(34 days)
The iTClamp®50 is a trauma clamp device for the temporary control of severe bleeding in the extremittes, axilla, inguinal areas, scalp, and neck.
The iTClamp50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal.
The iTClamp50 controls bleeding by sealing the skin closed to apply direct pressure to the cut edges of the skin and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair.
The device is provided sterile and is for single use.
The iTClamp50 consists of the following components:
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- Suture needles
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- Tray w/Tyvek lid
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- Locking mechanism
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- Lock release mechanism
Here's an analysis of the provided text regarding the iTClamp®50 device, focusing on acceptance criteria and the study proving its performance:
Device: iTClamp®50 (modified version seeking K150813 clearance)
Predicate Device: iTClamp®50 (K140805)
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several "Design verification and validation testing" activities and states that "Design verification and validation testing has demonstrated that the device meets predefined acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results/performance metrics for each test. It rather states what each test was intended to verify.
| Acceptance Criteria (Intended Verification) | Reported Device Performance (Summary) |
|---|---|
| Leakage Test: To verify that the device can create a liquid tight seal. | Demonstrated that the device meets predefined acceptance criteria for creating a liquid tight seal. (No specific quantifiable performance metric provided, e.g., "no leakage for X duration at Y pressure"). |
| Minimum Holding Torque: To verify that the force applied to the device during function does not deform the needles or damage the pressure bars. | Demonstrated that the device meets predefined acceptance criteria for resisting deformation of needles or damage to pressure bars under applied force. (No specific quantifiable performance metric provided). |
| Needle Pullout Force Test: To verify that the needle pullout force of the device is within specification. | Demonstrated that the device meets predefined acceptance criteria for needle pullout force (i.e., within specification). (No specific quantifiable performance metric provided). |
| Maximum Arming Force Test: To verify that the force required to arm the device is within specification. | Demonstrated that the device meets predefined acceptance criteria for arming force (i.e., within specification). (No specific quantifiable performance metric provided). |
| Maximum Closing Force Test: To verify that the force required to close the device is within specification. | Demonstrated that the device meets predefined acceptance criteria for closing force (i.e., within specification). (No specific quantifiable performance metric provided). |
| Button Disengaging Force Test: To verify that the force required to release the device is within specification. | Demonstrated that the device meets predefined acceptance criteria for button disengaging force (i.e., within specification). (No specific quantifiable performance metric provided). |
| Operational Environmental Tests: To verify the function of the device within specified environments. | Demonstrated that the device meets predefined acceptance criteria for functioning within specified environments. (No specific quantifiable performance metric or environmental conditions provided). |
| Usability Tests: To verify the technological modifications did not affect end-user usability of the device. | Demonstrated that the technological modifications did not negatively affect end-user usability. (No specific usability metrics or user feedback provided). |
| Package Testing: To verify that the updated packaging met specifications for sterility. | Demonstrated that the updated packaging met specifications for sterility. (No specific quantifiable performance metric or sterility assurance level provided). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the design verification and validation tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature). These types of tests are typically conducted in a laboratory setting by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts for ground truth) is typically relevant for studies involving subjective interpretation, like imaging analysis. The described tests are primarily engineering design verification and validation tests for a mechanical device. Therefore, the concept of "ground truth established by experts" in the clinical diagnostic sense does not directly apply to these tests. The "ground truth" for these tests would be the established engineering specifications and performance targets set by the manufacturer.
4. Adjudication Method (for the test set)
Given that these are primarily engineering verification tests, an "adjudication method" in the sense of resolving discrepancies between expert interpretations is not applicable. The results of these tests (e.g., force measurements, leakage detection) are objective measurements against predefined specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, the document does not indicate that a Multi Reader Multi Case (MRMC) comparative effectiveness study was done. The studies described are focused on verifying the design and functionality of the device itself, not on comparing reader performance with and without AI assistance, as the iTClamp®50 is a physical medical device, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, the concept of "standalone algorithm performance" is not applicable here as the iTClamp®50 is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for these design verification and validation tests is the predefined engineering specifications and performance requirements for the device. For example, for the "Needle Pullout Force Test," the ground truth would be the specified acceptable range of force. For "Leakage Test," the ground truth is "liquid tight seal" according to a defined methodology.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning or AI models. Since the iTClamp®50 is a physical medical device and not an AI algorithm, there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).