Search Results

The Beactive Brace is applied to the upper calf just below the knee such that the pressure pad presses against the soleus muscle located just to the outside of the back of the knee for the purposes of temporarily reducing lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is intended for over-the-counter distribution.

The Beactive® Brace is a brace intended to temporarily reduce lower back pain that radiates down the leg associated with normal household or work activities. The Beactive® Brace is an adjustable, cylindrically-shaped band that fits over the upper calf on either leg. Integrated into the wall of the brace is a disk-shaped protrusion (pressure pad) that projects inward the leg. The pressure pad presses against the soleus muscle located just to the back of the knee. The pressure pad exerts even pressure on the soleus muscle near its origin at the fibula. The Velcro strap is designed to focus the pressure on the pressure pad on the calf. As a soleus muscle compression brace, it uses both compression as well as anterior glide forces onto the proximal tibiofibular joint to temporarily reduce low back pain.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Beactive® Brace:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a numerical or pass/fail threshold manner. Instead, it describes general effectiveness and safety observations. Based on the provided "Effectiveness" and "Safety" sections, we can infer the following:

• Produced clinically significant reduction in pain (≥30%) in 52% of subjects.
• Pain index reported at 15 minutes and 1 hour (while performing activity or in the worst pain position) declined clinically significantly: 32% (15 min) and 40% (1 hour).
• Clinically significant improvement in the disability index (Oswestry Disability Index Questionnaire) in 12% of subjects in the treatment group (after four days or one week of wear). |
  | Safety: | |
  | - Absence of adverse events. | - Subjects experienced no adverse events during the clinical trials.
• Some subjects experienced an increase in pain, but labeling cautions the user to cease use and consult a physician if this occurs.
• Some individuals may be sensitive to materials, but labeling cautions the user to stop if skin becomes irritated. |
  | Biocompatibility: | |
  | - Meet biocompatibility standards for medical devices. | - Battery of testing included: Cytotoxicity, Sensitization, Irritation. (Results are not detailed beyond stating they were "conducted"). |

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

The document does not explicitly state the exact sample size for the clinical study. It refers to "a majority of subjects," "52% of subjects," and "12% of subjects," which indicates a quantitative study, but the total 'N' is missing.

• Sample Size: Not specified (referred to as "subjects").
• Data Provenance: Not explicitly stated (e.g., country of origin). It's a clinical study conducted as part of a 510(k) submission, suggesting it was likely conducted in accordance with FDA regulations, but whether it was prospective or retrospective is also not stated. However, the design of "before using," "while performing motion," "while at rest," and "after a week" suggests a prospective design.

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

The document does not mention the use of experts to establish ground truth independently for the clinical study. The "ground truth" for pain reduction and disability improvement was based on self-reported patient outcomes using established scales (10-point pain scale, Oswestry Disability Index Questionnaire).

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for the clinical study data or for establishing ground truth. The data appears to rely on direct patient reporting.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was performed or mentioned. The clinical study evaluated the Beactive® Brace itself, not its impact on human reader performance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The Beactive® Brace is a physical medical device (limb orthosis), not an algorithm or AI system. Therefore, the concept of an "algorithm only" or "standalone" study does not apply.

7. The Type of Ground Truth Used

• For Clinical Study: Patient self-reported pain levels (10-point pain scale) and disability index scores (Oswestry Disability Index Questionnaire). This is considered outcomes data / patient-reported outcomes.
• For Biocompatibility: Laboratory testing results (Cytotoxicity, Sensitization, Irritation). This is laboratory-based evidence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable, as it's not an AI/ML model.

Ask a specific question about this device

Type 297: Can be used on its own as a lumbar support device or as a conductive garment for use with cleared Transcutaneous Electrical Nerve Stimulation (TENS) devices for the following: The symptomatic relief and management of chronic and intractable pain in the lower back region. Assists in correctly positioning and repositioning pads on difficult to reach locations of the lower back. Lumbar support.
Type 298: Can be used on its own as a lumbar support device only.

