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510(k) Data Aggregation
(422 days)
The Aptiva™ v2.13U is a multifunctional transcutaneous electrical nerve stimulator (TENS) equipped with a surface electromyography and electroneurography.
Aptiva™ is indicated for symptomatic relief and management of chronic pain, intractable pain and/or as an adjunctive treatment for the management of post-traumatic pain.
The dynamic surface electromyography and electroneurography system is used for biofeedback, relaxation training, and muscle re-education as well as monitoring and display of bioelectric signals produced by muscles, stimulate peripheral nerves, and monitor and display the electrical activity produced by nerves.
The Aptiva™ v2.13U consists of a console on a mobile floor stand, power cord, battery charger, patient remote control, cables, and Manuals (User and Application). The Aptiva™ v2.13U is provided in four functional models (Ballet, Flamenco, Hip-Hop, and Jazz). EMG features are provided in the Ballet and Hip Hop models. One version of the Ballet model (Option Etoile) includes electroneurography (ENG) functions and a printer. Aptiva™ v2.13U uses commercially available electrodes. Models designated "Light" versions do not include the full treatment databases.
The provided text describes a 510(k) summary for the Lorenz Biotech Aptiva™ v2.13U device. This document focuses on demonstrating substantial equivalence to predicate devices and detailing the device's intended use and technological characteristics.
Regarding your request for acceptance criteria and a study proving the device meets them, the provided text does NOT contain information about specific performance acceptance criteria for diagnostic accuracy, sensitivity, specificity, or other clinical performance metrics, nor does it detail a study that evaluates these metrics in a clinical context.
Instead, the "PERFORMANCE TESTING" section states: "Testing included in this premarket notification includes electrical safety, electromagnetic compatibility, and design verification and validation testing. No materials of the Aptiva™ v2.13U are in direct contact with treatment sites and therefore no biocompatibility testing was provided. Test results demonstrate that the Aptiva™ v2.13U fulfills the prospectively defined performance specifications."
This indicates that the performance testing focused on engineering and safety specifications, not clinical efficacy or diagnostic accuracy as would be assessed in a study with a test set, ground truth, and expert readers. The 510(k) process for this type of device often relies on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics and intended use, rather than conducting new clinical effectiveness studies for each submission.
Therefore, I cannot fulfill most of your request based on the provided text.
Here's what I can provide based on the information given, and where most of your requested points cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Type | Reported Device Performance/Testing |
|---|---|
| Clinical Performance (e.g., diagnostic accuracy, sensitivity, specificity) | Not reported. The document does not provide clinical performance metrics. The submission focuses on substantial equivalence based on intended use, indications for use, operational characteristics, and fundamental technological characteristics, and safety/engineering testing. |
| Electrical Safety | "Test results demonstrate that the Aptiva™ v2.13U fulfills the prospectively defined performance specifications." (Specific criteria and results not detailed in the summary.) |
| Electromagnetic Compatibility | "Test results demonstrate that the Aptiva™ v2.13U fulfills the prospectively defined performance specifications." (Specific criteria and results not detailed in the summary.) |
| Design Verification & Validation | "Test results demonstrate that the Aptiva™ v2.13U fulfills the prospectively defined performance specifications." (Specific criteria and results not detailed in the summary. This likely refers to engineering design and functional testing against internal specifications, not clinical performance.) |
| Biocompatibility | "No biocompatibility testing was provided." (Justified by no direct patient contact with materials.) |
The following information cannot be provided as it is not present in the given text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- 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)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
The Aptiva™ v2.13U is a Transcutaneous Electrical Nerve Stimulator (TENS) and EMG/ENG device, which are typically cleared through 510(k) based on established safety and performance standards for electrical devices and substantial equivalence, rather than extensive clinical studies for diagnostic accuracy that would involve a "test set" and "ground truth" in the way described for, for example, an AI imaging device.
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(99 days)
The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles.
The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices provide a treatment in static, intermittent, progressive and cycling distraction forces to relieve pressures on micentifies that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions.
