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510(k) Data Aggregation
(74 days)
TOURNIQUET CUFF; PNEUMATIC TOURNIQUET
The intended use of a tourniquet cuff is to restrict blood flow to a patient's limb during surgery.
Tourniquet cuffs are composed of either a plastic or cloth cover, over one or more plastic or rubber bladders. There are one or more plastic tubes leading from the bladder to a connector that attaches to a compressor. All work on the same principal, a compressor inflates the bladder(s) with air to restrict the blood flow in the limb during surgery.
Here's an analysis of the provided text regarding the acceptance criteria and study for Medical Instruments Technology, Inc.'s reprocessed tourniquet cuffs:
Acceptance Criteria and Device Performance Study for Reprocessed Tourniquet Cuffs
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Characteristics: | Reprocessed devices were "substantially equivalent" to new devices. |
| - Color | (Implicitly met, as "substantially equivalent") |
| - Dimensions | (Implicitly met, as "substantially equivalent") |
| - Damage | (Implicitly met, as "substantially equivalent") |
| Performance Characteristics: | Reprocessed devices were "substantially equivalent" to new devices. |
| - Ability to hold pressure | (Implicitly met, as "substantially equivalent") |
| Bio-compatibility & Cleanliness: | Met. |
| - Freedom from residual bioburden | Achieved through washing procedure utilizing chosen cleaning agents. |
| - Freedom from residual cleansers | Achieved through rinsing after washing. |
| - Continued cleanliness | Achieved by packaging in an environmentally controlled room. |
| Sterilization & ETO Residuals: | Met. |
| - Sterilization system validation | ETO sterilization system validated. |
| - Acceptable residual ETO levels | Residual ETO testing performed and reduced to an acceptable level. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It broadly refers to "reprocessed tourniquet cuffs" and "the predicate device" during comparisons.
The data provenance is internal to Medical Instruments Technology, Inc. and is retrospective, as the testing was performed on their reprocessed devices and compared against an existing predicate device (Instrumed, Color Cuff K890014).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set in the traditional sense of clinical or diagnostic evaluation. The assessments seem to be engineering and performance-based comparisons conducted by MIT.
4. Adjudication Method
The document does not describe an adjudication method for the test set, as there is no indication of multiple reviewers or differing interpretations of results requiring resolution. The evaluation appears to be a direct comparison against pre-defined parameters by MIT staff.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic imaging or interpretation tasks where human readers make assessments. The device in question is a reprocessed medical instrument, and the evaluation focuses on its physical and performance characteristics, not human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The entire evaluation described is a standalone assessment of the reprocessed device's physical and performance characteristics, comparing it directly to the predicate device without human-in-the-loop performance being a factor. The "algorithm" here is the reprocessing procedure and subsequent quality checks, which are evaluated on their own merits.
7. Type of Ground Truth Used
The "ground truth" for the test set was essentially the characteristics and performance of the new predicate device (Instrumed Color Cuff K890014). The reprocessed cuffs were evaluated for "substantial equivalence" against this established benchmark.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of device evaluation. This concept is typically associated with machine learning or AI models. The evaluation here is for a physical medical device, not a software algorithm that would require training data.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned or implied, the method for establishing its ground truth is not applicable.
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