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510(k) Data Aggregation
(268 days)
Bemer INT. AG
B.Light Clear Evo:
- The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face.
B.Light Restore Evo: — Use of light-based treatment to reduce wrinkles on the face.
The BEMER devices are noninvasive, fully reusable components such as electrodes), and have configurations allowing both patient / home and professional / office use. The subject device is specific to the LED based applications.
Low Level Light Therapy (LLLT) delivered via Light Emitting Diodes (LED) is a nonthermal technology used to modulate cellular activity with specific (nm) of light. Through photo biomodulation, photons are absorbed by chromophores within cells that are being treated. Various beneficial effects of LLLT delivered via light-emitting diodes at relatively low intensities have been reported, especially in indications where stimulation of healing, reduction of pain and inflammation, restoration of function, and skin rejuvenation are required. Light-emitting diode therapy (LED) is safe, nontoxic, and a noninvasive therapy for the treatment of Acne and the reduction of wrinkles and fine lines on the face.
The provided document is a 510(k) Premarket Notification from the FDA for B.Light Clear Evo and B.Light Restore Evo devices. The document mainly focuses on establishing substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. It does not contain information about explicit acceptance criteria or a dedicated clinical study proving the device meets specific performance criteria.
Therefore, many of the requested details, especially those related to clinical studies, will be marked as "Not provided in the document."
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly stated) | Reported Device Performance (from "Comparison of Subject vs. Predicates" and "Non-clinical Testing") |
|---|---|
| B.Light Clear Evo (Acne treatment) | |
| Wavelengths: 465 nm ± 20 nm (Blue) and 645 nm ± 20 nm (Red) | Reported: Blue: 465 nm ± 20 nm; Red: 645 nm ± 20 nm (Matches) |
| Irradiance source: LEDs | Reported: LEDs (Matches) |
| Power intensity (Red): 0.76 mW/cm² | Reported: Red: 0.76 mW/cm² (Matches) |
| Power intensity (Blue): 1.20 mW/cm² | Reported: Blue: 1.20 mW/cm² (Matches) |
| Treatment dose: 1 J/cm² per treatment | Reported: 1 J/cm² per treatment (Matches) |
| Treatment time: 8 minutes per day, 30 days | Reported: 8 minutes per day, 30 days (Matches) |
| Total treatment time: 240 minutes | Reported: 240 minutes (Matches) |
| B.Light Restore Evo (Wrinkle reduction) | |
| Wavelengths: 860 nm ± 20 nm (IR) and 645 nm ± 20 nm (Red) | Reported: IR: 860 nm ± 20 nm; Red: 645 nm ± 20 nm (Matches) |
| Irradiance source: LEDs | Reported: LEDs (Matches) |
| Power intensity (Red): 0.56 mW/cm² | Reported: Red: 0.56 mW/cm² (Matches) |
| Power intensity (IR): 1.40 mW/cm² | Reported: IR: 1.40 mW/cm² (Matches) |
| Treatment dose: 1 J/cm² per treatment | Reported: 1 J/cm² per treatment (Matches) |
| Treatment time: 8 minutes per day, 30 days | Reported: 8 minutes per day, 30 days (Matches) |
| Total treatment time: 240 minutes | Reported: 240 minutes (Matches) |
| General Safety and Performance | |
| Safety and EMC standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-57 | Reported: Compliance with these standards (Matches) |
| Biocompatibility standards: ISO 10993-1 | Reported: Compliance with ISO 10993-1 (Matches) |
| Software/Firmware/Microprocessor controlled | Reported: Yes (Matches, indicating successful functionality testing) |
| Home healthcare environment | Reported: Testing covered home healthcare (Matches, indicating suitability for intended use environment) |
| Non laser-light source equipment | Reported: Testing covered non laser-light source equipment (Matches) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided in the document. The document primarily relies on non-clinical performance testing and comparison to predicate devices, not clinical trials with patient test sets.
- Data Provenance: Not applicable, as no clinical trial data for the subject device is presented. The document mentions non-clinical testing.
