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The STATIM 600B are dynamic air removal (pre-vacuum) table-top steam sterilizers that are intended for use by a healthcare provider to sterilize medical products by means of pressurized steam.

The STATIM 6000B are suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATIM 6000B has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such in incomplete sterlization and/or damage to the autoclave.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a steam sterilizer (autoclave). It does not contain information about an AI/ML powered device, its acceptance criteria, or the study used to validate its performance. The document focuses on establishing substantial equivalence for the sterilizer, specifying its indications for use, and providing a table of sterilization cycles, temperatures, times, and load descriptions.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a different type of medical device.

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The BRAVO G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterlizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.

It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The BRAVO G4 has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

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The provided text describes a 510(k) premarket notification for a steam sterilizer, the BRAVO G4 Chamber Autoclave. It outlines the device's indications for use and lists various sterilization cycles with their parameters. However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to software performance, AI algorithms, or diagnostic accuracy.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types, as these are not present in the provided text.

The document focuses on the regulatory clearance of a physical medical device (a steam sterilizer) and its operational parameters, not on an AI or software-driven medical device.

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The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.

It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

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This document describes a 510(k) premarket notification for the "STATCLAVE G4 CHAMBER AUTOCLAVE," a steam sterilizer. The FDA has determined it is substantially equivalent to legally marketed predicate devices.

The document outlines the device's indications for use: "The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be steam." It's explicitly stated that the device "has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization."

The document includes a table of program descriptions, cycle times, temperature, and dry times for various load types.

Based on the provided text, the following information regarding acceptance criteria and a study to prove device performance can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides performance parameters for different sterilization programs. While not explicitly labeled as "acceptance criteria" in a formal sense, these are the validated operational parameters for the device's intended use. The "reported device performance" is implicitly that the device operates according to these specifications to achieve sterilization.

Note: The acceptance criteria for a sterilizer would typically involve demonstrating a Sterility Assurance Level (SAL) of 10^-6 or better for microbial inactivation, along with meeting physical parameters like temperature, pressure, and biological indicator (BI) kill rates. These specific details are not provided in this regulatory letter, which focuses on substantial equivalence to a predicate device. The table above reflects the operational parameters of the device as cleared.

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

• Sample size for test set: Not specified in the provided text.
• Data provenance: Not specified in the provided text. This document is an FDA 510(k) clearance letter, not the study report itself. It refers to a "premarket notification," which usually includes performance data, but that data is not detailed here. It's highly probable the data would be prospective studies conducted by the manufacturer for validation.

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

• This information is not applicable and not provided. Sterilizer validation typically involves microbiological testing (e.g., biological indicators, inoculated product) and physical parameter monitoring, rather than expert consensus on images or interpretations.

4. Adjudication method for the test set:

• Not applicable and not provided. (See point 3).

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 a medical device (sterilizer) and not an AI/imaging diagnostic tool that involves human readers or AI assistance in interpretation.

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

• Not applicable. This is a standalone medical device (sterilizer), and its performance is assessed directly through its physical and microbiological efficacy, not through an algorithm's classification or diagnostic ability.

7. The type of ground truth used:

• While not explicitly stated in this document, the ground truth for sterilizers is typically established through microbiological validation methods, such as:
  • Biological Indicators (BIs): Spore strips or suspensions are placed in worst-case locations within the load and chamber. After the cycle, these BIs are incubated, and the absence of growth (i.e., kill of highly resistant spores) serves as the ground truth for sterility.
  • Direct Inoculation: Instruments or materials are intentionally inoculated with high concentrations of resistant microorganisms and then processed. Subsequent culturing determines if all microbes were killed.
  • Physical Parameters: Monitoring and verification of temperature, pressure, and steam penetration throughout the cycle against validated ranges.
• The "acceptance criteria" implicitly include achieving a validated sterile outcome based on these scientific ground truths.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of machine learning or AI. Its development and validation are based on engineering principles, material science, and microbiology.

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

• Not applicable. (See point 8).

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The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.

It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

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The provided text describes a steam sterilizer (STATCLAVE G4 Chamber Autoclave), not an AI-powered medical device that requires a study to prove its performance based on AI/human interaction, ground truth, or statistical metrics like sensitivity/specificity.

Therefore, many of the requested categories are not applicable. I will extract the relevant information regarding the device's performance based on the provided text.

