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The Pre-B. Seal Lung Biopsy Plug System is indicated for sealing pleural punctures to reduce the risk of pneumothoraces (air leaks) associated with percutaneous, transthoracic needle lung biopsies and to provide accuracy in marking a biopsy needle entry site for visualization during surgical resection.

The Pre-B. Seal Lung Biopsy Plug System is indicated for use in adult patients (age > 21 years).

The Pre-B. Seal Lung Biopsy System is a sterile single-use medical device comprised of the following components:

• Prefilled Hydrogel Syringe
• Delivery System 15cm length, 16cm length, 20cm length

The model numbers are:

• Pre-B. Seal Lung Biopsy Plug System 15cm (Model # FG0001)
• Pre-B. Seal Lung Biopsy Plug System 16cm (Model # FG0002)
• Pre-B. Seal Lung Biopsy Plug System 20cm (Model # FG0003)

The Delivery System is comprised of an introducer pre-assembled with a delivery needle, with depth markings on the external surface of the introducer. The delivery needle and introducer are both constructed of stainless steel. A pebax white depth marker ball sits on the introducer and may be used in addition to the markings as a depth indicator. The delivery system is ethylene oxide (EO) sterilized and is patient contacting (≤ 24 hours (includes transient contact).

The prefilled syringe contains a sealant (hydrogel) which acts as an absorbable lung biopsy plug. The hydrogel plug consists of gelatin, saline and hyaluronic acid. The plug is provided in ready to use configuration within a prefilled hydrogel syringe. The hydrogel is biodegradable.

The prefilled hydrogel is steam sterilized. The hydrogel is patient contact (> 30 days (i.e., permanent)) The syringe is indirect patient contacting.

These components have been designed for use during a CT-guided transthoracic lung biopsy procedure. The syringe is attached to the delivery system and then purged using a standard hypodermic purging technique outside of the patient. The distance from the skin to the pleura surface is measured using CT imaging, and using this information, the device is advanced to the intended deployment location within the lung under CT guidance. The hydrogel plug is deployed via the prefilled syringe below the surface of the lung through the delivery system. The hydrogel plug creates a seal around the delivery system through which a biopsy is conducted. When the biopsy is complete, the delivery system is withdrawn, and the hydrogel plug remains in place to fill the void and marks the biopsy needle entry site for visualization during surgical resection. The hydrogel plug is biodegradable and resorbs over approximately 49 days.

The provided FDA 510(k) clearance letter and summary describe the acceptance criteria and a GLP animal study that demonstrates the Pre-B Seal Lung Biopsy Plug System meets these criteria. Since the device is a physical medical device (lung biopsy plug) and not an AI/Software as a Medical Device (SaMD), several of the requested questions related to AI (e.g., number of experts for ground truth, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for the Selio Medical Limited Pre-B Seal Lung Biopsy Plug System are largely derived from the requirements specified in the Special Controls (21 CFR 878.4755) for absorbable lung biopsy plugs and demonstrated through comparative testing with the predicate device (Bio-Seal Lung Biopsy Tract Plug System, DEN090007).

Table 1: Acceptance Criteria and Reported Device Performance

Study Details for Device Performance

The core study proving the device meets the acceptance criteria is the GLP (Good Laboratory Practice) Animal Study, complemented by various non-clinical bench testing.

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Animal Study): A swine model was used. The exact number of animals or specific 'sample size' for the test set is not explicitly stated in numerical terms (e.g., "n=X animals") within this document. The document states a comparison was done between the proposed device and the predicate device in the swine model.
   • Data Provenance: The study was a prospective animal study, conducted in a GLP (Good Laboratory Practice) environment. The country of origin is not specified, but GLP implies a standardized, regulated conduct of non-clinical safety studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable (N/A): This refers to Human Factors/AI studies. For a physical device like a biopsy plug, the "ground truth" for performance (e.g., pneumothorax rate, migration, resorption) is established by direct observation, measurement, and pathological analysis in the animal model by trained veterinarians, pathologists, and study scientists in a GLP setting, not through expert consensus on images.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A: Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from human reader interpretations (e.g., in radiological studies). In an animal study, endpoints are typically objectively measured and evaluated by the study team, often including pathological assessment. Discrepancies would be resolved through standard GLP study procedures and internal review processes, not specifically these reader adjudication models.

4. 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, N/A: This is not an AI/SaMD study, but a physical medical device. Therefore, MRMC studies are not relevant for proving the performance of the Pre-B Seal Lung Biopsy Plug System. The comparison was the proposed physical device vs. the predicate physical device in an animal model.

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

   • No, N/A: This pertains to AI performance. The device is a physical product designed for human interaction and use during a medical procedure.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the GLP Animal Study, the ground truth for device performance and safety endpoints (e.g., device visibility, deployment accuracy, expansion/resorption characteristics, incidence of pneumothorax, hydrogel plug migration, degradation, embolization, biocompatibility: local and systemic effects, overall animal health) was established through:
     • Direct observation and measurement during the procedure.
     • Imaging (CT guidance for visibility, positioning, deployment).
     • Pathological assessment (for degradation/resorption, local effects, embolization, etc.) by qualified personnel (e.g., veterinary pathologists).
     • Outcomes data based on the animal's health and post-procedure observations.

7. The sample size for the training set:

   • N/A: This term applies to machine learning or AI models. This is a physical device developed through traditional engineering design and testing, not by training an AI model.

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

   • N/A: As above, this is for AI models. The design of the Pre-B Seal Lung Biopsy Plug System was based on engineering principles, material science, and testing against pre-defined specifications and regulatory requirements, not a training set.

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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:

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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