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 provided in the document. This information would typically come from a clinical study, which is not detailed here for the subject device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the document, as no clinical study with a 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
- No MRMC comparative effectiveness study was done or reported in this document. The devices are light therapy devices and do not involve "readers" or "AI assistance" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The devices are light therapy applicators, not diagnostic algorithms. The performance discussed is the physical characteristics and safety of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical testing, the "ground truth" refers to established engineering standards, specifications, and regulatory requirements (e.g., IEC 60601 series for safety and EMC, ISO 10993-1 for biocompatibility). The document indicates that the device met these standards. No clinical ground truth (like pathology or outcomes data) for the subject device's performance in treating acne or wrinkles is presented in this document.
8. The sample size for the training set
- Not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. The document describes a physical medical device, not an AI/ML algorithm.
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(29 days)
Bemer INT AG
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
BEMER therapy system Evo is a noninvasive physical medicine device that can be used as a supportive therapy to increase local blood circulation.
BEMER Therapy System Evo improves local blood distribution via electromagnetic stimulatory principles. The indications for use allow application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.
The device is noninvasive, fully reusable (no disposable components such as electrodes), and has configurations allowing both patient/home and professional/office use.
This submission is for the redesigned BEMER Therapy System Evo model including all previous applicators plus a new applicator, B.BED Evo.
The device contains firmware that controls the user interface. It also contains the pulse generator, battery charger, audio and pushbutton controller.
This document is a 510(k) Premarket Notification from the FDA regarding the BEMER Therapy System Evo. It addresses the substantial equivalence of the BEMER Therapy System Evo to previously cleared predicate devices (K151834 and K210174).
The document does not describe an AI/ML-driven device or study involving human readers, AI assistance, or expert adjudication for ground truth establishment. Instead, it focuses on the equivalence of a physical medical device (a powered muscle stimulator) based on its technological characteristics, intended use, and non-clinical performance testing.
Therefore, I cannot extract the information required by your prompts (acceptance criteria for AI/ML, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, etc.) because these concepts are not relevant to the described device and its regulatory submission.
The document details performance testing for physical device characteristics rather than algorithm performance on data. The "performance testing" mentioned refers to measurements of:
- BEMER signal waveform current output (AC RMS in mA) generated from the console.
- Magnetic flux output (uT) from the applicators at all signal intensity input levels.
These are engineering performance specifications for a physical device, not a study evaluating an AI model with human reading.
In summary, the provided text does not contain the information needed to answer your questions as it pertains to a physical medical device clearance, not an AI/ML device.
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(13 days)
Bemer INT. AG
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The indications for use allow application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance. The BEMER devices are noninvasive, fully reusable (no disposable components such as electrodes), and have configurations allowing both patient/home and professional/office use. This submission is specifically requesting to add the applicators, B.BODY and B.SIT to the already cleared BEMER Therapy System. The device contains firmware that controls the user interface. It also contains that controls the pulse generator, battery charger, audion and pushbutton controller.
The provided text is a 510(k) premarket notification document for a medical device, the BEMER Classic Set and BEMER Pro-Set, specifically requesting to add new applicators (B.BODY and B.SIT) to an already cleared system.
This document does not contain information about a study proving the device meets acceptance criteria related to a diagnostic AI or imaging-based device. The context is for a powered muscle stimulator. Therefore, the questions about acceptance criteria for AI algorithms, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes are not applicable to this document's content.
The document focuses on demonstrating substantial equivalence to a predicate device (K151834) for new accessories (applicators B.BODY and B.SIT). The "acceptance criteria" here are based on similarity to the predicate device and compliance with relevant electrical safety, EMC, and biocompatibility standards.
Here's a breakdown of the relevant information from the document, tailored as much as possible to the spirit of your request, but acknowledging the difference in device type:
Device Type: Powered Muscle Stimulator (Non-invasive tissue stimulation via magnetic field induction)
Indications for Use:
- To temporarily increase local blood circulation in healthy leg muscles.