Here's the information as applicable:

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

   The device's performance is described by its sterilization programs, temperatures, exposure times, and minimum drying times for various load types. This constitutes the operational criteria and expected performance.

   Program	Load Description	Sterilization Temperature / Exposure Time	Minimum Drying Time**	Maximum Load	Reported Device Performance (Operational Parameters)
   Solid/Unwrapped	IUSS CYCLE* for unwrapped solid instruments (mirrors, explorers), hinged instruments (hemostats) on trays.	132°C / 270°F for 4 minutes	Not Applicable	6.0 Kg / 13.2 lbs	Meets the specified temperature and time for sterilization.
   Solid/Wrapped	Wrapped IMS cassettes with solid instruments, rigid sterilization containers with solid instruments or single-pouched solid instruments on a pouch rack.	132°C / 270°F for 4 minutes	25 minutes (up to 6 kg / 13.2 lbs)

15 minutes (up to 1.4 kg / 3 lbs**) | 6.0 Kg / 13.2 lbs | Meets the specified temperature, time, and drying for sterilization. |
| Hollow/Unwrapped | IUSS CYCLE* for unwrapped dental handpieces on trays. | 132°C / 270°F for 4 minutes | Not Applicable | 6.0 Kg / 13.2 lbs | Meets the specified temperature and time for sterilization. |
| Hollow/Wrapped | Single-pouched dental handpieces on a pouch rack. | 132°C / 270°F for 4 minutes | 25 minutes (up to 6 kg / 13.2 lbs)
15 minutes (up to 1.4 kg / 3 lbs) | 6.0 Kg / 13.2 lbs | Meets the specified temperature, time, and drying for sterilization. |
| Textiles/Porous Wrapped | Textiles | 132°C / 270°F for 4 minutes | 20 minutes | 2.0 Kg / 4.4 lbs | Meets the specified temperature, time, and drying for sterilization. |
| Rubber & Plastic | IUSS CYCLE* for unwrapped solid or hollow instrument | 121 °C / 250°F for 20 minutes | Not Applicable | 2.0 Kg / 4.4 lbs | Meets the specified temperature and time for sterilization. |

*IUSS: Immediate Use Steam Sterilization cycle.
**For optimal drying of these loads, SciCan recommends using only one pouch rack loaded on the second from top rail.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes a steam sterilizer, not an AI/diagnostic device that relies on a test set of 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 information is not applicable. Sterilizers are validated through engineering and microbiological testing, not expert interpretation of outputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   This information is not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   This information is not applicable. The device operates as a standalone sterilizer, but the concept of "standalone performance" as it applies to an AI algorithm is not relevant here. Its performance is inherent to its mechanical and thermodynamic operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   The "ground truth" for a steam sterilizer would be the achievement of sterility according to validated microbiological standards (e.g., sterilization of biological indicators), and the physical parameters (temperature, pressure, time) being met. This document does not detail the specific validation studies but rather presents the approved operational parameters once those validations are complete.

8. The sample size for the training set
   This information is not applicable.

9. How the ground truth for the training set was established
   This information is not applicable.

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The SALUS® - Hygiene is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The SALUS® - Hygiene is a reusable instrument reprocessing container intended to enclose and organize instruments that are designed to withstand steam sterilization and to maintain sterility of the reusable instruments during storage. The SALUS - Hygiene is suitable for use in dynamic air removal steam sterilizers.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "SALUS® - Hygiene Instrument Reprocessing Container." It outlines the FDA's determination of substantial equivalence for the device. Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/Machine Learning medical device.

Instead, this document pertains to a physical medical device (a sterilization container) and its performance is demonstrated through validation of sterilization cycles. The "acceptance criteria" here are inherent in the successful validation of these cycles (e.g., sterilization temperature, exposure time, drying time for specific sterilizer types and loads). The "study that proves the device meets the acceptance criteria" refers to the sterilization validation studies conducted by the manufacturer, the results of which are summarized in the table provided.

Therefore, I cannot extract the information required for an AI/ML device from this document. The questions you've posed (sample size for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are specific to the development and validation of AI/ML algorithms, not sterile processing containers.

If you can provide a document describing the regulatory submission and validation for an AI/ML medical device, I would be happy to help answer your questions.

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The STATIM 2000/5000 G4 Cassette Autoclaves are steam flush pressure pulse dynamic air removal steam autoclaves designed for the reprocessing of reusable medical instruments to achieve successful sterilization in a clinical setting. They utilize saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms.

