(66 days)
The SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator sheets are designed to detect the presence of residual air in pre-vacuum steam sterilizers. When tested in a pre-vacuum sterilizer operating at 134 C, the indicator sheet will demonstrate a uniform color change from cream or blue to dark brown/black when proper sterilizations have been met and no significant amounts of air are present. This test pack and indicator sheets are intended for use as described in AAMI/ANSI ST-46.
The SPSmedical Air View™ Bowie Dick Test Pack (BD Test Pack) is a disposable device which is intended for use as a replacement for the ANSI/AMMI ST46:2002 BD Test Pack. The SPSmedical AirView™ Bowie Dick Indicator Sheets are designed to be used within the ANSI/AMMI ST46:2002 BD Test Pack.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the SPSmedical AirView™ Bowie Dick Test Pack & AirView™ Bowie Dick Indicator Sheets:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and statistical analysis as would be found in a research paper. Therefore, some of the requested information (like specific statistical acceptance criteria, effect size for MRMC studies, or training set details) is not explicitly stated or applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to the ANSI/AMMI ST46:2002 BD Test Pack (the gold standard for such tests) and the 3M Comply Bowie & Dick Test Pack predicate device. This implies: | Based on the results of laboratory tests, the SPSmedical AirView™ Bowie Dick Test Pack and AirView™ Bowie Dick indicator sheets are substantially equivalent to the predicate 3M Comply Bowie Dick Type Test Pack and indicator sheets, and functionally equivalent to the ANSI/AMMI ST46:2002 BD Test Pack. |
| Visual Indication of Sterilization/Air Removal: Clear and uniform color change from cream or blue to dark brown/black when proper sterilization and air removal conditions are met in a pre-vacuum sterilizer operating at 134°C. | The device provides a visual indication. "Its internal indicator sheet changes to It siguial and was for in the enames and color under proper sterilization and air removal conditions. A failure would result in a non-uniform color change on the indicator sheet." (Typo in original text, assumed "changes to a signal color"). |
| Identification of Failure: Non-uniform color change on the indicator sheet in case of residual air. | "A failure would result in a non-uniform color change on the indicator sheet." |
| Resistance to Steam Penetration & Air Trapping: Layers of paper providing resistance and trapping air, consistent with the function of a Bowie Dick Test Pack. | "The layers of paper within the SPSmedical AirView™ Bowie Dick Test Pack provide resistance to steam penetration and also trap air between them which is difficult for marginal performing pre-vacuum sterilizers to remove." |
| Shelf Life: 3 years from the date of manufacture. | "The shelf life of the SPSmedical Bowie-Dick Test Pack and indicator sheets shall be 3 years from the date of manufacture, when stored in a cool, dry place (15-30℃)." |
| Biocompatibility/Safety: Materials used are safe for intended use. | "A risk analysis was performed... and our associated risk and that the product is safe for its intended use and handling." |
| Insensitivity to Acidic/Basic Environment: Indicators should not be affected by extreme pH. | "Testing verified that the indicators in their unprocessed form are not sensitive to an acidic or basic environment. Testing verified that the indicators in their processed form are not sensitive to an acidic or basic environment." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "laboratory tests" and "testing" but does not quantify the number of test packs or indicator sheets used in the study.
- Data Provenance: The testing was conducted by SPSmedical Supply Corp. based in Rush, NY, USA. The data is retrospective in the sense that it was collected prior to the 510(k) submission, but the specific nature (e.g., controlled lab experiments, field tests) is not detailed beyond "laboratory tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This type of device (chemical indicator) does not typically involve human expert interpretation of raw data in the same way as, for example, medical imaging. The ground truth would be established by the physical and chemical properties of the sterilizer environment (e.g., presence or absence of residual air at specified temperature) and the expected color change.
- Therefore, no "experts" were used to establish ground truth in the sense of clinician concordance. The ground truth is inherent to the physical conditions of the steam sterilization process.
4. Adjudication Method for the Test Set
- Not applicable. As noted above, the evaluation of a chemical indicator's performance against physical conditions does not involve human adjudication of results in the way medical device diagnostic studies do. The outcome (color change) is a direct chemical reaction to the physical environment.
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-assisted diagnostic device, nor does it involve human "readers" in the context of interpreting complex images or data. It's a simple, direct chemical indicator.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- Yes, in a sense. The device itself (the indicator sheet) acts as the "algorithm" by changing color based on the physical conditions. Its performance is entirely standalone in detecting and indicating the presence of residual air. There is no human variability in the detection of the condition, only in the interpretation of the color change. The study evaluated this standalone function.
7. The Type of Ground Truth Used
- The ground truth was established by the physical conditions within a pre-vacuum steam sterilizer, specifically the presence or absence of residual air when operating at 134°C, as defined by standards like ANSI/AAMI ST46:2002. The expected outcome is a specific color change (or lack thereof) based on these objective physical parameters.
8. The Sample Size for the Training Set
- Not applicable. This device is a chemical indicator, not a machine learning or AI model that requires a training set. The "training" for such a device is its chemical formulation and physical construction.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of an AI/ML device. The chemical and physical principles governing the indicator's behavior are established scientific principles.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).