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510(k) Data Aggregation
(182 days)
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:
| Acceptance Criteria (Special Controls) | Reported Device Performance and Evidence |
|---|---|
| 1. Non-clinical and Clinical Performance Testing | Based on independent Core Lab measurements, 97.3% [95% CI: 93.2, 99.3] of SpaceOAR treated subjects achieved a >25% reduction in rV70. Clinical results showed that the primary effectiveness hypothesis was met (percent of SpaceOAR subjects with 25% reduction in dose in the rectal V70 region was > 70% with statistical significance, p<0.0001). The study results support that SpaceOAR increased the space between the prostate and rectum and resulted in less radiation in the rectal area. There were no device-related serious adverse events. |
| (i) Performance bench testing must demonstrate appropriate perirectal space creation and maintenance for the duration of prostate radiotherapy. | Bench tests (gel time, pot life, swelling, in vitro disappearance) were conducted on final, finished, sterilized devices, often exposed to worst-case irradiation, to assess functional performance. Animal studies demonstrated simple injection and hydrogel space maintenance through 13 weeks (sufficient for radiotherapy). |
| (ii) Performance bench testing must demonstrate that therapeutic radiation levels do not alter the performance of the device. | Bench tests were performed on final manufactured product, often exposed to worst-case irradiation prior to testing. Animal studies demonstrated no effect on local tissue response due to irradiation. |
| (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. | Animal studies successfully demonstrated SpaceOAR System product specifications, specifically gel time, pot life, and swelling. They also showed that the hydrogel completely absorbs in vivo. The clinical study demonstrated deployment via injection and subsequent reduction in rectal radiation dose. The hydrogel maintains space for approximately 3 months and is completely absorbed via hydrolysis (renal filtration) in approximately 6 months. |
| (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. | The clinical study indicated that the device remained in place, leading to a sustained reduction in rectal radiation. The hydrogel is designed to maintain space for approximately 3 months (the duration of radiotherapy) and then completely absorb within 6 months. Long-term follow-up from European and US clinical trials and post-market AE data on over 2600 SpaceOAR systems did not record any AE's or complications related to persistent hydrogel or long-term safety issues. There were no CTCAE Grade 3 or Grade 4 procedural or rectal events. |
| (v) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the spacer. | Sterilization is performed via (b)(4) contract sterilization facility to a Sterility Assurance Level (SAL) of 1x10. Sterility was validated in accordance with ISO 11137-2. The clinical study reported no incidences of infections associated with the device. |
| (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. | Functionality testing was performed on SpaceOAR System devices following irradiation and storage under specified conditions. This testing supports a 24-month shelf life. |
| (vii) The device must be demonstrated to be biocompatible. | Biocompatibility testing was performed on both the hydrogel and non-patient contacting components consistent with ISO 10993-1. Results demonstrated the product is non-cytotoxic, non-irritating, non-sensitizing, non-mutagenic, and elicits no acute or sub-acute systemic toxicity. Animal studies confirmed local and systemic compatibility with no signs of toxicity. |
| 2. Risk Management Activities (end-user initial training program for proper spacer deployment technique) | The labeling includes detailed instructions for system preparation, assembly, positioning, and injection, along with guidance on ultrasound imaging and preventing rectal wall penetration. Note: The document explicitly states the requirement for an end-user training program in the Special Controls, but does not detail the implementation or evaluation of such a program in the provided study summary. |
| 3. Device Labeling Requirements (summary of complications, warnings, detailed instructions, expiration date) | The labeling is consistent with clinical data and covers hazards, warnings, contraindications, and other relevant information. It includes detailed instructions, warnings on transrectal administration, precautions for implantation, observed injection failures, potential complications, and mitigation strategies. An expiration date supported by performance data is included. Note: The document confirms the content of the labeling meets the requirements, rather than describing a study to prove adherence to these labeling controls. |
Study Information
The acceptance criteria are addressed by the results of a prospective, randomized, parallel-arm, multicenter clinical study and various non-clinical (bench and animal) studies.
1. A table of acceptance criteria and the reported device performance:
See table above.
2. Sample size used for the test set and the data provenance:
- Clinical Study (Test Set):
- Total Randomized: 222 subjects
- Treatment Group (SpaceOAR): 149 subjects
- Control Group (No Spacer): 73 subjects
- Data Provenance: The study was conducted at 20 investigational sites in the United States. It was a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The clinical study mentions that "All adverse events were reviewed by an independent Clinical Events Committee (CEC)."
- It also states: "Based on independent Core Lab measurements, 97.3% [95% CI: 93.2, 99.3] of SpaceOAR treated subjects achieved a >25% reduction in rV70."
- 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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(202 days)
TraceIT™ Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures. TracelT hydrogel is intended to mark tissue for at least 3 months after injection.
TracelT Tissue Marker is a sterile, single use, polymerized polyethylene glycol (PEG) hydrogel that is delivered to mark a surgical location via a needle or cannula. The hydrogel material is visible under MRI, CT, and ultrasound for up to three months after the injection: The material hydrolyzes and is cleared from the body approximately six (6) months after injection.
The provided text is a 510(k) summary for the TraceIT™ Tissue Marker and supporting FDA correspondence. This documentation pertains to a medical device's regulatory clearance based on substantial equivalence to predicate devices, rather than a study demonstrating performance against specific acceptance criteria for an AI/ML diagnostic or prognostic device.
Therefore, the input does not contain the information requested to answer the questions about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details for an AI/ML device.
The document focuses on:
- Device Description: A sterile, single-use, polymerized polyethylene glycol (PEG) hydrogel delivered via needle or cannula to radiographically mark soft tissue.
- Indication for Use: To radiographically mark soft tissue during a surgical procedure or for future surgical procedures. Intended to mark tissue for at least 3 months after injection.
- Visibility: Visible under MRI, CT, and ultrasound for up to three months.
- Predicate Devices: BiomarC Tissue Marker (K001807) and Coaptite Tissue Marker (K012955).
- Performance Data: States "In vitro and in vivo preclinical tests were performed to verify and validate the safety and effectiveness of TraceIT Tissue Marker and assure substantial equivalence to the predicate devices." However, no specific performance metrics or acceptance criteria are detailed.
- Basis for Substantial Equivalence: Based on similar intended use, principle of operation, and technological characteristics to predicate devices.
Conclusion: The provided text does not include the detailed information required for the requested table and study breakdown concerning acceptance criteria and performance data for an AI/ML enabled device. This document is a regulatory submission demonstrating substantial equivalence, not a performance study of a diagnostic AI algorithm.
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