Search Results

Teeter Decompression Devices are multiple user, reusable devices for home use, intended to provide traction to the spine while stretching the para-spinal muscles and soft tissues. The devices provide non-powered traction and are meant for use by adults.

Use of the Teeter Decompression Devices is indicated for the following conditions: back pain, muscle tension, degenerative disc disease, spinal degenerative joint disease, spinal stenosis, herniated disc, spinal curvature due to tight muscles, sciatica, muscle spasm, and facet syndrome.

Teeter's decompression devices are designed to decompress the spine and stretch paraspinal soft tissues. The devices are non-powered, external (non-invasive) and usercontrolled. Decompression is accomplished in various ways depending on the model within the Teeter product family.

The provided document is a 510(k) premarket notification for "Teeter Decompression Devices" and their accessories. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Lo-Bak TRAX) and does not contain the type of acceptance criteria and rigorous scientific study details typically associated with advanced AI/ML medical devices.

Therefore, an answer fulfilling all the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be generated from the given text.

The document describes non-powered mechanical devices (inversion tables, gravity boots, and other manual traction devices) and their intended use. The "performance data" section only mentions "Safety evaluations (Inversion table and gravity boots only)" and "Risk analysis," which are general assessments for mechanical devices rather than the detailed clinical or validation studies for AI/ML algorithms that your request implies.

Here's a breakdown of why the requested information is absent:

1. Acceptance Criteria and Reported Device Performance: While the document outlines the "Indications for Use" and compares technological characteristics to a predicate, it does not present a table of specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, AUC for an AI device) or detailed performance metrics against those criteria.
2. Sample Size and Data Provenance (Test Set): No information about a test set, its sample size, or data provenance (country, retrospective/prospective) is provided. The document focuses on mechanical design and functional equivalence.
3. Number of Experts and Qualifications (Ground Truth): Since there's no mention of a test set or AI algorithm requiring ground truth, there's no information on experts or their qualifications for establishing ground truth.
4. Adjudication Method: Not applicable as there's no test set requiring ground truth adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The devices are mechanical and do not involve human readers interpreting output from an AI.
6. Standalone Performance: No mention of standalone algorithm performance, as there is no algorithm.
7. Type of Ground Truth: Not applicable, as no AI algorithm is involved that would require a ground truth.
8. Sample Size for Training Set: No training set is mentioned, as there is no AI/ML component.
9. Ground Truth for Training Set: Not applicable.

In conclusion, the input document describes a Class I medical device (Nonpowered Orthopedic Traction Apparatus and Accessories) which is a physical, mechanical device. The substantial equivalence determination for such devices typically relies on engineering and safety testing, comparison of design and materials with existing devices, and a demonstration that the new device does not raise new questions of safety or effectiveness. It does not involve the elaborate clinical validation studies and AI/ML specific performance metrics asked in your prompt.

Ask a specific question about this device