Search Results

The SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated. SPOR-TEST PA Biological Indicators are qualified using Getinge Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

The SPOR-TEST PA Biological Indicator Kit is exclusively intended to monitor the Steris System 1 liquid chemical sterilization process, with Steris 20 sterilant. The product contains chromatography strips that are inoculated with Geobacillus stearothermophilus spores at a nominal population of 10^6 per strip. Sterile tubes of Getinge Media (modified soybean casein digest broth) and a transfer loop are also included. The SPOR-TEST PA Biological Indicator Kit is used in the same manner as the Steris® Process Biological Indicator Kit.

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in a structured manner that allows direct extraction into the requested table format. The document is a 510(k) summary for a biological indicator kit, focusing on its equivalence to a predicate device rather than detailed performance study results against specific criteria.

However, I can extract the closest information available regarding performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size: "Samples from a minimum of 3 different lots of SPOR-TEST PA were tested." The exact number of individual indicators tested per lot is not specified.
• Data provenance: Not explicitly stated, but given it's a submission to the FDA by "Getinge USA, Inc." located in Rochester, NY, it is presumed to be US-based. The study appears to be prospective for the purpose of demonstrating the device's performance qualities, as it describes actively testing samples of the new device.

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

• This information is not provided in the document. The "ground truth" for a biological indicator typically involves observing growth or no growth of the spores under controlled conditions, which doesn't usually involve human experts in the same way, for example, a medical imaging diagnosis does. The determination of "survive" or "killed" is a direct biological outcome.

4. Adjudication method for the test set:

• This information is not provided. As mentioned above, the assessment of biological indicators (growth/no growth) is generally a direct observation rather than requiring expert 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:

• An MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices involving human interpretation, especially with AI assistance. The SPOR-TEST PA Biological Indicator Kit is a direct biological indicator, not a diagnostic imaging or AI-assisted interpretation device. The document mentions "human readers improve with AI vs without AI assistance" which is not applicable to this device.

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

• A standalone performance study was not done in the context of an algorithm. This device is a biological indicator; its performance is the direct result of biological interaction (spore survival/kill) with a sterilant, not an algorithm.

7. The type of ground truth used:

• The ground truth is based on the biological outcome of the Geobacillus stearothermophilus spores – specifically, whether they survive or are killed under controlled peracetic acid sterilization conditions. This is a direct measure of efficacy.

8. The sample size for the training set:

• This information is not applicable and therefore not provided. The device is a biological indicator, not an AI or machine learning model that requires a training set.

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

• This information is not applicable for the same reason as point 8.

Ask a specific question about this device

The Getinge Biosign Steam-24 Biological Indicator is a steam sterilization monitor designed specifically for biological testing of 121°C, 134°C gravity and pre-vacuum and flash gravity and prevacuum steam sterilization cycles with results available after 24 hours incubation.

The Getinge Biosign Steam-24 Biological Indicator is a self-contained biological indicator designed for biological testing of steam 121°C and 134°C pre-vacuum and gravity and flash steam sterilization cycles. When used to monitor steam cycles, the product is intended to give the user results after 24 hours incubation. The Biosign Steam-24 Biological Indicator contains 10^6 Geobacillus stearothermophilus (nee Bacillus stearothermophilus) spores/carrier. The Biological Indicator is selfcontained with an ampule containing culture medium in the same vial as the spore strip.

Here's an analysis of the provided text, focusing on acceptance criteria and the study details:

Acceptance Criteria and Device Performance Study

The Getinge Biosign Steam-24 Biological Indicator is intended to show results after 24 hours of incubation. The primary acceptance criterion for this modified device over its predicate is improved incubation time while maintaining sterilization effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: The document states that "different lots of Biosign Steam-24 were tested." However, no specific number of lots or individual Biological Indicators (BIs) tested is provided.
• Data Provenance: The study was likely conducted internally by Getinge USA, Inc. The data is retrospective in the sense that the testing was performed, and the results were then compiled for the 510(k) submission. The country of origin for the data is implicitly the USA, where Getinge USA, Inc. is located.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. This type of device relies on a physicochemical reaction (spore inactivation) for its function, not subjective expert interpretation. The ground truth is intrinsically linked to the biological viability of the Geobacillus stearothermophilus spores and their known resistance to steam sterilization, coupled with objective observation of growth in the culture medium.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The assessment of spore growth/no growth (which determines positive/negative results) is an objective biological outcome based on a color change or turbidity in the culture medium. There is no mention of subjective interpretation or a need for expert adjudication.

