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510(k) Data Aggregation
(156 days)
Enraf-Nonius, B.V.
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(268 days)
Enraf-Nonius, B.V.
The Curapuls 670 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as:
- Relieving pain;
- Reducing muscle spasm;
- Increasing range of motion of contracted joints using heat and stretch techniques; and
- Increasing blood flow to tissues in the treatment area.
The Curapuls 670 is a two-channel microprocessor-controlled unit for pulsed shortwave therapy. Through inductive electrodes (Circuplodes), high-frequency electric currents are produced within the body. Pulsed energy at 27.12 MHz is absorbed by soft tissues. Three sizes of Circuplodes (140mm, 90mm and elliptical) are available to accommodate different size treatment areas.
Deep heating of tissue is achieved with ease by means of inductive electrodes. The user can connect two applicators. Activation of each applicator can be controlled from the console menu.
This device is a prescription equipment. Use by any persons other than physicians is prohibited.
This document is a 510(k) clearance letter for a medical device called Curapuls 670, a shortwave diathermy unit. It details the device's characteristics, its comparison to a predicate device (BTL-703), and the non-clinical testing performed to establish its substantial equivalence.
However, the provided text does not contain information related to an AI/ML-driven device or a study involving human-in-the-loop performance, such as a multi-reader multi-case (MRMC) study. It describes a physical therapy device used for applying therapeutic deep heat. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML evaluation (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.
The "acceptance criteria" and "study" described in this document are focused on demonstrating the safety and effectiveness of the Curapuls 670 as a medical device for therapeutic deep heating, primarily through non-clinical testing and comparison to a predicate device.
Let's extract what is available regarding acceptance criteria and the "study" (non-clinical testing) from the provided text:
Acceptance Criteria and Study for Curapuls 670 (Non-AI Device)
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of quantitative acceptance criteria for performance in the way one might expect for an AI model (e.g., specific sensitivity/specificity thresholds). Instead, the "acceptance criteria" for this device are primarily met by demonstrating compliance with recognized medical device safety and performance standards and showing substantial equivalence to a legally marketed predicate device.
The reported "device performance" is primarily qualitative and centered around its stated indications for use and its electrical/thermal properties.
| Acceptance Criteria (Implied by Standards & Equivalence) | Reported Device Performance / Compliance |
|---|---|
| Safety & Essential Performance (Electrical, Mechanical) | Complies with IEC 60601-1, ANSI AAMI ES60601-1. Full electrical safety testing performed. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2. EMC testing done to evaluate emissions and immunity. |
| Software Life Cycle Processes | Complies with IEC 62304. |
| Risk Management | Complies with ISO 14971. |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and skin sensitization). |
| Usability | Usability assessments done to verify user interface, safety features, and satisfactory performance. |
| Therapeutic Efficacy (Heat Generation) | Demonstrated ability to maintain tissue temperature in the range of approximately 40-45°C in vivo. |
| Substantial Equivalence to Predicate Device | Indications for Use are identical. Technological characteristics (working frequency, energy type, user interface, firmware control) are mostly identical. Minor differences (power source, mode of operation, applicator attachments, dimensions) are discussed and deemed not to raise new questions of safety or effectiveness. |
| Ability to achieve stated Indications for Use | "Used for applying therapeutic deep heat in body tissues in adults for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area." The thermal effect on tissue testing supports this. |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a dataset for an AI model. The document refers to "final, finished devices" undergoing testing. The number of physical devices tested isn't specified, but it's a small manufacturing sample for validation, not a large patient data sample.
- Data Provenance: Not applicable for an AI dataset. The "data" here refers to test results from physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device requiring expert labeling of data. The ground truth for performance is based on established engineering and medical device standards (e.g., temperature measurements, electrical safety parameters, usability assessments).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader interpretations that 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. An MRMC comparative effectiveness study was not done. This is not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm. The device's performance is inherently "standalone" in the sense that it performs its physical function (producing heat) independently, but it is operated by a human user (a physician).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on:
- Engineering specifications and regulatory standards: Compliance with IEC, ISO, and ANSI/AAMI standards for electrical safety, EMC, biocompatibility, and software quality.
