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The STERRAD® 50/100S/200 Test Pack is used for routine monitoring of the STERRAD® 50, STERRAD® 100S and STERRAD® 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads containing devices that do not exceed claims of the cycle.

The STERRAD® 50/100S/200 Test Pack consists of a pouch which holds a closed vial containing a STERRAD® CYCLESURE® 24 Biological Indicator (BI) and silicon mats. The vial and its corresponding cap have defined orifices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the STERRAD® 50/100S/200 Test Pack:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "at least as resistant" performance compared to a biological model, and the chemical indicator functioning "appropriately." The study focuses on proving substantial equivalence to predicate devices, rather than meeting specific numerical performance thresholds in a typical diagnostic sense.

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

• Sample Size: "Test Packs assembled from three lots of CYCLESURE® 24 Biological Indicator (BI)" were used for both survival curve and fraction negative data collection. The exact number of test packs within each batch or for each exposure condition is not specified.
• Data Provenance: The data appears to be prospective as it involves controlled experimental exposures of the test packs to sterilizers to evaluate their resistance. The country of origin of the data is not explicitly stated but is implicitly associated with the manufacturer (Advanced Sterilization Products, Irvine, CA, USA).

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

This type of device (biological indicator/test pack for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way a diagnostic imaging AI might. The "ground truth" here is the scientifically established biological model for the sterilization resistance and the physical/chemical properties of the indicator. Therefore, the concept of "experts establishing ground truth" in the traditional sense is not directly applicable.

Instead of human experts, the standard for comparison (ground truth) is the "biological model developed for their respective cycles." This model represents the scientifically validated susceptibility of microorganisms to the sterilization process.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is based on a "biological model" and scientific measurement, not on human consensus or adjudication of subjective interpretations.

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

No. This is a scientific and engineering performance study rather than a clinical multi-reader study. The device is a sterilization indicator, not a diagnostic tool requiring human interpretation comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this is essentially a standalone performance study. The device's performance (resistance to sterilization, chemical indicator change) is evaluated directly against established scientific models and performance criteria without human intervention in the primary measurement of its function. The "algorithm" here is the physical and chemical design of the indicator responding to the sterilization process.

7. Type of Ground Truth Used

The ground truth used is a scientifically established biological model representing the resistance of microorganisms to the sterilization process, combined with physical-chemical properties for the chemical indicator. This is based on validated scientific principles of sterilization efficacy.

8. Sample Size for the Training Set

Not applicable. This device is a passive indicator/test pack, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its performance is inherent in its design and manufacturing.

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

Not applicable, as there is no "training set" for this type of device.

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This Premarket Notification is to expand the Indications for Use for the STERRAD 50 Sterilizer (K981625) and the STERRAD 100S Sterilizer (K991999) to include titanium as a compatible material and to expand the lumen sizes to include medical devices with only a single stainless steel lumen in the following configurations:

• An inside diameter of 1 mm or larger and a length of 125 mm or shorter
• An inside diameter of 2 mm or larger and a length of 250 mm or shorter .

The validation testing for these two new lumen sizes was conducted using a maximum of 10 lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing.

For information pertaining to previously cleared materials and lumen sizes, please reference K981625 and K991999.

The STERRAD® 50 & 100S Sterilizers are self-contained stand-alone systems of hardware and software designed to sterilize medical instruments and devices using a patented hydrogen peroxide gas plasma process. Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide into the vaporizer bowl where the solution is heated and transformed into a vapor, introducing the vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with radio frequency (RF) electrical energy.

The equipment (hardware and software) for the STERRAD® 50 & 100S Sterilizers is the same as that of the predicate devices. The hardware consists of a sterilization chamber onto which is mounted a variety of instruments and components, housed in a covered frame. The system also uses accessories such as disposable sterilant cassettes, reusable instrument trays, printer paper and ink cartridges.

