(332 days)
The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
The OrthoCor General Use Device (marketed as the OrthoCor Active Device) is a portable (battery operated) non-invasive shortwave diathermy medical device. Through the use of resonators and two applicator coils, the device applies electromagnetic energy at a radio frequency (RF) of 27.12MHz 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 General Use Device delivers the pulsed RF signal of 6.5±0.5µWs/cm³ to the tissue target via inductive coupling using two applicator coils. It is a general use device and can be positioned on the body with a wrap designed to hold the device in place at the location that requires treatment.
The provided document is a 510(k) summary for the OrthoCor Active Device, a nonthermal shortwave therapy (SWT) device. It reclassifies the device from Class III to Class II and details the substantial equivalence to a predicate device, the OrthoCor Active Knee System (K091996).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define "acceptance criteria" in the traditional sense of a clinical trial's primary endpoints. Instead, the focus is on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing technical specifications and intended use.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (OrthoCor Active Device) |
|---|---|
| Indications for Use: Adjunctive use in the palliative treatment of postoperative edema and pain in superficial soft tissue. | Meets: "Adjunctive use in the palliative treatment of postoperative edema and pain in superficial soft tissue" (Matches predicate) |
| Exposure Duration: 30 minutes. | Meets: 30 minutes (Matches predicate) |
| Anatomical site: General Use. | Achieved: General Use (Broader than predicate's "Knee") |
| Peak Power: 0.5W. | Meets: 0.5W (Matches predicate) |
| Average Output Power (over 1 second): 2mW. | Meets: 2mW (Matches predicate) |
| Energy Density (µ): 6.5. | Meets: 6.5 (Matches predicate) |
| Voltage: 3V. | Meets: 3V (Matches predicate) |
| Therapy control burst width: 2ms/PPR 2±.03Hz. | Meets: 2ms/PPR 2±.03Hz (Matches predicate) |
| Burst frequency: 2Hz. | Meets: 2Hz (Matches predicate) |
| Duty Cycle (%): 0.4%. | Meets: 0.4% (Matches predicate) |
| Current: 10mA. | Meets: 10mA (Matches predicate) |
| Frequency - short wave: 27.12 MHz. | Meets: 27.12 MHz (Matches predicate) |
| Peak B Field (T): 0.004042 T. | Meets: 0.004042 T (Matches predicate) |
| Output impedance: 50 Ohm. | Meets: 50 Ohm (Matches predicate) |
| Applicator Size, Coil perimeter: 108.6cm. | Meets: 108.6cm (Matches predicate) |
| Applicator Type: Induction coil. | Meets: Induction coil (Matches predicate) |
| Safety and Effectiveness (Bench Testing): As safe and effective as the predicate device. | Meets: "The results of the bench and safety testing indicated that the new device is as safe and as effective as the predicate device. The energy/area is the most relevant measure because it is the total energy deposited into the body per specific area. The OrthoCor device and the predicate device all have similar energy/area measurements." |
| Conformity to Standards: IEC 60601-1, IEC 60601-1-2. | Meets: Conformity to these standards is implied by the document listing them under "Conformity to Standards". |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states "Clinical data submitted: No" for both the OrthoCor General Use Device and the predicate device (K091996). This indicates that no clinical test set (human subjects) was used for this 510(k) submission.
- Data Provenance: Not applicable, as no clinical data was submitted. The data primarily consists of bench testing results and technical specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable, as no clinical test set requiring expert ground truth was used for this 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set requiring adjudication was used for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical data submitted: No."
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device and not an AI-assisted diagnostic tool, and no clinical studies were performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable, as this is a medical device (nonthermal shortwave therapy) and not an algorithm or AI system. Its performance is evaluated based on its physical and electrical properties.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on engineering specifications and bench testing measurements that demonstrate the device's adherence to its design parameters and its equivalence in those parameters to a legally marketed predicate device.
8. The Sample Size for the Training Set
- Not applicable, as this submission is not for an AI/machine learning device. There is no concept of a "training set" in the context of this 510(k).
9. How the Ground Truth for the Training Set was Established
- Not applicable, as this submission is not for an AI/machine learning device.
§ 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.