- In vivo thermal measurements: Direct measurement of tissue temperature increase (40-45°C) to validate the therapeutic heating capability.
- Usability assessments: Evaluation of the user interface and safety features by presumably qualified personnel to ensure satisfactory operation.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device trained on a dataset.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for an AI model.
In summary, the provided FDA 510(k) clearance letter pertains to a non-AI medical device (Shortwave Diathermy). Therefore, the detailed questions appropriate for an AI/ML device's validation study are largely irrelevant to this document. The "acceptance criteria" are met by demonstrating compliance with established safety and performance standards relevant to physical therapy equipment and showing substantial equivalence to a predicate device.
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(244 days)
Enraf-Nonius, B.V.
Therapeutic Ultrasound is indicated for:
• Pain Relief
• Reduction of muscle spasms
• Localized increase in blood flow
• Increase range of motion of contracted joints using heat and stretch techniques
This device is a multi-frequency ultrasound therapy equipment. The mounted applicators provide both 1 and 3 MHz operation. Depending on the area of treatment, two different types of applicators, large and small, are available. They are suitable for treatment under water.
Contact control suspends the application of ultrasound energy when acoustical contact with the treatment area becomes insufficient. The user can connect two ultrasound applicators. Activation of each applicator can be controlled from the ultrasound menu.
This device is a prescription equipment. Use by any persons other than physicians is prohibited.
This document is a 510(k) Summary for the Sonopuls 190 medical device, which is an ultrasound therapy equipment. It aims to demonstrate substantial equivalence to a predicate device (Sonomed IV/V).
Here's a breakdown of the requested information based on the provided text, focusing on the study that proves the device meets acceptance criteria:
The context of the provided document is a 510(k) submission for a non-AI-powered therapeutic ultrasound device. Therefore, many of the requested elements specifically pertaining to AI/ML device performance and testing (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or explicitly mentioned in this type of submission. The "acceptance criteria" here primarily refer to meeting regulatory standards and demonstrating substantial equivalence to a predicate device, rather than a specific performance metric for a diagnostic AI model.
However, I will extract what is available and note where the information is not present due to the nature of the device and submission.
1. A table of acceptance criteria and the reported device performance
The document doesn't provide specific quantitative "acceptance criteria" for the device's therapeutic performance in a table format with corresponding "reported device performance" in the way one might expect for a diagnostic AI device (e.g., sensitivity/specificity targets). Instead, it relies on demonstrating compliance with various electrical safety, performance, biocompatibility, and software standards, and showing that any differences from the predicate device do not raise new questions of safety or effectiveness.
The closest equivalent to "performance" for this type of device relates to its physical output parameters (e.g., intensity, frequency, temperature rise, penetration depth) and compliance with safety standards. The "acceptance criteria" are implied by adherence to the listed standards and the conclusion of substantial equivalence.
Here's a table based on the "7. Technological Characteristics" and "8. Discussion of Differences", which details the device's specifications and compares them to the predicate, and serves as an indirect form of "performance" demonstration in this context. The "acceptance criteria" are implied to be "comparable to or not raising new questions of safety/effectiveness compared to the predicate device, and compliant with relevant standards."
