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510(k) Data Aggregation
(245 days)
Symptomatic relief of chronic intractable pain
Adjunctive treatment for the management of post-traumatic or post-surgical pain
The TENS/IF 14 is a combination TENS and Interferential device which delivers nerve stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device may be powered by either 4 AA batteries or by an AC adapter, that when plugged into a wall outlet provides 6 VDC to the unit. A patient compliance timer can memorize 60 sets of operation records; the total record time is 999 hours.
Here's an analysis of the provided 510(k) summary for the TENS/IF 14, focusing on acceptance criteria and the supporting study information:
Summary of Acceptance Criteria and Device Performance:
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Safety Testing | Passed all applicable tests per IEC 60601-1-2. | This is a general compliance statement to an international standard for medical electrical equipment. Specific criteria within this standard are not detailed, but it implies adherence to electrical safety, electromagnetic compatibility, and other general safety requirements. |
| Electrical Leakage Current | Meets standard requirements. | Specific numerical limits are not provided, but the device confirmed compliance. |
| Electrode & Lead Wire Safety | Meets standard requirements. | Specific criteria are not provided, but the device confirmed compliance. |
| Output Current | Meets standard requirements. | Specific numerical limits (e.g., current range, type of current) are not provided, but the device confirmed compliance. |
| Power Density | Meets standard requirements. | Specific numerical limits are not provided, but the device confirmed compliance. |
| Technological Characteristics | Output specifications, device design, waveforms, and programmability are substantially equivalent to predicate devices. | This is not an acceptance criterion in the traditional sense of a performance metric, but rather a demonstration of similarity to already-approved devices, which is key for 510(k) clearance. |
Study Information Pertaining to Acceptance Criteria:
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Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set in the context of clinical or performance data. The testing primarily involved engineering performance and safety testing in accordance with IEC 60601-1-2.
- Data Provenance: The standard testing (IEC 60601-1-2) would typically be conducted by the manufacturer or a certified testing laboratory. The document doesn't specify a country of origin for any "data" beyond the manufacturing and submission location. This is not a study involving patient data.
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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. This device's clearance is based on engineering and safety performance testing against a recognized standard (IEC 60601-1-2) and demonstration of substantial equivalence to predicate devices, not on a clinical test set requiring expert ground truth for diagnostic accuracy or treatment efficacy.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As stated above, this was not a clinical or comparative performance study that would involve expert adjudication of results. The "adjudication" was effectively by the testing laboratory confirming compliance with the technical standard.
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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 nerve stimulator, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of AI assistance is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (nerve stimulator), not an algorithm or software-as-a-medical-device (SaMD). Its performance is inherent in its electrical output and safety, not in an algorithmic assessment.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the safety and performance testing, the "ground truth" was compliance with the technical specifications and safety limits defined by the IEC 60601-1-2 standard. There was no clinical ground truth (like pathology or outcomes data) being established for this type of submission.
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The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
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(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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(198 days)
The Basba E-Machine is intended for use as a symptomatic relief and management of chronic and acute pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
The Basba E-Machine is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
The Basba E-Machine is a non-invasive, transcutaneous electrical stimulation device, which is intended for use as an adjunctive treatment for individuals suffering from chronic intractable pain. The system consists of a.TENS Unit, AC-DC adapter to power the unit and a serial RS-232 connection cable. The Unit is approximately 17 cm x 15 cm x 4 cm. Two light emitting diodes (LED) are located on the faceplate of the Unit. The green LED indicates the working status of the device and the red LED is the power indicator. There are four sockets located on the faceplate of the Unit: three of them labeled "OUT" provide the output electrical current for 3 different types of connectors and the fourth socket is the ground socket labeled GND.
The Basba E-Machine is a Transcutaneous Electrical Nerve Stimulator (TENS) device. The provided document is a 510(k) premarket notification summary and the FDA's clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting an efficacy study with acceptance criteria and performance data in the typical sense of a clinical trial.
Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be directly filled from this document. This submission primarily relies on comparing technical characteristics and intended use to already cleared devices.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide specific acceptance criteria or performance metrics (e.g., pain reduction scores, percentage of users experiencing relief) in a quantifiable manner as would be expected from a clinical efficacy study. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence in technical, functional, and performance characteristics to existing predicate devices.
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance |
|---|---|
| Safety: Device operates without raising new safety concerns. | "The Basba E-Machine performs as intended and does not raise any new safety or efficacy issues." Functional performance testing and electrical safety testing were conducted. |
| Functional Performance: Operates as intended for a TENS device. | "The Basba E-Machine has comparable technical and performance characteristics as currently marketed TENS devices." "The E-Machine and the referenced predicate devices use similar electronic components to provide electrical stimulation via paired electrodes to the subject. All of these devices are operated at continuous wave duty cycles." |
| Efficacy: Performs comparably to predicate TENS devices for intended use. | "The Basba E-Machine is designed to comply with the generally accepted performance specifications for TENS devices." "The Basba E-Machine performs as intended and does not raise any new safety or efficacy issues." It has the "same intended uses and similar technical, functional and performance characteristics" as predicate devices. |
| Electrical Safety: Compliant with relevant standards. | Electrical safety testing was conducted. (Specific standards or results not detailed in this summary.) |
| Intended Use: Matches predicate devices for pain relief. | "The Basba E-Machine is intended for use as a symptomatic relief and management of chronic and acute pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain." This matches the general intended use of predicate TENS devices. |
2. Sample Size for Test Set and Data Provenance
The document describes functional performance and electrical safety testing of the device itself, but does not describe a clinical study on a human test set. Therefore, information like sample size, country of origin, or retrospective/prospective nature for clinical data is not applicable or provided.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This submission does not involve expert-adjudicated ground truth from a clinical study.
4. Adjudication Method
Not applicable. This submission does not involve clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not performed. This is a 510(k) submission for a TENS device, which typically relies on demonstrating substantial equivalence to predicate devices based on technical specifications and intended use, rather than a direct comparative clinical trial against a "without AI" arm.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is not an algorithm or AI system. It's a physical TENS device. The performance described (functional and electrical safety testing) is inherently "standalone" in the sense that it refers to the device's own operation.
7. Type of Ground Truth Used
The "ground truth" for this 510(k) submission is primarily the technical specifications and established safety/efficacy profiles of the predicate devices. The Basba E-Machine's tests (functional performance and electrical safety) demonstrate its compliance with, and similarity to, these established benchmarks. There is no biological or clinical "ground truth" established for individual cases as would be found in diagnostic device studies.
8. Sample Size for Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How Ground Truth for Training Set Was Established
Not applicable. No training set for an AI/ML algorithm is involved.
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