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The Integrity Spinal Care System 3.0 provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica.

Device Description

The Integrity Spinal Care System 3.0 incorporates the same principles and working characteristics of the predicate devices, the DRX9000 True Non Surgical Decompression System (K060735) and is same in size, shape and function. The components of The Integrity Spinal Care System 3.0 are substantially equivalent in form, fit, function and configuration to its predicate device the DRX9000 True Non Surgical Decompression System (K060735).There are similar key design technical characteristics; multi-function table designed to applied distraction forces and controlled by a computer console, same/similar components for treatment and measurement; similar size, power source, and performance.

AI/ML Overview

The Integrity Spinal Care System 3.0 is a spinal decompression device. The provided text indicates that no clinical data was required for its 510(k) clearance, as non-clinical comparisons to its predicate device, the DRX9000 True Non Surgical Decompression System (K060735), demonstrated substantial equivalence. Therefore, the information regarding acceptance criteria and a study proving the device meets these criteria is limited to non-clinical testing.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion/Parameter	Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device	Substantial equivalence in principles, characteristics, size, shape, function.	"incorporates the same principles and working characteristics of the predicate devices," and "is same in size, shape and function." "substantially equivalent in form, fit, function and configuration." "essentially the same product as the predicate device."
Component Equivalence to Predicate Device	Similar/same components for treatment and measurement.	"has the same components to the DRX9000 True Non Surgical Decompression System."
Performance in Applying Controlled Tensions	Accurately controlled tensions, smooth and gentle logarithmically applied distraction, smooth logarithmic release rate, cyclic periodicity, upper limits on distractions.	"delivers accurately controlled tensions in the same manner as its predicate device." "smooth and gentle logarithmically applied distraction tensions, the smooth logarithmic release rate of tensions and relaxation cycles, the cyclic periodicity, the upper limits on distractions."
Safety Features	Inclusion of a patient safety switch.	"patients hold a patient safety switch to allow at anytime the pausing of any tensile forces." "patients can stop the treatment by pressing the patient hand held safety switch."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2.	"The device is in compliance with the following safety standards: ... IEC 60601-1-2:2001 Medical Electrical Equipment Part 1 2: General requirements for ● Safety - Collateral Standard, Electromagnetic Compatibility - Requirements and Tests."
Electrical Safety	Compliance with IEC 60601-1.	"The device is in compliance with the following safety standards: ... IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988: Amendment 1, 1991-11, Amendment 2, 1995."
Risk Management	Application of risk management to medical devices (ISO 14971).	"The Integrity Spinal Care System has been reviewed for risk management utilizing ISO 14971:2007, Application of risk management to medical devices ensuring all aspects of the device are reviewed for potential hazards."
Tension Measurement Accuracy	Displayed tension readings comparable to calibrated dynamometer and predicate devices.	"Measurements of tension demonstrate that the tension readings displayed and noted from the calibrated dynamometer are comparable to predicate devices."

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

Sample Size for Test Set: Not applicable in the context of clinical data for this 510(k). The non-clinical testing involved a "calibrated dynamometer" to stimulate a patient, implying a hardware-based test rather than a patient dataset. The sample size for this non-clinical test is not specified, but it refers to a device-to-device comparison and standard compliance tests.
Data Provenance: Not applicable for clinical data. For non-clinical tests, the data was generated internally by the applicant (Integrity Life Sciences) and/or by an "independent party" for evaluation of modifications to appearance.

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

Not applicable as no clinical ground truth was established for the 510(k) clearance. The determination of substantial equivalence was based on non-clinical engineering and performance comparisons.

4. Adjudication Method for the Test Set

Not applicable as no clinical ground truth was established.

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 physical traction system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical traction system, not an algorithm, and its performance is inherently "standalone" in the sense that its mechanical operation is evaluated independently of a human interpreter.

7. The Type of Ground Truth Used

For functional and performance characteristics, the "ground truth" was established by comparison to the predicate device (DRX9000 True Non Surgical Decompression System) and compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, ISO 14971). The accuracy of tension display was verified against a calibrated dynamometer.

8. The Sample Size for the Training Set

Not applicable as no machine learning algorithm was involved, and thus no training set was used.

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

Not applicable as no machine learning algorithm was involved.

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