(89 days)
The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical muscles and vertebrae when used in conjunction with fixed or variable height traction tables. It is indicated for use as a treatment for spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain and compression fractures.
The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical muscles and vertebrae when used in conjunction with fixed or variable height traction tables. It is indicated for use as a treatment for spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain and compression fractures.
The ATP9 machine mounts on available Akron traction tables and mobile traction stand. Traction force is applied to the patient using Akron traction harnesses. The ATP9 utilizes a DC-powered motor gearbox connected to a rope drum via a clutch. The rope is connected to a harness attached to the patient. The high force hold time and low force rest time programs are selectable from 1 second minimum to 99 seconds maximum, with a high traction force range of 2-200 lbs. and low traction force range of 2-196 lbs. There are seven combinations of therapy including static, intermittent, progressive, regressive and cyclic.
This is a 510(k) premarket notification for a medical device (Akron ATP9 Traction Machine), not a study report or clinical trial. Therefore, most of the requested information regarding acceptance criteria and performance studies is not explicitly provided in this type of document.
A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already legally marketed. It typically relies on design comparisons, performance testing (often to industry standards), and safety considerations rather than extensive clinical studies with human subjects to prove new efficacy claims or compare against human readers.
However, I can extract what is available and explain why other requested information is not present.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with reported device performance in the manner one would expect for a study evaluating a diagnostic or AI-driven device. Instead, it describes general safety and performance parameters:
| Acceptance Criteria (Implied) | Reported Device Performance/Features |
|---|---|
| Force Range | High traction force range: 2-200 lbs. |
| Low traction force range: 2-196 lbs. | |
| Hold/Rest Time | Selectable from 1 second minimum to 99 seconds maximum. |
| Therapy Combinations | Seven combinations available (static, intermittent, progressive, regressive, cyclic). |
| Safety Fault Conditions | Detects eleven fault conditions: control system failure, low supply voltage, AC power failure, motor power supply failure, battery failure, excess tension detected, high force control setting failure, strain gauge failure, strain gauge mismatch, motor malfunction, unexpected increase in tension, and cord drive fault. |
| International Standards | Conforms to IEC601-1, EN60601-1-2: 1993, EN60601-1/A2: 1995, EN60601-1-4: 1997. Manufactured to ISO9002 and EN46002. (This implies that the device has met the requirements of these standards during its development and testing). |
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. The 510(k) submission generally discusses engineering testing and adherence to standards rather than clinical "test sets" or patient data provenance.
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 applicable and not provided. The "ground truth" concept is relevant for studies evaluating diagnostic accuracy, often with expert consensus, which is not the focus of this 510(k) for a traction machine.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided for the reasons stated above.
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. An MRMC study is typically for evaluating diagnostic performance (especially with AI assistance), which is not relevant for a physical therapy traction machine. There is no AI component mentioned in this device description.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. There is no algorithm mentioned that would operate standalone or without human intervention; the device is a physical therapy machine.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable and not provided. The assessment of this device is based on its mechanical performance, safety features, and compliance with recognized standards, not on "ground truth" for diagnostic accuracy.
8. The sample size for the training set
This information is not applicable and not provided. There is no machine learning or AI component mentioned that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the reasons stated above.
§ 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).