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The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.

The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately.

The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.

The provided text is a 510(k) summary for the Caerus Active System and Avenue8, seeking substantial equivalence to predicate devices. It describes performance data and a clinical study conducted.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that non-clinical performance testing and a clinical study were conducted to verify device performance and satisfy special controls. However, it does not explicitly state specific acceptance criteria values (e.g., "The device must achieve X% pain reduction to be considered effective") and then report the results against those criteria in a tabular format. Instead, it reports outcomes from the clinical study and compliance with standards.

We can infer "performance" from the clinical study's outcome in terms of pain reduction effect.

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

The text describes a clinical study which serves as the "test set" for demonstrating clinical performance.

• Sample Size: 120 patients enrolled.
  • 48 in the Active System (Shortwave Diathermy + Heating Therapy) group.
  • 43 in the SOC group. (Note: The sum of these two groups is 91, not 120. There's a discrepancy in the provided numbers, as 120 is the total. This could imply other groups or just a rounding/reporting discrepancy. Assuming the reported group sizes are correct for the Active System and SOC groups, the remaining 29 participants are unaccounted for in this specific breakdown).
• Data Provenance: Not specified, neither country of origin nor retrospective/prospective. However, a clinical study implies prospective data collection.

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

• This information is not provided in the document. For a clinical study measuring pain, the "ground truth" is typically the patient's self-reported pain score (Mankowski scale in this case), not an expert consensus on interpreting data like images. Therefore, expert consensus in the traditional sense (e.g., radiologists interpreting images) is not applicable here.

4. Adjudication Method for the Test Set

• This information is not applicable as the "ground truth" is patient-reported pain scores, not adjudicated data. There's no mention of an adjudication process for these scores.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here. This device involves direct patient treatment and pain measurement, not interpretation of data by multiple human readers (e.g., radiologists) with or without AI assistance. The study described is a clinical trial comparing the device's efficacy against standard of care.

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

• This question is not applicable. The device (Active System) is a physical medical device that delivers therapy, not a standalone AI algorithm for diagnosis or interpretation. The clinical study evaluates the device's performance as a treatment.

7. The Type of Ground Truth Used

• The "ground truth" for the clinical study was patient-reported pain assessment scores, specifically using the Mankowski scale, measuring the change from baseline at the end of 2 weeks.

8. The Sample Size for the Training Set

• This information is not applicable or not provided. This document describes a medical device for treatment, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The clinical study serves to validate the device's effectiveness, not to train an algorithm. There is no mention of an algorithm or AI component that would require a training set.

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

• This information is not applicable or not provided as there is no "training set" in the context of an AI/ML algorithm for this device.

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The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. It is also indicated for the temporary relief of minor muscle and pain associated with overexertion, strains, sprains and arthritis.

Pulsed electromagnetic field wrap

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a "Pulsed Electromagnetic Field Wrap" and primarily discusses regulatory aspects, indications for use, and general controls provisions. It does not include details on performance studies, test sets, expert qualifications, or comparative effectiveness.

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Adjunctive treatment of postoperative pain

The RecoveryRx® device is a pulsed shortwave therapy device. The circuitry consists of low voltage (3 V) digital/analog electronics that control all timing functions to produce the therapeutic radiofrequency (RF) field, where the antenna is placed directly above the therapeutic site. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply, transfers the RF energy to the target tissue as a localized therapy with no far field effects.

The provided text describes the regulatory filing for a medical device called "RecoveryRx®". It is a pulsed shortwave therapy device intended for the adjunctive treatment of postoperative pain. However, the document does not contain acceptance criteria and information about a study proving that the device meets specific acceptance criteria in the context of an AI/Machine Learning (ML) enabled medical device.

Instead, the document details a traditional medical device submission (510(k)) where the manufacturer demonstrates substantial equivalence to predicate devices (ActiBand and Ivivi) by providing:

• Technological characteristics comparison: Showing the RecoveryRx® has similar features and operates on the same principles as the predicate devices.
• Non-clinical performance data: Electrical safety, electromagnetic safety, and biocompatibility testing, demonstrating compliance with relevant standards.
• Clinical data: Results from two randomized, double-blinded, placebo-controlled studies to show effectiveness in reducing postoperative pain, which supports its intended use.

Therefore, I cannot directly answer your prompt, as the requested information (acceptance criteria for AI/ML performance, test set details, expert ground truth, MRMC study, standalone performance, training set details) is specific to AI/ML device validation and is not present in this document. This document describes a physical medical device, not an AI/ML software device.

To answer your prompt, I would need a document that describes the validation of an AI/ML-enabled medical device.

However, I can extract the relevant information from the provided text that describes the clinical studies performed to demonstrate the device's effectiveness, which is analogous to "proving the device meets" its intended therapeutic effect (not an AI/ML performance metric).

Here's a breakdown of what is provided regarding the device's performance validation, interpreted in light of your request:

Study Proving Therapeutic Effect (Not AI/ML Performance)

The document describes two clinical studies to demonstrate the effectiveness of RecoveryRx® in reducing postoperative pain.