The units are intended to sterilize heat and moisture stable medical instruments (including handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The STATIM 2000/5000 G4 Cassette Autoclaves are only intended for heat stable instruments.

Not Found

This document is a 510(k) premarket notification from the FDA regarding the STATIM 2000/5000 G4 Cassette Autoclave. It outlines the intended use and sterilization cycles of the device but does not contain information on acceptance criteria for device performance, nor does it describe any study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information, which typically involves performance metrics like sensitivity, specificity, accuracy, F1-score, AUC, or other statistical measures, and details about a study conducted to validate these metrics.

The document only states the cycles, temperatures, times, and max loads for different types of instruments for sterilization. It confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to a device already on the market and does not raise different questions of safety and effectiveness.

To directly answer your numbered points based only on the provided document:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The tables show intended use parameters (temperature, sterilization/drying time, max load, intended use) for different cycles, not performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
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): Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
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 device is an autoclave, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an autoclave, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document. For a sterilizer, ground truth would typically relate to microbiological inactivation verification (e.g., spore log reduction), but details are absent.
8. The sample size for the training set: Not applicable. This device is an autoclave, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence for a medical device (autoclave), and as such, it focuses on the device's intended use and regulatory classification rather than detailed performance study results or AI-specific evaluation criteria.

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The E-STATIS type 40 dental system is intended for use by dental professionals in the performance of dental restoration, prophylaxis and endodontic procedures.

The E-STATIS 40 System is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. The system provides control for motorized handpieces by converting pneumatic output from the dental treatment center to permit the operation of electrically driven dental handpieces.

The E-STATIS type 40 Electric Motor System is designed for use in various dental procedures including dental restoration, prophylaxis and endodontics. The system is comprised of a power supply, control unit, hose and a brushless micro motor.

The control unit is equipped with five customizable endo settings including torque control, with the option of auto-stop, auto-forward and auto-reverse-forward. In addition, there are also three standard customizable operative modes. All E-STATIS components are modular and can be placed wherever the operator chooses.

The inputs to the control unit are supplied by a control panel with touch screen operation. The touch-sensitive screen has clear, user friendly symbols and provides individual selection and usage of the parameters to the individual needs of the dentist. The touch pad is removable and can be mounted either internally or externally on the dental unit.

Here's an analysis of the provided text regarding the E-STATIS 40 System, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary for a medical device (E-STATIS 40 Electric Motor System). A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies as might be found in a PMA (Premarket Approval) submission. Therefore, some of the information requested, particularly regarding clinical study details like sample sizes, expert qualifications, and specific efficacy metrics, is not typically included or required in a 510(k) submission of this nature.

However, I will extract and infer information relevant to your request based on the available text.

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format for a clinical study. Instead, the "performance" discussed relates to the engineering and functional specifications of the device, which are typically verified through validation testing.

Table of Acceptance Criteria and Reported Device Performance (Inferred/Summarized):

Study Details:

Given the nature of a 510(k) for a dental handpiece, the "study" referred to is primarily performance testing (bench testing) and validation testing rather than a large-scale clinical trial.

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

   • Sample Size: Not specified for the performance testing. For devices like this, the "sample size" would refer to the number of units tested. This information is typically detailed in internal validation reports, not in the 510(k) summary.
   • Data Provenance: The testing was conducted by or for the manufacturer, SciCan, based in Toronto, Canada. The data is internal testing data. It is retrospective/prospective bench testing, not clinical data from patients.

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

   • This is not applicable to this type of submission. The "ground truth" for the device's functional performance (speed, torque, safety) is established by engineering specifications, recognized industry standards (e.g., for electrical safety, EMC), and material science principles, not by expert consensus on clinical cases.

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

   • Not applicable. Adjudication methods are relevant for clinical studies where human interpretation of data (e.g., radiology images) requires consensus. For device performance testing, results are quantitative and objective.

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:

   • No, this was not done. This device is a mechanical dental motor system, not an AI-assisted diagnostic tool. MRMC studies are specific to evaluating diagnostic accuracy and reader performance, commonly in imaging.

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

   • No, this was not done. This is not an algorithmic or AI-based device. Its performance is purely mechanical and electrical, designed to be used by a human dental professional.

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

   • The "ground truth" for the performance testing of this device is based on engineering specifications, industry standards, and validated measurement techniques. For example, the accuracy of the RPM measurement would be verified against traceable calibration standards. Software functionality would be verified against design requirements.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/machine learning model for this medical device. The device's operation is deterministic based on its hardware and programmed software, not learned from a dataset.

