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The Aesculap Sterilcontainer System is a reusable sterilization container system (consisting of solid & perforated bottoms, a perforated lid w/ filter retention plates, and reusable polytetrafluoroethylene (PTFE) filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in pre-vacuum steam and IUSS (Immediate Use Steam Sterilization modalities. The SterilContainer System for includes accessories such as silicone mats, baskets, trays, and racks.

The SterilContainer with PrimeLine Pro Lid is used in conjunction with Aesculap's Sterilcontainer Systems (K792558/K944864/K053389/K112671). The SterilContainer with PrimeLine Pro Lid is designed to be compatible for use with pre-vacuum steam and IUSS sterilization. The lid is manufactured from anodized aluminum and utilizes a reusable polytetrafluoroethylene (PTFE) filter. The SterilContainer with PrimeLine Pro Lid is offered in a various colors and range of sizes as the predicates including full, ¾, and half sizes lids.

The Aesculap SterilContainer with PrimeLine Pro Lid is a reusable sterilization container system designed to sterilize and maintain the sterility of medical devices. The device was found to be substantially equivalent to its predicate devices based on non-clinical performance testing.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each test. It mentions that "Test were performed in best/mid/worst case sized regarding vent to volume ratio and container size." The data provenance is not specified, but the testing was conducted by a "qualified testing laboratory" in accordance with FDA guidance and AAMI standards. This indicates a prospective and controlled experimental design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is not an AI/imaging device requiring expert interpretation for ground truth. The performance testing involves objective measures of sterilization efficacy, microbial challenge, sterility maintenance, and cleaning effectiveness, which do not typically rely on expert consensus for ground truth establishment in the same way an AI diagnostic tool would.

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

Not applicable. As noted above, this device does not involve human interpretation or subjective assessment that would require an adjudication method.

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 is not an AI device, so MRMC studies and the concept of human readers improving with AI assistance are not relevant.

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

Not applicable. This is not an algorithm-based device. The testing focuses on the physical and functional performance of the sterilization container system.

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

The ground truth for the performance testing is based on established scientific and regulatory standards for sterilization, microbial challenge, sterility maintenance, and cleaning efficacy.

• Sterilization Efficacy: Ground truth is a 6 log reduction and SAL of $10^{-6}$ as per biological indicator results and half-cycle validations.
• Microbial Aerosol Challenge: Ground truth is the absence of microbial growth in the contents after exposure to a defined amount of aerosol microorganisms.
• Event Related Sterility Maintenance: Ground truth is the absence of microbial growth in the contents after storage periods, indicating sterility was maintained.
• Cleaning Effectiveness: Ground truth is a protein level of less than $6.4 \mu g/cm^2$ and a hemoglobin level of less than $2.2 \mu g/cm^2$ per device, as determined by laboratory analysis.

These are objective, measurable outcomes based on established scientific principles and regulatory benchmarks.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable. As there is no training set for this device, a method for establishing its ground truth is not relevant.

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The BiowaveHOME Neuromodulation Pain Therapy Device is indicated for:

• · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain
• · Symptomatic relief of acute pain
• · Symptomatic relief of post-operative pain

The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Homewaye Neuromodulation Pain Therapy Device (K072123). Biowaye Corporation's parent Homewave Neuromodulation Pain Therapy Device (K072123) is a TENS type device with a single optimized operational mode for the treatment of pain. Biowaye has made some minor modifications to the Homewaye Neuromodulation Device resulting in the proposed BiowaveHOME device. The minor modifications involve the following:

• . BiowaveHOME has a newer more advanced power supply, two lithium iron phosphate batteries, that will last longer between charges and can sustain approximately 3 times the number of charge/discharge cycles versus Homewave's three lithium ion batteries. Lithium iron phosphate rechargeable batteries are also safer than lithium ion with respect to overheating and over or under charging issues.
• . BiowaveHOME utilizes a larger custom LCD display with larger characters making it much easier to read the intensity and count down timer and other information as compared to Homewave.
• . BiowaveHOME has a PAUSE button added to the face of the device giving the patient an obvious choice to pause or stop the treatment if necessary.
• . BiowaveHOME has a smaller more ergonomic form factor making it easier to hold and move about as compared to Homewave.
  The modified BiowaveHOME Neuromodulation Pain Therapy Device has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123.

