(197 days)
The A.T.S. 3000 Automatic Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including: Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations
The Zimmer A. T.S. 3000 Automatic Tourniquet System is a non-sterile device intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. The system consists of the A.T.S. 3000 control unit that is coupled to the patient with the applied part (inflatable pneumatic tourniquet cuff) via the connecting tubing. The tourniquet cuff is applied to the patient prior to the procedure beginning. The connecting tubing is attached to the inflatable tourniquet cuff and plugged into the A.T.S. 3000's connector ports.
The Zimmer A.T.S. 3000 Automatic Tourniquet System is a non-sterile device designed to temporarily occlude blood flow in a patient's extremities during surgical procedures. The device was found to be substantially equivalent to other legally marketed tourniquet systems (Richards Pressure Sentry Tourniquet and Zimmer A.T.S. 2000 Tourniquet System), and its LOP feature was found substantially equivalent to the Medasonics Versatone D9 stethoscope.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Predicate Equivalence | Substantially equivalent to existing devices in design, materials, and indications for use. | The device is substantially equivalent to the Richards Pressure Sentry Tourniquet and the Zimmer A.T.S. 2000 Tourniquet System. The LOP feature is substantially equivalent to the Medasonics Versatone D9 stethoscope. |
| Applicable Standards | Meets applicable sections of "Guidance for FDA Reviewers and Industry," May 29, 1998. | The device meets applicable sections of this guidance document. |
| Meets ANSI/AAMI/ISO 10993-1:1997, "Biological evaluation of Medical Devices." | The device meets this standard. | |
| Performance Testing | Electrical safety | Testing completed. |
| Hardware and Software | Testing completed. | |
| Software validation | Validation completed. | |
| Environmental testing | Testing completed. | |
| Performance testing | Testing completed. | |
| Risk Analysis | Risk analysis conducted. | Risk analysis completed. |
| Clinical Performance | Clinical data requirements | Clinical data and conclusions were not needed for this device due to its substantial equivalence to established predicate devices and the nature of the device (temporary occlusion of blood flow, well-understood mechanism). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly mention a "test set" in the context of clinical data for performance evaluation because it states that clinical data and conclusions were not needed for this device.
The performance assessment was based on non-clinical testing and comparison to predicate devices. Therefore, details like sample size, provenance, retrospection/prospection are not applicable for a traditional clinical "test set" in this context.
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, as clinical data and a "test set" requiring expert ground truth were not used for device acceptance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as clinical data and a "test set" requiring adjudication were not used for device acceptance.
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 pneumatic tourniquet system, not an AI-assisted diagnostic or interpretative tool that would involve multi-reader multi-case studies or AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to a physical medical device like a pneumatic tourniquet system. There is no "algorithm only" performance to evaluate in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance, the "ground truth" was established by compliance with recognized standards and guidance documents (e.g., "Guidance for FDA Reviewers and Industry," ANSI/AAMI/ISO 10993-1:1997), and through established engineering and safety testing protocols. The substantial equivalence to predicate devices also serves as a baseline for expected performance and safety, derived from their long-standing use and acceptance in the medical field.
8. The sample size for the training set
Not applicable. This device is a physical medical device and does not involve AI or machine learning models that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 878.5910 Pneumatic tourniquet.
(a)
Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.