(266 days)
SpaceOAR Vue Hydrogel 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 SpaceOAR Vue Hydrogel to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Vue Hydrogel is composed of biodegradable material and maintain space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
The SpaceOAR Vue Hydrogel consists of components for the preparation of a synthetic, absorbable hydrogel spacer and a delivery mechanism provided in a sterile, single use package. The SpaceOAR Vue Hydrogel is a synthetic, absorbable polyethylene glycol (PEG)-based hydrogel that upon injection creates a space that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the perirectal spacer to reduce the radiation dose delivered to the anterior rectum. SpaceOAR Vue Hydrogel is completely synthetic with no animal or human derived components. It is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment (approximately 3 months) and is completely absorbed by the patient's body over time (about 6 months).
The SpaceOAR Vue Hydrogel consists of two syringes containing the PEG Precursor solution and the Accelerator solution (a buffered salt solution). The Precursor solution is formed by the user through the reconstitution of PEG powder with a Diluent (Trilysine buffer) solution (that is provided in a third syringe). The Accelerator solution is provided ready for use. The Syringes filled with the Precursor solution and the Accelerator solution are assembled with other applicator components, including a Y-connector for mixing the Precursor and Accelerator, and a needle to facilitate delivery of the hydrogel by injection to the tissue located between the anterior rectal wall and the prostate.
The provided document does not contain acceptance criteria for device performance or a study that specifically proves the device meets such criteria in terms of clinical outcomes or reader performance.
The document is a 510(k) summary for the SpaceOAR Vue Hydrogel. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (SpaceOAR® Hydrogel System) rather than presenting a de novo clinical study with specific performance metrics for the new device.
Here's what can be extracted based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for clinical effectiveness is provided in the document. The performance data section lists types of testing performed, but not the specific acceptance criteria or results for each beyond stating that "The subject device has met the same device specifications as the predicate device."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterilization Validation | Met requirements |
| Modulus Testing | Met requirements |
| Gel Volume (Swell) Testing | Met requirements |
| Gel Time Testing | Met requirements |
| Pot Life Testing | Met requirements |
| Usability Testing | Met requirements |
| Biocompatibility Testing | Met requirements |
| Preclinical Testing | Met requirements |
| Overall Device Specification | Met the same finished device specifications as the predicate device |
2. Sample size used for the test set and the data provenance
The document does not detail a "test set" in the context of clinical performance or image interpretation. The testing mentioned in Section VII ("PERFORMANCE DATA") appears to be primarily related to engineering, material science, and safety testing of the device itself (e.g., sterilization, gel properties, usability, biocompatibility, preclinical testing). Therefore, information on sample size for a test set (e.g., patient cases) or data provenance (country of origin, retrospective/prospective) is not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as the submission focuses on substantial equivalence based on technical characteristics and predicate device performance, not a new clinical study assessing image interpretation or a specific disease outcome requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication by experts is described.
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 MRMC study is mentioned. This device is a hydrogel spacer, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This question is not applicable. The device is a physical hydrogel spacer used in conjunction with radiotherapy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe a clinical study that would require "ground truth" in the sense of comparing device output to a definitive diagnosis. The device's primary function is to physically create space and reduce radiation dose, which would be evaluated through physical properties and radiation dosimetry, not diagnostic accuracy.
8. The sample size for the training set
The document does not describe a training set. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning algorithm.
§ 892.5725 Absorbable perirectal spacer.
(a)
Identification. An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum. The absorbable spacer maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing. For all clinical investigations used to support premarket notification submissions for this type of device, line listings of the study data must be provided.
(i) Performance bench testing must demonstrate appropriate perirectal space creation and maintenance for the duration of prostate radiotherapy.
(ii) Performance bench testing must demonstrate that therapeutic radiation levels do not alter the performance of the device.
(iii) Performance in vivo testing must demonstrate appropriate deployment of spacer as indicated in the accompanying labeling, and demonstrate appropriate expansion and absorption characteristics in a clinically relevant environment.
(iv) Clinical study must demonstrate appropriate spacer stability and lack of migration for the entire course of radiotherapy, complete absorption, and lack of long term toxicity.
(v) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the spacer.
(vi) Shelf-life testing must demonstrate the stability of the physical characteristics of the spacer throughout the shelf-life as indicated in the accompanying labeling.
(vii) The device must be demonstrated to be biocompatible.
(2) The risk management activities performed as part of the manufacturer's § 820.30 design controls must document an appropriate end user initial training program which will be offered as part of efforts to mitigate the risk of failure to correctly operate the device, including, but not limited to, documentation of an appropriate end user initial training program on the proper spacer deployment technique.
(3) The device labeling must include the following:
(i) A detailed summary of reported or observed complications related to the use of the device;
(ii) Appropriate warnings;
(iii) Detailed instructions for system preparations and detailed implant procedure instructions; and
(iv) An expiration date that is supported by performance data as specified in paragraph (b)(1)(vi) of this section.