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The Axiom BioLaser LLLT Series-3 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

The Axiom Bio LLLT Series -3 is a non thermal triple diode infrared laser.

There is no information in the provided text regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary and the FDA's clearance letter for the Axiom BioLaser LLT Series-3, which establishes its substantial equivalence to predicate devices for its intended use in temporarily relieving hand and wrist pain associated with Carpal Tunnel Syndrome.

Therefore, I cannot provide the requested information in the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or multi-reader studies.

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The Axiom BioLaser LLLT Series-1 is for adjunctive use in providing temporary relief of minor chronic Neck and shoulder pain of musculoskeletal origins.

The Axiom Bio Laser LLT Series - 1 is a single diode laser which produces an Output power of no more than 5 mW of energy with a 660 nm wavelength.

The provided 510(k) summary for the Axiom BioLaser LLLT Series-1 details regulatory information and declares substantial equivalence to a predicate device, the Erchonia PL2000. It does not contain information about acceptance criteria, device performance, clinical study design, or ground truth establishment.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any study.
• The sample size for the training set.
• How the ground truth for the training set was established.

The 510(k) summary explicitly states that the substantial equivalence is due to the technical aspects of both devices (Axiom BioLaser LLLT Series-1 and Erchonia PL2000) being "Significantly equivalent," leading to the "same treatment For the intended use of providing temporary relief of minor chronic neck And shoulder pain of musculoskeletal origins." This suggests FDA clearance was based on equivalence to a legally marketed predicate device rather than a new clinical study demonstrating specific performance metrics against acceptance criteria.

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The DRX3000 provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRX3000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

Device Trade Name: DRX3000 Traction Equipment
Common Name: Power Traction Equipment
Classification Name: Power traction equipment
Class and Reference Product Code: Class II (21 CFR Section 890.5900) 89 ITH

The provided text does not contain information about acceptance criteria or a study proving that the DRX3000 meets such criteria. The document is a 510(k) summary for the DRX3000 Traction Equipment, outlining its description, predicate devices, and intended use for relief from low back pain. It states that the device is substantially equivalent to legally marketed predicate devices and mentions that "clinical trials carried out by VAX-D endorse the principle of decompression and similar studies using similar technology have reported the same results." However, it does not provide details about these studies, their methodologies, sample sizes, acceptance criteria, or specific performance metrics of the DRX3000 device itself.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented for the DRX3000.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method: Not 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 relevant to this device, which is a traction equipment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than on detailed clinical performance studies of the DRX3000 itself with specific acceptance criteria.

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The DRX5000 provides a program of treatments for relief from pain for those patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the DRX5000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

The DRX5000 is a powered traction equipment device. The bed is a stand on/stand off tilt type bed that allows the fully clothed patient to step onto a footrest while it is in near vertical position. The bed and patient can then be slowly lowered to the horizontal treatment position using a remote controller hand held by the practitioner. The bed is split into two cushions, each slide able in the horizontal plane only on low friction runners and each being able to be locked independently. Distraction tensions are applied to the patient via a pelvic harness while the upper body of the patient is anchored to the locked upper cushion via a chest harness. The lower cushion, which is unlocked and on which the patient's lower trunk is rested, is able to slide easily thus reducing almost completely any frictional movement between patient and bed cushion when distraction tensions are applied, this concentrates virtually all the forces to the affected part of the lumbar spine. The traction unit is mounted to the foot of the tower and the belt pulley system is attached to a vertical movable platform incorporated into the tower at the foot end of the bed. This enables the distraction tensions to be applied at differing angles to the patient (between 0 and 30 degrees). The traction unit is programmed and controlled from a control panel fitted into the tower to give static or intermittent distraction. The minimum and maximum distraction settings are 0-200 lbs. Treatment parameters i.e. tensions and time are continuously monitored and shown by LCD readout at the time of treatment set up and during treatment. At the conclusion of treatment time, tension always returns to zero. A DVD player, which is incorporated in a separate section of the control panel, and headphones provide comfort and relaxation to the patient and provides and opportunity for patient education via clinical tapes. There is instantaneous release of all tensions if the patient pushes the button on the hand held Patient Safety Switch, or the Stop Button, or Emergency Stop on the control panel has been pushed by the practitioner. The DRX5000 will not operate if the Patient Safety Switch is not working properly or has not been tested prior to each treatment. The treatment cannot be restarted when a patient activates the Patient Safety Switch or the Stop Button has been pushed during treatment unless all treatment parameters are manually re-entered into the controller.

The provided text describes the DRX5000 Traction Equipment and its 510(k) submission, primarily focusing on its equivalence to predicate devices and safety features. However, it does not include a study proving the device meets specific acceptance criteria related to its performance in relieving pain or decompressing intervertebral discs.

Instead, it relies on:

• Predicate Device Equivalence: Stating that the DRX5000 "incorporates various principles and working characteristics of the predicate devices" (3-D Active Trac and Tru-Trac 401 Traction Device).
• Reference to Existing Clinical Trials: It mentions, "Clinical trials carried out by VAX-D (K951622) endorse the principle of decompression and similar studies using similar technology have reported the same results." It then directs the reader to appendices, which are not provided in the input text.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the given document.

Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not provided. The text only references clinical trials performed by VAX-D (K951622) and "similar studies," but no details about their sample sizes or data provenance are given for these external studies, nor for any specific test set for the DRX5000 itself.

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

• Not provided.

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

• Not provided.

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

• Not applicable. This device is traction equipment, not an AI software or imaging interpretation tool that involves human readers.

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

• Not applicable. This device is traction equipment.

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

• Not explicitly stated for the DRX5000. For the referenced VAX-D studies, it can be inferred that the "principle of decompression" led to positive "results," which likely implies patient outcomes data (e.g., pain relief, improved function).

8. The sample size for the training set:

• Not applicable/Not provided. This is physical medical equipment, not a machine learning algorithm that requires a training set.

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

• Not applicable/Not provided.

In summary, the document serves as a 510(k) submission focusing on the equivalence of the DRX5000 to existing devices and its safety features. It references clinical evidence for the underlying principle of decompression therapy in general (citing VAX-D studies), but it does not present a specific study validating the DRX5000 against detailed acceptance criteria with statistical performance metrics, sample sizes, or ground truth methodologies directly related to the DRX5000's efficacy.

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