The Baxolve XP Conductive Garment Accessory and Lumbar Support Kit (Types 297 and 298) is an innovative and comfortable to wear lumbar support belt. It is intended to help relieve lower back pain. The belt is supplied with a detachable sacral pad ("pelotte") that is covered with a stretch towel cover and can be attached to the inside of the belt. For additional comfort, this pelotte includes an array of flexible rubber fingers that ensure the compressive force and it can accommodate movement during walking. The belt may be used simply as a lumbar support device and can provide an adjustable degree of compression to the lumbo-sacral region due to the elasticated nature of the belt itself. To optimize support in the lumbar spine area, Baxolve XP incorporates "Duopress", an easy to adjust twin compression Compression may be increased with the optional detachable external belt system. compression straps. The type 297 version of the Baxolve XP garment may be connected to transcutaneous Electrical Nerve Stimulation (TENS) devices manufactured by Bio-Medical Research Ltd. and is supplied with a pack of four adhesive pads, four electrode stud covers and instructions for use. The type 298 Baxolve XP garment is similar to the type 297 garment except it is intended as a stand-alone lumbar support device. For purposes of hygiene, the Baxolve XP garment may be cleaned and instructions for device care are included in the user manual.

The provided document is a 510(k) premarket notification for a medical device called the "Baxolve XP Conductive Garment Accessory & Lumbar Support Kit". It focuses on establishing substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document explicitly states: "No clinical studies have been submitted as part of this premarket notification."

This means that the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established from a study proving criteria.

Instead, the document primarily addresses:

• Contact details and device name
• Regulatory classification and product codes
• Identification of equivalent legally marketed predicate devices (Neurotech Baxolve, K023913; Ultrastim Kit, K013532)
• Description of the device and its intended use/indications for use
• Statement that there are no technological characteristics that could affect safety or effectiveness
• Compliance with quality system regulations (21 CFR 820, I.S. EN ISO 13485:2003) and risk management standards (EN ISO 14971:2007)
• Confirmation of CE marking

The FDA's letter (pages 3-4) confirms the substantial equivalence determination but also notes that this does not mean the device complies with all requirements of the Act or other federal statutes and regulations. The marketing of the device is permitted based on its substantial equivalence to predicate devices, not on specific clinical performance metrics demonstrated through a new study.

Ask a specific question about this device

The neurotech BACKTENS device is intended to provide to pain associated with sore and The neurotech BACKTENS device is intentiou to provins time sump and the program and in activities

The NeuroTech BackTENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery. The device is intended to provide a non-invasive therapy for over the counter sale.

The provided text describes a 510(k) summary for the NeuroTech® BackTENS & Lumbar support Type 294 device. However, it does not contain any information about acceptance criteria or a study designed to prove the device meets specific performance metrics for clinical efficacy or accuracy in the way described in the prompt.

Instead, the document focuses on:

• Substantial Equivalence: The primary goal of this 510(k) submission is to demonstrate that the NeuroTech BackTENS device is substantially equivalent to a legally marketed predicate device (NeuroTech© Smart-TENS, Type 456, K961376).
• Safety and Performance to Standards: The device's safety and performance are assessed against existing, recognized electrical safety and electromagnetic compatibility (EMC) standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 601-1-1, IEC 601-1-2, IEC 61000-4-2, IEC 61000-4-3, DD ENV 50204, EN 55011). It also mentions hazard, risk, and failure mode effects analyses.
• Electrical Output Comparison: Non-clinical tests involved comparing the electrical outputs of the new device to the predicate device, showing similar results.
• Intended Use: The device is indicated for transcutaneous electrical nerve stimulation (TENS) for symptomatic relief and management of chronic lower back pain, and for lumbar support.

Therefore, I cannot populate the table or answer most of the questions as the required information (acceptance criteria, performance data, clinical study details, ground truth, expert opinions, sample sizes for testing/training sets, MRMC study, standalone performance) is not present in the provided text.

The document details the regulatory process (510(k) submission, FDA review, substantial equivalence determination) rather than the results of an empirical study with performance metrics.

Here's an attempt to address the prompt based only on the available information, with the understanding that most sections will be marked as "Not Provided" or "Not Applicable" for a traditional device performance study.

1. Table of acceptance criteria and the reported device performance

• IEC 60601-1:1990
• IEC 60601-2-10
• IEC 601-1-1 (A1:1991, A2:1995) |
  | Compliance with EMC Standards | Designed and independently tested to:
• IEC 601-1-2
• IEC 61000-4-2:1995
• IEC 61000-4-3:1997
• DD ENV 50204:1996
• EN 55011:1998 |
  | Hazard, Risk, FMEA | Hazard analysis, risk analysis, and failure mode effects analysis have been carried out. |
  | Final Performance Testing | All devices are subject to final performance testing (industry practice). |

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

• Sample Size (Test Set): Not provided. The document describes "non-clinical tests" comparing electrical outputs, but no specific sample size for device units tested or patients is mentioned.
• Data Provenance: Not provided, beyond the manufacturer being Bio-Medical Research Ltd in Galway, Republic of Ireland. The tests mentioned are likely in-house or by independent testing labs for electrical/EMC compliance, not clinical data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Provided: The document does not describe a clinical test set requiring expert-established ground truth. The "tests" mentioned are primarily electrical and safety compliance.

