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510(k) Data Aggregation
(253 days)
Turbett Instrument Pod
The Turbett Instrument Pod is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turbett Surgical filters.
The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132C) and exposure time of 4 minutes.
. The TS1500 Container may be loaded to a maximum weight of 375 lbs. in any tray. Minimum drying time for loads up to 140 lbs. is 10 minutes, for loads up to 375 lbs. 30 minutes.
. The TS1200 Container may be loaded to a maximum weight of 120 lbs. in any tray. Minimum drving time is 10 minutes.
The TS1000 Container may be loaded to a maximum weight of 100 lbs. not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.
The system was validated with 1mm x 500mm lumens. .
Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.
The Turbett Instrument Pod is a rigid sterilization container with a fenestrated door holding a single-use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Trays within the container are separated by dividers to ensure separation and maximum steam exposure. The container is available in three sizes (TS1500 34"x24"x22"; TS1200 34" x17" x22"; TS1000 23" x17" x 22"). The original container (TS1500) has been validated to sterilize 375 lbs. of instruments along with the dividers. The validation was conducted with 15 instrument trays at 25 lbs. each to represent the most challenging case. Additional containers include the TS1200 and TS1000 sizes which can hold 120 lbs. of instruments. Sterilized instruments can be transported and stored for up to 30 days within the closed container.
The Turbett Instrument Pod is loaded into the autoclave with a dedicated transfer carriage. The container is constructed of 304 stainless steel with an anodized aluminum filter housing/door.
The use of a single-use disposable filter cartridge installed in the fenestrated door eliminates the need for a sealed gasket found on other rigid containers. The omission of a reusable gasket eliminates contamination risks due to failed reusable gaskets.
The provided text describes the non-clinical testing performed for the Turbett Instrument Pod, a rigid sterilization container. The study aims to demonstrate that the device meets acceptance criteria for sterilization efficacy, thermal profile, and transportation shelf life.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Type of Testing | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Pre-vacuum sterilization efficacy (AAMI ST77, ISO 17665-1) | Demonstrate Sterilization Capabilities | 10-6 SAL (Sterility Assurance Level) | PASSED |
| Thermal Profile (AAMI ST77) | Demonstrate Heat Penetration in Load | Minimum temperature of 270°F (132°C) achieved within 2 minutes and maintained. | PASSED |
| Transportation Shelf life Study (AAMI ST77, Modified ASTM D4169-14) | Simulate transportation followed by a shelf life study. | No growth 30 days following sterilization, loading, unloading, and transport. | PASSED |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test sets for any of the studies (pre-vacuum sterilization efficacy, thermal profile, or transportation shelf life).
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Implicitly, since these are design validation tests, they would be 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)
The document does not mention the use of experts to establish ground truth for this device. The testing described is hardware-centric (sterilization, heat penetration, biological growth), and ground truth is based on physical and microbiological measurements against predefined scientific/engineering criteria (e.g., SAL, temperature, presence of growth).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The concept of adjudication methods (like 2+1, 3+1) is typically relevant for studies involving human interpretation of data, such as medical image analysis. Since this study involves testing of a physical sterilization container against engineering and microbiological standards, adjudication methods are not applicable and are not mentioned.
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 is not an AI/software device. Therefore, no MRMC comparative effectiveness study was done, and this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an algorithm or AI device. Therefore, no standalone performance study in the context of an algorithm was done. The studies listed (sterilization efficacy, thermal profile, transportation shelf life) are inherently standalone in the sense that they evaluate the device's performance against objective criteria, not in conjunction with human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these tests is based on:
- Sterility Assurance Level (SAL): A predefined microbiological standard of 10^-6, meaning a 1 in a million chance of a non-sterile unit.
- Physical Measurements: Specific temperature and time parameters (270°F (132°C) minimum temperature achieved within 2 minutes and maintained).
- Microbiological Culture Results: Absence of microbial growth after specified conditions and timeframes.
Essentially, the "ground truth" is defined by established scientific and engineering standards for sterilization and material handling, as outlined by AAMI ST77, ISO 17665-1, and ASTM D4169-14.
8. The sample size for the training set
This device does not involve machine learning or AI, so there is no training set in the typical sense.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
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(90 days)
Turbett Instrument Pod
The Turbett Instrument Pod is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turbett Surgical filters.
The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132℃) and exposure time of 4 minutes.
o The TS1500 Container may be loaded to a maximum weight of 375 lbs. not to exceed 25 lbs. in any tray. Minimum drying time for loads up to 140 lbs. is 10 minutes, for loads up to 375 lbs. 30 minutes.
. The TS1200 Container may be loaded to a maximum weight of 120 lbs. not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.
The TS1000 Container may be loaded to a maximum weight of 100 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.
The system was validated with 1mm x 500mm lumens. Do not use with instruments containing lumens with an inner diameter of smaller than 1mm and an overall length longer that 500mm.
Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.
The Turbett Instrument Pod is a rigid sterilization container with a fenestrated door holding a single-use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Trays within the container are separated by dividers to ensure separation and maximum steam exposure. The container is available in three sizes (TS1500 34"x24"x22"; TS1200 34" x17" x22"; TS1000 23" x17" x 22"). The original container (TS1500) has been validated to sterilize 375 lbs. of instruments along with the dividers. The validation was conducted with 15 instrument trays at 25 lbs. each to represent the most challenging case. Additional containers include the TS1200 and TS1000 sizes which can hold 120 lbs. of instruments.
