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The Turbett Surgical 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 Turbett Surgical Filters.

The unit is intended to be used in a pre-vacuum steam sterilizers with a pre-vacuum cycle of 270°F (132°C) and exposure time of 4 minutes.

• 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 140lbs. is 10 minutes, for loads up to 375 lbs. is 30 minutes.
• The TS1200 Container may be loaded to a maximum weight of 300 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes for loads up to120 lbs. and 30 minutes for loads up to 300 lbs.
• 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 0.7 mm x 500 mm and 1.0 mm x 850 mm rigid and flexible lumens.

Use only uncovered, perforated, or wire mesh general delivery trays within the Turbett Surgical Instrument Pod.

The Turbett Surgical Instrument Pod is a multi-tray 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. Unwrapped, uncovered, perforated sterilization trays are stacked into the container, separated by anodized aluminum dividers, which allow steam to evenly penetrate and allow condensation to drain.

The container is manufactured from 304 stainless steel sheet metal and bar stock. The container is sealed on all sides except one which is the door / filter panel.

The single fenestrated door consists of two perforated anodized aluminum panels which cover the exposed container side wall. A custom-made disposable filter consisting of 2 layers of filter paper separated by a layer of compressible single-use gasket material is placed between the two perforated metal panels of the door. Spring loaded latches compress the anodized aluminum door frame with filter assembly to the container for a secure seal.

The Turbett Surgical Instrument Pod is loaded into the auto clave with a dedicated transfer mechanism and cart.

The provided FDA 510(k) clearance letter and summary for the Turbett Surgical Instrument Pod does not describe an AI/ML device or a study involving human readers or ground truth derived from expert consensus, pathology, or outcomes data. Instead, it describes a rigid sterilization container used for medical instruments.

Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) are not applicable to this medical device submission.

The "study" in this context refers to non-clinical performance testing of the physical sterilization container.

Here's the information that can be extracted and presented based on the provided document, framed within the context of hardware device performance testing:

Device Description

The Turbett Surgical Instrument Pod is a multi-tray rigid sterilization container designed to enclose other medical devices for sterilization by a healthcare provider. It allows sterilization of enclosed materials and maintains sterility for up to 30 days. It is intended for use in pre-vacuum steam sterilizers with specific temperature and exposure times. The container is made of stainless steel and aluminum, includes a single-use filter, and accommodates various sizes of instrument loads and lumens.

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through a series of non-clinical tests to demonstrate its safety and effectiveness as a sterilization container. The acceptance criteria were based on medical device sterilization standards.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical Performance Testing)

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

   • The document does not specify exact sample sizes (e.g., number of containers tested) for each non-clinical test.
   • It mentions three specific container models (TS1500, TS1200, TS1000) and indicates that the system was validated with specific rigid and flexible lumens (0.7 mm x 500 mm and 1.0 mm x 850 mm for the subject device).
   • Data provenance: Not explicitly stated, but typically for 510(k) submissions, non-clinical tests are conducted by the manufacturer or accredited testing laboratories in a controlled environment as part of the design validation process. This is a prospective testing design to meet regulatory standards.

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

   • Not applicable in the context of AI/ML. For this physical device, "ground truth" is established by adherence to recognized consensus standards for sterilization and medical device testing (e.g., ANSI/AAMI ST77:2013, ANSI/AAMI ST79:2007, TIR 30:2011, ANSI/AAMI HE75:2013). The "experts" are the qualified personnel within the testing laboratories who perform the tests according to these validated methods.

3. Adjudication method:

   • Not applicable. This is not a human-in-the-loop or interpretation-based task that would require adjudication. Results are quantitative measurements against defined criteria.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size of improvements:

   • No. This is not a study assessing human reader interpretation of images or data.

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

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is defined by established consensus standards and validated chemical/physical/biological testing methods (e.g., sterility assurance levels, gravimetric measurements for dryness, chemical residue analysis, microbial growth/no-growth observations).

7. The sample size for the training set:

   • Not applicable. No AI/ML training set is mentioned or implied.

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

   • Not applicable. No AI/ML training set is mentioned or implied.

Summary regarding AI/ML criteria: The provided document pertains to a physical medical device (sterilization container) and its non-clinical performance testing. It does not involve AI/ML, human readers, image analysis, or expert consensus-based ground truth typical of AI/ML device clearances.

