(513 days)
The Hem-Avert Perianal Stabilizer is indicated for the prevention of external hemorrhoids during vaginal childbirth.
This is a single use, disposable, sterile instrument. The Hem-Avert™ Perianal Stabilizer consists of three components:
- rigid polymer base manufactured from a medical grade polycarbonate
- centrally located cushioning pad composed of a laminate of medical grade polyester non-woven tape and medical grade polyethylene foam tape
- two lateral hook and loop adhesive strips (with liners) which provide the tension required to keep the instrument firmly in place during delivery.
The cushioning pad and adhesive strips are manufactured from materials commonly associated with medical instruments and used in medical procedures.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: HEM-AVERT PERIANAL STABILIZER
Intended Use: Prevention of external hemorrhoids during vaginal childbirth.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the Special Controls and the Results section of the clinical study, we can infer the primary performance acceptance criteria and how the device performed against them.
| Acceptance Criterion (Inferred from Special Controls/Clinical Study Objective) | Reported Device Performance (from Clinical Study) |
|---|---|
| Biocompatibility: Device must be demonstrated to be biocompatible. | Passed: Cytotoxicity, Irritation, and Sensitization studies showed no signs of cytotoxicity, significant irritation, or sensitization. Materials commonly associated with medical instruments were used. |
| Mechanical Strength: Device must withstand forces encountered during use (e.g., pushing force during labor). | Passed: Bench testing showed the Hem-Avert could endure a compressive load of 188N to flattening without breaking. Clinical study demonstrated the device stayed in place during labor. |
| Safety and Effectiveness: Device must prevent hemorrhoids in women undergoing spontaneous vaginal delivery. | Passed: Clinical study showed 100% success (no hemorrhoids) in the Hem-Avert group (34 subjects) versus 75% success in the Control group (39 out of 52 subjects). (p-value = 0.0012) |
| Sterility: Device must be provided sterile. | Passed: Sterilization validation achieved a sterility assurance level (SAL) of 10^-6, with no positive growth in tested samples. |
| Labeling Compliance: Labeling must include specific instructions and comply with prescription device requirements. | Passed: Stated that labeling complies with 21 CFR 807.87(e) and 21 CFR § 801.109, and includes the "Caution: Federal law restricts this device..." statement. Specific instructions regarding placement and use are also required by special controls. |
| Risk Mitigation: Identified risks (Skin/tissue trauma, Device failure, Infection, Adverse tissue reaction, Pain) must be mitigated. | Addressed: Nonclinical analysis, testing (biocompatibility, mechanical), and labeling are cited as mitigation methods for various risks. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set (Clinical Study Efficacy Analysis):
- Hem-Avert (Treatment) Group: 34 subjects
- Control Group: 52 subjects
- Total for efficacy analysis: 86 subjects
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is to the FDA, suggesting a US context.
- Retrospective or Prospective: Prospective. The study involved subject enrollment, screening, randomization, device placement during delivery, and follow-up examinations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The text does not specify the number of experts (physicians) involved in establishing the ground truth (presence/absence of hemorrhoids) during the clinical study.
- Qualifications of Experts: The study was conducted at "OBGYN physician clinics" and "Delivery sites." Physicians at these sites would be qualified OBGYN doctors responsible for labor, delivery, and postpartum assessment.
4. Adjudication Method for the Test Set
- The text does not explicitly describe an adjudication method beyond the physician's observations during "follow-up examination and data collection prior to discharge from hospital" to determine the presence of hemorrhoids. It implies that the treating physicians made the assessment. There's no mention of independent reviewers or a consensus process for the clinical outcome.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a physical medical device (perianal stabilizer), not an AI algorithm or imaging diagnostic tool that would typically involve human readers interpreting results with or without AI assistance. Therefore, there is no effect size reported for human readers improving with AI vs. without AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- N/A (Not Applicable). As mentioned above, this is a physical medical device, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The device itself (Hem-Avert) operates standalone in its mechanism of action by providing mechanical support; there is no "human-in-the-loop" once it's placed, beyond the physician's initial placement and decision to use it. The clinical study did evaluate its standalone performance (the device's effect in preventing hemorrhoids compared to no device).
7. Type of Ground Truth Used
- Expert Clinical Observation. For the efficacy endpoint (prevention of hemorrhoids), the ground truth was established by the physician's visual examination and assessment after delivery to determine the presence or absence of hemorrhoids. This is based on clinical signs and symptoms, observed by a medical professional.
8. Sample Size for the Training Set
- Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI. Performance was evaluated in a clinical trial, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI model, the question of how its ground truth was established is not relevant.
§ 884.5200 Hemorrhoid prevention pressure wedge.
(a)
Identification. A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special controls for this device are:(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.
(2) The labeling must include specific instructions regarding the proper placement and use of the device.
(3) The device must be demonstrated to be biocompatible.
(4) Mechanical bench testing of material strength must demonstrate that the device will withstand forces encountered during use.
(5) Safety and effectiveness data must demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery, in addition to general controls.