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

   • Not applicable. As there is no training set.

Summary regarding the 510(k) context:

A 510(k) submission aims to demonstrate "substantial equivalence" to a predicate device. For mechanical and electrical devices like the E-STATIS 40 System, this primarily involves:

• Showing the same intended use.
• Having similar technological characteristics (e.g., operating principles, design).
• Providing performance testing (bench testing) to ensure the device meets its own specifications and is safe and effective when compared to the predicate, often by referencing recognized standards (e.g., electrical safety, EMC).
• Software validation to ensure the software performs as intended.

The document states, "Performance testing was conducted to evaluate the rotational speed and torque measurements of the devices. Testing was also conducted to validate the safety and efficiency of the device, including electrical safety, electromagnetic compatibility and validation verification testing of the software. Testing was conducted in accordance with recognized standards." This sentence summarizes the scope and nature of the "study" that supports the device meeting its functional requirements and, by extension, being substantially equivalent to its predicates.

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The BRAVO series of Autoclaves are intended to be used in medical and dental practices, hospitals, clinics and other associated facilities to sterilize re-usable medical and dental instruments (including dental handpieces) and medical materials that are heat and moisture resistant and compatible with the steam sterilization process.

The BRAVO series of Autoclaves are not intended nor recommended for the sterilization of fluids, liquids, or pharmaceutical products.

The BRAVO series of Autoclaves are table-top vacuum steam sterilizers designed to process medical and dental instruments to achieve successful sterilization. The units utilize saturated steam at high pressures and temperatures to attain an effective kill of infectious bio-organisms.

BRAVO autoclaves are equipped with either a 17 or 21 litre sterilization chamber and feature an advanced fractionated vacuum system to achieve complete air removal from the sterilization chamber and effective final vacuum drying with an effective final vacuum to minimize the presence of condensation from the finished load.

Instruments are placed onto a sterilization tray which is then inserted into the sterilization chamber and the unit is closed. One of the ten pre-set sterilization cycles is selected and the unit is started. The units are fully automatic for the complete sterilizing cycle.

An exclusive steam generation system, combined with an advanced control system, guarantees optimal thermodynamic parameters during the entire sterilization process.

The devices offer sterilization programs optimized for the effective and fast sterilization of various instruments and materials used in the medical and dental environments. Depending on the preset cycle chosen, the devices will progress through a series of pulses which consist of one to three vacuum draws followed by pressurization to create steam in order to remove any air from the sterilization chamber. They will then maintain the projected sterilization time, vent down to atmospheric conditions and begin a heated vacuum dry cycle that will run for a predetermined period of time depending on the model as well as the cycle selected. The devices then return to atmospheric conditions so that the door can be opened to remove the processed load.

This document describes the BRAVO series of autoclaves (17, 17V, 21V) and formally requests its clearance by the FDA under 510(k) K090265. The submission highlights the device's technological characteristics, intended use, and substantial equivalence to a predicate device (M.O.C.O.M. Millennium series Autoclaves, K050263).

However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

The tables in the document describe the available sterilization programs, their parameters (temperature, sterilization time, dry time), maximum load, and intended use. These are specifications of the device's functionality rather than acceptance criteria for a performance study.

Therefore, for the information requested regarding acceptance criteria and a study proving their fulfillment, the following can only be inferred as not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: The document lists the operational parameters for each sterilization cycle (e.g., "134°C (273°F)" for "4 min." sterilization time, "16.5 min" dry time for "134 POROUS/WRAPPED" cycle). These are the designed performance parameters, not measured performance against specific acceptance metrics in a study. The document states that the devices "guarantees stable and homogeneous thermodynamic parameters during the entire sterilization process," but it doesn't provide data to support this claim, nor does it define what "stable and homogeneous" specifically means as an acceptance criterion.

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

• Sample Size: Not mentioned.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned.

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

• Not applicable as no specific performance study with a test set and ground truth is described.

4. Adjudication Method for the Test Set:

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study is not mentioned. This type of study is more relevant for diagnostic devices where human interpretation is involved, not for an autoclave that performs a fixed sterilization cycle.

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

• While the autoclave operates autonomously, the document does not describe a "standalone performance study" in the context of an algorithm's performance. The device's operation is its standalone performance, and the parameters listed are its functional specifications.