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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

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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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:

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):

2. 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.
3. 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.
4. 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).
5. MRMC comparative effectiveness study and effect size: Not applicable. This is a physical sterilization container, not an AI-assisted diagnostic tool.
6. Standalone performance (algorithm only without human-in-the loop performance): Not applicable. There is no algorithm. The device performs its function physically.
7. 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.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Turbett Surgical Container 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 Turbett Surgical filters.

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F (132°C) and exposure time of 4 minutes. The container may be loaded with up to 15 trays and up to 25 lbs. per tray.

Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens. The total weight of instruments and trays validated is 375 lbs.

Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.

The Turbett Surgical Container 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 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. Actual expected loads in hospital settings are likely to be less. Sterilized instruments can be stored for up to 30 days within the closed container.

The Turbett Surgical Container 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 Turbett Surgical Container and its approval through the 510(k) pathway, which means it demonstrated "substantial equivalence" to a predicate device. This process typically focuses on comparing the new device's characteristics and performance to a legally marketed predicate, rather than establishing strict acceptance criteria and proving the device meets them through a deeply detailed study in the same way a novel high-risk device might.

However, based on the provided text, we can extract the validation parameters and the evidence used to support the substantial equivalence claim.

Here's an analysis of the "acceptance criteria" and "study" information as it relates to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, specific rigid "acceptance criteria" for performance are not explicitly stated with numerical targets in the same way a clinical trial might, but rather the performance is demonstrated to be equivalent or better than the predicate device across various tests. The "reported device performance" is the outcome of these validation tests.

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

• Sample Size: The document does not specify a numerical "sample size" in terms of how many units of the container were tested, or how many sterilization cycles were performed for each test. It mentions "Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens." This describes the configuration of the test load, not a statistical sample size for the test itself.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a medical device in the US, the testing would typically be conducted by the manufacturer or contracted labs under their direction, likely in a prospective manner according to established standards.

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

This information is not provided in the document. For device validation testing as described (thermal profiles, sterilization efficacy, microbial challenges, etc.), "experts" in the sense of medical professionals establishing a ground truth (like radiologists reviewing images) are generally not involved. Instead, the "ground truth" is established by adherence to recognized consensus standards (like ANSI/AAMI ST77 and AAMI TIR 30) and the scientific principles behind sterilization and cleaning. The "experts" would be the personnel conducting and interpreting these standardized tests, whose qualifications are typically laboratory scientists or engineers specialized in sterilization validation.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation (e.g., image analysis by multiple radiologists) to resolve discrepancies and establish a robust ground truth. For device validation tests like those listed, the results are typically quantitative measurements or pass/fail criteria against a standard, not subject to human interpretation discrepancies that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human performance (e.g., diagnostic accuracy) changes with or without AI assistance. The Turbett Surgical Container is a physical medical device (sterilization container), not an AI algorithm, so this type of study is irrelevant and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone study was not done. This question is also typically relevant for AI/software as a medical device. The Turbett Surgical Container is a physical device; its "performance" is its ability to facilitate sterilization and maintain sterility, which is tested independently of human intervention during the sterilization process itself (though human operators load and unload the device).

7. The Type of Ground Truth Used

The ground truth for the validation of the Turbett Surgical Container was established through adherence to recognized industry standards and scientific principles related to sterilization, cleaning, and human factors. Specifically, the document references:

• ANSI/AAMI ST77: Containment Devices for Reusable Medical Device Sterilization testing (which includes pre-vacuum thermal profile, steam pre-vacuum sterilization efficacy, pre-vacuum dry time, microbial aerosol challenge, and 30-day shelf-life study).
• AAMI TIR 30: A Compendium of Processes, Materials, Test Methods and Acceptance Criteria for Cleaning Reusable Medical Devices testing (protein analysis and Total Organic Carbon Manual cleaning methods).
• ANSI/AAMI HE75: Human Factors Engineering- Design of Medical Devices testing (human factors usability study).

The "ground truth" is that if the device performs successfully under these standardized testing protocols, it meets the requirements for a sterilization container.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning or AI algorithms where data is used to train a model. For a physical medical device like the Turbett Surgical Container, there is no AI model or training set in this context. The manufacturing process and design are based on engineering principles and materials science, not data-driven model training.

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

This information is not applicable because, as explained above, there is no "training set" for this physical medical device.

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