This is a 510(k) premarket notification for the BiowaveHOME Neuromodulation Pain Therapy System. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting a new clinical study with specific acceptance criteria as you would typically find in a PMA or De Novo submission.

Therefore, the provided document does not contain the information requested about acceptance criteria and a study proving device performance against those criteria in the way you would expect for a novel device.

Here's why and what information can be extracted:

• No new performance study: The document explicitly states that this is a "Special 510(k)" and that the "purpose of this Special 510(k) is to obtain clearance to market a modified version of the Homewave Neuromodulation Pain Therapy Device (K072123)." It emphasizes that the modified BiowaveHOME device "has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123." This means Biowave Corporation is leveraging the prior clearance of the predicate device (K072123) and argues that the modifications are minor and do not significantly alter the device's fundamental safety or effectiveness.
• Basis for Substantial Equivalence: The submission focuses on comparing the BiowaveHOME with its predicate (Homewave Neuromodulation Pain Therapy Device, K072123) and other related predicate devices (Deepwave (BiowavePRO), K053389; Deepwave Percutaneous (BiowavePENS), K053389) on design, function, intended use, and indications. The argument is that since the modified device is so similar to an already cleared device, it is "substantially equivalent" and does not require new efficacy studies.

Therefore, many of your requested items about a performance study, acceptance criteria, sample sizes, experts, ground truth, and MRMC studies, are not applicable or not present in this type of submission.

However, I can provide the available information:

• Device Name: BiowaveHOME Neuromodulation Pain Therapy System
• Product Code: GZJ (Transcutaneous electrical nerve stimulator for pain relief)
• Indications for Use:
  • Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain
  • Symptomatic relief of acute pain
  • Symptomatic relief of post-operative pain

Here's a breakdown of what can and cannot be answered based on the provided text:

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

   • Not applicable/Not provided. This submission does not define new acceptance criteria for a clinical performance study because it's based on substantial equivalence to a predicate device. Performance is assumed to be equivalent to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable/Not provided. No new clinical "test set" was used for performance validation in this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided. No independent expert review of a test set for ground truth was conducted for this 510(k).

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

   • Not applicable/Not provided. No test set adjudication method is mentioned as no new clinical study was conducted.

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 device is a pain therapy system, not an AI-assisted diagnostic tool.

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

   • Not applicable/Not provided. This is a hardware neuromodulation device, not an algorithm.

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

   • Not applicable/Not provided. No new ground truth assessment for clinical performance was performed for this 510(k). The "ground truth" for its effectiveness is implicitly tied to the prior clearance of its predicate device, based on the studies that supported that predicate.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is not an AI/ML device that requires a training set.

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

   • Not applicable/Not provided. As above, no training set is relevant here.

In summary, this document is an FDA 510(k) clearance letter and its associated summary for a device that is essentially a modified version of an already cleared device. It relies on demonstrating substantial equivalence rather than presenting new clinical study data with specific acceptance criteria.

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The Aesculap SterilContainer System is a reusable sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility for 360 days. The SterilContainer System includes accessories such as mats, baskets, trays, holders, organizers, filters, indicator cards and tamper proof locks.

The Aesculap SterilContainer is designed as a container system that will allow for sterilization and storage of other medical devices. This system consists of full, three-quarter, half, quarter, and extra long and wide body container system. There are a variety of accessories also available for this container system. This container is designed to be compatible for use in pre-vacuum steam, pre-vacuum immediate use steam and EtO sterilization. The container bottom is manufactured in anodized aluminum and has stainless steel handles on each end. There are two types of lids for the container bottom. There are anodized aluminum lids that have removable retention plates to hold the filter and a stainless steel latch on each end to lock the lid only to the container bottom. There are also Prime Line lids available for use that are manufactured in the material commonly known as Radel R. The PrimeLine lids have a reusable filter system. The reusable filter is for Pre-vac steam and Immediate Use steam sterilization only.