Sterilized instruments can be stored for up to 30 days within the closed container.
The Turbett Instrument Pod is loaded into the autoclave with a dedicated transfer carriage. The container is constructed of 304 stainless steel with an anodized aluminum filter housing/door.
The use of a single-use disposable filter cartridge installed in the fenestrated door eliminates the need for a sealed gasket found on other rigid containers. The omission of a reusable gasket eliminates contamination risks due to failed reusable gaskets.
The provided document is a 510(k) summary for the Turbett Instrument Pod, a medical device classified as a sterilization wrap/container. It outlines the device's indications for use, its comparison to a predicate device, and the non-clinical testing performed to demonstrate its safety and effectiveness.
However, this document does NOT describe the acceptance criteria and study proving the device meets those criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled diagnostic or assistive device.
The questions you asked (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are highly relevant to the rigorous evaluation of AI/ML medical devices. The Turbett Instrument Pod is a physical device used for sterilization, and its evaluation process is based on traditional engineering and microbiology testing, not AI/ML performance.
Therefore, I cannot answer the specific questions about AI/ML device acceptance criteria and study details using the provided text. The text does not contain any information about:
- AI/ML algorithms
- Image analysis or diagnostic tasks
- Human reader improvement with AI assistance
- Expert radiologists or multi-reader studies
- Training or test datasets in the context of machine learning
Instead, I can describe the acceptance criteria and study details related to the physical medical device as presented in the document.
Acceptance Criteria and Study for the Turbett Instrument Pod (Physical Sterilization Device)
The Turbett Instrument Pod is a sterilization container. Its acceptance criteria and proof of meeting them are based on its ability to effectively sterilize and maintain sterility of enclosed instruments, as well as its cleanability and physical characteristics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Name of Test/Citation | Purpose | Acceptance Criteria | Results (Reported Device Performance) |
|---|---|---|---|
| Pre-Vacuum thermal profile (TS1000, TS1500) | |||
| ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization | To demonstrate steady-state thermal conditions throughout the containers during processing | Demonstrate various locations within the container can reach and maintain exposure temperature | Pass - All locations at or above exposure temperature |
| Pre-Vacuum sterilization efficacy (TS1500) | |||
| ANSI/AAMI ST77:2006 Containment Devices for Reusable Medical Device Sterilization | To validate sterilization efficacy in a 4-minute steam pre-vacuum cycle | Achieve a 10⁻⁶ SAL (Sterility Assurance Level) | Pass - 10⁻⁶ SAL demonstrated |
| Pre-Vacuum sterilization efficacy (TS1000, TS1500) | |||
| ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization (likely referring to drying test based on results) | To demonstrate drying capability after a 4-minute steam pre-vacuum cycle | Pre/Post weight difference less than 0.2% and no visible moisture after specified drying time | Pass - Units were within weight specifications and visibly dry |
| Microbial Aerosol Challenge (TS1500) | |||
| ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization | To determine microbial barrier properties in maintaining sterility integrity | Demonstrate maintenance of sterility by no growth of internal test coupons following exposure to microbial aerosol | Pass |
| Protein analysis and Total Organic Carbon Manual and Mechanical Cleaning Methods | |||
| AAMI TIR30:2011 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices | To demonstrate effectiveness of manual and mechanical cleaning of the device | Residual protein samples and Total Organic Carbon within test limit | Pass |
| 30-Day Event Related Shelf Life Study (TS1500) | |||
| ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization | To demonstrate container contents can be maintained in a sterile state for up to 30 days | Maintain sterility of contents for 30 days | Pass |
The documentation specifies that testing of the TS1000 and TS1500 models bracketed the parameters for the TS1200, implying that separate explicit tests were not run for the TS1200 for all mentioned criteria, as its performance was inferred from the other two models.
Regarding the AI/ML specific questions (which are not applicable to this document):
- Sample sizes used for the test set and data provenance: Not applicable. For a physical device, "test set" would refer to the number of physical units tested, experimental repetitions, or biological indicators used. The document implies sufficient units were tested to demonstrate the specified criteria, but explicit numbers for each test are not given (e.g., how many cycles or replicate experiments). Data provenance is not mentioned, as it's a physical product test.
- Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for sterilization efficacy is established through standardized microbiological and chemical tests using biological and chemical indicators, not by human expert review of images or data.
- Adjudication method for the test set: Not applicable. Test results are objective measurements (e.g., 10⁻⁶ SAL, weight change, presence/absence of microbial growth, chemical limits).
- MRMC comparative effectiveness study and effect size: Not applicable. This is a physical sterilization container, not an AI-assisted diagnostic tool.
- Standalone performance (algorithm only without human-in-the loop performance): Not applicable. There is no algorithm. The device performs its function physically.
- The type of ground truth used: For sterilization, the ground truth is established through standard laboratory methods utilizing biological indicators (e.g., Geobacillus stearothermophilus spores for steam sterilization) to quantify sterilization assurance levels, along with physical and chemical indicators to monitor cycle parameters. For drying, it's weight change and visual inspection. For cleaning, it's established by specific chemical tests for residual protein and total organic carbon. For microbial barrier, it's the absence of growth after microbial challenge.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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