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510(k) Data Aggregation
(83 days)
Barrigel is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space, it is the intent of Barrigel to reduce the radiation dose delivered to the anterior rectum. Barrigel is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient's body over time.
Barrigel Injectable Gel is a sterile, transparent, biodegradable gel of stabilized hyaluronic acid (HA) at a concentration of 20 mg/mL in phosphate buffered saline. The HA, formulated utilizing Q-Med's patented NASHA™ technology, is produced from non-animal hyaluronic acid by fermentation of Streptococcus species of bacteria. The HA gel is cross-linked with 1,4-butanediol diglycidyl ether (BDDE) under alkaline conditions, thereby creating ether bonds between the HA chains, resulting in a three-dimensional network. The gel is insoluble in water and organic solvents. Barrigel is supplied in a single-use glass syringe, containing 3 mL of product. Each syringe is terminally sterilized by moist heat in a heat-sealed pouch of PET/Tyvek® and packaged in a cardboard carton. Barrigel is intended for use by health-care professionals only and should be stored up to 25° C (77° F). Barrigel is manufactured for Palette Life Sciences by O-Med AB, a subsidiary of Galderma AB. The Barrigel needle is a sterile 18G stainless-steel needle, 20 cm in length, provided with an optional stylet and protected by a polyester sheath which is removed prior to use. The needle is sterilized by radiation and two (2) needles are provided in each heat-sealed pouch of PET/Tyvek®, packaged in a cardboard carton. The Barrigel needle is identical to the needle used during the Barrigel IDE study and is manufactured for Palette Life Sciences by R.K. Manufacturing.
The provided text describes the acceptance criteria and study results for Barrigel Injectable Gel, an absorbable perirectal spacer.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: Achievement of a 25% reduction in the volume of the rectum receiving 90% of the prescription radiation dose. Minimally acceptable success rate established by the predicate device was 70%. | 98.6% of complete cases in the Barrigel group achieved at least a 25% reduction in the volume of the rectum receiving 90% of the prescription dose. The lower boundary of the 95% confidence interval (LCL) is 0.923, and the one-sided p-value is < 0.0001, demonstrating study success. |
| Key Secondary Safety Objective: The Barrigel spacer does not increase the evidence of acute Grade 2+ GI toxicity within the first 3 months following treatment (non-inferiority to control group). Non-inferiority margin of 10%. | The proportion of subjects with one or more acute Grade 2 or higher toxicities was 0.028 in the Barrigel group and 0.147 in the control group. The upper limit of the one-sided 95% CI (UCL) for the difference in proportions (Barrigel minus control) was -0.1189. As UCL < 0.10, Barrigel is non-inferior. Additionally, the two-sided Fisher's Exact p-value was < 0.05, indicating Barrigel was superior to control for this endpoint. Study success demonstrated. |
| Biocompatibility: Meet acceptance criteria for various endpoints (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Subacute/Sub-chronic Toxicity, Genotoxicity, Implantation, Chronic Toxicity, Carcinogenicity). | Barrigel met the acceptance criteria of all listed biocompatibility endpoint tests. |
| Performance Testing (Bench): Meet acceptance criteria for physio/chemical characteristics (HA Content, Gel Content, Extractable Carbohydrates, Swelling Factor, pH, Particle Size Distribution, Bacterial endotoxins, Sterility, Viscoelastic Properties, Osmolality, Elemental Impurities, Residual Proteins, Enzymatic Degradation, Extrusion Force). | All acceptance criteria were met, with minimal variation between production lots. |
| Performance Testing (Animal): Minimal to no reaction to irradiated Barrigel compared to non-irradiated control, and complete absorption (≥ 90%) with subsided tissue reactivity. | Test results demonstrated minimal to no reaction to irradiated Barrigel compared to the non-irradiated control. Barrigel Injectable Gel was considered completely absorbed per ISO 10993-6 criteria. |
| Long-term Resorption: Complete resorption of the gel. | From IDE G190206: Limited follow-up: 73.6% mean resorption at 18 months in 20 patients. Lack of complete resorption data for all subjects. From Goñi data (Restylane SubQ): Complete resorption at 60 months post-injection in 27 male subjects. From RPAH1 data (Restylane SubQ): Complete gel resorption for 18.5% of patients at 1-year, and 42.3% after 2 years in 36 male subjects. |
| Adverse Events: No unexpected adverse device effects (UADEs) or Barrigel-related adverse events. | There were no reports of unexpected adverse device effects (UADEs) or Barrigel-related adverse events in the IDE G190206 study. |
2. Sample Size Used for the Test Set and the Data Provenance:
- IDE G190206 (Main Clinical Study):
- The document mentions "98.6% of the complete cases in the Barrigel group" for the primary effectiveness endpoint, suggesting a test set derived from the subjects randomized to the Barrigel group. The exact number of patients in the Barrigel group that formed the "complete cases" for this analysis is not explicitly stated as a single number but would be a subset of the total enrolled subjects for IDE G190206.