| Characteristic / Acceptance Metric | Subject Device Performance (Sonopuls 190) | Predicate Device (Sonomed IV/V) Performance | Discussion/Substantial Equivalence Commentary (Implicit "Acceptance") |
|---|---|---|---|
| Indications for Use | Pain Relief, Reduction of muscle spasms, Localized increase in blood flow, Increase range of motion of contracted joints using heat and stretch techniques | Same as Subject Device | Similar. Formally accepted for substantial equivalence. |
| Product Code & Regulation | IMI, 890.5300 | IMI, 890.5300 | Identical. Formally accepted for substantial equivalence. |
| Crystal Material | PZT-8 (lead zirconate titanate) piezoceramic material | PZT | Similar. Accepted. |
| Technology of ultrasound generation | piezoelectric | piezoelectric | Identical. Accepted. |
| Power source | 100 - 240 VAC +/- 10% | 100 - 240 VAC | Similar. Accepted. |
| Output Mode | Continuous, Pulsed | Continuous, Pulsed | Identical. Accepted. |
| Intensity | 0 - 3.0 W/cm² | 0.1 - 2.0 W/cm² (cont), 0.1 - 3.0 W/cm² (pulsed) | Similar. Accepted. |
| Frequency | 1 MHz, 3 MHz | 1 MHz +/-5%, 3 MHz +/-5% | Similar. Accepted. |
| Acoustic Working Frequency and Accuracy (MHz) | 5 cm², 0.8 cm² and 1 MHz: 0.98 MHz ± 5%; 3 MHz: 3.1 MHz ± 5% | 1 MHz ± 5%, 3.3 MHz ± 5% | Similar. Accepted. |
| Effective Radiating Area (ERA) and Accuracy | 5 cm² applicator: 5 cm² ± 20%; 0.8 cm² applicator: 0.8 cm² ± 20% | 3.2cm² +/- 10% | Different. The ERA for the subject device's 5cm² applicator is larger and less accurate than the predicate's. However, it's deemed acceptable because it's identical to a cleared reference device (Omniversa) which uses the same parameters, thus raising no new safety questions. |
| Beam Nonuniformity Ratio (BNR) and Accuracy | 6:1 maximum | 2.8:1 maximum | Different. Subject device has a higher BNR. Accepted because BNR values in other cleared devices range between 2 and 6:1, and reliance on the thermal tissue testing using the reference device. No new safety/performance questions. |
| Maximum Value of the Output Power (Rated Output Power) and Accuracy (W) | 5 cm² applicator: 10 W ± 20%; 0.8 cm² applicator: 2 W ± 20% | 6.4 W ± 20% | Different. Subject device has higher maximum output power. Accepted because the reference device (Omniversa) was used safely in thermal tissue testing to support the submission, implying safety at these power levels. |
| Peak Temperature Rise vs. Time and Tissue Depth | 1.0MHz, 2.0W: 4.8°C for 10 min, depth 2.5cm; 3.0MHz, 2.0W: 5.8°C for 3 min, depth 0.8cm | 1MHz, 6.4W: 18°C for 20 min, depth 3cm; 3.3MHz, 6.4W: 19°C for 20 min, depth 1cm | Different. Subject device has less temperature rise over shorter time/shallower depth. Accepted as lower/slower temperature rise is "safer for the patient." |
| Maximum Patient Contact Surface Temperature of Treatment Head | 5 cm² applicator: |
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(120 days)
ENRAF-NONIUS B.V.
The ELTRAC 471 Traction device, with its accessories, is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The ELTRAC 471 Traction device may be used to treat pain and symptoms associated with the following conditions: hermiated discs, bulging or protruding intervertebral discs, degenerative disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.
The Eltrac 471 traction device applies forces to the spine to alleviate pain caused by a variety of pressure on muscular or skeletal structures. It exerts defined forces on the human body to alleviate pain and utilizes computer technology for programming of different kinds of traction.
This device is intended for use by professional users only, such as qualified personnel in physiotherapy, rehabilitation and adjacent areas. The device is designed with a plastic housing that holds the motor and has a full color touch screen interface on which the professional user can enter various parameters by touch. The forces from the motor are transferred to the patient by cords and connected accessories. Sequential programming is possible for programming combinations of traction which can be stored as favorites for later use.
The provided text describes the regulatory clearance for the "Eltrac 471 Traction device" based on substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria through performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance against those criteria are not present.
However, I can extract the information that is available regarding regulatory requirements and the non-clinical performance evaluation.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) against which the Eltrac 471 was compared. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized non-clinical standards.
