Search Results

As a TENS device, the CP Relief Wand Rx - TENS/NMES is intended for use as an adjunctive therapy for pain management for medical purposes such as symptomatic relief of chronic intractable pain and relief of acute post surgical and post-traumatic pain.

As an EMS device, the CP Relief Wand Rx - TENS/NMES is intended for use for relaxation of muscle spasm, increasing local blood circulation, muscle re-education, prevention or retardation of disuse atrophy, prevention of venous thrombosis of the calf muscles immediately after surgery, and maintaining on increasing range of motion.

The CP Relief Wand Rx - TENS/NMES®("Wand") is a multitherapy medical device that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

The CP Relief Wand Rx - TENS/NMES is portable with self-contained electrodes. The device is powered by a standard non-rechargeable 9-volt alkaline battery. A charger is not used due to the low current drain and long battery life of the low power circuitry.

In operation, the electrode end of the CP Relief Wand Rx - TENS/NMES is positioned to touch the skin. The electrical pulses travel from one electrode, through the skin, through the underlying tissue, and back through the skin to the other electrode. Controls on the unit are provided for power, intensity, pulse width, and pulse polarity.

This FDA 510(k) clearance letter pertains to a TENS/NMES device, not an AI/ML-driven medical device. Therefore, the information typically found in a study proving an AI/ML device meets acceptance criteria (such as performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment) is not present in this document.

The document discusses the substantial equivalence of the "CP Relief Wand Rx - TENS/NMES" to predicate devices based on regulatory parameters, specifications, and the leveraging of performance testing from the primary predicate. It does not describe a new study specifically designed to assess the performance of the device against acceptance criteria in the context of an AI/ML model.

Therefore, I cannot provide the requested information for acceptance criteria and study details as they relate to an AI/ML device, as this document does not contain that type of data.

The document primarily focuses on:

• Substantial Equivalence: Arguing that the new device is as safe and effective as previously cleared devices.
• Expansion of Indications for Use: Adding EMS functionality, which is justified by comparison to a second predicate device that already has EMS indications.
• Performance Data (Leveraged from Predicate): Citing existing standards compliance from the primary predicate device, rather than new performance studies on an AI/ML algorithm.

If you have a document describing an AI/ML device and its validation study, I would be happy to analyze it for the requested information.

Ask a specific question about this device

When used as a pedicle screw fixation system in skeletally mature patients, the NGarde System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment and kyphosis.

In addition, when used as a pedicle screw fixation system, the NGarde System is indicated in patients:
Who are receiving fusions with autogenous graft only; Who are having the device fixed or attached to the lumbar or sacral spine; Who are having the device removed after the development of a solid fusion mass.

The NGarde System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polyaxial top-loading design, are composed of titanium 6Al-4V alloy or titanium 6A1-7Nb, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium 6A104V alloy and synthetic polycarbonate urethane (PCU) polymer, are 6.0mm in diameter, and are also available in a range of lengths, from 40mm to 200mm.

The modification which is the subject of this Special 510(k) consists of the addition to the NGarde System of two alternate pedicle screws, offered in commercial distribution, which may be used at the physician's discretion as an alternative to the NGarde Systems screws. These alternative pedicle screws are similar and comparable to the NGarde screws and are available in a range of diameters and lengths.

The provided document describes the NGarde System, a pedicle screw system, and its 510(k) summary for a modification. The document explicitly states that no clinical testing was conducted to support this submission. Therefore, it does not contain the detailed information requested regarding device performance, sample sizes, expert involvement, or comparative effectiveness studies.

However, it does provide some information about non-clinical performance and a general statement about acceptance criteria.

Here's the breakdown of what can be extracted based on the provided text:

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

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

• Sample Size: Not specified. The document only mentions "verification and validation tests."
• Data Provenance: Not specified, as no clinical testing was conducted.

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 no clinical testing was performed, and thus no "ground truth" was established in a clinical context for a test set. The validation was based on non-clinical performance data.

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

• Not applicable as no clinical testing was performed.

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

• No MRMC study was done. The device is a physical pedicle screw system, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable for clinical ground truth. For the non-clinical verification and validation, the "ground truth" would be defined by engineering specifications, material properties, and biomechanical standards against which the device performance was measured.

8. The sample size for the training set

• Not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable.

Summary of the Study:

The study referenced for the NGarde System's modification (a Special 510(k)) was primarily a non-clinical performance evaluation. The document states:

• "Non-Clinical Performance and Conclusions: Such verification and validation tests were identified as appropriate to address the results of a risk analysis for the subject Modification were completed, and met all acceptance criteria."
• "Clinical Performance: No clinical testing was conducted to support this submission."

