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SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.

The SpaceOAR 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)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 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 (approximately 6 months).

This submission describes a modification to an already cleared device (SpaceOAR Hydrogel System), not a new device requiring a full de novo clearance or a new 510(k) for a substantially different device. Therefore, the "acceptance criteria" and "study" described are focused on demonstrating that the modified device performs equivalently to the predicate device and does not introduce new safety or effectiveness concerns, rather than establishing efficacy of the device from scratch.

Here's a breakdown of the requested information based on the provided text, recognizing the context of a device modification:

Description of Acceptance Criteria and the Study Proving Device Meets Acceptance Criteria

The acceptance criteria for the modified SpaceOAR System are implicitly defined as demonstrating that the changes do not negatively impact the device's functional and performance specifications compared to the predicate device and that it remains biologically safe.

The study described is a series of design verification tests and assessments conducted to confirm that the modified device continues to function as intended and is substantially equivalent to the previously cleared SpaceOAR System (K181465).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the specific sample sizes for each of the repeated design verification tests (e.g., number of units tested for tensile strength, shelf life, etc.). It only mentions that the tests were "repeated."

Data Provenance: The testing appears to be internal design verification and validation testing conducted by Boston Scientific Corporation. The provenance is internal company data, not clinical data from external sources.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device modification submission relies on engineering design verification and validation testing to demonstrate equivalence, not on expert-adjudicated clinical ground truth for a test set. Clinical data and expert ground truth were not used for this specific submission given the "limited changes to device components, packaging and labeling."

4. Adjudication Method for the Test Set

Not applicable. As noted in point 3, this was not a clinical study requiring expert adjudication of a test set. The assessment relied on a risk analysis to determine the necessary verification tests.

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

Not applicable. The SpaceOAR System is a medical device (hydrogel spacer), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

Not applicable. The SpaceOAR System is a physical medical device, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For this specific submission (device modification), the "ground truth" is essentially the established performance specifications and safety profile of the predicate device (K181465). The "study" aims to verify that the modified device continues to meet these same engineering specifications and does not introduce new safety concerns.

8. The Sample Size for the Training Set

Not applicable. This submission concerns a physical medical device and its manufacturing/component changes, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted in point 8, there is no training set for a machine learning model in this submission.

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