Here's a breakdown of the acceptance criteria and the studies conducted for the STERRAD® 50 and STERRAD® 100S Sterilization Systems, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

                                                                   The In-Use testing demonstrated that the STERRAD® 50 and 100S Sterilization Systems were effective sterilizers of stainless steel lumen devices.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |

| No cytotoxicity or toxic residuals on processed materials | Cytotoxicity test results indicated that titanium materials processed did not induce in vitro cytotoxicity. Residues testing showed no toxic sterilant residuals. |

Note: SAL of 10^-6 means there is a one in a million chance of a non-sterile unit. SLR values of 6.0 or higher indicate a 6-log reduction in microbial population, which is a common standard for sterilization.

2. Sample Size and Data Provenance

• Test Set Sample Sizes:
  • Titanium Surface Sterilization: Not explicitly stated, but performed with "titanium materials representative of the materials commonly used in re-usable medical devices."
  • Lumen Sterilization: Not explicitly stated, but for the validation loads, a "maximum of 10 lumens per load" was used for the 1mm x 125mm and 2mm x 250mm lumens. The half-cycle validation tests used sufficient materials to demonstrate the SAL.
  • Tyvek-Mylar Pouched Device Sterilization: Not explicitly stated, but conducted with 1mm x 125mm and 2mm x 250mm stainless steel lumens in pouches.
  • Simulated Use Testing: Not explicitly stated how many devices, but used "devices representative of lumen claims."
  • In-Use Sterility Testing: Not explicitly stated how many devices, but used "Devices representative of lumen claims for the STERRAD® 50 Sterilization System" that were "used in routine surgeries at local hospitals."
• Data Provenance: Retrospective and prospective. The In-Use Sterility Testing involved devices "used in routine surgeries at local hospitals," suggesting data collected from real-world usage scenarios (retrospective element) which were then transported for prospective testing with the STERRAD systems. The other validation testing appears to be prospectively designed lab studies. No specific country of origin is mentioned beyond "local hospitals" for the in-use testing, implying a US-based context given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

• This information is not provided in the summary. The ground truth for sterilization is typically established through microbiological testing (e.g., demonstrating the death of a highly resistant test organism), rather than expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are primarily microbiological challenge tests for sterilization efficacy, not human interpretation tasks requiring adjudication.

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

• No MRMC comparative effectiveness study was mentioned or performed. The device is a sterilizer, meaning its performance is assessed by its ability to render medical devices sterile, not by human interpretation or diagnosis. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this type of device.

6. Standalone Performance Study

• Yes, standalone performance studies were done. All the validation tests described (Surface Sterilization, Lumen Sterilization, Tyvek-Mylar Pouched Device Sterilization, Simulated Use Testing, In-Use Sterility Testing, Toxicity Testing) are assessing the algorithm/system-only performance of the STERRAD® 50 and 100S sterilizers without human intervention in the sterilization process itself. The "overkill" approach used in the validation testing directly assesses the system's ability to achieve a robust sterility assurance level.

7. Type of Ground Truth Used

• The primary ground truth used is microbiological evidence of sterility, specifically:
  • Inactivation of B. stearothermophilus endospores: This is a highly resistant bacterial spore used as a biological indicator to challenge sterilization processes. Its inactivation to a specific Sterility Assurance Level (SAL) (e.g., 10^-6) or log reduction (e.g., 6-log reduction) serves as the ground truth for effective sterilization.
  • Sterility Assessment: Direct assessment of the absence of viable microorganisms after processing.
  • Toxicity testing: Used to establish ground truth that no cytotoxic effects or toxic residuals remain.

8. Sample Size for the Training Set

• This information is not applicable. The STERRAD® Sterilization System is a physical-chemical sterilization device, not an AI/ML algorithm that is "trained" on data in the traditional sense. Its operation is based on pre-defined scientific principles of hydrogen peroxide gas plasma sterilization, not on learning from a dataset.

9. How Ground Truth for the Training Set Was Established

• This information is not applicable for the reasons stated above. The system's "operating parameters" or "settings" are developed through scientific and engineering principles, not through a "training set" with established ground truth. The validation studies described in the summary are designed to prove the device meets performance criteria, not to train it.