Therefore, the "study" demonstrating that the device meets acceptance criteria was a series of non-clinical verification and validation tests. These tests were designed to address potential risks associated with the modification (addition of two alternate pedicle screws) and ensure that the modified system performed comparably to its predicate devices in terms of mechanical and material properties, as defined by "rigorous design control and risk analysis procedures." The specific acceptance criteria and detailed test results are not provided in this summary but were presumably part of the comprehensive submission to the FDA.

Ask a specific question about this device

When used as a pedicle screw fixation system in skeletally mature patients, the N Fix II System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the N Fix II System is indicated in patients:

• . who are receiving fusions with autogenous graft only:
• . who are having the device fixed or attached to the lumbar or sacral spine;
• who are having the device removed after the development of a solid . fusion mass.

The subject N Fix II device is a posterior instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polyaxial top-loading design, are composed of titanium 6Al-4V ELI alloy, and are available in 5.5mm, 6.5mm, and 7.5mm diameters, in lengths ranging from 35mm to 60mm. Rods are composed of titanium 6Al-4V ELI alloy and synthetic polycarbonate urethane (PCU) polymer, are 6.0mm in diameter, and are available in lengths from 40mm to 200 mm.

Here's an analysis of the provided text regarding the N Fix II Pedicle Screw System, focusing on the requested information:

Analysis of Acceptance Criteria and Study for N Fix II Pedicle Screw System (K061774)

Based on the provided K061774 510(k) summary, the N Fix II Pedicle Screw System is a mechanical device, and its approval process relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing, rather than studies involving diagnostic accuracy or human reader performance.

Therefore, many of the requested points related to AI/algorithm performance, ground truth establishment for AI, human expert involvement, and MRMC studies are not applicable to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for this type of device are primarily implicit in demonstrating "substantial equivalence" to existing, legally marketed predicate devices. The study supporting these criteria consists of the non-clinical tests described below.

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

• Test Set Sample Size: Not explicitly stated in terms of number of screws or rods. The "test set" would consist of the various configurations of the N Fix II Pedicle Screw System (different screw diameters, lengths, rod lengths, and material combinations) subjected to bench testing.
• Data Provenance: The tests are non-clinical, likely performed in a laboratory setting. There is no mention of country of origin for data as it's not patient-derived. The tests would be prospective in nature, as they are specifically conducted to support this submission.

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

Not applicable. For a mechanical device like a pedicle screw system, "ground truth" is established by recognized engineering standards and validated testing methodologies, not by human expert consensus or clinical assessment of images. Performance metrics (e.g., fatigue life, pull-out strength) are objectively measured.

4. Adjudication Method for the Test Set

Not applicable. As the tests are non-clinical and objective (e.g., mechanical load testing), there is no need for an adjudication method by human experts. The results are quantitative measurements against predetermined specifications or in comparison to predicate device performance.

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 device is a surgical implant, not an AI diagnostic or assistive tool.

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

Not applicable. This device is a surgical implant, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is based on:

• Engineering Standards and Specifications: Adherence to recognized national and international standards for spinal implants (e.g., ASTM, ISO standards for fatigue, static mechanical properties, material biocompatibility).
• Performance of Predicate Devices: The measured performance parameters of the N Fix II system must be comparable to, or better than, the performance data available for the cited predicate devices.
• Material Specifications: Verification that the materials used meet industry specifications and are appropriate for human implantation.

8. The Sample Size for the Training Set

Not applicable. This device is a surgical implant; there is no "training set" in the context of machine learning or algorithms.

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

Not applicable. There is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the N Fix II Pedicle Screw System meets acceptance criteria is a series of non-clinical performance tests. These tests are conducted in accordance with recognized standards, designed to demonstrate the substantial equivalence of the subject device to its predicate devices in terms of:

• Design: Verifying that the physical dimensions and structural configuration are appropriate and comparable.
• Materials: Confirming the use of biocompatible and mechanically suitable materials, identical to or comparable with those in predicate devices.
• Performance: Measuring mechanical properties such as fatigue strength, static strength, and other relevant biomechanical parameters to ensure they are at least equivalent to, if not superior to, the predicate devices. This involves subjecting device components (screws, rods, and assemblies) to simulated physiological loads.

The document explicitly states: "Nonclinical tests, including those conducted in accordance with recognized standards, have demonstrated the substantial equivalence of the subject device to commercially-available predicates in terms of performance." and "The results of all testing demonstrated the substantial equivalence of the subject devices to the predicate devices."

The conclusion is that the N Fix II Pedicle Screw System is substantially equivalent to legally marketed predicate devices, confirming it meets the necessary safety and effectiveness criteria for its intended use through rigorous bench testing.

Ask a specific question about this device