- To stimulate healthy muscles in order to improve and facilitate muscle performance.
Instead of "Acceptance Criteria for AI Performance," the document discusses "Substantial Equivalence" to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from "Comparison of Technological Characteristics" and "Non-clinical Testing"):
| Characteristic / "Acceptance Criteria" (Predicate Baseline) | Subject Device (New Applicators: B.BODY & B.SIT) Performance | Justification/Comment |
|---|---|---|
| Classification Code (Primary: NGX 890.5850) | Same (NGX 890.5850) | Substantially Equivalent |
| Indications for Use | Same as predicate | Substantially Equivalent |
| Primary Mode of Action (Non-invasive tissue stimulation via magnetic field induction) | Same | Substantially Equivalent |
| Treatment of large and/or multiple regions simultaneously | Yes | Substantially Equivalent |
| Intensity Settings (1-10) | B.BODY: 1-6 (Basic Plan Treatment); B.SIT: 1-10 | B.BODY has lower max intensity as it's for superficial muscles |
| Treatment Time (8-20 minutes) | B.BODY: 8 min; B.SIT: 8-20 min | Substantially Equivalent for B.SIT. B.BODY is fixed 8 min. |
| Average Flux Density (max. level) | B.BODY: ≈ 35 µT (Basic), ≈ 50 µT (Plus); B.SIT: ≈ 100 µT (Basic), ≈ 150 µT (Plus) | B.BODY is lower than predicate (100/150 µT) due to superficial target. B.SIT is same. |
| Power Consumption (System) (30 Watt max.) | Same (30 Watt max.) | Substantially Equivalent |
| Input/Output (System) | Same (100-240 VAC 50-60 Hz, 0.6A; 12-15.1 VDC, 2.0A; Optional 7.2 V Li-Ion battery) | Substantially Equivalent |
| Biocompatibility | Yes (tested to ISO 10993-5, ISO 10993-10) | Meets standards |
| Number of output modes (1) | Same (1) | Substantially Equivalent |
| Number of output channels/ports (2 for each) | Same (2 for each) | Substantially Equivalent |
| Software/Firmware/Microprocessor controlled | Yes (Unchanged from predicate) | No new concerns |
| Timer Range (8-20 minutes) | Same | Substantially Equivalent |
| Compliance with voluntary standards (IEC 60601-1, IEC 60601-1-2, EN 60601-1-6, EN 62366, EN 60601-1-11) | Yes (Unchanged but evaluated under these standards for new design) | Meets standards |
| Sterilization (Not provided sterile) | Same (Not provided sterile) | Substantially Equivalent |
| Performance Testing (Signal waveform current output, magnetic flux output) | Performance testing demonstrated equivalence. | Data supports equivalence, though specific values not detailed beyond max flux density. |
2. Sample Size and Data Provenance:
- This document describes non-clinical performance testing of electrical and magnetic outputs, not a clinical study with human subjects or a test set of patient data.
- Therefore, concepts like "sample size used for the test set" (in the context of patient data) and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable. The testing was laboratory-based, comparing the new applicators' performance characteristics to the already cleared predicate.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. Ground truth in the context of AI/medical imaging refers to expert interpretation of patient data. This document describes performance validation of physical device characteristics against engineering specifications and predicate device performance. No expert human interpretation of medical images or patient outcomes data for ground truth establishment is mentioned or required for this type of device and submission.
4. Adjudication Method:
- Not applicable. This refers to methods for resolving discrepancies in expert ground truth for medical data. Not relevant here.
5. MRMC Comparative Effectiveness Study:
- Not applicable. This is a study design for evaluating the impact of AI on human reader performance. This submission is for a physical therapy device, not a diagnostic AI system, and does not involve human readers interpreting AI output.
6. Standalone Performance (Algorithm Only):
- Not applicable. This relates to AI algorithm performance without human intervention. The BEMER device is a physical therapy device; there is no "algorithm only" performance in the sense of an AI model's output.