- For the key secondary safety objective, the proportion of subjects with Grade 2+ GI toxicities was 0.028 in the Barrigel group and 0.147 in the control group. The total number of subjects in each of these groups is not explicitly provided in this section but implies a comparison between the Barrigel and control groups.
- Provenance: Prospective, multicenter study conducted over 14 study sites. Country of origin not specified, but typically US for an FDA IDE study.
- Goñi data: 27 male subjects. Retrospective clinical study.
- RPAH1 clinical study: 36 male subjects. Prospective clinical study.
- Resorption Data from IDE G190206 (Table 1):
- Immediate Post-Injection: 98 patients
- 3-Month Visit: 96 patients
- 12-Month Visit: 55 patients
- 18-Month Visit: 20 patients
- This data represents a portion of the IDE study subjects followed for resorption.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not explicitly state the number of experts or their qualifications for establishing ground truth for the clinical study (IDE G190206). Outcomes like "25% reduction in the volume of the rectum receiving 90% of the prescription radiation dose" and "acute Grade 2+ GI toxicity" would be assessed by medical professionals during the study, but the specific process for establishing "ground truth" (e.g., blinded review by a panel of experts) is not detailed. The assessment of toxicity (Grade 2+ GI toxicity) would typically follow standardized grading scales (e.g., CTCAE) applied by treating physicians or study investigators.
4. Adjudication Method for the Test Set:
The document does not explicitly describe an adjudication method (like 2+1, 3+1, or none) for the test set's ground truth, especially for the efficacy and safety endpoints. The assessments were part of a "randomized, controlled, single-blinded multicenter study," which suggests that patients and possibly some study personnel were blinded, but the specific process for confirming the endpoints (e.g., independent review of imaging or toxicity by multiple blinded experts) is not provided.
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:
No. The study described is a clinical trial comparing Barrigel Injectable Gel (a physical spacer) to a control group without the spacer. It does not involve human readers using or not using AI, nor does it measure an "effect size of how much human readers improve with AI vs without AI assistance."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. Barrigel Injectable Gel is a medical device (an injectable gel), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the effectiveness endpoint (rectal volume reduction) was based on:
- Pre-injection and immediate post-treatment CT and MRI scans.
- This is based on imaging data and objective measurements.
The ground truth for the safety endpoint (GI toxicity) was based on:
- Clinically assessed acute Grade 2+ GI toxicity within the first 3 months following treatment.
- This represents clinical outcomes data, likely assessed by investigators based on defined criteria (e.g., CTCAE grading).
For resorption, it was based on:
- Clinical data from patient visits for the IDE study (volume changes).
- Follow-up MRIs for the Goñi data.
- Follow-up digital rectal examinations for the RPAH1 data.
8. The Sample Size for the Training Set:
The document does not describe a "training set" in the context of an AI/algorithm. Barrigel is a physical medical device. The "training set" concept is typically relevant for machine learning models. The clinical study (IDE G190206) involved a patient population for evaluating the device's performance.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no "training set" in the context of an AI/algorithm given this product description. The ground truth for the clinical evaluation data was established as described in point 7.
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