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510(k) Data Aggregation
(134 days)
- temporary relief of minor muscle and joint aches, pains and stiffness
- temporary relief of muscle spasm
- temporary relief of minor pain and stiffness associated with arthritis
- promoting relaxation of the muscle tissue
- temporary increase in local blood circulation
OptonPro is a topical heat lamp with laser light. It emits energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature. The OptonPro contents a Class IV laser unit with four simultaneously operating diodes with wavelengths of 810nm and 980mm transmitting their energy to an applicator through a flexible fibre optic cable. The applicator has an output spot size of 10 mm. The optimum ration of absorption and penetration depth quarantees efficient stimulation of tissue and pain receptors. The treatment effect of the OptonPro is achieved with 980nm and 810nm. Additionally the OptonPro contains an aiming beam with 650nm. Skin type, indication and desired depth of treatment define the operating mode and the required energy. Two operating modes are possible: continuous wave and serial pulse. The duty cycle can be adapted additionally (1:1 – 1:10). Patient feedback and direct access to the treatment parameters enable to adjust the application for individual requirements and to achieve treatment times of a few minutes. The OptonPro includes comprehensive safety features. In addition to multi-step activation of the laser by the software, with software security key lock and footswitch for starting treatment, protective glasses, an emergency off switch and a hardware interlock are included in the system. The performance of the laser unit can be tested with an integrated power control unit. A thermal threshold test offers a tool to assess the warmth sensitivity and the individual local absorption rate. Additionally the user is assisted with a special reminder function for a delivered particular amount of energy. OptonPro is an intuitive therapy system with touch screen and menu-quided operation. The maximum output power is 7 W. The adjustable output power corresponds with the chosen duty cycle. The OptonPro has a large colour display with 12 inch. A SD card is used as a memory, as a logbook and for updates. Individual adjustments can be made at any time and saved for easy access. A program menu with 3 fixed programs and a favourites and memory menu with 120 memory slots fur custom programs collects the most common settings and shows them when the OptonPro is started if required.
The provided document is a 510(k) premarket notification for the Zimmer MedizinSysteme OptonPro, an infrared lamp device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria for a new device's performance.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not available in this document because they are typically required for demonstrating efficacy and safety of novel devices, or for AI/software devices, which this infrared lamp is not.
However, I can extract the information that is present concerning performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Therapeutic temperature range | 40 – 45°C |
| Maximum transition time to reach therapeutic temperature range | 5 minutes |
| Duration therapeutic temperature range is maintained | 10 minutes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "a few test candidates" (No specific number provided)
- Data Provenance: Not specified, but given it's a submission from Zimmer MedizinSysteme GmbH (Germany), it's likely originating from Europe.
- Retrospective/Prospective: The wording "temperature measurements were conducted" suggests a prospective measurement approach for the non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not available in the document. The testing described is non-clinical performance measurement (temperature), not a diagnostic or clinical assessment requiring expert ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable as the described testing involves physical measurements, not observational or diagnostic interpretations 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
- An MRMC study was not done. This device is an infrared lamp for therapeutic heating, not an AI or diagnostic imaging device that would typically involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- A standalone algorithm performance study was not done. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests was based on direct temperature measurements on test candidates, establishing whether the device could consistently reach and maintain a specified therapeutic temperature range.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This document describes the 510(k) submission for a physical device, an infrared lamp, not an AI or machine learning model that would have a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. As there is no training set for an AI model, there is no ground truth establishment for it.
In summary: The document is primarily a regulatory submission demonstrating substantial equivalence for an infrared lamp based on technological characteristics and non-clinical performance data (temperature output). It does not present clinical trial data or performance metrics common for AI/diagnostic devices that would involve human experts, large test sets, or ground truth derived from pathology or outcomes data.
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(123 days)
The indications for use of the proposed device are the same as those for the predicate devices.
