Search Results

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.

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.

The OrthoCor 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/cm3 to the tissue target via the inductive coupling with an applicator coil. OrthoPods are snapped into medial and lateral slots on the knee wrap to activate the system. Treatment may occur directly through dressings, clothing, casts, compression garments or supports. The OrthoCor device is substantial equivalent to the Ivivi Torino II device in parameters, treatment and power

Here's an analysis of the provided text regarding the OrthoCor Knee System and its acceptance criteria, focusing on the requested information:

This submission (K091996) is for a medical device (OrthoCor Knee System), not an AI/ML device. Therefore, many of the questions related to AI/ML specific criteria (such as training sets, ground truth methodology for AI, MRMC studies, and stand-alone algorithm performance) are not applicable to this document. The submission focuses on demonstrating substantial equivalence to a predicate device through bench testing of physical parameters rather than performance against a clinical ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OrthoCor Knee System are based on its physical and electrical characteristics matching those of its predicate device, the Ivivi Torino II (K070541). The "reported device performance" here refers to the OrthoCor Knee System meeting these specified parameters during bench testing.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: This type of submission relies on bench testing of the device's physical and electrical properties, not on a clinical "test set" in the sense of patient data. The sample size would refer to the number of devices or components tested to ensure consistent output. This specific number is not provided in the document.
• Data Provenance: The data comes from bench testing performed by ORTHOCOR MEDICAL, Inc. It is not patient data from a specific country, nor is it described as retrospective or prospective clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This question is not applicable as the evaluation is based on objective physical/electrical measurements against established standards and predicate device specifications, not on expert-adjudicated ground truth from a clinical standpoint. Product conformity to standards like IEC 60601-1 would typically be verified by qualified engineers or testing facilities.

4. Adjudication Method for the Test Set

• This question is not applicable. There is no "adjudication method" in the traditional sense for this type of bench testing. The device's output parameters are measured and compared directly to the specified criteria and the predicate device's characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a non-AI therapeutic device based on demonstrating substantial equivalence through technical specifications, not a clinical effectiveness study involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, this is not applicable. The OrthoCor Knee System is a physical medical device that delivers energy, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is the specified technical parameters and performance characteristics of the predicate device (Ivivi Torino II K070541), along with conformity to international electrical and electromagnetic safety standards (IEC 60601-1, IEC 60601-1-2). The device is deemed acceptable if its measured outputs and characteristics meet or fall within the acceptable range of these established benchmarks.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable. There is no "training set" as this is not an AI/ML device.

Ask a specific question about this device