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The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.

The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable, batterypowered vacuum pump/waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for homecare and healthcare environments. The SOMAVAC® 100 may be used for most instances a surgeon determines a closed suction drain device is applicable. The SOMAVAC® 100 is compatible with drains commonly used after surgeries and is intended to be used by a single patient. The SOMAVAC® 100 is to be installed by trained medical personnel. Post-installation (in patient setting or at home), the SOMAVAC® 100 is intended to be operated by patients or their caregivers.

The provided text is related to the FDA 510(k) clearance for the SOMAVAC® 100 Sustained Vacuum System. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's clinical performance against specific acceptance criteria for a novel AI or diagnostic system.

Therefore, many of the requested categories in your prompt cannot be fully addressed from the provided text. The document describes changes to a previously cleared device (SOMAVAC® 100, K222856) specifically regarding an additional sterilization method (ethylene oxide) for its drain connector accessories. The performance testing section focuses on validating this new sterilization method and its impact on packaging.

Here's an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are not presented in a table format for a clinical outcome or diagnostic accuracy in this document. Instead, the "performance testing" focuses on validating the sterilization method and its effects on packaging integrity, referencing existing standards. The acceptance criteria essentially reflect compliance with these standards.

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

The document does not specify a "test set" in the context of patient data or algorithm performance. The testing mentioned relates to the physical and chemical properties associated with the new sterilization method and packaging. Therefore, no information on sample size for a "test set" for device performance (e.g., fluid removal efficiency in patients) or data provenance (country, retrospective/prospective) is available.

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

Not applicable. The document does not describe a test set requiring expert-established ground truth for clinical or diagnostic performance. The validation of sterilization and packaging integrity would typically involve laboratory testing by qualified personnel, but not "experts" in the sense of clinicians establishing ground truth from patient data.

4. Adjudication method for the test set

Not applicable. There is no mention of an adjudication method as the testing concerns physical and chemical properties of the device components/packaging, not clinical or diagnostic outcomes requiring expert consensus.

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. This device is a powered suction pump, not an AI or diagnostic tool that would involve human readers or image interpretation.

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

Not applicable. This device is a physical medical device (suction pump), not an algorithm or AI system.

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

For the performance testing related to the new sterilization method, the "ground truth" is established by adherence to recognized international standards (ISO 11135, ISO 10993-7, ASTM F88/F88M, ASTM 1886). These standards define acceptable parameters for sterilization efficacy, residuals, and packaging integrity.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As above, there is no training set for this device.

Summary of Device Performance (from the document):

The SOMAVAC® 100 Sustained Vacuum System, in this submission (K231063), is essentially the same device as its predicate (K222856). The only change covered by this 510(k) is the addition of Ethylene Oxide (EO) as a sterilization method for the drain connector accessories, alongside the existing gamma radiation method.

The study presented here focuses on validating this new sterilization method and confirming that it does not negatively impact the device's safety or effectiveness. This was achieved by demonstrating compliance with ISO standards for EO sterilization and biological evaluation, and by conducting packaging evaluations (seal strength and integrity) post-sterilization, which all "Passed". The conclusion is that the device remains substantially equivalent to the predicate.

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The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.

The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery-powered vacuum pump/waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for homecare and healthcare environments. The SOMAVAC® 100 may be used for most instances a surgeon determines a closed suction drain device is applicable. The SOMAVAC® 100 is compatible with drains commonly used after surgeries and is intended to be used by a single patient. The SOMAVAC® 100 is to be installed by trained medical personnel. Post-installation (in patient setting or at home), the SOMAVAC® 100 is intended to be operated by patients or their caregivers.

This document details a 510(k) premarket notification for the SOMAVAC® 100 Sustained Vacuum System. It establishes substantial equivalence to a predicate device, K180606.

Here’s an breakdown of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of "acceptance criteria" against which a clinical performance study would be evaluated in terms of sensitivity, specificity, accuracy, or similar metrics. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SOMAVAC® Device, K180606) through non-clinical performance testing and direct comparison of specifications.

The "performance" described refers to the device's functional characteristics and compliance with standards, rather than diagnostic or treatment efficacy from a clinical study. The table below summarizes the key comparisons made to demonstrate substantial equivalence, which serves as the "acceptance criteria" for this type of regulatory submission in the absence of a new clinical claim.

Study Information

The document describes non-clinical testing rather than a traditional “study” with patient data.

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical performance verification and validation. The "test set" would refer to the physical devices and components tested. The provenance is not explicitly stated in terms of country of origin of "data," but it implicitly comes from the manufacturer's internal testing. The testing is prospective in the sense that the new device was built and then tested.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For non-clinical performance testing of a physical device like this, "ground truth" is established by engineering specifications, validated measurement equipment, and industry standards (e.g., electrical safety, EMC). Expert review would be part of the design and verification processes but not as a formal "ground truth" for a test set in the clinical sense.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This type of adjudication is typically used in clinical studies for interpretation of imaging or clinical outcomes, not for engineering performance testing.