Ultrasound therapy:
- Relief of pain, muscle spasms and joint contractures
- Relief of pain, muscle spasms and joint contractures that may be associated with:
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar tissues
- Relief of pain, muscle spasms and joint contractures resulting from:
- Capsular tightness
- Capsular scarring
Electrotherapy:
- Relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Symptomatic relief or management of chronic, intractable pain
- Post-traumatic acute pain
- Post-surgical acute pain
The Soleoline has a clear contemporary color screen showing all parameters necessary for therapy as well as modem touch control. Individual program start configuration and clear, simple menu navigation make operation of the device easy and comfortable for users. 120 storage bins for individual program settings makes working with the Soleoline a lot easier. The compact design saves room in the practice and is highly suited for use in home visits. The combination of electrotherapy and ultrasound therapy in a single system enables the use of the established combination therapy. It is a prescription device administered to patients by a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics.
Soleoline is a device family consisting of Soleo Stim and Soleo SonoStim, Soleo Sono includes an ultrasound module, Soleo Stim includes a stimulation current therapy module and Soleo SonoStim includes a combination of a stimulation current module and an ultrasound module.
The stimulation current module is used for stimulation current therapy according to the standard medical practices. It offers multiple waveforms; Monophasic, High Voltage, Micro Current, Asymmetrical Biphasic, Interferential, Medium Frequency, Premodulated currents for nerve stimulation and muscle therapy for mono channel and dual channel operation. The regulated output of the current stimulation module may be chosen from Constant Current (CC) or Constant Voltage (CV).
The dual frequency ultrasound module (800kHz and 2.4MHz) offers two different size ultrasound heads, 1cm² and 5cm² and pulsed and continuous duty cycles.
At combination therapy (simultaneous procedure) the features for ultrasound can be used together with the different stimulation waveforms. All functions of the 0.8MHz and 2.4MHz ultrasound can be combined with the following waveforms:
Monophasic, High Voltage, Micro Current, Symmetrical Biphasic, Medium Frequency, Premodulated
The therapy menu helps the clinicians to assign the indications of each body region to the appropriate therapy program.
The provided document is a 510(k) Summary for the Zimmer MedizinSysteme Soleoline device family. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy from scratch through entirely novel clinical studies. Therefore, the information provided focuses on comparisons to existing devices and compliance with standards, rather than new studies with acceptance criteria and detailed performance metrics as one might find for a novel AI device.
Based on the provided text, here is an attempt to address the points, acknowledging the nature of a 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document doesn't present "acceptance criteria" in the typical sense of a novel device study (e.g., target sensitivity/specificity). Instead, substantial equivalence is demonstrated by showing that the new device (Soleoline) has the same intended use and similar technological characteristics as the predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is essentially a comparison of technical specifications against the predicate devices.
Here's a table summarizing key comparisons from the document, which implicitly serve as demonstration of equivalent performance to the established predicate devices:
| Feature/Parameter | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Zimmer Soleoline) |
|---|---|---|
| General | ||
| Intended Use | Same as Predicate Devices (Ultrasonic diathermy, Powered muscle stimulator, etc.) | Same as Predicate Devices (Ultrasonic diathermy, Powered muscle stimulator, Ultrasound and muscle stimulator) |
| Indications (Electrotherapy) | Matched to Predicate Devices (Relaxation of muscle spasm, pain relief, etc.) | Matched to Predicate Devices (Relaxation of muscle spasm, pain relief, etc.) |
| Indications (Ultrasound) | Matched to Predicate Devices (Pain relief, muscle spasms, joint contractures, etc.) | Matched to Predicate Devices (Pain relief, muscle spasms, joint contractures, etc.) |
| Prescriptive Use | Yes | Yes |
| Maximum adjustable therapy time | 60 min (for electrotherapy), 30 min (for ultrasound) | 60 min (electrotherapy, general), 30 min (ultrasound) |
