(104 days)
The enspire 3000 Chemical Indicator is a peracetic acid concentration indicator for routine monitoring of the liquid chemical sterilization cycle of the enspire 3000 employing S40 Sterilant.
The unprocessed enspire 3000 Chemical Indicator is blue. When exposed in the enspire 3000 processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator color changes from the start to the pass color. See reference colors on the bottle.
The enspire 3000 Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. The product is manufactured by application of the indicator ink by screen printing to a substrate with the indicator ink printed thereon. A clear, sterilant-permeable polyether block amide laminate is adhesively bonded to the polypropylene strip following printing of the ink, completely covering the ink.
Here's a breakdown of the acceptance criteria and study information for the Celerity Chemical Indicator for enspire 3000 CLCSPS, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Reactive Ink Suitability Study | 100% of indicator text ink shows no smearing, no discoloration and no fading | PASS |
| Comparative Sensitivity | A minimum of 75% of indicator from each lot to show a PASS result when exposed to Pass cycle | PASS (100% PASS) |
| Comparative Specificity | 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS (100% FAIL) |
| Analytic Sensitivity | A minimum of 75% of indicator from each lot to show a PASS result when exposed to Pass cycle | PASS (100% PASS) |
| Analytic Specificity | 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS (100% FAIL) |
| Post-Processing Stability (Outside Processor) Study | A minimum of 75% of indicator from each lot to show a PASS result when exposed to Pass cycle at each time point; 100% of indicators to show a FAIL result when exposed to the Fail cycle at each time point | PASS |
| Post-Processing Stability (Inside Processor) Study | A minimum of 75% of indicator from each lot to show a PASS result when exposed to Pass cycle at each time point; 100% of indicators to show a FAIL result when exposed to the Fail cycle at each time point; 100% CI from each lot correctly interpreted by inexperienced reader | PASS |
| Blind Study | A minimum of 75% of indicator from each lot to show a PASS result when exposed to Pass cycle; 100% of indicators to show a FAIL result when exposed to the Fail cycle; 100% CI from each lot correctly interpreted by inexperienced reader | PASS |
| Contaminants Study | 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS |
| Exposure to Temperature Extremes Study | CI start color to remain unchanged after exposure to three freeze/thaw cycles before processing; ≥75% CI from each lot to show a PASS result; 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS |
| Light Stability Study | CI start color to remain unchanged after exposure to fluorescent light before processing; ≥75% of indicator from each lot to show a PASS result when exposed to Pass cycle; 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS |
| Open Bottle Stability Study | ≥75% of indicator from each lot to show a PASS result when exposed to Pass cycle; 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS |
| Shelf Life Study | ≥75% of indicator from each lot to show a PASS result when exposed to Pass cycle; 100% of indicators to show a FAIL result when exposed to the Fail cycle | PASS |
| Human Factors Study | Users complete all critical tasks | PASS |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the Comparative Sensitivity, Comparative Specificity, Analytic Sensitivity, and Analytic Specificity studies (and likely many other studies based on the acceptance criteria phrase "each lot"), 3 lots of the proposed device were tested.
- The exact number of individual indicators within each lot used for testing is not explicitly stated. However, the acceptance criteria are given as percentages of indicators ("minimum of 75% of indicator from each lot" or "100% of indicators").
- Data Provenance: The document does not specify the country of origin of the data. The studies are non-clinical performance testing, meaning they are laboratory or engineering-based tests, not human subject studies. They are presumably prospective for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: For the "Post-Processing Stability (Inside Processor) Study" and the "Blind Study," it mentions "inexperienced reader." This implies at least one, and likely more, inexperienced readers were used. It does not state how many experts, if any, were used alongside or to establish ground truth for these readings beyond the "inexperienced reader."
- Qualifications of Experts: The document specifies "inexperienced reader" for certain studies. It does not provide further qualifications for these readers or for any experts involved in establishing ground truth for other tests. For most of the chemical indicator tests, the "ground truth" is intrinsically defined by the chemical conditions (concentration of peracetic acid, temperature, time) to which the indicator is exposed.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for reconciling interpretations from multiple readers. For tests involving "inexperienced readers," it simply states whether "100% CI from each lot correctly interpreted." This suggests a binary outcome (correct/incorrect) without detail on reconciliation if there were multiple readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The performance testing is for a chemical indicator, not a diagnostic imaging device that typically uses MRMC studies. The "Human Factors Study" is mentioned, indicating usability assessment, but not an MRMC study related to diagnostic accuracy improvement.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- This device is a chemical indicator, which is a physical material that changes color based on chemical exposure. It is not an algorithm or software. Therefore, the concept of a "standalone algorithm" study does not apply. Its performance is inherent to the material and its chemical reaction, which is then visually interpreted.
7. Type of Ground Truth Used
- The ground truth for this device is based on defined chemical conditions (e.g., concentration of peracetic acid, exposure time, temperature). For "Pass Conditions" and "Fail Conditions," specific mg/L of peracetic acid (PAA) are used as the reference standard (e.g., ≥2200 mg/L PAA for Pass, 1750-1820 mg/L PAA and 0 mg/L PAA for Fail). This is a highly controlled and objective measure of the chemical environment.
8. Sample Size for the Training Set
- This device is a passive chemical indicator, not an AI/ML algorithm. Therefore, there is no training set in the typical sense used for machine learning models. The device's color change mechanism is based on established chemical principles, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
- As there is no training set for an AI/ML algorithm, this question is not applicable. The "ground truth" for the device's design and verification is based on fundamental chemistry and engineering principles for chemical indicators.
§ 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).