(160 days)
Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.
Instalief™ is a device designed for the treatment of internal and external hemorrhoids by the application of cold directly to the swollen hemorrhoidal tissue. The device consists of an outer bag which houses an endothermic salt, a smaller water-containing frangible bag, an insertion tip with an attached compliant balloon, as well as a separate component that aids in the usage of the device, known as the squeezer. To use the device, the user first bursts the frangible bag by pressing on it, initiating an endothermic process between the water and endothermic salt. The user then inserts the shaft of the device into the anal canal (for internal hemorrhoids) or applies to the outer tissues (for external hemorrhoids), and squeezes the bag with the aid of the squeezer. This action transfers the cold fluid generated into the balloon, which provides targeted cold therapy to the hemorrhoids. Instalief™ is meant to be used for 6 - 8 minutes.
This document describes information about the Instalife Hemorrhoidal Cooling Device, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Protocols) | Reported Device Performance (Summary of Results) |
|---|---|
| Inflated Static Load Pull Test (VV0001P) | Passed |
| Balloon Burst Volume Test (VV0002P) | Passed |
| Compression Test (VV0007P, VV0009P) (Against Predicate Aniuce) | Both Devices Passed (Instalief™ and Predicate) |
| Cold Duration Test (VV0003P, VV0008P) (Against Predicate Aniuce) | Cold duration similar to predicate |
| In-vitro cytotoxicity – Elution method | Non-cytotoxic |
| Skin sensitization test in guinea pigs (guinea pig maximization test) | Non-sensitizing |
| Intracutaneous reactivity test in New Zealand white rabbits | Non-reactive |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of devices tested for balloon burst or cold duration). The data provenance is derived from these non-clinical tests performed by the manufacturer, Privi Medical Pte Ltd. It is a retrospective evaluation of the device's performance against established test protocols. The country of origin for the data (where the tests were conducted) is not specified, but the company is located in Singapore.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for the non-clinical tests was established by objective performance metrics derived from laboratory testing, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. As the tests were non-clinical performance and safety evaluations, there was no adjudication method involving human interpretation. The results were objectively determined based on test protocol criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing is not applicable for establishing substantial equivalence of Instalief™."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable as the device is a physical medical device (a hemorrhoid cooling device), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence was primarily based on:
- Performance Documentation (Test Protocols): Objective criteria for structural integrity, functional performance (like cold duration), and biocompatibility detailed in specific test protocols (e.g., VV0001P, VV0002P).
- Comparison to Predicate Device: Direct comparison of physical characteristics and functional performance against the predicate device (Anuice) also served as a "ground truth" for showing similar safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. The Instalief™ device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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