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510(k) Data Aggregation
(362 days)
The BrachyGel Vaginal Hydrogel Packing System is a single-use, non-sterile, disposable, non-powered positioning device that delivers self-expanding hydrogel that forms and expands within the vaginal cavity. The purpose of this device is to displace the vaginal wall and adjacent pelvic tissues during radiation therapy planning and delivery, to reduce dose to adjacent tissues by attenuation of radiation dose, and to stabilize radiation treatment equipment during radiation therapy planning and delivery. The placement of the hydrogel device requires a physician or physician directed healthcare professional, and is performed as a separate procedure outside of brachytherapy applicator insertion. computed tomography and/or magnetic resonance imaging exam, radiation treatment planning and radiation treatment delivery. This device is not intended to be inserted into the uterine cavity or rectum. This device is intended to be in place temporarily and removed after less than 24 hours.
The device, BrachyGel Vaginal Hydrogel Packing System (BVHPS), is intended for patients receiving brachytherapy for gynecological cancers. The BVHPS works by displacing the rectum and bladder, providing radiation attenuation and stabilizing the brachytherapy applicator. The device contains components for the preparation of a polyethylene glycol (PEG) based polymer hydrogel and hydrogel delivery system (Figure 1). After the bag is placed into the vaginal space, the hydrogel precursors are injected into the therapy bag and the hydrogel forms in situ, causing the bag to expand and displace nearby tissue and stabilize the brachytherapy applicator. The bag containing the hydrogel is later removed after the brachytherapy treatment delivery is complete. The physician may instill saline via the device's saline port to soften the hydrogel for easier extraction of the therapy bag. The hydrogel is not bioresorbable.
The provided text describes the BrachyGel Vaginal Hydrogel Packing System and its clinical evaluation for De Novo classification. However, it does not describe an AI medical device or a study proving that an AI device meets acceptance criteria. The information focuses on the physical device's performance, safety, and equivalence to standard care in a clinical setting.
Therefore, I cannot fulfill the request as it pertains to an AI medical device and its acceptance criteria, as the input document describes a physical medical device (a vaginal hydrogel packing system) and its associated clinical study, not an AI algorithm or its performance. The concept of "acceptance criteria for an AI device" as typically understood (e.g., sensitivity, specificity, AUC) is not applicable to the BrachyGel Vaginal Hydrogel Packing System.
To answer your prompt fully, I would need a document describing an AI medical device and its performance study.
If we interpret "acceptance criteria" broadly to refer to the device's performance as demonstrated in the provided text, and "study" to refer to the clinical trial conducted for the BrachyGel device, I can construct a response based on the available information, but it will not involve AI-specific metrics.
Assuming the request is a misinterpretation of the provided text, and the intent is to describe the acceptance criteria and study for the BrachyGel Vaginal Hydrogel Packing System as described, here is the information:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for BrachyGel Vaginal Hydrogel Packing System
The provided document describes the BrachyGel Vaginal Hydrogel Packing System, a physical medical device, not an AI device. Therefore, the acceptance criteria and study detailed below pertain to the performance and safety of this physical device in a clinical setting, primarily focusing on its non-inferiority to standard care and other performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly laid out in a quantifiable table as one might see for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, they are defined by the success of the clinical study in demonstrating non-inferiority in dosimetric results, acceptable safety profile, and favorable user experience. The "acceptance criteria" here implicitly refer to demonstrating the device's intended performance and safety profile, as outlined in the "Special Controls" section.
| Acceptance Criteria (Implied from Study Objectives and Special Controls) | Reported Device Performance (Clinical Study Results) |
|---|---|
| Clinical Performance: | |
| - Radiation dose to adjacent organs at risk (D2cc for rectum/bladder) | - Bladder D2cc: Mean difference (Gauze - BVHPS) was 0.07 Gy. Percent of HR-CTV D90 difference (Gauze - BVHPS) was -0.57%. No clinically meaningful differences. |
| - Rectal D2cc: Mean difference (Gauze - BVHPS) was -0.17 Gy. Percent of HR-CTV D90 difference (Gauze - BVHPS) was -4.90%. No clinically meaningful differences. | |
| - Device stability | - Investigator observations noted the BVHPS device remained solid and in appropriate position throughout the treatment planning and delivery process. Also addressed by bench testing (Table 1: "Stability of the Applicator" - Pass). |
| - Ability to deploy, expand, and remove the device | - Placement and removal demonstrated in all studied cases. Physician survey showed BVHPS with significantly higher "extremely easy" (21.1%) and "somewhat easy" (66.7%) scores compared to gauze (0% "extremely easy", 72.4% "somewhat easy"). Patient surveys suggested less discomfort during placement and removal with BVHPS (23.3% "none" vs. 7.4% for gauze). Bench testing ("Bag Burst Strength - Burst Volume" and "Mechanical and Dimensional Testing of Connectors") passed, showing adequate function. |
| - Patient comfort | - Patient survey: Less discomfort during placement and removal for BVHPS (23.3% none, 36.7% mild) compared to standard packing (7.4% none, 44.4% mild). Overall discomfort: BVHPS showed slightly higher "none" (6.7% vs 3.7%) and "mild" (46.7% vs 40.7%) discomfort. |
