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The ELTRAC 471 Traction device, with its accessories, is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The ELTRAC 471 Traction device may be used to treat pain and symptoms associated with the following conditions: hermiated discs, bulging or protruding intervertebral discs, degenerative disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.

The Eltrac 471 traction device applies forces to the spine to alleviate pain caused by a variety of pressure on muscular or skeletal structures. It exerts defined forces on the human body to alleviate pain and utilizes computer technology for programming of different kinds of traction.

This device is intended for use by professional users only, such as qualified personnel in physiotherapy, rehabilitation and adjacent areas. The device is designed with a plastic housing that holds the motor and has a full color touch screen interface on which the professional user can enter various parameters by touch. The forces from the motor are transferred to the patient by cords and connected accessories. Sequential programming is possible for programming combinations of traction which can be stored as favorites for later use.

The provided text describes the regulatory clearance for the "Eltrac 471 Traction device" based on substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria through performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance against those criteria are not present.

However, I can extract the information that is available regarding regulatory requirements and the non-clinical performance evaluation.

Here's a breakdown of the available information based on your request:

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

The document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) against which the Eltrac 471 was compared. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized non-clinical standards.

The "performance" is generally described as meeting safety and functionality requirements through verification and validation tests against these standards.

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

This information is not provided in the document. The non-clinical performance refers to "Verification and validation tests" conducted by Enraf-Nonius, B.V., but details about specific test sets, sample sizes, or data provenance (e.g., retrospective/prospective, country of origin) are absent. This is typical for submissions based on substantial equivalence for non-clinical devices where the "test set" would be the device itself subject to engineering and safety tests.

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)

This information is not provided. Clinical ground truth, experts, or their qualifications are not mentioned, as no clinical testing was performed or required. The "ground truth" for non-clinical tests would typically be defined by engineering specifications and standard requirements.

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

This information is not provided. Adjudication methods are relevant for clinical studies, which were explicitly stated as "Not applicable" for this device.

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

This information is not applicable and not provided. This device is a physical therapy traction device, not an AI-assisted diagnostic or imaging device used by human readers/interpreters. No MRMC study was conducted.

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

This information is not applicable in the context of typical AI algorithm-only performance. The "device" itself, the Eltrac 471, performs its function (applying traction) independently to the extent of its programming. The "non-clinical performance" section describes tests on the device's electrical, safety, and software functionality, which could be considered a form of standalone testing for the device's inherent design.

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

For the non-clinical performance, the "ground truth" implicitly used would be engineering specifications, design requirements, and the pass/fail criteria defined by the cited international standards (ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304). This does not involve clinical "ground truth" like pathology or outcomes data, as no clinical studies were performed.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "software" component refers to control software, not a learned model.

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

This information is not applicable and not provided for the reasons stated in point 8.

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The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles.

The MTD 4000 may be used to relieve peripheral radiation/sciatica and pain associated with:

• Protruding discs
• Bulging discs
• Herniated discs
• Degenerative disc disease
• Posterior facet syndrome
• Acute facet problems
• Radicular pain
• Prolapsed discs
• Spinal root impingement
• Hypomobility
• Degenerative joint disease
• Facet syndrome
• Compressions fractures
• Joint pain
• Discogenic pain

The MTD 4000 (Mettler Traction Decompression) system is an easy to use device that offers static and intermittent traction with user definable hold, rest, and treatment times. It gently pulls the cervical spine or lumbar spine in opposite directions to draw the soft tissue around the cervical or lumbar joints and separate the distance between bone sections of the vertebra.

The provided text is a 510(k) Summary Statement for the Mettler Traction Device, MTD 4000. It details the device's description, intended use, and a comparison to predicate devices for substantial equivalence.

However, the document does not contain information about specific acceptance criteria for a study, nor does it present the results of a study designed to prove the device meets such criteria.

The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for performance, a common requirement for new or higher-risk devices.

Therefore, I cannot fulfill your request for the following information based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing technological characteristics to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or study data is described.
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): No ground truth establishment or expert involvement in a study is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication is 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: This device is a physical traction device and does not involve AI or human readers in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is mentioned in relation to performance criteria.
8. The sample size for the training set: Not applicable as it's not an AI/ML device that requires training.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide is a comparison table of the MTD 4000 with predicate devices, highlighting similar features and differences in physical characteristics and user interface configurations. This comparison serves to demonstrate substantial equivalence, rather than meeting specific performance acceptance criteria from a study.

The FDA's letter (Page 3-4) states that they "have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This confirms the nature of the submission and review process.

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