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The Game Ready system is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulate kneading and stroking of tissues using an inflatable wrap. The Game Ready system is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.

Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, Large, Right (590432-04); Game Ready Shoulder Wrap, Medium, Left (590424-04); Game Ready Shoulder Wrap, Large, Left (590434-04); Game Ready Hip/Groin Wrap, Right (590602-04); Game Ready Hip/Groin Wrap, Left (590604-04); Game Ready Straight Knee Wrap (590100-04); Game Articulated Knee Wrap (590160-04); Game Ready Ankle Wrap, Large (590330-04); Game Ready Ankle Wrap, Extra Large (590340-04)

The provided text is an FDA 510(k) clearance letter for the Game Ready System, a powered inflatable tube massager. It does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act. It outlines regulatory requirements for the manufacturer but does not include details on performance assessment studies or acceptance criteria that would typically be found in a clinical or validation study report.

Therefore, I cannot extract the requested information from the provided input.

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The CORGRIP* SR Nasogastric/Nasointestinal (NG/N) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal of displacement of the tubes for adult patients.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes used for testing/training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or the type of ground truth used.

The document is an FDA clearance letter for a medical device (CORGRIP* SR NG/NI Tube Retention System). It confirms the device's substantial equivalence to legally marketed predicate devices and outlines regulatory requirements for the manufacturer. It specifies the indications for use but does not delve into the studies or data used to establish that equivalence or any performance metrics.

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COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only AVANOS* and Diros RF Probes and accessories, such as Cooled / Standard RF Pain Management Probes, Cannulas, and Introducers. Use of the CRG System is limited to the indications cleared under these devices and accessories.

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

The provided text is an FDA 510(k) clearance letter for the COOLIEF* Radiofrequency Generator. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, ground truth establishment, or expert qualifications).

The letter primarily:

• Acknowledges receipt and review of the 510(k) premarket notification.
• Determines substantial equivalence to legally marketed predicate devices.
• Outlines general controls provisions and other regulatory requirements applicable to the device.
• Specifies the "Indications for Use" for the device.

Therefore, I cannot provide a response with the information requested in your bullet points as it is not present in the given document.

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The Avanos* CORTRAK* 2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding the placement of Avanos Medical CORTRAK* 2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

The Avanos* CORTRAK* 2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding the placement of Avanos Medical CORTRAK* 2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

The provided text is a letter from the FDA regarding the 510(k) premarket notification for the CORTRAK* 2 Enteral Access System. This letter determines substantial equivalence but does not contain the detailed acceptance criteria and study information requested. It primarily focuses on regulatory compliance, general controls, and classification of the device.

Therefore, I cannot extract the specific information about:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This type of information would typically be found in the 510(k) summary document or the full submission, which is not provided here.

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The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed ostecarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.

The COOLIEF® SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADV ANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVAN CED) to create RF lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.

The COOLIEF* Cooled Radiofrequency Kit Advanced is a modification to the predicate COOLIEF* Cooled Radiofrequency Kit cleared under K163461. The subject device consists of the following:

• COOLIEF* Cooled Radiofrequency Probe Advanced
• COOLIEF* Cooled Radiofrequency Fluid Tubing Kit ●
• COOLIEF* Cooled Radiofrequency Fluid Delivery Introducer ●

The modifications to the subject device are specific to the probe and fluid tubing kit.

The subject probe and fluid tubing kit are also included in the COOLIEFSINERGY Cooled Radiofrequency Kit Advanced.

The subject device has several configurations based on the anatomic region of use, length of the introducer and probe, and the length of the active electrode. The COOLIEF* Cooled Radiofrequency Kit Advanced is composed of fluid delivery introducers, probes, and fluid tubing kit. The kit is sterile, non-pyrogenic, and single-use. The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue.

The COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVANCED) to create RF lesions in nervous tissue. This device includes the same components as the COOLIEF* Cooled RF Kit Advanced, but also includes an Epsilon The Epsilon Ruler is a circular stainless-steel ruler that may be used during the COOLIEF Ruler. SINERGY* procedure to assist the user in providing a 'template' around the foramen, which is specific to performing procedure around the sacroiliac (SI) nerve.

This document is a 510(k) summary for the COOLIEF® Cooled Radiofrequency Kit Advanced, a medical device for creating lesions in nervous tissue. It details the device's characteristics, comparison to predicate devices, and non-clinical testing results.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that clinical data was not applicable for the subject device and therefore was not provided. All testing mentioned is "non-clinical testing" or "bench performance testing." The sample sizes for these non-clinical tests are not specified in the provided text, nor is the provenance of the data beyond being "bench performance testing."

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

This information is not applicable as there was no clinical study described that involved establishing a ground truth with experts. The stated tests are non-clinical, focusing on device performance and safety parameters.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical study described. Adjudication methods are typically relevant for human-led assessments in clinical trials.

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 described is a radiofrequency kit, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI or MRMC studies in the provided text.

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

This information is not applicable. The device is hardware (a radiofrequency kit) and not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable as no clinical studies with a ground truth were conducted or described. The "ground truth" for the non-clinical tests would be the established engineering and safety standards and specifications to which the device was tested.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable. As stated above, the device does not involve a training set or ground truth in the context of an algorithm.

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COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.

