(50 days)
The Model SC-3008 Sequential Circulator is a manual, sequential, pneumatic compression device, intended for the primary or adjunctive treatment of primary or secondary lymphedema. The device is also intended for the additional or alternate treatment of venous insufficiency, and chronic venous stasis ulcers associated with venous insufficiency, as well as general treatment of swelling of the extremities. The device is intended for home or hospital use.
The device consists of a manual pump (e.g., the user manually adjusts the pressures, while the inflate/deflate cycle times remain constant) and a sleeve or garment containing discrete, segmented inflatable chambers externally applied over the affected extremity. The pump consists of a compressor capable of a maximum pressure of 150mmHg, and provides graduated, or gradient, pressurization to the chambers (e.g., sequential inflation of distal to proximal, with distal chambers inflated to a greater pressure than the proximal ones). . A calibrated dial gauge displays pressure in the range of 0-125mmHg.
As each chamber is inflated, the pressure is held constant until all chambers are inflated, in order to prevent reverse gradient flow. Once all chambers are inflated, they are then all released simultaneously, and the cycle repeats. Pressures within the chambers are adjustable - pressure to chambers 1 &2 is controlled by a user-adjusted regulator on the pump. Pressure in chambers 384, 5&6, and 7&8 can be individually lowered from the default factory settings.
Garments are available in 10 sizes, and custom garments are available in variations from these standard sizes; an adapter is available to support bilateral treatment:
Arm - Small | Leg - Small | Leg - Adjustable Small
Arm - Medium | Leg - Medium | Leg - Adjustable Medium
Arm - Large | Leg - Large | Leg - Adjustable Large
Arm - w/ Shoulder | Arm - Custom | Leg - Custom
The provided text is a 510(k) summary for the Model SC-3008 Sequential Circulator, a medical device. It states that "Performance testing was performed and assures that the product meets its specifications." However, it does not provide details on specific acceptance criteria, the results of the performance testing, or the methodology used for the study.
Therefore, many of the requested details about acceptance criteria, study design, and results cannot be extracted from the given text.
Here is what can be inferred from the text:
1. Table of acceptance criteria and reported device performance:
The document states "Performance testing was performed and assures that the product meets its specifications." This implies that there were specifications (acceptance criteria) that the device performance was compared against, and the device met them. However, the specific criteria and actual reported performance values are not provided in the text.
2. Sample size used for the test set and the data provenance:
Not provided. The document does not describe a clinical study with a test set of data. It only mentions "Performance testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. This device is a sequential circulator, a physical therapy device. The concept of "ground truth" established by experts in the context of image interpretation or diagnostic tools typically does not apply to this type of device's performance testing described here.
4. Adjudication method for the test set:
Not applicable/Not provided. No clinical test set involving expert adjudication is described.
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 not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a manual pneumatic compression device, not an algorithm. Its performance is inherent in its mechanical operation.
7. The type of ground truth used:
Not provided. Given the nature of the device, "ground truth" for its performance would likely refer to objective measurements of pressure, cycle times, gradient accuracy, and durability against predefined engineering specifications. However, the specific type of ground truth (e.g., direct measurement, simulated conditions, etc.) and its establishment are not described.
8. The sample size for the training set:
Not applicable/Not provided. This is not a machine learning or AI device, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).