The BioProtect Balloon Implant 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 the BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum.

The BioProtect Balloon Implant System is composed of a balloon made of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

The BioProtect Balloon Implant™ System is composed of a single use, biodegradable, inflatable balloon implant, designed to act as a spacer between the prostate and the rectum. The BioProtect Balloon Implant System is supplied sterile. The balloon is implanted transperineally using transrectal ultrasound (TRUS) guidance and remains stable throughout the radiation treatment and gradually degrades over time.

The BioProtect Balloon Implant System consists of single use components detailed below:

1. Balloon biodegradable, inflatable balloon acts as a spacer between the prostate and rectal wall.
2. Balloon Deployer delivery system, the balloon is mounted and folded on the deployer
3. Delivery Kit - an applicator system used to position and deploy the balloon in the intended location. It includes an 18-gauge echogenic needle, blunt-tipped tissue dilator, and balloon introducer sheath.

The BioProtect Balloon Implant System is for prescription use only.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Device Name: BioProtect Balloon Implant™ System

Indications for Use: The BioProtect Balloon Implant 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 the BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum. The BioProtect Balloon Implant System is composed of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

1. Table of Acceptance Criteria and Reported Device Performance

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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:

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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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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."

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.

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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.

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.

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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 space it is 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.

SpaceOAR System is a polyethylene glycol (PEG) hydrogel that upon injection creates a space 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 SpaceOAR System consists of components for the preparation of a synthetic, absorbable hydrogel spacer and a delivery mechanism provided in a sterile, single use package. Once assembled as shown in the figure above, the Y-connector allows for hydrogel injection via an 18 gauge needle. The spacer is formed by mixing two solutions, the Precursor and the Accelerator. The Precursor solution is formed through the mixing of the Diluent solution (Trilysine buffer solution) with the PEG powder. The Accelerator solution is a salt buffer solution.

This document describes the regulatory decision for the SpaceOAR System, an absorbable perirectal spacer. It outlines the acceptance criteria (defined as "Special Controls" by the FDA) and summarizes the study used to demonstrate the device meets these criteria.

Acceptance Criteria and Reported Device Performance

The FDA's special controls serve as the acceptance criteria for the absorbable perirectal spacer. The device's performance, as reported in the clinical study, is summarized below:

• The specific number and qualifications of experts for the CEC or Core Lab are not detailed in the provided text.

4. Adjudication method for the test set:

• Adverse events were reviewed by an independent Clinical Events Committee (CEC). This suggests an adjudication process, but the specific rules (e.g., majority vote, single expert decision, etc.) for the CEC are not described.
• Rectal V70 reduction measurements were assessed by an independent Core Lab, implying expert review and calculation, but the details of their adjudication (if any across multiple readers) are 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, this was not an MRMC comparative effectiveness study involving human readers and AI assistance.
• This study was a head-to-head comparison of a physical medical device (SpaceOAR System) versus a control group (no spacer) in the context of prostate cancer radiation therapy, focusing on the device's ability to reduce rectal radiation dose and associated adverse events. It does not involve AI or human interpretation performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No, this is not applicable. The SpaceOAR System is a physical medical device (a hydrogel spacer), not an algorithm or AI system. Therefore, standalone algorithm performance was not relevant or assessed.

7. The type of ground truth used:

• Clinical Outcomes/Measurements:
  • Primary Effectiveness Endpoint: Percentage of subjects achieving a >25% reduction in rV70 (rectal volume receiving at least 70Gy). This was measured via "independent Core Lab measurements" and "investigator measurements," which rely on medical imaging (likely CT scans used for treatment planning) and calculation of radiation dose distribution.
  • Primary Safety Endpoint: Proportion of subjects with Grade 1 or greater rectal adverse events or procedure adverse events through 6 months. This was based on clinical assessment of adverse events reviewed by an independent Clinical Events Committee.
  • Secondary Endpoints included incidence of CTCAE Grade 1 or greater or Grade 2 or greater rectal or procedural events, changes in EPIC Urinary and Sexual domains, and medication changes.
• Non-clinical Ground Truth: Bench testing used predefined performance specifications (e.g., gel time, pot life, swelling, in vitro disappearance). Animal studies used observations of hydrogel behavior, tissue response, and absorption.

8. The sample size for the training set:

• Not applicable in the conventional sense for an AI/algorithm. The clinical study described is the primary clinical evidence for the device's effectiveness and safety, not a training set for an algorithm.
• However, the document does mention "long term follow up from the European and US clinical trials and post market AE data on over 2600 SpaceOAR System since CE Mark approval in 2010 and Australian TGA approval in 2011" as additional supporting evidence for safety, particularly regarding long-term toxicity which could be considered a form of real-world "training" or validation data if one were to stretch the analogy. This data was not described as a formal training set for an algorithm.

9. How the ground truth for the training set was established:

• Not applicable, as there was no AI/algorithm training set. The clinical study formed the basis for establishing the device's performance against its intended use and safety profile through rigorous scientific methodology (randomized controlled trial with pre-defined endpoints and independent review).

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