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

• MRMC Study Done: No. An MRMC study is not relevant for this type of device. Biological indicators do not involve human readers interpreting complex imaging or data. Their function is to provide a clear, objective biological result (growth or no growth) indicating successful or failed sterilization.

6. Standalone Performance (Algorithm Only) Study

• Standalone Study Done: Yes, in effect. The evaluation of the Biosign Steam-24 Biological Indicator's performance (incubation time and steam resistance) is a standalone assessment of the device itself. It operates independently of human interpretation beyond observing the final growth result. There is no "human-in-the-loop" interaction in the function of the BI; it is a direct measurement of sterility conditions.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth is based on biological viability and spore inactivation kinetics. For sterilization, the ground truth is whether the Geobacillus stearothermophilus spores, known to be highly resistant to steam, were successfully killed. This is objectively determined by the absence of growth (no color change/turbidity) in the culture medium after incubation. The D-value (Decimal Reduction Time) also represents a quantitative measure of resistance used to establish ground truth for effectiveness.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. Biological indicators are not machine learning algorithms that require a "training set." Their performance is based on established biological principles and physical testing, not data-driven model training.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable. As there is no training set for a biological indicator in the machine learning sense, there is no ground truth established for a training set. The performance characteristics (spore count, resistance, incubation time) are inherent properties of the biological system and its design, verified through standardized laboratory testing procedures as outlined by the CDRH Guidelines.

Ask a specific question about this device

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C. The instant readout integrator card gives the operator a prediction of the biological test outcome. When the chemical integrator "PASS" changes from purple to green, it indicates correct exposure conditions of temperature, time and steam.

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a test pack designed specifically for biological testing of steam 132°C pre-vacuum sterilization cycles. When used to monitor steam 132°C pre-vacuum cycles, the product is intended to give the user an instant reassurance based on a result from a steam integrator card, and after biological indicator incubation, even greater assurance that the sterilizer operated at proper sterilization parameters.

The Biosign SSI Test Pack with Instant Readout Integrator is constructed using a self-contained Geobacillus stearothermophilus biological indicator (10"spores/strip), placed inside a small package of porous and nonporous materials, and includes a steam integrator card. The package simulates the biological indicator 16-towel test pack as defined by ANSI/AAMI ST46-1993. The instant readout integrator card provides immediate verification that the test pack was exposed to sterilization parameters, when the word "PASS" imprinted with a purple indicator ink, changes to green. The biological indicator gives an even greater assurance that sterilization occurred, when the incubated spores display no growth, as indicated by no color change (red) in the growth media.

The shelflife of the new Biosign SSI Test Pack with Instant Readout Integrator is the same as the predicate Biosign EZ-VU Test pack (18 months). The biological indicator is the generally limiting factor and the shelflife of the product can never go beyond the shelflife of the biological indicator, or the shelflife of the integrator card, whichever is shortest.

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is the same size as, utilizes the same materials and is constructed the same as the Biosign EZ-VU Test pack, only with the addition of the instant readout indicator card printed with the integrator ink utilized in the SteriTec Biological Test Pack with Instant Readout Integrator. Since the integrator card was designed to function inside a test pack, its placement in the biological test pack offers no difference in functional environment. The same Biosign biological indicator with Geobacillus stearothermophilus is utilized in the Biosign SSI Test Pack with Instant Readout Integrator, as is used in the Biosign EZ-VU Test pack.

Here's a breakdown of the acceptance criteria and the study details for the Biosign SSI Test Pack with Instant Readout Integrator, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criteria for this device revolve around demonstrating substantial equivalence to its predicate devices in terms of function and performance, specifically for monitoring 132°C pre-vacuum steam sterilization cycles. The performance is assessed for both the instant readout integrator card and the biological indicator.

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

• Sample Size: "Samples from 3 different lots of Biosign SSI Test Pack with Instant Readout Integrator" were used. In addition, "different lots of Biosign EZ-VU Test Pack and SteriTec Biological Test Pack with Instant Readout Integrator were also run." While the specific number of packs per lot is not stated, the use of multiple lots for both the new device and predicates suggests a reasonable attempt at demonstrating consistency.
• Data Provenance: The testing was conducted internally by Getinge USA, Inc. The nature of the testing (running samples in sterilization equipment) means it's a prospective study of the device's performance under controlled conditions. The country of origin for the data is implicitly the USA, where Getinge USA, Inc. is located.

