(85 days)
Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
The Zeobi is a portable battery powered non-invasive therapy device which applies to the body electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The Zeobi was designed to deposit mean radio frequency energy in tissue which is equivalent to that of the Torino II. The Zeobi delivers the RF signal to the tissue target via inductive coupling with an applicator coil. The device is portable and treatment can occur directly through dressings, clothing, casts, compression garments or supports.
Here's a breakdown of the acceptance criteria and study information for the Zeobi device, based on the provided text:
Acceptance Criteria and Device Performance
The core of the "acceptance criteria" in this context is the concept of "substantial equivalence" to a predicate device. For the Zeobi, the predicate device is the SofPulse Torino II (K070541). The study's purpose is to demonstrate that the Zeobi is substantially equivalent to the Torino II regarding its indications for use, technical specifications, operating performance features, and general design.
| Acceptance Criteria (from Predicate Device - Torino II) | Reported Device Performance (Zeobi) |
|---|---|
| Indications for Use: | |
| Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue | Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue |
| Technical Specifications: | |
| Carrier Frequency: 27.12 MHz | 27.12 MHz |
| Burst Duration: 2 msec | 2 msec |
| Burst Repetition: 2 Hz | 2 Hz |
| Energy Density: $0.13 \pm 0.02 \mu$ Ws/cm³ | $0.13 \pm 0.02 \mu$ Ws/cm³ |
| Electrical Safety: Conforms with IEC 60601-1 | Conforms with IEC 60601-1 |
| Electromagnetic Safety: Conforms with IEC 60601-1-2 | Conforms with IEC 60601-1-2 |
| Power Supply: In-Circuit Battery Source: Primary Lithium Coin Cell Batteries (2) | Detachable Battery Pack: Primary Lithium Coin Cell Batteries (2) |
| User Display: LED Display with two green lights | Multi-Function LCD Display |
| Treatment Modes: • Automatic mode: 6 treatments per for three days, 3 treatments per day for 3 days and 2 treatments per day until shut off or battery depletes • Manual mode: user activated | • Automatic mode: 12 treatments every two hours until the unit is shut off or battery depletes • Manual mode: user activated |
| Treatment Time: Maximum of 30 minutes | Maximum of 15 minutes |
Study Details for Zeobi (K121338)
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Sample size used for the test set and the data provenance:
- No clinical test set with human subjects was used. The study relied on bench testing of the device's technical specifications.
- The document implies that the "test set" for performance evaluation consisted of the Zeobi device itself undergoing various physical and electrical measurements.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth for the bench testing would be established by the specifications of the predicate device (Torino II) and relevant industry standards (IEC 60601-1, IEC 60601-1-2). The experts would be the engineers and technicians performing the tests, but their specific qualifications are not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None specified, as no clinical test set requiring adjudication was used. The evaluation was based on direct measurement comparisons to established performance parameters.
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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:
- No MRMC study was done, as this is a physical therapy device and not an imaging-based diagnostic tool involving "human readers" or AI assistance in that context.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is a physical therapy device; therefore, the concept of "standalone algorithm performance" as typically applied to AI/ML devices is not applicable. The device's performance is intrinsically linked to its physical output and application by a user for therapeutic purposes.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the technical specifications (carrier frequency, burst duration, repetition, energy density, safety standards) was based on bench testing against the specifications of the predicate device (SofPulse Torino II K070541) and adherence to recognized international standards (IEC 60601-1, IEC 60601-1-2).
- The "Indications for Use" ground truth was established by being identical to the predicate device.
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The sample size for the training set:
- This document describes a 510(k) submission for a medical device focusing on substantial equivalence through technical comparison, not an AI/ML device requiring a "training set." Therefore, a training set is not applicable.
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How the ground truth for the training set was established:
- As there is no training set mentioned or implied for this device, this question is not applicable.
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.