7. The Type of Ground Truth Used:

• Not applicable as no specific performance study requiring ground truth is described. For an autoclave, "ground truth" would typically relate to successful sterilization (e.g., biological indicator kill rates). This information is not provided.

8. The Sample Size for the Training Set:

• Not applicable as this is not a machine learning or algorithm-based device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Not applicable.

Summary of what is available from the document:

The provided text focuses on the functional specifications of the BRAVO autoclaves, establishing their intended use and claiming substantial equivalence to a predicate device. It describes the sterilization cycles (temperature, time, load capacity) but does not detail any specific performance studies with acceptance criteria, test sets, or ground truth data. Such information would typically be found in verification and validation reports, which are usually referenced or summarized within a 510(k) submission but are not fully elaborated in this summary.

The document implicitly relies on the fact that an autoclave, operating at specified temperatures and times, under validated conditions (which are not detailed here), is accepted as achieving sterilization. The submission leverages the predicate device's prior clearance and presumably similar technological characteristics and performance metrics.

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The STATIM 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection.

The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) that are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 134℃ (273%) or 121 °C (250°F). The STATIM 7000 Cassette Autoclave is not intended nor recommended for the sterilization of liquids, cloths, text les, biomedical waste and certain rubber and plastic materials specified in the Operator's Manual.

The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 7000 Cassette Autoclave are as follows:

The STAT/M 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization. The unit utilizes saturated steam at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. Instruments are placed within the provided cassette, the cassette is placed within the armature, the cycle parameters are selected and the start button depressed. The unit is then fully automatic for the complete sterilizing cycle.

The provided document, K072466, is a 510(k) Summary for the STATIM 7000 Cassette Autoclave. This document outlines the device's intended use and general characteristics, but it is not a study report proving the device meets specific acceptance criteria based on performance studies.

A 510(k) submission generally relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive performance studies with detailed acceptance criteria and statistical analysis as might be found for a novel AI/software device. For a sterilizer, performance is typically confirmed through validation studies (e.g., biological indicator tests, temperature distribution studies) conducted internally by the manufacturer against recognized standards. These summaries rarely include the detailed data asked for in your prompt.

Therefore, many of the requested fields cannot be filled from the provided text because the document is not a performance study report in the way your prompt describes for a device involving AI or software analysis of data.

Here's an attempt to answer based on the available information, noting where data is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines the intended use and operational parameters (temperature, time) for different sterilization cycles. For a sterilizer, the ultimate acceptance criterion is achieving sterilization (i.e., effective kill of infectious bio-organisms). The "reported device performance" in this context refers to the specified cycle parameters that are intended to achieve sterilization. The document does not provide quantitative performance metrics (e.g., sterilization assurance level, spore log reduction) and a direct comparison to
acceptance criteria for those metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not provided. This document is a 510(k) summary, not a detailed study report. Sterilizer performance is typically established through validation studies. The specific sample sizes (e.g., number of cycles, number of biological indicators) for such validation would not typically be in a 510(k) summary. Data provenance would likely be from the manufacturer's internal testing facilities (SciCan Ltd. in Canada).

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

• Not applicable/Not provided. For a sterilizer, "ground truth" for basic performance validation is established by objective measurements (temperature probes, pressure sensors) and the results of biological indicators (e.g., sterility achieved or not). It does not involve expert interpretation in the way an AI diagnostic device would.

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

• Not applicable/Not provided. Adjudication methods are relevant for subjective interpretations by multiple experts, which is not the case for sterilizer validation.

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 device is a sterilizer, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance in interpretation.

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

• Not applicable. This device is a mechanical/electrical sterilizer, not an algorithm.

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

• For sterilizers, the ground truth for effectiveness is typically established through:
  • Biological Indicator (BI) tests: Using highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to ensure sterilization. Failure to recover viable spores after a cycle indicates sterilization.
  • Physical Monitoring: Calibrated sensors to verify temperature, pressure, and time parameters are met throughout the sterilization chamber.
  • Chemical Indicators (CI): Strips or labels that change color when exposed to specific sterilization conditions.
• The document itself does not explicitly state which of these methods were used for validation, but these are standard for sterilizer testing.

8. The sample size for the training set

• Not applicable/Not provided. This device is a sterilizer. It does not use "training data" in the sense of machine learning. Its design and performance are based on engineering principles (thermodynamics, microbiology) and validation studies, not on learning from a dataset.

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

• Not applicable. See point 8.

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