The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices with the optional EMG (a.k.a. sEMG) biofeedback feature may be used to relieve peripheral radiation/sciatica and nain associated with:
➤ Protruding discs
➤ Bulging discs
➤ Herniated discs
➤ Degenerative disc disease
➤ Posterior facet syndrome
➤ Acute facet problems
➤ Radicular pain
➤ Prolapsed discs
➤ Spinal root impingement
➤ Hypomobility
➤ Degenerative joint disease
➤ Facet syndrome
➤ Compressions fractures
➤ Joint pain
➤ Discogenic pain
EMG (a.k.a. sEMG)
Determination of the activation magnitude and timing of muscles for:
a) retraining of muscle activation
b) coordination of muscle activation
Determination of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education
The Chattanooga Group powered traction device consists of an electric traction treatment unit, and may be sold with the following: EMG (a.k.a. sEMG) biofeedback feature, Pull-Pattern intermittent traction preset feature, patient traction treatment table device, positioning bolster accessories, patient traction belt accessories, high volt pulsed electrotherapy device and miscellaneous traction devices and/ or accessories. The device is intended to be used in hospitals, physical therapy clinics and chiropractic clinics for treatment in static, intermittent, progressive, regressive and cyclic, distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). The device is restricted to sale by or on the order of a licensed physician or licensed practitioner.
The primary features of the Triton/ Tru-Trac/ TX/ Triton DTS Traction hardware are the traction unit (a.k.a. traction head), display screen, traction rope, mounting assembly and patient stop treatment switch.
The EMG biofeedback feature is used to detect muscle activation and relaxation for Frie ENC oferous traction therapy. The treating clinician determines the minimum muscle activation or minimum muscle relaxation threshold set point. This is done by utilizing the visual display. The intermittent traction reacts to these threshold settings and administers prescribed traction treatment. The Pull Pattern feature is a preset of intermittent traction settings, less the setting of traction force, less setting of traction time. Force and time parameters are determined by the treating clinician.
The provided information does not describe a study that proves the device meets specific acceptance criteria in terms of performance metrics or clinical outcomes. Instead, it details the submission for 510(k) premarket notification for the Triton/ Tru-Trac/ TX/ Triton DTS Traction device, which primarily relies on demonstrating substantial equivalence to legally marketed predicate devices.
The acceptance criteria mentioned are related to compliance with recognized consensus standards for medical equipment safety and electromagnetic compatibility, rather than clinical efficacy or specific performance benchmarks.
Here's a breakdown of the requested information based on the provided text, with notes where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Compliance Standard) | Reported Device Performance (Compliance) |
|---|---|
| UL 60601-1: 2003 (Standards for Medical Equipment Part 1: General Requirements for Safety, 1st Edition) | In compliance |
| IEC 60601-1-2: 2001 (Medical Electrical Equipment Part 1 - 2: General requirements for Safety - Collateral Standard, Electromagnetic Compatibility --Requirements and Tests, 2nd Edition) | In compliance |
Note: The document does not specify performance acceptance criteria related to clinical effectiveness (e.g., specific pain reduction percentages, range of motion improvements, or target success rates). The primary "performance" reported is compliance with safety and EMC standards and technical similarity to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size of Test Set: Not applicable. The submission is for a medical device seeking market clearance through substantial equivalence, not a clinical study with a test set of patient data for performance evaluation against ground truth. The "test set" here refers to the device itself being tested for compliance with technical standards.
- Data Provenance: Not applicable for a clinical test set. The data provenance described is the device's technical specifications and comparisons to predicate devices for substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. This document does not describe a study where experts established ground truth for a clinical test set. The "ground truth" for this submission revolves around established safety and EMC standards, and the technical characteristics of predicate devices.
- Qualifications of Experts: Not applicable for a clinical test set. The compliance with standards would be assessed by testing laboratories and regulatory bodies.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of an adjudication process for a clinical test set in this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document does not describe an MRMC comparative effectiveness study.
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no MRMC study was conducted, and the device is a powered traction unit, not an AI-assisted diagnostic or interpretative system. The optional EMG biofeedback feature provides data for the clinician but isn't described as an AI-driven interpretive tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? No. The device is a physical therapy traction unit, and its function involves direct human application and interaction (clinician administering treatment, patient interacting with the device). There is no "algorithm only" performance that would be evaluated in a standalone study without human involvement.
7. Type of Ground Truth Used
- Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" is established by:
- Regulatory Standards: Compliance with recognized safety and electromagnetic compatibility standards (UL 60601-1: 2003, IEC 60601-1-2: 2001).
- Predicate Device Characteristics: The technical specifications and indications for use of the listed predicate devices (e.g., Triton/Tru-Trac/TX Traction, Eskotek EST Trac 401 Traction, etc.) serve as the benchmark for demonstrating substantial equivalence. The argument for substantial equivalence is based on comparing the new device's features, intended use, and technological characteristics to those of legally marketed predicate devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI-driven device that requires a training set of data for an algorithm. The device is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
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