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CELOX Vascular is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French

CELOX Vascular is a kit that consists of a hemostatic pad and an optional adhesive bandage. The adhesive bandage is a 3M Tegaderm 4" x 4-3/4" bandage (reference K973036), or equivalent self adhesive security bandage. The hemostatic pad is a CELOX Hemostatic Granules on Sheet cleared in K080079 on July 9, 2008.

The provided document describes the CELOX Vascular device and its substantial equivalence determination. Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative manner (e.g., minimum sensitivity, specificity, or specific hemostasis rates to be achieved in a clinical trial). Instead, it describes demonstrating hemostasis and performance as effectively as a predicate device.

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

• Sample Size for Test Set: 11 vascular access procedures.
• Data Provenance: Pre-clinical porcine model testing. (The country of origin for the testing is not specified, but the company is based in the UK.)
• Retrospective/Prospective: The nature of "pre-clinical porcine model testing" typically implies a prospective design for the animal study itself.

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

This information is not provided in the document. The document refers to the results of a "pre-clinical porcine model testing" and the observation of "demonstrated hemostasis" and "successfully controlling all bleeding." The methods for assessing hemostasis and whether experts were involved in defining "ground truth" for the success of these procedures are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study described is a pre-clinical animal (porcine) model assessing the device's ability to achieve hemostasis, not a study involving human readers or AI assistance.

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

This question is not applicable as the CELOX Vascular is a physical medical device (hemostatic pad and adhesive bandage), not an AI algorithm or software. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

The ground truth for the device's performance (i.e., hemostasis) was established through direct observation and measurement of bleeding control in a pre-clinical porcine model. This can be considered outcomes data in an animal model context – the direct outcome being the cessation of bleeding.

8. The Sample Size for the Training Set

This question is not applicable. The CELOX Vascular is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

This question is not applicable as there is no training set for a physical device.

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The S8 ADVANCE self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients.

The S8 ADVANCE system has two treatment modes: auto-titrating APAP and fixed-pressure CPAP. The S8 ADVANCE system is intended for home and hospital use.

The S8 ADVANCE System is similar to the predicate devices, (S8 Escape II and S8 Pioneer) with a micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA. The system comprises the flow generator, patient tubing, mask (patient interface) and humidifier.

The performance and functional characteristics of the S8 ADVANCE system includes all the clinician and user friendly features of the S8 Escape II (K080079) with the addition of the auto-titrating mode equivalent to the S8 Pioneer (K041209).

This document is a 510(k) Premarket Notification for the S8 ADVANCE system, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a dedicated study report comparing its performance against predefined criteria in the same way a novel device might.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test/training sets, expert adjudication methods, and MRMC studies are not typically found in a 510(k) submission of this nature. This submission asserts that the new device performs similarly to existing, already cleared devices.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state a table of "acceptance criteria" with corresponding "reported device performance" in the way one might expect for a de novo device or a clinical trial report. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices. The "performance" is considered equivalent to the predicate devices.

The document states:

• "Design and Verification activities were performed on the S8 ADVANCE System as a result of the risk... and confirmed the product met the predetermined acceptance criteria." (Section 1)
• The device generates "Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an 'air splint' for effective treatment of OSA." (Section 0)
• "The performance and functional characteristics of the S8 ADVANCE system includes all the clinician and user friendly features of the S8 Escape II (K080079) with the addition of the auto-titrating mode equivalent to the S8 Pioneer (K041209)." (Section 0)

Thus, the acceptance criteria are implicitly that the S8 ADVANCE must perform comparably to the S8 Escape II (for CPAP features) and the S8 Pioneer (for auto-titrating APAP features) within the specified pressure range and for its intended use. No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a novel function are provided, as the core functionality is claimed to be similar to legally marketed devices.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices through engineering design, verification, and comparison of technical specifications, rather than a clinical study with a "test set" of patient data.

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

Not applicable/Not provided. As there is no specific "test set" of patient data described with a ground truth established by experts, this information is not relevant to this type of submission.

4. Adjudication method for the test set

Not applicable/Not provided. Same reasoning as 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

Not applicable/Not provided. This is a device for treating sleep apnea, not an imaging diagnostic device that would involve "human readers" or "AI assistance" in the sense of image interpretation. Therefore, an MRMC study is not relevant to this submission.

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

Not applicable/Not provided in this context. The S8 ADVANCE is a therapeutic device that delivers pressure based on internal algorithms for CPAP and APAP modes. Its performance is evaluated on its ability to deliver pressure and respond to physiological signals in a manner similar to predicate devices, not as a standalone diagnostic algorithm for human interpretation. The "algorithm only" performance refers to the device's internal control logic, which is part of the "Design and Verification activities" mentioned but not detailed in this summary.

7. The type of ground truth used

Not applicable in the context of diagnostic performance. For a therapeutic device like this, "ground truth" would relate to the accuracy of its pressure delivery, response to patient needs (e.g., auto-titration), and safety, as compared to established engineering and medical standards, and the performance of predicate devices. This is achieved through engineering verification and validation against known standards and predicate device performance, not typically against a "ground truth" derived from patient outcomes or pathology in a clinical study for a 510(k).

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device that would require a "training set" of data in the typical sense. Its functionality is based on established control systems and algorithms.

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

Not applicable/Not provided. Same reasoning as above.

Summary of Study (Based on 510(k) Submission):

The "study" in this context refers to the design and verification activities undertaken to demonstrate substantial equivalence of the S8 ADVANCE system to the predicate devices, S8 Escape II (K080079) and S8 Pioneer (K041209).

• Objective: To demonstrate that the S8 ADVANCE is substantially equivalent to the predicate devices for the treatment of Obstructive Sleep Apnea (OSA) in adult patients, suitable for home and hospital use.
• Methodology: The submission states that "Design and Verification activities were performed on the S8 ADVANCE System... and confirmed the product met the predetermined acceptance criteria." These activities likely included:
  • Comparison of Intended Use: Shown to be similar.
  • Comparison of Operating Principle: Shown to be similar (micro-processor controlled blower system generating CPAP).
  • Comparison of Technologies: Claimed to be similar.
  • Comparison of Manufacturing Process: Claimed to be the same.
  • Performance and Functional Characteristics Analysis: The S8 ADVANCE "includes all the clinician and user friendly features of the S8 Escape II... with the addition of the auto-titrating mode equivalent to the S8 Pioneer." This implies testing against the specifications and performance characteristics of the predicate devices.
  • Compliance with Guidance Documents: The device complies with FDA Draft Reviewer Guidance for Ventilators (July 1995), FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005), and FDA Off-the-Shelf Software Use in Medical Devices (September 9, 1999).
• Data Provenance: The nature of the "Design and Verification activities" suggests internal engineering and testing data without specific mention of external clinical data or patient cohorts.
• Conclusion: ResMed determined, and the FDA concurred, that the S8 ADVANCE System is substantially equivalent to the S8 Escape II and S8 Pioneer. This means the device met the "acceptance criteria" of being comparable in safety and effectiveness to the predicate devices already on the market.

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