1. Acceptance Criteria and Reported Device Performance (Therapeutic Effect)

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The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

The Provant Therapy System is nearly identical to the previously cleared Provant System Model 4201 (cleared under K091791), except for the device labeling. Specifically, unlike the Provant System Model.4201, the Provant Therapy System does not include a contraindication for use in patients with metal implants. The device includes a Control Unit and Treatment Applicator. Disposable Applicator Covers are provided for the Treatment Applicator for infection control and to provide appropriate contact surfaces for the patient. The Control Unit for the Provant Therapy System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The case contains a lockable hinge to prevent accidental closure of the lid. Upon opening the Provant case, the user sees the control panel of the Control Unit. The main electronics of the Control Unit are housed beneath its control panel. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy, inserted into a Disposable Applicator Cover, and placed directly over the area to be treated. Device labeling is also located inside the case cover. Four pre-drilled holes in the underside of the case allow for attachment of the device to the optional roller stand (sold separately). The Disposable Applicator Covers of the Provant Therapy System are single-use-only and are intended to minimize contagion and help protect the Treatment Applicator from biological contamination. The Disposable Applicator Covers contain a Radio Frequency Identification Device (RFID) tag which guards against reuse of used Disposable Applicator Covers.

This document describes the Provant Therapy System, a nonthermal shortwave diathermy (SWT) device, and its substantial equivalence to a predicate device. The information provided is primarily focused on reclassification and regulatory clearance rather than a typical AI/ML device study. Therefore, some of the requested categories for AI/ML device studies may not be directly applicable or fully detailed in the provided text.

Here's an analysis based on the given information:

Acceptance Criteria and Reported Device Performance

The device, Provant Therapy System, was cleared based on substantial equivalence to a predicate device (Provant System, Model 4201). The primary "acceptance criteria" here relate to demonstrating that the updated device (Provant Therapy System) is as safe and effective as the predicate, specifically with the removal of a contraindication for patients with metal implants.

Study Information

This submission is a 510(k) for a medical device reclassification/modification, not a study of an AI/ML algorithm. Therefore, many of the typical AI/ML study parameters are not applicable.

1. Sample size used for the test set and the data provenance:

   • Test Set: For the nonclinical performance, a "validated tissue phantom with a variety of metal implants" was used. The specific number of implants or types of tests is not detailed beyond "variety."
   • Data Provenance (Clinical Data): Retrospective analysis of the FDA MDR/MAUDE database, Regenesis and other industry complaint data (over 175,000 patients and over 3,000,000 treatments), and medical literature. The country of origin for these databases and literature is not specified but generally refers to US FDA data and global medical literature.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this is a physical device and the "ground truth" for the nonclinical testing was based on temperature measurements in a tissue phantom. For the retrospective analysis, the "ground truth" was the absence of reported adverse events related to heating from metal implants, which would be based on medical records and adverse event reporting systems, not expert consensus on specific cases.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. The nonclinical testing involves physical measurements (temperature). The retrospective analysis relies on reported adverse events, not a diagnostic interpretation that would require adjudication.

4. 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/ML device and no MRMC study was performed or required for this 510(k) submission.

5. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is not an AI/ML algorithm. The device operates independently for therapy delivery.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Nonclinical Test: Physical measurements (temperature rise) in a validated tissue phantom.
   • Clinical (Retrospective): Absence of reported adverse events (outcomes data/safety data) related to metal implant heating, extracted from a large database and medical literature.

7. The sample size for the training set:

   • Not applicable. There is no AI/ML algorithm requiring a training set for this device.

8. How the ground truth for the training set was established:

   • Not applicable. There is no AI/ML algorithm requiring a training set for this device.

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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.

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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.

Study Details for Zeobi (K121338)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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The Provant System is intended for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Much like the predicate Regenesis Model 42 device, the new Provant System includes a Control Unit and Treatment Applicator. Disposable Applicator Covers are provided for the Treatment Applicator for infection control and to provide appropriate contact surfaces for the patient. The predicate Provant System contains the same components. The Control Unit for the Provant System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The case contains a lockable hinge to prevent accidental closure of the lid. Upon opening the Provant case, the user sees the control panel of the Control Unit. The main electronics of the Control Unit are housed beneath its control panel. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy, inserted into its Disposable Applicator Cover, and placed directly over the area to be treated. Device labeling is also located inside the case cover. Four pre-drilled holes in the underside of the case allow for attachment of the device to the optional roller stand (sold separately). The Disposable Applicator Covers of the Provant System are single-use-only and are intended to minimize contagion and help protect the Treatment Applicator from biological contamination. The Disposable Applicator Covers contain a Radio Frequency Identification Device (RFID) tag which guards against reuse of used Disposable Applicator Covers.

The provided text is a 510(k) summary for the Provant System, a shortwave diathermy device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study specifically proving the device meets acceptance criteria. As such, the information needed to fully answer your request regarding acceptance criteria and a study demonstrating performance against those criteria is largely absent.

Here's an breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary explicitly states: "Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic Act."