The COOLIEF* Radiofrequency Generator (CRG) System uses controlled radiofrequency energy to generate heat that is used to create lesions in neurological tissues or to coagulate and decompress disc material to treat symptomatic patients with contained herniated discs. The following components of the predicate Pain Management Generator-TD (K072478), which must be used together, have been modified and are the subject of this 510(k): a) COOLIEF* Radiofrequency Generator (CRG), b) COOLIEF* Quad Pump Unit (QPU), and c) COOLIEF* Therapy Cables.

The provided text describes the 510(k) premarket notification for the COOLIEF* Radiofrequency Generator (CRG) System. It lists general and technological characteristics of the device and compares them to a predicate device, along with non-clinical performance data.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum accuracy percentages). Instead, it lists various performance tests conducted and their successful completion, implying that "Pass" is the acceptance criterion for each test.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical testing (performance testing). For these tests, specific sample sizes are not explicitly stated. For example, "Therapy Cable Mechanical Testing" implies that multiple cables were tested, but the number is not provided. Similarly, for "Bench-Top Lesion Validation," the number of lesions or trials is not detailed.

No clinical data was used for this submission, therefore, none of the typical provenance information (country of origin, retrospective/prospective) applies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the submission relies on non-clinical performance data and engineering verification tests. The "ground truth" for these tests would be established by the expected technical specifications and standards (e.g., a flow rate of >18mL/min, successful completion of a software test protocol). It doesn't involve subjective expert review in the way medical image analysis or diagnostic decision-making would.

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

This section is not applicable as the submission focuses on non-clinical performance testing and engineering verification. Adjudication methods are typically used in clinical studies or studies involving expert interpretation where there might be disagreements on ground truth.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not applicable to this submission. The device is a radiofrequency generator, not an AI-powered diagnostic or assistive tool for human readers. No AI assistance or human reader performance is mentioned.

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

This section is not applicable. The device is a hardware system (radiofrequency generator, pump, cables) and is not an algorithm or AI product capable of standalone performance.

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

The ground truth for the non-clinical performance tests is based on engineering specifications, established standards (e.g., IEC 60601 series), and expected functional performance. For instance, for "Quad Pump Unit Flow-Rate Verification," the ground truth is whether the measured flow rate meets the specified >18mL/min. For "Software Verification and Validation," the ground truth is compliance with the software requirements and absence of critical bugs. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this type of submission.

8. The sample size for the training set

This section is not applicable. The submission describes a medical device (radiofrequency generator system), not a machine learning or AI model that requires a training set.

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

This section is not applicable as there is no training set for this device.

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CORTRAK* 2 Equilateral Enteral Access System is an electrical device designed to aid qualified operators in the placement of Avanos NG feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK* 2 Equilateral Enteral Access System can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.

CORTRAK* 2 Equilateral Enteral Access System (EAS) device is designed to track the path of an 8 Fr or greater Avanos feeding tube tip during the patient placement procedure. A coil winding at the distal end of the transmitting stylet acts as a transmitter, and its signal is detected by the externally-positioned receiver unit. The received signals are input to the attached All-In-One Monitor unit. The resulting raw data is processed, recorded, and presented to the operator in a meaningful and intuitive screen tracing. The CORTRAK*2 Equilateral EAS device is an electrical device that does not contact the patient, is not sterilized, and is reusable. Like the predicate device, it is intended to be use in clinical environment.

The provided document describes a device modification for the CORTRAK® 2 Equilateral Enteral Access System. However, it does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of diagnostic performance or clinical effectiveness.

The document focuses on demonstrating substantial equivalence to a predicate device (K113351) by showing that the changes made (updated PC Single Board Computer, Display Processor Module, Operating System, GUI, removal of USB boot, removal of battery conditioning requirement) do not alter the intended use, safety, or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving their fulfillment as it is not present in the provided text.

Here is what I can extract based on the information provided, explaining why certain sections cannot be filled:

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

   • Not Available. The document outlines "nonclinical testing" which focuses on compliance with standards (IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 62304) to demonstrate that the modified device continues to meet performance specifications and that the changes do not raise new safety or effectiveness issues. It does not present specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics against such criteria. The "Results" column in the table only states "Pass" for compliance with these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Available. The nonclinical testing mentioned does not involve a "test set" in the context of clinical performance or diagnostic accuracy. It refers to engineering and software verification tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Available. Ground truth establishment by experts is not relevant to the type of nonclinical testing described.

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

   • Not Available. Adjudication methods are not relevant to the nonclinical testing described.

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. The device described (CORTRAK® 2 Equilateral Enteral Access System) is an electrical device designed to aid operators in placing feeding tubes and confirming placement. It is not an AI-assisted diagnostic tool that would typically involve human readers or MRMC studies for improved diagnostic effectiveness. The changes are technical updates to electronics and software.

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

   • Not Applicable. As mentioned above, this device "aids qualified operators." It is not a standalone diagnostic algorithm.

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

   • Not Applicable. Ground truth in the context of diagnostic/clinical performance is not discussed. The nonclinical testing refers to compliance with engineering and quality standards.

8. The sample size for the training set

   • Not Available. The document does not describe the development of an AI algorithm or a "training set."

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

   • Not Available. As there is no described AI algorithm or training set, this information is not present.

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