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The SPRINT PNS System is indicated for up to 60 days for:

• · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
• · Symptomatic relief of post-traumatic pain;
• · Symptomatic relief of post-operative pain.

The SPRINT PNS System is not intended to treat pain in the region innervated by the cranial and facial nerves.

The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.

I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain the information necessary to describe acceptance criteria and a study proving a device meets them in the context of an AI/ML medical device.

The document pertains to the SPRINT PNS System, which is a Peripheral Nerve Stimulator. The performance data section focuses on "nonclinical testing" (like biocompatibility, electrical safety, software V&V, etc.) and a review of "product complaint data" from commercial use.

Specifically, the document does not contain any of the following information relevant to your request:

• Acceptance Criteria for AI/ML Performance: There are no metrics like sensitivity, specificity, AUC, or other clinical performance thresholds for an AI/ML model.
• Study Proving AI/ML Device Performance: There is no mention of a study design (test sets, ground truth establishment, expert readers, etc.) that would typically be conducted for an AI/ML device for diagnostic or prognostic purposes.
• Sample sizes for training or test sets for an AI/ML model: These concepts are not applicable to the SPRINT PNS system described.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI/ML test set.
• MRMC comparative effectiveness study or standalone AI performance.
• Type of ground truth used (pathology, outcomes data) for an AI/ML device.
• How ground truth for a training set was established for an AI/ML model.

The document is a standard FDA 510(k) clearance for a physical medical device (a nerve stimulator) based on substantial equivalence to a predicate device, focusing on safety, technological characteristics, and existing complaint data for that type of device. It does not describe an AI/ML-driven device or its validation.

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The Homewave Neuromodulation Pain Therapy Device is indicated for:

• . Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain
• Symptomatic relief of acute pain .
• Symptomatic relief of post-operative pain .

The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Deepwave Neuromodulation Pain Therapy Device (K052289) and the Deepwave PENS Neuromodulation Pain Therapy Device (K061166). The parent Biowave Deepwave Neuromodulation Pain Therapy Device (K052289) and Biowave Deepwave PENS Neuromodulation Pain Therapy Device (K061166) have indications for use that are the same as TENS and interferential stimulation devices.

Biowave has made some minor modifications to the Deepwave Neuromodulation Device resulting in a safer and easier-to-use device for the end-user (called the Homewave device). The minor modifications are as the follows:

• Homewave has a smaller power supply (lithium ion polymer rechargeable . battery) that will last approximately 3 hours vs. 8 hours for Deepwave)
• . Homewave includes a custom connector at the end of the electrode that houses an electronic integrated circuit ("chip"). The Homewave device checks the electronic chip when the electrode is attached to the leadwires, and the leadwires to the device. The electronic chip limits the use of the pad to 5 twenty-minute treatments or 100 minutes of total use.
• . Treatment time is fixed for Homewave at 20 minutes vs. adjustable between 5-60 minutes for Deepwave.

The modified Homewave Neuromodulation Device has the identical intended use, indications and functionality as the original Deepwave Neuromodulation Device described in K052289 and the Deepwave PENS Neuromodulation Pain Therapy Device described in K061166.

This K072123 document is a Special 510(k) summary for the Biowave Homewave Neuromodulation Pain Therapy Device. It describes minor modifications made to a previously cleared device (Deepwave Neuromodulation Pain Therapy Device, K052289) and asserts substantial equivalence to predicate devices.

Based on the provided document, there are no specific acceptance criteria or a study described that directly proves the device meets specific performance criteria through a clinical trial or performance study.

The document focuses on demonstrating substantial equivalence based on design and functional similarities to previously cleared predicate devices, rather than presenting new performance data against specific acceptance criteria. This is typical for a Special 510(k) for minor modifications.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: No such table is present as no new performance study was conducted or presented to satisfy specific criteria.
• Sample size used for the test set and the data provenance: No test set or associated data is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set was used to establish ground truth.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 device is an electrical nerve stimulator, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Device and Basis for Substantial Equivalence (as per the document):

The Homewave Neuromodulation Pain Therapy Device is a modified version of the Deepwave Neuromodulation Pain Therapy Device (K052289) and Deepwave PENS Neuromodulation Pain Therapy Device (K061166).

Key modifications in the Homewave device include:

• Smaller lithium-ion polymer rechargeable battery (approx. 3 hours vs. 8 hours for Deepwave).
• Custom connector with an electronic integrated circuit ("chip") that limits electrode use to 5 twenty-minute treatments or 100 minutes total.
• Fixed treatment time of 20 minutes (vs. adjustable 5-60 minutes for Deepwave).

The basis for substantial equivalence is stated as:
"Biowave Corporation's Homewave and Deepwave devices are similar in design and function. Both devices offer a dual sinusoidal signal with a frequency difference of 122 Hz. Both the proposed and predicate devices are software controlled TENS units that provide the user with pain reduction. The conclusion of this technical comparison is that Biowave's Homewave Device is substantially equivalent to the predicate devices for the indications specified."

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