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ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

The Swift-Lock™ anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or interspinous/supra-spinous ligament.

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I am sorry, but the provided text does not contain information about acceptance criteria or studies proving device performance. The document is an FDA 510(k) clearance letter for a medical device (Swift-Lock™ Anchor) and an "Indications for Use Statement."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given text.

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The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.

The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set sample sizes and ground truth establishment.

The document is a 510(k) clearance letter from the FDA for a device called "Rapid Programmer, Version 3.3.0" by Advanced Neuromodulation Systems. It establishes the device's substantial equivalence to a predicate device and outlines general regulatory requirements. The "Indications for Use" section describes what the device is intended for, but not how its performance was evaluated against specific criteria.

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Advanced Neuromodulation Systems Penta Lead Kits are indicated for the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach and are intended to be used with Advanced Neuromodulation Systems receivers, transmitters, and/or antennae.

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Penta lead kits". This document is a regulatory communication and does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies related to the device's performance. Therefore, I cannot extract the requested information from this text.

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ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

The Cinch™ anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or inter-spinous/supraspinous ligament.

The Cinch™ anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or inter-spinous/supraspinous ligament.

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the Advanced Neuromodulation Systems (ANS) Cinch Anchor Model 1194. This type of document declares that a new device is substantially equivalent to a legally marketed predicate device, meaning it does not require a new premarket approval (PMA) and can be marketed subject to general controls.

This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, often through design and technological characteristics, and sometimes through performance testing if the new device has different technological characteristics that raise new questions of safety and effectiveness. However, the details of such performance testing, if conducted, are not part of this clearance letter.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based on the provided text. The document is strictly an FDA clearance letter and does not include the detailed study information required.

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The ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. ANS Percutaneous Leads model number 3066, 3161, 3163, 3166, 3169, extension model numbers 3382, 3383, 3341, 3342, 3343, and receiver model number 3408, transmitter model number 3508, and antenna model numbers 1220 and 1230 are also indicated to stimulate electrically peripheral nerves to relieve severe intractable pain.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Wide Spaced Quattrode Leads." It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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Advanced Neuromodulation Systems, Trial Cable is indicated for the treatment of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Trial Cable is used as an accessory in the Multiprogram Trial Stimulator System (MTS ™). MTS ™ system is intended to be used with ANS Leads (percutaneous) to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or post operatively for up to a maximum of thirty days.

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This document is a letter from the FDA regarding a 510(k) premarket notification for a device named "Trial Cable." It grants clearance for the device, stating it is substantially equivalent to legally marketed predicate devices.

The letter explicitly does not contain any information about:

• Acceptance criteria or reported device performance for the "Trial Cable."
• Any study conducted to prove the device meets acceptance criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any studies.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document primarily focuses on regulatory approval and compliance requirements for the "Trial Cable."

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Advanced Neuromodulation Systems Tripole 8C, Tripole 16C, and Exclaim 8 Lead Kits are indicated for the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach and are intended to be used with Advanced Neuromodulation Systems receivers, transmitters, and/or antennae.

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I apologize, but this document, which appears to be an FDA 510(k) clearance letter, does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for an AI/device study.

This document is a regulatory approval letter for a medical device called "Lamitrode Series Leads" (spinal cord stimulators). It confirms that the devices are substantially equivalent to previously marketed devices and can be marketed. It discusses regulatory requirements, classifications, and general controls.

The information you are requesting would typically be found in the summary of safety and effectiveness data or the clinical study report that would have been submitted as part of the 510(k) application, but those detailed study documents are not present in the provided text.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, and performance metrics based on the provided text.

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Advanced Neuromodulation Systems 90 cm and 110 cm (3100 and 3200 Series) Leads are indicated for the management of chronic pain of the trunk and/or limbs either as the sole mitigating agent, or as an adjunct to other modes of therapy as part of a multidisciplinary approach and are intended for use with Advanced Neuromodulation Systems receivers, IPGs, transmitters, and/or antennae.

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This document, K053250, is a 510(k) premarket notification letter from the FDA regarding the ANS 3100 and 3200 series leads. It is primarily an approval letter and an "Indications For Use" statement. It does not contain any information about acceptance criteria, study details, or device performance data.

Therefore, I cannot provide the requested information based on this document. To answer your questions, I would need access to the actual 510(k) submission or supporting clinical study reports for the device.

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The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.

This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.

I am sorry, but the provided text does not contain information about the acceptance criteria or the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the Rapid Programmer device, Models 3830 and 3831. It primarily discusses the substantial equivalence determination and the regulatory requirements for the device.

Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about device performance studies.

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The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

The Axxess® Butterfly Anchor accessory is intended to be used with the ANS Axxess percutaneous permanent and trial leads to secure the leads to the interspinous ligament.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Axxess® Butterfly Anchor." It primarily addresses the device's substantial equivalence to previously marketed predicate devices and its intended use.

However, this document DOES NOT contain the type of acceptance criteria or details of a study (like an MRMC or standalone study) to prove device performance.

This letter is a regulatory approval document, not a detailed technical report of a performance study. It confirms that the FDA has reviewed the manufacturer's submission and determined that the device is "substantially equivalent" to existing legal predicate devices. This determination is based on the information provided in the original 510(k) submission (K052418), which is not fully included here.

Therefore, I cannot provide the requested information about acceptance criteria and study details from this document. The information you're asking for would typically be found in the manufacturer's original 510(k) submission, specifically in the sections outlining performance testing and clinical data (if any was required for this type of device).

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