| Patient Leakage Current (Normal) | < 1mA | < 1mA |
| Patient Leakage Current (Single Fault) | < 0.5mA | < 0.5mA |
| Compliance with Voluntary Standards | IEC/EN 60601-1, -1-2, -2-5, -2-10; 21 CFR 898 | Yes, IEC/EN 60601-1, -1-2, -2-5, -2-10; 21 CFR 898 (for relevant modules) |
| Electrotherapy Specifics (Examples) | ||
| Number of Output Modes | Varied across predicates (e.g., 10 for Vectra Genisys, 5 for Galva 5M) | 8 (Interferential, Premodulated, Monophasic, Medium Frequency, Asymmetrical Biphasic, Symmetrical Biphasic, High Volt, Microcurrent) |
| Regulated Current/Voltage | Both CC and CV | Both CC and CV |
| Monophasic Rectangular (Max Output Voltage) | 25V@500Ω, 100V@2kΩ, 200V@10kΩ (Galva 5M) | 24.7V@500Ω, 99.9V@2kΩ, 180V@10kΩ |
| Microcurrent (Max Output Current) | 1mA@500Ω, 1mA@2KΩ, 1mA@10kΩ (Vectra Genisys) | 0.98mA@500Ω, 0.99mA@2kΩ, 1.02mA@10kΩ |
| Symmetric Biphasic Rectangular (Pulse Width) | 20μs-1000μs (Vectra Genisys), 100μs-1500μs (Galva 5M) | 100μs-1000μs |
| High Voltage (Max Output Current) | 250mA@500Ω, 100mA@2kΩ, 20mA@10kΩ (Galva 5M) | 250mA@500Ω, 75mA@2kΩ, 15mA@10kΩ |
| Ultrasound Specifics | ||
| Frequencies | 1 and 3.3MHz (Vectra Genisys), 0.8 and 3 MHz (Sono 5) | 0.8 and 2.4 MHz |
| Intensity | 0-3.0 W/cm² | 0-3.0 W/cm² |
| Duty Cycle | Examples: 1:1, 1:2, 1:5 (Vectra Genisys); 1:2, 1:5 (Sono 5) | 1:1, 1:2, 1:3, 1:5, 1:10 |
| BNR | 5.0:1 or less (Vectra Genisys), 6.0:1 or less (Sono 5) | 4.3:1 or less |
| ERA | Varied across predicates and applicator sizes | Examples: 5cm²: 2.30 cm² (0.8MHz), 2.38 cm² (2.4MHz); 1cm²: 1.08 cm² (0.8MHz), 0.54 cm² (2.4MHz) (all values ±20%) |
Note: The "acceptance criteria" here are implied by the specifications of the predicate devices. The study demonstrating compliance is the "Non-clinical Tests Performed" which verified the device's technical characteristics against these standards.
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 510(k) summary. For a 510(k) submission, the primary "test set" is often the comparison of technical specifications against predicate devices and adherence to recognized standards. It's likely that internal engineering and performance testing was conducted, but details on sample size, data provenance, and study design are not typically required or included in this summary document beyond stating that "Validation documentation, product testing and a comparison of the technical characteristics and features according to relevant standards were provided."
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 is not applicable/not provided. The document describes a medical device, not an AI or diagnostic tool that requires expert-established ground truth for its performance evaluation in the clinical sense. The ground truth for this type of device is its adherence to technical specifications and safety standards as verified by engineering tests and comparison to predicate devices, and its intended effect being recognized within standard medical practices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable/not provided. Adjudication methods are typically associated with resolving discrepancies in expert interpretations during the establishment of ground truth for diagnostic studies, which is not the nature of this 510(k) submission.
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 is not applicable/not provided. MRMC studies are used for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not relevant to a powered muscle stimulator/ultrasound diathermy device. The study described is a technical comparison for substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable/not provided. This device is not an algorithm, but a physical medical device. Its "standalone" performance is its technical operation according to specifications, which was implicitly demonstrated through the non-clinical tests and comparison to predicates.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is the technical specifications and safety performance demonstrated by the predicate devices and the relevant voluntary standards (e.g., IEC/EN 60601 series, 21 CFR 898). The new device is considered substantially equivalent if it meets or has comparable technical characteristics within the established safety and effectiveness profile of these predicate devices and standards.
8. The sample size for the training set
This is not applicable/not provided. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable / not provided for the same reason as point 8.
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