| Safety Profile (Adverse Events) | - No increase in serious adverse events compared to the standard packing control group. Three adverse events were "definitely" or "possibly" related to BVHPS: Grade 2 Vaginal Pain, Grade 1 Vaginal Hemorrhage, and another Grade 2 Vaginal Pain, all resolved without sequelae. |
| Imaging Clarity | - Mixed results. Physicians reported fewer "very clear" ratings for BVHPS (0%) compared to gauze (23.1%), but more "clear" ratings (60.5% vs 43.6%). Physicists gave more "excellent" (44.7% vs 25.6%) and "good" (42.1% vs 53.9%) ratings for BVHPS completeness, but fewer "very clear" ratings for imaging clarity (31.6% vs 38.5%). |
| Non-clinical Performance (Bench Testing): | |
| - Effect of therapeutic radiation levels on device integrity | - "Hydrogel Raw Material Characterization Before and After Irradiation": Pass. No evidence of altered rheological properties. |
| - Bioburden testing | - Passed predetermined acceptance criteria. |
| - Structural integrity of container (tensile, leakage, burst strength) | - "Bag Integrity - Leak Test": Pass. "Bag Burst Strength - Burst Volume": Pass. Test methods like ASTM F1886/F1886M-16 and ASTM F88/F88M-21 (for seal strength) were used for shelf life and package integrity, implying these aspects were acceptable. |
| - Space creation and maintenance | - Addressed by "Stability of the Applicator" bench test (Pass) and clinical observations that the device displaced tissue and stabilized the applicator. |
| - Biocompatibility | - All tested endpoints (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Materials mediated pyrogenicity) passed according to ISO 10993. |
| - Shelf life and functionality | - Established at 6 months, supported by package and functional testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical study accrued a total of 20 evaluable patients out of a planned enrollment of 40. Twenty-one patients were initially enrolled, but one was not treated due to disease progression. This sample size was deemed sufficient to judge comparability of D2cc between the two methods, although not large enough to statistically determine non-inferiority as initially powered.
- Data Provenance: The study was conducted at a single site, the University of Virginia. The data is prospective, collected during a randomized clinical trial comparing the BrachyGel device to standard vaginal packing (gauze) in patients receiving HDR brachytherapy for cervical cancer. The country of origin is USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For this physical device, "ground truth" primarily refers to the actual dosimetric measurements and clinical observations.
- Dosimetric Measurements: These were derived from CT scans obtained after applicator placement and vaginal packing for brachytherapy planning. The "experts" involved are the radiation oncologists and physicists who designed and administered the brachytherapy, calculated the doses (D2cc, D90), and evaluated the imaging and packing completeness. While the exact number of individuals involved in the dosimetric calculations and image interpretations isn't specified, the text states that "a total of 5 physicians at the University of Virginia performed BVHPS insertion and removal." The study also involved evaluation by "physicians" and "physicists" (plural). Their qualifications are implied by their roles in a university medical center and their ability to conduct a clinical trial for FDA submission.
- Clinical Observations/Surveys: Five physicians performed insertions/removals and completed surveys. The "physicists" involved also provided evaluations through surveys. The "experts" here are those physicians and physicists directly involved in the patient care and study assessments. No external or blinded panel of experts was described for establishing a "ground truth" beyond the routine clinical workflow and study assessments.
4. Adjudication Method for the Test Set
No explicit adjudication method (e.g., 2+1, 3+1) for resolving disagreements in "ground truth" or primary endpoint measurements is described. The dosimetric values (D2cc) are quantitative measurements derived from treatment plans. Physician and physicist evaluations (e.g., completeness, imaging clarity) were collected via surveys, and while collective results are presented, an adjudication process for individual discrepancies is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This question is not applicable. The study was a randomized non-inferiority clinical study evaluating a physical medical device (BrachyGel) against a standard of care (gauze packing). It did not involve AI assistance, human readers interpreting images with or without AI, or an MRMC study design for an AI algorithm. Therefore, there is no effect size related to AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical hydrogel packing system, not an AI algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the primary endpoint (dosimetric results, D2cc for bladder and rectum) was based on quantitative dosimetric calculations from CT imaging, which are standard in brachytherapy planning. These are essentially "outcomes data" in terms of radiation delivery to organs at risk.
For secondary and exploratory endpoints:
- Adverse Events: Clinical documentation based on clinical observation and patient self-report, graded by CTC AE v5 criteria.
- Patient Discomfort: Patient-reported outcomes via surveys.
- Physician/Physicist Evaluations: Clinician-reported outcomes via surveys, based on their physical examination and interpretation of CT images.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning. The clinical trial serves as the primary dataset for regulatory evaluation.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for an AI algorithm provided in the context of this physical device.
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