Search Results

The Harvey® PV Dry is a prevacuum and post vacuum drying sterilizer intended to provide sterilization of wrapped or unwrapped medical instruments, surgical devices and other heat stable devices in pouches, surgical packs, dental handpieces, instruments, surgical devices and outer water is required for operation of the Harvey® PV Dry.

The sterilizer has four standard cycles: Unwrapped Instruments (135C for 3 minutes); Wrapped Instruments (121C for 30 minute); Special, for dental handpieces (5 minutes (155c for 11ve manator), I 2015 (15) 10 11 (15 ) 10 routine testing of the steam penetration capability into packs. The parameters are fixed for each cycle.

The Harvey® PV Dry is a pre/post-vacuum table top steam sterilizer. Its enclosure is made of plastic. The outside dimensions are 15.5"Hx19"Wx23"D, it weighs 115lbs and the chamber is 10" in diameter. The chamber is made from stainless steel at 45 it weighs 11910s and the enamour is 10 - an Mechanical Engineers (ASME) Pressure Vessel Code.

The provided text is a 510(k) summary for the Harvey® PV Dry steam sterilizer. While it discusses the device's technical characteristics, intended use, and substantial equivalence to a predicate device, it does not explicitly contain a table of acceptance criteria nor a detailed study report that proves the device meets specific acceptance criteria in a quantitative manner as typically found in medical device performance studies.

The document states that "Validation studies were conducted by SPS Medical Supply Corporation... Validation testing is in accordance with ANSI/AAMI ST55, ANSI/AAMI ST37. Since neither standard specifically addresses handpiece cycle validation, additional handpiece cycle validation testing was performed with the protocol being written in accordance with FDA Draft Guidance Document on Dental Handpieces, 1995, and the Guidance on Premarket Notification Submissions for Sterilizers Intended for Use in Health Care Facilities, 1993. Successful sterilization was achieved in all three validations and the declarations of conformity to the consensus standards are located in Section III. Testing results and raw data are contained in the product's device master record."

However, this summary does not provide the specific numerical acceptance criteria (e.g., "sensitivity > X%", "specificity > Y%") or the detailed performance metrics (e.g., "observed sensitivity Z%", "observed specificity W%") from these validation studies. It only states that "Successful sterilization was achieved in all three validations."

Therefore, I cannot populate the table or answer all the questions directly from the provided text. I will answer what is available and indicate when information is not present.

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

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 for Test Set: Not specified in the provided text. The text mentions "all three validations" but does not quantify the number of cycles, loads, or biological indicators used within those validations.
• Data Provenance (Country of Origin): Validation studies were conducted by SPS Medical Supply Corporation, located at 6789 West Henrietta Road, Rush, NY 14543, USA.
• Retrospective or Prospective: Not explicitly stated, but validation studies for new medical devices are typically prospective.

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 information is not applicable and not provided. The ground truth for sterilizers is typically established through the use of biological indicators and physiochemical indicators, designed to confirm microbial inactivation, rather than expert interpretation of data points.

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

• This information is not applicable and not provided. Sterilization validation does not typically involve expert adjudication in the same way as diagnostic imaging studies. The outcome is determined by the growth or non-growth of biological indicators and readings from chemical/physical indicators.

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

• This information is not applicable and not provided. This is a sterilizer, not an AI-assisted diagnostic device that would involve human readers.

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

• This information is not applicable and not provided. This is a standalone medical device (sterilizer), but the concept of "algorithm only" and "human-in-the-loop" performance doesn't apply in the context of a steam sterilizer validation in the way it would for AI/software devices. The sterilizer operates autonomously through its programmed cycles.

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

• The ground truth for sterilization efficacy is established by biological indicators (containing highly resistant bacterial spores), which, when processed in a sterilizer cycle, are subsequently incubated to determine if all spores have been killed. A lack of growth confirms sterilization. Additionally, chemical and physical indicators are used to confirm critical sterilization parameters (temperature, pressure, time, steam penetration).

8. The sample size for the training set

• This information is not applicable and not provided. Sterilizers are validated based on performance testing against standards, not typically "trained" using data sets in the way AI algorithms are.

