(89 days)
The Propper PASS/FAIL Challenge Pack is indicated for use in testing gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.
The PASS/FAIL Challenge Pack consists of a Propper Vapor Line steam sterilization integrator placed inside a test pack similar in construction to the Propper BT- O.K. M steam sterilization test pack.
The provided document is a 510(k) summary for the Propper PASS/FAIL Challenge Pack, a biological/chemical indicator for steam sterilizers. It serves as a premarket notification for a Class II medical device, indicating that its approval is based on substantial equivalence to existing legally marketed devices, rather than comprehensive clinical trial data.
Therefore, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the way a clinical trial report would. Instead, it focuses on demonstrating substantial equivalence.
Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state a table of "acceptance criteria" with numerical targets and then list "reported device performance" against those targets in the manner of a clinical study report.
Instead, the closest equivalent is the statement under "Substantial Equivalence":
"Composite results from comparative testing of these products are given in the two figures which accompany this summary."
- Acceptance Criteria (Implied): The implied acceptance criterion is that the performance of the Propper PASS/FAIL Challenge Pack should be "substantially equivalent" to predicate devices. This means it should demonstrate similar performance characteristics as established, legally marketed biological test packs for steam sterilization.
- Reported Device Performance: The document states that "Composite results from comparative testing of these products are given in the two figures which accompany this summary." These figures (which are not included in the provided text) would presumably show the comparative performance data, allowing for an assessment of substantial equivalence.
Without those figures, specific performance metrics cannot be reported.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in the provided text. The phrase "comparative testing of these products" suggests tests were conducted, but the number of units tested (sample size) is not given.
- Data Provenance: Not specified. It's unclear if the testing was prospective or retrospective, or the country of origin of the data.
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 type of information is not relevant or applicable to this device. As a biological/chemical indicator, its "ground truth" is determined by its physical and chemical response to specific sterilization conditions (temperature, time, steam penetration) rather than expert interpretation of images or patient outcomes. The performance is assessed by observing a color change or growth/no-growth of microorganisms.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept is not applicable to the evaluation of a biological/chemical indicator. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth from multiple expert interpretations, often in diagnostic imaging, which is not relevant here.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done, and is not applicable to this device. MRMC studies are used for evaluating diagnostic devices that involve human interpretation (like AI-assisted imaging). The Propper PASS/FAIL Challenge Pack is a physical indicator, not a diagnostic aid requiring human interpretation in that sense. Its function is to provide a direct readout of sterilization conditions.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: This concept also does not apply to the Propper PASS/FAIL Challenge Pack. It's not an algorithm or software. It is a physical device that responds to environmental conditions. Its "standalone performance" would be its inherent response to steam sterilization conditions, which would have been tested, but it's not described in terms of an algorithm's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a biological/chemical indicator like this is the known, controlled conditions of the steam sterilizer.
- For example, if testing at 121°C gravity displacement, the ground truth is that the sterilizer did reach and maintain 121°C for the specified time. The indicator is then observed to see if it correctly registers this (e.g., color change or no growth).
- Similarly for prevacuum sterilizers at 134°C.
Essentially, the "ground truth" is established by the physical parameters of the sterilization cycle itself, as measured by calibrated equipment, and verifying if the indicator responds as expected.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. The Propper PASS/FAIL Challenge Pack is not an AI/ML device, so it doesn't have a "training set" in the computational sense. Its design and manufacturing are based on chemical and biological principles, not machine learning.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
In summary:
The provided 510(k) summary is for a physical biological/chemical indicator. Many of the questions (experts, adjudication, MRMC, AI, training sets) are designed for evaluating AI/ML-driven diagnostic devices or those requiring complex human interpretation, and therefore do not apply to this submission. The core of this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices through comparative performance testing. The specifics of that comparative testing, including exact acceptance criteria and the detailed data, are referenced as being in accompanying figures, which are not included in the text provided.
§ 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).