The provided text describes the Aesculap SterilContainer System for sterilization. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with pass/fail thresholds in a formal table separate from the performance results. Instead, it presents the validated sterilization cycle parameters and states that the device was "fully validated" according to FDA and AAMI standards. The reported device performance is that it meets these validated parameters and achieves a 360-day event-related shelf life.

• Pre-vacuum steam (270°F, 4 min. exposure, 30 min. dry)
• Pre-vacuum immediate use steam (270°F, 3 min. (non-porous) / 4 min. (porous) exposure)
• Ethylene Oxide (130°F, 60 min exposure, ≥ 50% RH, 725 mg/L gas pressure) | Achieved: "fully validated for pre-vacuum steam, pre-vacuum immediate use steam, and EtO sterilization processes." |
  | Shelf Life | Maintain sterility for 360 days. | Achieved: "360 days of event related shelf life testing has been conducted." |
  | Compatibility | Compatible with specified lids, filters, and accessories for each sterilization method. | Achieved: Detailed tables provided for compatibility across various configurations and accessories. |
  | Max Load Weight | Accommodate maximum load weights of 25 pounds or less (AAMI/AORN recommendation). | Achieved: "Max total weight 25 pounds." |
  | Vent to Volume Ratio | Meet predetermined standards for the "worst case vent to volume ratio" to ensure sterilization. | Achieved: "This container represents the worst case vent to volume ratio for the SterilContainer System," and validation was successful. |
  | Reuse Testing | Maintain performance after repeat sterilization cycles. | Achieved: "100 cycles minimum" for container, "2,200 cycles (lid)" for reusable filter. |

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

The document does not explicitly state the numerical sample size used for the test set in terms of number of containers or cycles. However, it does state:

• "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications 510(k)'s' for Aesculap SterilContainer was completed on this new three-quarter size 8" (187mm) container of the worst case vent to volume ratio..."
• The testing was conducted by "a qualified testing laboratory."

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given that it's a 510(k) submission for a new device, the testing would inherently be prospective in nature, specifically designed to validate the new device.

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

This type of information is not applicable to this submission. The "ground truth" for sterilization efficacy is established through standardized biological and physical indicator tests, not expert consensus on medical images or patient outcomes. The testing was performed in a laboratory setting per established standards (FDA and AAMI).

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to a process where multiple human reviewers independently assess data (e.g., medical images) and disagreements are resolved by an expert panel. Sterilization and shelf-life testing relies on objective, measurable scientific and engineering principles (e.g., microbial kill, barrier integrity), not subjective human interpretation requiring adjudication.

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 is a medical device for sterilization, not an AI-powered diagnostic or assistive tool for human readers/clinicians, so an MRMC study is not relevant.

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

This refers to the performance of a device on its own, without human intervention in its function during testing. In this context, the device (the SterilContainer) was tested in a standalone manner as its primary function is to achieve and maintain sterility independently when subjected to specified sterilization cycles. The performance data presented (sterilization cycle parameters met, 360-day shelf-life) reflects the container's inherent capabilities.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for sterilization efficacy is typically established through:

• Biological Indicators (BIs): Contain a known number of highly resistant microorganisms (e.g., bacterial spores). A successful sterilization cycle renders the BI sterile, demonstrating microbial kill.
• Chemical Indicators (CIs): React to one or more sterilization parameters with a visible change in color or state.
• Physical Monitoring: Readings from sterilizer gauges, thermometers, pressure recorders, and timers confirm that the physical parameters (temperature, pressure, time) of the cycle were met.
• Barrier Integrity Testing: For shelf-life, tests ensure the container maintains a sterile barrier over time, often involving microbial ingress challenges or visual inspection for damage.

The document implicitly refers to these methods by stating: "These validations were conducted in accordance with FDA and AAMI standards by a qualified testing laboratory." These standards prescribe the use of BIs, CIs, and physical monitoring for sterilization efficacy, and specific tests for packaging integrity and shelf-life.

8. The Sample Size for the Training Set

Not applicable. Training sets are relevant for machine learning or AI models. This device is a physical container, and its performance is evaluated through conventional engineering and microbiological testing, not by training an algorithm.

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

Not applicable, for the same reason as point 8.

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