(165 days)
OrthoCor Knee System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis.
The OrthoCor Active Knee System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies 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 OrthoCor Knee System delivers the pulsed RF signal of 6.5±0.5µWs/cm to the tissue target via the inductive coupling with an applicator coil. The system also includes disposable, single-use, air activated OrthoPods that provide heat. The OrthoPods are snapped into medial and lateral slots on the knee wrap. Treatment may occur directly through dressings, clothing, casts, compression garments or supports.
The provided text describes a 510(k) submission for the OrthoCor Active Knee System, a medical device for pain and edema. The submission primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons and adherence to safety standards, rather than conducting a detailed clinical study with acceptance criteria for device performance in a clinical context.
Therefore, many of the requested categories related to clinical performance studies, ground truth establishment, expert adjudication, and sample sizes for training/test sets are not applicable or not provided in this document.
Here's the information that can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (OrthoCor Active Knee System) |
|---|---|
| Technology: Deposit athermal RF energy in tissue | Technology: Deposit athermal RF energy in tissue |
| Anatomical sites: Superficial soft tissues | Anatomical sites: Superficial soft tissues (knee) |
| Practitioner: Licensed physician/chiropractor | Practitioner: Licensed physician/chiropractor |
| Portable: Yes | Portable: Yes |
| How Energy Deposited: Induction (coil applicator) | How Energy Deposited: Induction |
| Carrier Frequency: 27.12 MHz | Carrier Frequency: 27.12 MHz ± 5% |
| Burst duration: 2msec | Burst duration: 2msec |
| Burst frequency: 2Hz | Burst frequency: 2Hz |
| Energy Deposited Per Pulse: 6.5 µWs/cm³ | Energy Deposited Per Pulse: 6.5 µWs/cm³ |
| Electrical safety: Conforms with IEC 60601-1 | Electrical safety: Conforms with IEC 60601-1 |
| Electromagnetic safety: Conforms with IEC 60601-1-2 | Electromagnetic safety: Conforms with IEC 60601-1-2 |
| Power required: Battery or Mains | Power required: 3V-4.2V DC (battery) |
Study that proves the device meets the acceptance criteria:
The document states that "Equivalence was based on bench testing that showed the device produces the same outputs as the predicate as shown in the table below." This implies a bench testing study was conducted to compare the technical specifications and outputs of the OrthoCor Active Knee System against its predicate device (Ivivi Torino II K070541).
2. Sample size used for the test set and the data provenance: Not applicable. The submission relies on bench testing for technical equivalence, not clinical data sets with "test sets" in the context of AI/diagnostic device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This pertains to clinical studies, not technical equivalence bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in this context is the technical specifications and measured outputs of the predicate device (Ivivi Torino II K070541), which the OrthoCor Active Knee System aimed to match. The assessment was based on objective physical measurements during bench testing.
8. The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established: 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.