7. Type of Ground Truth Used:
- For this device, the "ground truth" (or basis for comparison) is the technical specifications and measurable electromagnetic outputs of the predicate device, along with adherence to recognized international standards for medical electrical equipment (e.g., IEC 60601 series, ISO 10993 series). No patient pathology or outcomes data is used as "ground truth" for this type of submission.
8. Sample Size for the Training Set:
- Not applicable. There is no AI training set involved in this 510(k) submission for a physical therapy device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, no training set or its ground truth establishment is relevant to this document.
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(597 days)
BEMER Int. AG
BEMER therapy systems (BEMER Classic Set, BEMER Pro-Set) are indicated for:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER therapy is offered in two system options-Classic and Professional. Both systems consist of a B.BOX console, a set of BEMER signal applicators, power pack, B.SCAN indicator and accessories for attachment. The B.PAD and B.SPOT applicators have been cleared for use in this submission.
BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The resulting increase in local blood distribution can broadly benefit patients. The indications for use allow the application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.
Acceptance Criteria and Device Performance:
The provided document is a 510(k) summary for the BEMER Classic Set and BEMER Pro-Set. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit acceptance criteria with specific performance metrics for the BEMER device itself.
However, the "Performance Testing" section states that "BEMER therapy systems are compliant with the following standards and have outputs that are within the same range as the predicate devices". This implies that the 'acceptance criteria' for the BEMER device's performance are that it meets these standards and operates within a comparable range to the predicate.
The "Technical and Performance Comparison" table (Table 12.1) details the comparison between the BEMER Therapy Systems (Subject Device) and the predicate device (Revitive IX, K143207) and a reference device (Neotonus MS-101 Magnetic Muscle Stimulator System, K973929).
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, direct acceptance criteria with specific numerical thresholds for increased blood circulation or improved muscle performance are not provided. Instead, the acceptance is based on demonstrating substantial equivalence by meeting regulatory standards and having comparable technical characteristics and functionality to the predicate device.
| Feature / Criteria (Implied) | Predicate Device (Revitive IX, K143207) Performance | Subject Device (BEMER Therapy Systems) Performance | Comparison Comments (from document) |
|---|---|---|---|
| Indications for Use (Key Acceptance) | - Temporarily increase local blood circulation in healthy leg muscles. |
- Stimulate healthy muscles to improve/facilitate muscle performance. | - Temporarily increase local blood circulation in healthy leg muscles.
- Stimulate healthy muscles to improve/facilitate muscle performance. | Same/Substantially Equivalent |
| Mode of Action | Non-invasive tissue stimulation via skin electrodes. | Non-invasive tissue stimulation via magnetic field induction. | "Effectiveness: As the mode of action differs from direct induction (predicate device) to indirect induction (subject device), safety and effectiveness must be proven via a comparative series of measurements" |
| Waveform | Pulsed symmetrical, constant amplitude during treatment. | Pulsed asymmetric, constant amplitude during treatment. | Minor difference, no impact on safety and effectiveness. |
| Shape | Rectangular, bipolar. | Sinusoidal, monopolar. | Minor difference, no impact on safety and effectiveness. |
| Pulse repetition rate | Foot: 20-53Hz; Body: 35-46Hz. | All accessories: 10-30Hz. | Minor difference, no impact on safety and effectiveness. |
| Single pulse duration | Foot: 0.4 - 7.5µS; Body: 1.4 - 33.6µS. | All accessories: 10 - 33µS. | Minor difference, no impact on safety and effectiveness. |
| Maximum Power density applied | Foot: 0.023 mA/cm2; Body: 0.082 mA/cm2. | All accessories: 35 - 100μT. | Minor difference, no impact on safety and effectiveness. |
| Maximum output voltage | @500Ω: 20-32V; @2kΩ: 95-118V; @10kΩ: 138-169V. | N/A (Does not directly apply voltage). | "Safety: The subject device does not directly apply voltage to the human body. Therefore, no new hazards were identified." |
| Maximum Output Current (directly applied) | @500Ω: 40-64mA; @2kΩ: 48-59mA; @10kΩ: 14-17mA. | All accessories:
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