(153 days)
The Integrity Spinal Care System provides a program of treatments for relief from pain for those patients suffering with low back pain or neck pain. Each treatment consists of a physician prescribed treatment period on the Integrity Spinal Care System and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
The Integrity Spinal Care System is a multi-function distraction table designed to apply distraction forces and controlled by a computer console. It has similar components for treatment and measurement, similar size, power source, and performance to the predicate devices. Key elements include a stand on/stand off tilt type bed, a split bed with two slideable cushions, a traction unit mounted to both ends of the bed with a belt pulley system attached to a vertical movable platform, a control panel for programming and controlling the traction unit, continuous monitoring of treatment parameters shown by LCD readout, automatic return to zero tension at the conclusion of treatment, an incorporated DVD player and headphones, and instantaneous release of tensions via a patient safety switch or stop buttons.
The provided text is related to a 510(k) summary for the "Integrity Spinal Care System," a traction equipment device. The document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's technical characteristics, intended use, indications for use, and safety features.
However, the document does not contain information about:
- Specific acceptance criteria for device performance (beyond compliance with recognized standards).
- A "study that proves the device meets the acceptance criteria" in terms of clinical performance or a formal performance study with a test set, ground truth, or expert review.
- Sample sizes for test or training sets.
- Data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically associated with performance evaluation of diagnostic or AI-based devices.
The document mainly states that "Non-clinical Tests: The Integrity Spinal Care System is as safe and effective as the predicate devices demonstrating compliance to FDA recognized Consensus Standards. A calibrated dynamometer won placed between the tower and bed to stimulate a patient. Measurements of tension demonstrate the tension readings displayed and noted from the calibrated dynamometer are compirative to predicate devices." This describes a basic technical comparison rather than a detailed performance study against acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with FDA recognized Consensus Standards | The device is in compliance with: |
- IEC 60601-1, Medical Electrical Equipment Part 1
- IEC 60601-2-38, Hospital Beds
- IEC 60601-1-2, Electromagnetic Compatibility
- ISO 14971:2007, Application of risk management to medical devices |
| Tension measurements comparable to predicate devices | "Measurements of tension demonstrate the tension readings displayed and noted from the calibrated dynamometer are comparative to predicate devices." (Performed using a calibrated dynamometer to simulate a patient). |
| Key descriptive elements and safety features as designed | The document lists 14 key descriptive elements (e.g., tilt bed, split cushions, harnesses, 10-200 lbs tension, LCD readout) and 8 summary safety features (e.g., 24-volt circuit, patient safety switch, manual re-entry of parameters, no manual override of max tension). The implication is that the device performs according to these listed characteristics. |
| Safety and effectiveness similar to predicate devices | The conclusion states: "The comparisons to the predicate devices demonstrate that the proposed device is safe and effective and does not raise any new potential safety risks and is substantially equivalent to the predicate devices." |
| Application of accurately controlled distraction tension to spine | The operating principles "permit the application of accurately controlled distraction tension to the lumbar and cervical spine in order to decompress the intervertebral discs and spinal structures." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes non-clinical bench testing using a "calibrated dynamometer" to simulate a patient. It does not involve a "test set" of patient data.
- Sample Size for Test Set: Not applicable / Not provided. The testing involved a dynamometer, not patient samples.
- Data Provenance: Not applicable / Not provided, as it was bench testing.
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 applicable. No ground truth based on expert review was established for this non-clinical test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a test set was mentioned.
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 traction equipment, not an AI-based diagnostic device where MRMC studies would typically be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm for standalone performance evaluation in the context of diagnostics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for a typical medical device performance study. For the non-clinical testing, the "ground truth" was the expected/designed tension readings and compliance with specified engineering and safety standards, as measured by a calibrated dynamometer.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a training set.
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).