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

• Not Applicable. This device is a biological indicator and chemical integrator for sterilization processes. The "ground truth" is not established by human experts interpreting images or complex data. Instead, it's established by the physical and biological processes of sterilization itself. The outcome (sterilization achieved vs. not achieved) is determined by the environmental parameters of the sterilizer (temperature, time, steam presence) and the viability of the biological spores.

4. Adjudication Method for the Test Set

• Not Applicable. As the ground truth is not expert-derived, there is no human adjudication process involved in determining the test set's outcome. The "readout" is built into the device: a color change for the integrator, or lack of growth for the biological indicator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No. An MRMC study is not relevant for this type of device. MRMC studies are typically used to evaluate diagnostic imaging devices where human readers interpret and make decisions based on complex visual information, and the AI's role is to assist or augment that interpretation. This device's function is a direct, objective chemical/biological response to sterilization parameters.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, effectively. The performance of the instant readout integrator card and the biological indicator can be considered "standalone" in that their function is an objective, automated response to the sterilization cycle.
  • The integrator card changes color (purple to green) if sterilization parameters are met, without human interpretation of nuanced data.
  • The biological indicator shows no growth if sterilization is achieved, which is an objective biological outcome based on spore viability.
  • While humans visually inspect the color change or growth, the "algorithm" (the device's chemical/biological mechanism) itself provides the direct output. The study described tests this standalone performance against predicate devices.

7. The Type of Ground Truth Used

• The ground truth is based on the physical and biological conditions of sterilization.
  • For the chemical integrator, the ground truth is whether the correct exposure conditions of temperature, time, and steam were met, as designed by the underlying chemical reaction.
  • For the biological indicator, the ground truth is whether the biological spores were killed (indicating a successful sterilization cycle), which is then verified by the absence of growth in the incubation media.
  • The predicate devices further serve as a reference for establishing "expected" ground truth performance.

8. The Sample Size for the Training Set

• Not Applicable / Not Explicitly Stated. This device is a physical/chemical/biological indicator, not an AI software algorithm that "learns" from a training set. Its design and performance are based on established scientific principles of sterilization biology and chemistry, not machine learning. Therefore, the concept of a "training set" as typically understood in AI/ML is not relevant here.

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

• Not Applicable. As there is no training set in the AI/ML sense, this question is not relevant. The device's fundamental function is based on established sterilization principles and material science, not a learned model from labeled data.

Ask a specific question about this device

The Model 833HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments and linens, by means of pressurized steam.

The 833HC Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates a large sized chamber and has the same control system and offers similar overall features as those on the 733HC Vacuum/Gravity Steam Sterilizers. These include: additional functionality, ease of use to the end user, large color display that will allow the user to choose from the entire list of available cycles, allows renaming and re-sequencing of sterilization cycles.

The provided document is a 510(k) summary for a steam sterilizer, not an AI/ML device, and thus does not contain information typically associated with studies proving device performance against acceptance criteria for AI algorithms. Therefore, most of the requested information (sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set information) is not applicable or present in this document.

However, I can extract the acceptance criteria and the statement regarding how the device meets them from the provided text.

Acceptance Criteria and Device Performance for Getinge Sourcing LLC Model 833HC Vacuum/Gravity Steam Sterilizer

This device is a steam sterilizer, and its performance is assessed against established industry standards for sterilization efficacy and safety, rather than through AI/ML model performance metrics. The core acceptance criterion for such a device is its ability to sterilize medical instruments effectively and safely according to recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. This is a physical medical device (steam sterilizer), not an AI algorithm. Its performance is demonstrated through adherence to engineering and sterilization standards, not data analysis on a test set. There is no mention of "test set" in the context of data for this device.

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

• Not Applicable. As a physical device, the "ground truth" for its efficacy is established by widely accepted microbiological principles and validated industry standards for sterilization, rather than expert consensus on a dataset.

4. Adjudication method for the test set:

• Not Applicable. No test set or adjudication process as defined for AI/ML algorithms is mentioned or relevant for this device.

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 device.

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

• Not Applicable. This is a standalone physical device, but not a standalone algorithm.

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

• Established Sterilization Standards and Physical Testing: The "ground truth" for a sterilizer's performance is biological inactivation (killing microorganisms) as demonstrated through validation studies that adhere to standards like AAMI ST8. While direct biological indicator testing results are not provided in this summary, the claim of meeting the standards implies such validation was performed.

8. The sample size for the training set:

• Not Applicable. This device does not use a "training set" in the AI/ML sense.

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

• Not Applicable. This device does not have a "training set."

Ask a specific question about this device