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: Not applicable. This device is a powered suction pump, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or cases in an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hardware product. While it contains software, the performance listed is for the complete system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical testing is based on:

   • Engineering specifications: The defined parameters for vacuum, flow, electrical characteristics, and physical properties.
   • Regulatory standards: Compliance with voluntary standards for electrical safety (e.g., IEC 60601-1), electromagnetic compatibility (e.g., IEC 60601-1-2), and powered suction pumps (e.g., ISO 10079-1).
   • Previous device performance: The performance of the predicate device (K180606) served as a benchmark for equivalence.

7. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The software changes were validated in accordance with FDA guidances for software in medical devices, but this is distinct from training an AI model.

8. How the ground truth for the training set was established: Not applicable. (See answer to point 7).

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The SOMAVAC™ Device is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.

The single-patient use SOMAVAC™ Device is capable of generating sustained vacuum at the end two surgical drains to effectively remove bodily fluids after plastic or general surgeries. The SOMAVAC™ Device has a battery-powered SOMAVAC™ Pump assembly to generate vacuum with accessories, including disposable collection units, two drain connectors, and one belt. All products are non-sterile. Surgical drains are not included. The SOMAVAC™ device is compatible with non-collapsible, open channel (proximal), smooth bore drains with a distal inner diameter of 3mm - 4.5mm (commonly 15 – 19 Fr.). Up to two drains can be attached to the SOMAVAC™ Device. Each disposable waste collection units collects up to 100 mL of fluid. Versions of the device will be marketed with factory-set single, vacuum pressure levels ranging from 60 to 350mmHg. The device maintains suction throughout its use in a manner analogous to a thermostat by selectively running the pump motors to maintain the preset pressure. The device stops when the collection units are full or if the collection units are detached from the device. SOMAVAC™ Pump assembly has light and sound indicators to help users identify when the collection unit is full and ready to be exchanged, the battery is ready to be changed, or if there is a malfunction.

The SOMAVAC™ Device, a portable battery-powered vacuum source/waste container for surgical and bodily fluid removal, underwent non-clinical testing to demonstrate substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria with corresponding reported device performance values in a side-by-side format. However, it lists several non-clinical tests conducted, implying that the device met the specifications and standards targeted by these tests. Based on the "Summary of non-clinical tests conducted for determination of substantial equivalence" section (page 6), the following can be inferred:

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

The study relies primarily on non-clinical bench testing. Therefore, the concept of a "test set" in the context of patient data or samples from a typical clinical study is not applicable. The samples used would be:

• Physical units of the SOMAVAC™ Device and its components for performance, electrical safety, and endurance testing.
• Materials used in the device for biocompatibility testing.
• Software code for verification and validation.

Data Provenance: The tests are described as non-clinical tests. The country of origin for these tests is not specified, but the submission is to the U.S. FDA, implying adherence to U.S. regulatory standards and potentially U.S. or internationally accredited testing laboratories. All tests are inherently retrospective in the sense that they evaluate manufactured device units against established specifications.

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

This information is not applicable as the determination of substantial equivalence was based on non-clinical engineering and bench testing, not on clinical assessment requiring expert interpretation of patient data or images to establish a "ground truth."

4. Adjudication Method for the Test Set:

This information is not applicable as there was no clinical study involving human judgment or interpretation of data that would require an adjudication method. Test results are compared against predetermined engineering specifications and industry standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the SOMAVAC™ Device to its predicate device(s)." This type of study would involve human readers (e.g., clinicians) evaluating cases with and without AI assistance, which is not relevant for this device.

6. Standalone Performance Study:

A standalone performance study in the context of typical AI device evaluation (algorithm only without human-in-the-loop performance using patient data) was not performed. The device is a physical medical device, not an AI diagnostic algorithm. The "standalone" performance described here relates to the device's technical specifications and functionality (e.g., vacuum, flow, battery life) as measured in a lab setting without human intervention beyond operating the test equipment.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests constitutes:

• Engineering Specifications: The design specifications the device was intended to meet (e.g., target vacuum pressure range, flow rate, battery operating times).
• Voluntary Standards: Established international and national standards for medical devices (e.g., ISO 14971, IEC 60601-1, ISO 10993).
• FDA Guidance Documents: Recommendations from FDA for software and other aspects.

8. Sample Size for the Training Set:

This information is not applicable. The SOMAVAC™ Device is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data.

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

This information is not applicable because there is no training set for this device.

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