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

• Not Applicable/Not Provided: There is no clinical test set described that would require 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

• No: This is a TENS device, not an AI or diagnostic imaging device. An MRMC study is not relevant to the information provided.

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

• Not Applicable: This is a physical medical device (TENS stimulator), not an algorithm or AI. Standalone algorithmic performance is not relevant.

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

• Not Applicable/Not Provided: For the electrical and safety tests, the "ground truth" would be the specified parameters in the standards and the electrical output of the predicate device. No clinical ground truth method is discussed.

8. The sample size for the training set

• Not Applicable: This is a physical medical device; there is no "training set" in the context of machine learning or algorithms.

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

• Not Applicable: As above, there is no training set mentioned or implied.

Summary of what the document does convey regarding device acceptance:

The NeuroTech BackTENS device was accepted by the FDA based on the demonstration of substantial equivalence to an existing predicate device (NeuroTech© Smart-TENS). This equivalence was supported by:

• Similar intended use.
• Comparable technological characteristics (e.g., delivery of stimulation signal, parameter settings, LCD screen, user compliance logging).
• Non-clinical tests showing similar electrical outputs between the two devices.
• Compliance with recognized national and international electrical safety and electromagnetic compatibility (EMC) standards (e.g., IEC 60601-1, IEC 601-1-2).
• Completion of risk management activities (hazard analysis, risk analysis, FMEA).

The acceptance criteria were therefore focused on meeting the requirements for substantial equivalence and demonstrating adherence to established safety and performance standards for transcutaneous electrical nerve stimulators, rather than an independent clinical efficacy study with specific performance metrics.

Ask a specific question about this device

The device is intended for prescriptive use.

Indications for Use:

• Transcutaneous electrical nerve stimulation for the symptomatic relief and . management of chronic and intractable pain in the lower back region. The device has no curative values and should only be used in conjunction with medical supervision.
• . Lumbar support.

The BAXOLVE™ TENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery.

The device is intended to provide a non-invasive prescriptive therapy.

The provided text does not contain detailed information about specific acceptance criteria related to device performance in a clinical study for the NeuroTech® BAXOLVE™, Type 294. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through technological comparison and non-clinical tests (electrical outputs and compliance with standards). It does not present a clinical study with acceptance criteria and reported device performance in the same manner one might expect for a diagnostic or therapeutic device requiring such evidence for market clearance.

Therefore, many of the requested elements cannot be extracted from the given document.

Here's a breakdown based on the available information:

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

No explicit acceptance criteria for device performance in a clinical setting are provided, nor is there a table of reported device performance. The 510(k) emphasizes:

• Technological Comparison: The BAXOLVE™ is similar to the Smart-TENS in its delivery of the stimulation signal and similar parameter settings.
• Non-clinical Tests: Comparisons of electrical outputs for the two devices show similar results. Both were designed and independently tested to specific IEC and EN standards (e.g., IEC 60601-1:1990, IEC 60601-2-10, IEC 601-1-1, IEC 601-1-2, IEC 61000-4-2, IEC 61000-4-3, DD ENV 50204, EN 55011).

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

Not applicable. The document describes non-clinical engineering and safety compliance tests, not a clinical study on human subjects with a test set.

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, as no clinical study with a test set and ground truth establishment is described.

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

Not applicable.

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 Transcutaneous Electrical Nerve Stimulator (TENS) and a truncal orthosis, not an AI-assisted diagnostic imaging device.

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

Not applicable. This is not an AI algorithm. The device itself is the standalone product. The non-clinical tests focus on the device's electrical output and safety compliance, not its performance as an algorithm.

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

For the non-clinical tests, the "ground truth" was adherence to established electrical output specifications and internationally recognized safety and electromagnetic compatibility standards (e.g., IEC 60601 series, EN 55011).

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a training set in the AI context.

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

Not applicable.

Ask a specific question about this device

The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "UltraStim Kit." It confirms the device's substantial equivalence to predicate devices for its intended use. This type of document does not contain the detailed acceptance criteria or the study that proves the device meets those criteria.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results) from this document. This letter is a regulatory approval notice, not a study report.

Ask a specific question about this device