Instead of performance against specific acceptance criteria, the submission focuses on demonstrating "substantial equivalence" to a predicate device (Regenesis Model 42) for the adjunctive use in the palliative treatment of postoperative pain and edema.

The device performance described is primarily the delivery of: "the same amount of energy to the subject and is therefore as safe and as effective as its predicate."

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The submission states, "Although the reusable portions of the Provant System have extensive clinical experience, this 510(k) Notice does not rely upon clinical data." Instead, it relies on "Bench testing data." The sample size for this bench testing is not specified, nor is the provenance of that data detailed beyond being "bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the submission explicitly states it does not rely on clinical data, therefore, no expert review for a test set ground truth would have been established.

4. Adjudication method for the test set

This information is not applicable as there was no test set involving human interpretation of clinical data that would require an adjudication method.

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 information is not applicable. The device is a "shortwave diathermy device" used for therapeutic purposes, not for aiding "human readers" in diagnostic tasks. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. This device is a therapeutic physical medicine device, not an algorithm-based diagnostic tool. Performance is evaluated based on its physical characteristics and energy delivery, not as a standalone algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence was based on bench testing data showing similar energy delivery capabilities between the new device (Provant System) and its predicate (Regenesis Model 42). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this 510(k) submission.

8. The sample size for the training set

This information is not provided and is largely irrelevant, as the submission relies on bench testing and not a machine learning model trained on a dataset.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" in the context of this device and submission type.

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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.

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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.

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

SofPulse (912-M10, Roma3 and Torino II) devices are shortwave diathermy medical devices which apply 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 SofPulse models were designed to deposit mean radio frequency energy in tissue which is equivalent to that of the predicate MRT device. All of the SofPulse options deliver the RF signal to the tissue farget via inductive coupling with an applicator coil. SofPulse devices are portable and treatment can occur directly through dressings, clothing, casts, compression garments or supports.

Here's an analysis based on the provided document, addressing your questions about the acceptance criteria and study details for the Ivivi SofPulse device (K070541):

Summary of Device and Regulatory Context:

The Ivivi SofPulse (Models 912-M10, Roma3, and Torino II) is a shortwave diathermy medical device (now reclassified as nonthermal shortwave therapy, SWT) that applies electromagnetic energy at a radio frequency of 27.12 MHz. It's intended for "adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue" by athermal means. This device was determined to be substantially equivalent to the predicate device, MRT (K903675).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than establishing specific acceptance criteria (e.g., a certain sensitivity, specificity, or clinical outcome threshold) as would be seen for a novel device or a device requiring a PMA.

For devices demonstrating substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate device. The performance is compared to the predicate's established characteristics.

Therefore, the table below presents the technological characteristics of the SofPulse and its predicate, which served as the basis for determining substantial equivalence.

Study Proving Acceptance Criteria:
The document states: "Equivalence of performance of the SofPulse and MRT was demonstrated with bench testing in saline tissue equivalents and with an animal model validated for evaluation of pain and edema." This implies these studies were conducted to show that the SofPulse performs comparably to the predicate MRT device across the listed technological characteristics and intended effects on pain and edema.

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

The document explicitly mentions:

• Bench testing in saline tissue equivalents: No sample size is provided for this. These are typically in-vitro, controlled experiments.
• Animal model validated for evaluation of pain and edema: No sample size is provided for the animal study (e.g., number of animals). The document does not specify the species or country of origin for the animal model.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, animal model studies are prospective by nature.

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

The document does not suggest the use of human experts to establish "ground truth" for the test set in the way one would for diagnostic imaging. Instead, the "ground truth" for demonstrating equivalence in an animal model would likely be objective physiological measurements of pain and edema (e.g., paw swelling, behavioral responses to pain stimuli, biochemical markers). Therefore, information about experts and their qualifications in this context is not applicable.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is relevant for clinical studies where human readers or evaluators make subjective judgments that need to be reconciled. Since the studies mentioned are bench testing and an animal model, such an adjudication method would not be applicable.

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

No. The document describes bench testing and an animal model study, not an MRMC study. MRMC studies are typically performed for diagnostic devices where human reader performance is a key metric.

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

The device is a therapeutic (nonthermal shortwave therapy) device, not a diagnostic algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable here. The device operates independently on the patient, but its effectiveness is clinically evaluated, not algorithmically.

7. The Type of Ground Truth Used

Based on the description of the studies:

• Bench Testing: Ground truth would be based on physical measurements (e.g., RF energy deposited, duty cycle measured by instrumentation) in a controlled environment (saline tissue equivalents).
• Animal Model: Ground truth would be based on objective biological/physiological measurements of pain and edema relief (e.g., quantified reduction in swelling, validated pain scales/responses, inflammatory markers).

8. The Sample Size for the Training Set

The document does not mention a "training set." This term is typically used in the context of machine learning or AI development. The studies mentioned (bench testing, animal model) are for verification and validation of the device's performance against its predicate, not for training a model.

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

As there is no mention of a training set, this question is not applicable.

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