The "performance" is generally described as meeting safety and functionality requirements through verification and validation tests against these standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety | Adheres to ISO 14971, IEC 60601-1, IEC 60601-1-2. Electronic safeguards of force and mechanical safety for maximum force limitation. Hardware mitigations protect from excessive force. Patient stop function. Remote control can decrease force but not increase it. |
| Basic Safety and Essential Performance | Adheres to IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Adheres to IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests). |
| Software Life Cycle Process | Adheres to IEC 62304. |
| Functionality | Applies forces to the spine, utilizes computer technology for programming, sequential programming possible, full color touch screen, transfers force via cords and accessories. |
| Technological Characteristics | Substantially equivalent to predicate device (Triton/Tru-Trac/TX/Triton DTS Traction devices) regarding electrical input, software control, motor-driven force delivery, safety/warning features. Minor differences in body positions, maximum treatment time (150 min vs 165 min), and force speed deemed not to raise new risks. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The non-clinical performance refers to "Verification and validation tests" conducted by Enraf-Nonius, B.V., but details about specific test sets, sample sizes, or data provenance (e.g., retrospective/prospective, country of origin) are absent. This is typical for submissions based on substantial equivalence for non-clinical devices where the "test set" would be the device itself subject to engineering and safety tests.
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)
This information is not provided. Clinical ground truth, experts, or their qualifications are not mentioned, as no clinical testing was performed or required. The "ground truth" for non-clinical tests would typically be defined by engineering specifications and standard requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for clinical studies, which were explicitly stated as "Not applicable" for this device.
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
This information is not applicable and not provided. This device is a physical therapy traction device, not an AI-assisted diagnostic or imaging device used by human readers/interpreters. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable in the context of typical AI algorithm-only performance. The "device" itself, the Eltrac 471, performs its function (applying traction) independently to the extent of its programming. The "non-clinical performance" section describes tests on the device's electrical, safety, and software functionality, which could be considered a form of standalone testing for the device's inherent design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance, the "ground truth" implicitly used would be engineering specifications, design requirements, and the pass/fail criteria defined by the cited international standards (ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304). This does not involve clinical "ground truth" like pathology or outcomes data, as no clinical studies were performed.
8. The sample size for the training set
This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "software" component refers to control software, not a learned model.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the reasons stated in point 8.
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(90 days)
ENRAF-NONIUS B.V.
Electrical Stimulation
The Flexible Rubber Electrodes are a family of electrodes that are supplied as accessories to Enraf-Nonius B.V. nerve and muscle stimulation equipment. Depending on electrode size and connection terminals, the following parts apply: 1460265 6 x 8 cm electrode with 4 mm female connection terminal, 1460272 4 x 6 cm electrode with 4 mm female connection terminal, 1460274 8 x 12 cm electrode with 4 mm female connection terminal, 3444128 4 x 6 cm electrode with 2 mm female connection terminal, 3444129 6 x 8 cm electrode with 2 mm female connection terminal, 3444130 8 x 12 cm electrode with 2 mm female connection terminal. The electrodes consist of carbon filled silicon rubber. For proper electrical contact with the patient the electrodes should be used in combination with moistened sponge pads. The electrode/sponge assembly is wrapped to the patient using fixation straps. Instructions for use are available in the Operating Instructions of the Enraf-Nonius B.V. nerve and muscle stimulators that the electrodes are to be used with. The following accessories apply: 1460266 Sponges Pads 6 x 8 cm, set of 4 pc, 1460273 Sponges Pads 4 x 6 cm, set 4 pc, 1460275 Sponges Pads 8 x 12 cm, set 4 pc, 3444020 Fixation strap 100 x 3 cm, 3444021 Fixation strap 250 x 3 cm.
The provided text is a 510(k) Summary for Flexible Rubber Electrodes. It describes the device, its indications for use, and a comparison of its technological characteristics to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or study designs (like sample sizes, expert involvement, or adjudication methods) that would typically be associated with proving a device meets acceptance criteria in the context of an AI/ML medical device.
The document is a submission for regulatory clearance (510(k)) for a physical medical device (electrodes), not an AI/ML product. The "Substantial Equivalence Summary" part focuses on comparing the new electrodes to existing ones based on physical characteristics (current density, power density), adherence to standards (IEC, MDD, CFR), and biocompatibility (cytotoxicity, skin irritation, dermal sensitization). These are traditional engineering and safety evaluations, not performance metrics derived from AI/ML models.
Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device or its associated study, as that content is not present in the provided document.
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