(128 days)
The TRACTION SYSTEM, DIGIT-TRAC 930 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.
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The provided text is a 510(k) premarket notification for a medical device called "TRACTION SYSTEM, DIGIT-TRAC 930." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new clinical study to establish safety and effectiveness from scratch.
Therefore, the document does not contain information about acceptance criteria, clinical studies with sample sizes, expert ground truth, or AI performance metrics as it would for a novel AI/software medical device.
Instead, the "study" proving the device meets acceptance criteria in this context refers to the comparison of the new device to predicate devices and adherence to electrical safety and electromagnetic compatibility (EMC) standards.
Here's the breakdown of the information that can be extracted or reasonably inferred based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred from regulatory requirements) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Intended Use | The device's intended use must be the same as or very similar to legally marketed predicate devices. | The TRACTION SYSTEM, DIGIT-TRAC 930 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body. This matches the intended use of the predicate devices. |
| Technological Characteristics | The device's technological characteristics must be substantially equivalent to predicate devices. Deviations must not raise new questions of safety or effectiveness. | The document states: "The TRACTION SYSTEM, DIGIT-TRAC 930 has been carefully compared to legally marketed devices with respect to intended use and technological characteristics." While specific characteristics are not detailed, the FDA's clearance implies that the technological characteristics were deemed substantially equivalent to the predicate devices (TEC VARI-TRAC II TRACTION UNIT and DYNATRON 900). This would typically include aspects like operating principles, force ranges, control mechanisms, etc., which are common to powered traction equipment. |
| Electrical Safety | Compliance with recognized electrical safety standards to ensure patient and user safety. | "Electrical Safety (EN 60601-1) testing have been done to validate the electrical safety of the device." This indicates the device passed EN 60601-1, meeting the acceptance criteria for electrical safety. |
| EMC (Electromagnetic Compatibility) | Compliance with recognized EMC standards to ensure the device operates without causing or being susceptible to electromagnetic interference. | "EMC (EN 60601-1-2) ... testing have been done to validate the electrical safety of the device." This indicates the device passed EN 60601-1-2, meeting the acceptance criteria for EMC. |
| Safety and Effectiveness | Overall demonstration that the device is as safe and effective as the predicate device(s). | The FDA's clearance letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device." This is the ultimate "reported performance" regarding safety and effectiveness for a 510(k), meaning the FDA accepted the demonstration of substantial equivalence. |
The following points address the other requested information, noting that most are not applicable to this type of device submission:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of device. This is a hardware device (powered traction equipment), not a software/AI device that would typically have a "test set" of data in the sense of patient images or other clinical records. The "tests" mentioned are technical standards for electrical safety and EMC.
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. Ground truth in the context of clinical data for AI/software is not relevant here. The "experts" involved would be electrical engineers and regulatory experts who performed and reviewed the technical standard testing (EN 60601-1 and EN 60601-1-2) and the comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" of clinical cases requiring adjudication in this submission.
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 is not an AI-powered device, and no MRMC study was conducted or required for this 510(k) clearance.
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 this device, "ground truth" relates to compliance with engineering standards and demonstration of similar design and function to established devices. The "ground truth" for the electrical safety and EMC tests is the defined requirements of the EN 60601-1 and EN 60601-1-2 standards.
8. The sample size for the training set
- Not applicable. This is a hardware device; there is no training set as would be used for machine learning.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is irrelevant.
§ 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).