(374 days)
The device use is for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying the device to the tissue, the inflammation is reduced. The base section is used for the treatment of external hemorrhoids and the neck/probe section is used for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the probe into the rectum.
Hemor-Rite Cryotherapy is an anatomically designed device for applying cold therapy (Cryotherapy) directly to the swollen hemorrhoidal veins of external hemorrhoids and the internal hemorrhoids within the rectal cavity. The direct application of cold provides prompt relief of itching, pain, and swelling. In addition, Hemor~Rite Cryotherapy is beneficial for the treatment of anal and perianal fissures due to the vasoconstriction and analgesia properties of the device. Hemor-Rite Cryotherapy has been designed taking the following factors into consideration: human anatomy and the medical concepts for treating the ailment.
Hemor-Rite Cryotherapy is an anatomically designed medical device ergonamicly shaped for application of cold therapy (Cryotherapy) directly to swollen hemorroidal veins of external hemorrhoids and internal hemorthoids within the rectal canal. The direct application of cold provides prompt relief of itching, pain, and swelling. The device consists of a sealed applicator containing a coolant formula. The HemorRite device is placed into the user's freezer until frozen. After the Hemor-Rite Cryotherapy device is frozen, the user inserts the device to te affected hemorrhoidal area. The probe is maintained in the area for 6-8 minutes, until the probe reaches body temperature, or up to a maximum of 10 minutes. The HemorRite Cryotherapy device is a reusable device.
Hemor~Rite is comprised of two pieces of plastic; the crown and the base.
The provided text describes the Hemor~Rite Cryotherapy device and a study to demonstrate its substantial equivalence to a predicate device (ANUICE). However, the document does not contain a comprehensive algorithm performance study with specific acceptance criteria, test set details, ground truth establishment for AI/ML devices, as would be expected for a submission for an AI-powered medical device. Instead, the study focuses on hardware and biological compatibility assessments.
Here's a breakdown of the information that can be extracted, acknowledging the limitations regarding AI/ML-specific criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material/Device Integrity | Accelerated Aging and Integrity | Results conclude Hemor~Rite is substantially equivalent to ANUICE. |
| Mechanical Strength | Investigation of Compression Strength | Results conclude Hemor~Rite is substantially equivalent to ANUICE. |
| Biocompatibility | Cytotoxicity (ISO 10993) | Results conclude Hemor~Rite is substantially equivalent to ANUICE. |
| Biocompatibility | ISO Intracutaneous (ISO 10993) | Results conclude Hemor~Rite is substantially equivalent to ANUICE. |
| Biocompatibility | Maximization Sensitization (ISO 10993) | Results conclude Hemor~Rite is substantially equivalent to ANUICE. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI/ML algorithm. The studies listed (Accelerated Aging, Compression Strength, Cytotoxicity, Intracutaneous, Maximization Sensitization) are typical for medical device material and physical property testing. The sample sizes for these tests are not provided, nor is the data provenance (e.g., country of origin, retrospective/prospective). These are laboratory-based tests on the device materials themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of studies described. The "ground truth" for these tests would be established by standardized testing protocols and analytical methods, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set
This is not applicable as the studies are not clinical trials or expert review processes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not conducted as this is not an AI/ML powered device. The device is a physical cryotherapy device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done
No, a standalone algorithm performance study was not done for the same reason as above.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed relates to the adherence of the device's materials and design to established safety and performance standards (e.g., ISO 10993 for biocompatibility), and its physical characteristics compared to the predicate device. It is based on laboratory testing and standardized analytical methods, not clinical outcomes or expert consensus on patient data.
8. The Sample Size for the Training Set
This is not applicable as there is no AI/ML algorithm being trained.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no AI/ML algorithm being trained.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a benchtop and biocompatibility testing program. The listed tests include:
- Accelerated Aging and Integrity: Likely to assess the device's durability and material stability over time under simulated aging conditions.
- Investigation of Compression Strength: To evaluate the device's mechanical robustness and ability to withstand forces during use.
- Cytotoxicity (ISO 10993): To determine if the device's materials release substances that are harmful to cells.
- ISO Intracutaneous (ISO 10993): To assess local skin irritation effects from the device materials.
- Maximization Sensitization (ISO 10993): To determine the potential for the device materials to cause allergic sensitization.
The conclusion of these tests was that "Hemor~Rite is substantially equivalent to ANUICE and is safe, as effective, and performs as well as or better than the predicate device." This implies that the device successfully passed these tests and demonstrated comparable or superior characteristics to the predicate device, thereby fulfilling the safety and performance requirements for marketing. The basis for substantial equivalence for this device is primarily its technological characteristics and the results of these non-clinical performance assessments.
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