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The STERRAD® 50 Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures. Because the cycle operates within a dry environment and at low temperatures, it is especially suitable for instruments sensitive to heat and moisture. (See list of recommended Materials in Section 3 of the Operator's Manual.)

The STERRAD® 50 Sterilizer can sterilize instruments which have diffusionrestricted spaces, such as the hinged portion of forceps and scissors.

Metal and nonmetal lumened instruments with inside diameters of 6 mm (¼ inch) or larger and lengths of 310 mm (12 inches) or shorter can be processed in the STERRAD® 50 Sterilizer. (See list of recommended Materials in Section 3 of the Operator's Manual.)

Additionally, medical devices with only a single stainless steel lumen which has an inside diameter of 3 mm (1/8 inch) or larger and a length of 400 mm (15 ¾ inches) or shorter can be processed in the STERRAD® 50 Sterilizer.

The STERRAD® 50 Sterilizer is a self-contained stand-alone system of hardware and software designed to sterilize certain medical instruments and devices, using a patented hydrogen peroxide gas plasma process. Sterilization is accomplished by injecting aqueous hydrogen peroxide into the vaporizer bowl where the solution is heated and transformed into a vapor, introducing this vapor into the process chamber under negative pressure and transforming the vapor into a gas plasma with RF electrical energy. The technology is particularly suited to the sterilization of heat and moisture sensitive instruments.

The hardware consists of a sterilization chamber onto which is mounted a variety of instruments and components, housed in a covered frame. The system also uses accessories such as disposable sterilant cassettes, reusable instrument trays, single-use biological and chemical indicators, printer paper and ink cartridges.

The sterilizer sits on a cart. The cart is designed for transportation of the sterilizer to its installation site, for mobility during servicing and as a structural support device.

Here's a breakdown of the acceptance criteria and study information for the STERRAD® 50 Sterilizer, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a sterilizer are generally defined by achieving a certain Sterility Assurance Level (SAL), typically 10⁻⁶, meaning a 1 in a million chance of a non-sterile unit. The studies consistently aimed to demonstrate this SAL.

Study Details

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

   • Test Organism: B. stearothermophilus spores (at least 1 x 10⁶ endospores for most tests).
   • Materials: Various materials representative of medical devices (e.g., metallic, polymer carriers, stainless steel). Specific quantities are not provided, but tests involved "various materials," "inoculated spore carriers," "mated biological indicator carriers," "stainless steel lumens," and "Tyvek pouched stainless steel lumens (Ten)."
   • Data Provenance: The studies were conducted by Advanced Sterilization Products (ASP), a division of Johnson & Johnson Medical, Inc., in Irvine, CA, USA, as part of their 510(k) submission. This indicates a retrospective evaluation of the device's performance through laboratory testing. "In-Use Sterility Testing" involved devices used in routine surgeries at a local hospital, then transported to ASP for sterilization, making this aspect prospective for the sterilization step with used instruments.

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

   • The ground truth for all sterilization studies is established by microbiological culture for the presence or absence of viable spores. The text does not mention the number or specific qualifications of human experts (e.g., microbiologists) used to perform or interpret these culture results. However, the methodology aligns with standard microbiological validation practices for sterilizers.

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

   • Not applicable in the conventional sense for a medical imaging or diagnostic device. The "ground truth" is determined by microbiological growth/no growth, which is an objective measurement based on established protocols. There is no mention of expert consensus or adjudication for these microbiological results.

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. This is a sterilization device, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and AI-related effect sizes are not applicable.

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

   • Not applicable as this is a sterilization device without an AI algorithm component. The performance evaluated is that of the sterilizer itself.

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

   • The primary ground truth used is microbiological culture data (presence/absence of B. stearothermophilus growth or other specified organisms). This is a direct measurement of sterility assurance. In the case of toxicity testing, "cytotoxicity and in vivo biocompatibility testing" provided the ground truth for residual toxicity.

7. The sample size for the training set:

   • Not applicable. This is a physical device (sterilizer), not a machine learning model. There is no concept of a "training set" in the context of validating its sterilization efficacy.

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

   • Not applicable, as there is no training set for this type of device validation.

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