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

• This information is not applicable and not provided (see point 8).

Ask a specific question about this device

The "Sterilemax" provides sterilization of standard loads of medical and dental instruments, as do the predicate units.

The B/T "Sterilemax" is a table top steam sterilizer. As in the case of the predicate units, the Sterilemax has a water reservoir, a heat source and a sealed chamber. The unit is designed with four standard cycles and one optional cycle. The standard cycles are: wrapped instruments (10 min at 135 C.), unwrapped instruments (3 min at 135 C), packs (30 minutes at 121 C.), the optional cycle for dental handpieces (10 min at 132 C.) and liquids for non-clinical applications (15 min at 121 C.). The chamber is constructed of stainless steel with a cast aluminum door and a silicone sealing gasket. The pressure chamber and components are designed, tested and stamped for conformance to ASME code. A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the process per the programmed parameters. The unit has an 80 character alpha-numeric display. This display provides program and process information to the user, as well as fault condition messages. The display also provides the user with instructions regarding device operation. The unit meets the requirements of UL/CUL3101-1, IEC 1010-1-92 safety standards. The unit is designed with additional user safety features such as, door interlocks and over temperature controls. The chamber is 12″ diameter by 18″ deep.

The provided text describes a 510(k) submission for a medical device, the "Sterilemax" autoclave. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials with specific acceptance criteria and detailed statistical analysis commonly found in AI/ML device submissions.

Therefore, many of the requested elements (like sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance metrics, etc.) are not applicable or not provided in this regulatory document.

However, I can extract the information that is present and indicate where information is missing or not relevant to this type of device submission.

Acceptance Criteria and Device Performance (for a Traditional Medical Device)

The "acceptance criteria" for a device like an autoclave are typically related to its ability to achieve sterility, as defined by recognized standards and validation methods. For this device, the key acceptance criterion is achieving "total kill" of microorganisms, indicating sterility.

Study Information

1. 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 as a number of "cases" or "samples" in a clinical or imaging study sense. The testing involved "recommended loads" using a "half cycle analysis," but the specifics of how many loads or cycles were tested are not detailed.
   • Data Provenance: Not specified. It can be inferred that the testing was conducted by the manufacturer, Barnstead/Thermolyne Corporation, likely in the US (given the US regulatory submission). It was likely prospective testing performed in a laboratory setting to validate the device's function.

2. 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)

   • Not Applicable. For an autoclave, "ground truth" is established through microbiological assays that determine the presence or absence of viable microorganisms after a sterilization cycle. This does not involve human expert interpretation in the same way an imaging diagnostic device would.

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

   • Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic studies. For an autoclave, the "outcome" is a clear microbiological result (sterile/not sterile).

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

   • Not Applicable. This is a traditional medical device (autoclave), not an AI/ML powered diagnostic or assistive tool. No human readers or AI assistance are involved in its primary function.

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

   • Partially Applicable (in a different context): The device itself operates "stand-alone" in performing its sterilization cycle without continuous human intervention during the process, once initiated. It is a machine executing a programmed process. The "software has been validated and documented under the requirements outlined in the 'Reviewer Guide for Computer Controlled Medical Devices'," indicating that the control logic (algorithm) was tested for its intended function. This is not the same as an AI/ML algorithm's standalone diagnostic performance.

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

   • Microbiological Assay / Total Kill Endpoint: The ground truth for sterilization is the absence of viable microorganisms, determined through "total kill endpoint" analysis using biological indicators or similar microbiological validation methods.

7. The sample size for the training set

   • Not Applicable. This is not an AI/ML device. "Training set" refers to data used to train a machine learning model, which is not relevant here. The device's software was "validated," implying verification of its programmed logic and parameters against specifications, not learning from data.

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

   • Not Applicable. As above, no training set in the AI/ML sense was used. The operational parameters (temperature, pressure, time) and cycles of the autoclave are based on established scientific principles of sterilization and validated through testing, not learned from a dataset with an established "ground truth."

Ask a specific question about this device