890.5500. Product Code ILY.

The BioFlex™ Prescription Unit and related Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, drug-free, and low cost benefit to the patient, the practitioner and the health care system.

The BioFlex™ Prescription Unit and related Treatment Heads is a" multi-mode" low level light treatment system configured for multiple treatment heads and powered by a flexible protocol controller that delivers various treatment protocols.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a summary of safety and effectiveness, a 510(k) clearance letter from the FDA, and an indications for use statement for the BioFlex Prescription Unit and related Treatment Heads.

It states that the device is substantially equivalent to predicate devices, and that factory calibration tests are conducted to verify accuracy and calibration. However, it does not provide specific acceptance criteria values, performance metrics for the device, details of a study (sample size, data provenance, ground truth, etc.), or any information about AI or human reader improvement.

Therefore, I cannot fulfill your request for the table, study details, or other specific information related to acceptance criteria and a study proving device performance based on the provided text.

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The BioFlex™ LD-175& LD-1200 Treatment Heads are intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

The BioFlex™ LD-175 & LD-1200 Treatment Heads are designed to be used only part of the BioFlex Professional System. This system was cleared in K023621. This system provides a low level Dior tex I royessional bysied displays the treatment sessions. As such, this device is a Class II device, having Regulation Number: 21 CFR part 890.5500. Product Code ILY.

The BioFlex™ LD-175 & LD-1200 Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, drug-free, and low cost benefit to the patient, the practitioner and the health care system.

This device is different from other predicate devices in that it is part of a regiment that uses proprietary, interchangeable treatment heads to allow various protocols (and software loaded in a P.C. computer to download protocols) and record session / patient data.

This document is a 510(k) summary for the BioFlex™ LD-175 & LD-1200 Treatment Heads and does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document primarily focuses on:

• Device Description and Intended Use: The BioFlex™ LD-175 & LD-1200 Treatment Heads are Class II Low Level Laser treatment heads that apply energy in the infrared spectrum for topical heating for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of muscle tissue. It is a prescription-only device.
• Substantial Equivalence: The manufacturer, Meditech International Inc., asserts that these treatment heads are substantially equivalent to three predicate devices: K 033768 (Altus Medical, Inc.), K031612 (Avicenna Laser Technology, Inc.), and K024179 (Palomar Medical Products).
• Quality System and Calibration: It states that the device "has benefited from design, development, testing and production procedures that conform to Quality Systems" and that "A series of factory calibration tests are conducted to verify the device is accurate and calibrated (and can maintain calibration over its useful life)."
• Safety and Effectiveness: A general statement is made that the device "is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy."

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about a specific study (sample size, data provenance, ground truth establishment, etc.) that demonstrates the device meets pre-defined acceptance criteria for safety or effectiveness.
3. Information on expert involvement, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the provided text. The document acts as a submission for regulatory clearance based on substantial equivalence to existing devices, rather than a detailed report of a performance study against specific acceptance criteria.

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The BioFlex "" Professional Therapy System is used by trained health care professionals and is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue.

The "Indications for Use" for this device cover three therapeutic applications;

• relief of neck and shoulder pain, and .
• relief of muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting . relaxation of muscle tissue.

The BloFlex ™ Professional Therapy System is designed for clinical applications to provide low level light therapy and record and display treatment sessions. This device is composed of:

• software {that runs in a qualified, ancillary computer}, ●
• proprietary hardware and software, and .
• flexible treatment heads. ●

The BioFlex ™ Professional Therapy System is a "multi-mode" low level light treatment system configured for multiple treatment heads powered by a flexible protocol controller that delivers various treatment protocols.

The provided document is a 510(k) summary for the BioFlex™ Professional Therapy System. It details the device's intended use and its substantial equivalence to a predicate device. However, it does not contain any information about specific acceptance criteria or an efficacy study that would prove the device meets such criteria.

The document discusses:

• The device's classification (Class II, Infrared Lamp).
• Its intended use: "to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue."
• Its substantial equivalence to the "Super Nova™ via K001179" predicate device.
• That safety and efficacy have been tested and confirmed, and that the company maintains an in-house reporting system for adverse events.
• Factory calibration tests are conducted to verify accuracy and calibration.

Therefore, I cannot provide the requested information as it is not present in the provided text.

To answer your request, a document detailing the results of a clinical study, performance testing, or a description of the acceptance criteria would be needed.

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