(21 days)
SpaceOAR Hydrogel System 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 Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Hydrogel System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
The SpaceOAR® Hydrogel System 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® hydrogel is a synthetic, absorbable polyethylene glycol (PEG)-base 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® 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® Hydrogel System 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 Yconnector 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.
This document is an FDA 510(k) summary for the SpaceOAR Hydrogel System. It is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and study results for a new device's performance.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not present in this type of FDA submission. The submission relies on the established performance of the predicate device.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The subject SpaceOAR® Hydrogel System met all acceptance criteria for verification and validation." However, it does not list specific quantitative acceptance criteria or their corresponding performance results in a table format. It only lists categories of tests performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterilization Validation | Met all acceptance criteria |
| Modulus Testing | Met all acceptance criteria |
| Gel Volume (Swell) Testing | Met all acceptance criteria |
| Gel Time Testing | Met all acceptance criteria |
| Pot Life Testing | Met all acceptance criteria |
| Endotoxin Testing | Met all acceptance criteria |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a "test set" or provide data provenance in the context of clinical performance for the subject device. The submission relies on equivalence to a predicate device. The performance data listed (sterilization, modulus, etc.) are engineering/laboratory tests.
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 does not detail a clinical study with a "test set" requiring expert ground truth in the traditional sense of diagnostic AI or imaging device evaluation.
4. Adjudication method for the test set
This information is not provided for the reasons stated above.
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
An MRMC comparative effectiveness study was not mentioned or provided in this 510(k) summary. This type of study is typically for diagnostic imaging devices and AI systems, not for a physical implantable device like a hydrogel spacer.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to the SpaceOAR Hydrogel System, which is a physical medical device and not an algorithm.
7. The type of ground truth used
For the engineering/laboratory tests listed (Sterilization Validation, Modulus Testing, etc.), the "ground truth" would be established by pre-defined engineering specifications and validated test methods. The submission implies that the results of these tests (e.g., sterilization effectiveness, material properties like modulus, gel volume, gel time, pot life, endotoxin levels) adhered to these specifications.
8. The sample size for the training set
This information is not applicable/not provided as this is a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided as this is a physical device.
Summary of Device Performance (based on this 510(k) summary):
The 510(k) application for the SpaceOAR Hydrogel System (K181465) demonstrates substantial equivalence to its predicate device (cleared under DEN140030). The core argument is that the subject device has identical design, materials, and sterilization cycle to the predicate device.
To support this claim, the manufacturer performed several verification and validation tests:
- Sterilization Validation: Confirmed the device's sterility.
- Modulus Testing: Evaluated the material's stiffness/elasticity.
- Gel Volume (Swell) Testing: Assessed how much the hydrogel swells.
- Gel Time Testing: Measured the time it takes for the components to form a gel.
- Pot Life Testing: Determined how long the mixed components remain viable for use.
- Endotoxin Testing: Ensured the absence of harmful bacterial endotoxins.
The document explicitly states: "The subject device is identical to the predicate device in design, materials and sterilization cycle; therefore, biocompatibility testing, shelf life testing, and clinical data were not required to support a determination of substantial equivalence." This means that the clinical performance and safety of the device are inferred from the predicate device, and the current submission focuses on verifying the manufacturing and design equivalence of the new device to the existing one. The "acceptance criteria" here largely pertain to meeting the engineering specifications and demonstrating manufacturing consistency with the already-cleared device.
§ 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.