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The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes for sterilization in any of the following sterilization machines/cycles:

• · STERRAD 100NX sterilization system using the Express and DUO cycles
• · STERRAD 100S sterilization system using the Standard cycle
• · Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• · Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
• · Steris V-PRO 1 using the V-PRO/Lumen cycle
  The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 12.2 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

The Endoscope Sterilization Tray is a stainless steel tray with silicone inserts and a stainless steel lid. The tray and lid have a grid pattern to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100NX and 100S and Steris V-PRO maX V-PRO 1 Plus and V-PRO 1 sterilization systems.

The provided text describes the regulatory clearance (K183139) for an "Endoscope Sterilization Tray" by Intuitive Surgical, Inc. It is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to demonstrate substantial equivalence, rather than proving safety and effectiveness de novo. Therefore, the study described is a non-clinical performance study to demonstrate substantial equivalence to the predicate device K180964, not a clinical study to establish new efficacy or safety claims.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial (e.g., a specific sensitivity or specificity threshold). Instead, it lists various tests performed to demonstrate that the device meets its functional requirements and is substantially equivalent to the predicate device. The "reported device performance" refers to the outcome of these tests.

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

• Sample Size: The document does not specify exact numerical sample sizes for each test. Phrases like "The subject Endoscope Sterilization Tray underwent..." or "Each tray was inspected..." suggest that multiple devices were tested for durability and reuse, but precise numbers are not given. For biocompatibility, it references "established biocompatibility results of the predicate device," implying no new animal or human testing for the subject device for biocompatibility.
• Data Provenance: The studies are described as "non-clinical testing" conducted by Intuitive Surgical, Inc. (the manufacturer). This is retrospective in the sense that it relies on existing knowledge for biocompatibility and laboratory/bench testing for performance. The location of the testing is not specified, but it's internal to the company or contracted out for specific tasks like sterilization validation.

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

Not applicable. This is not a study involving human interpretation or subjective data requiring expert consensus or ground truth establishment by human experts. It is a performance study of a physical medical device.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective data. The tests are objective performance measurements against engineering specifications and industry standards.

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

No. An MRMC study is relevant for diagnostic imaging or similar applications where multiple human readers interpret cases. This document describes non-clinical performance testing of a sterilization tray.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, industry standards (e.g., ANSI/AAMI ST77, ISO 10993-1, ASTM D4169-09), and validated test protocols designed to assess its functional requirements, biocompatibility, and ability to withstand sterilization and handling. For sterilization efficacy, the "ground truth" is typically defined by microbial reduction levels (e.g., sterility assurance level) achieved in validated sterilization cycles.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device that requires a training set.

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

Not applicable. This is not an AI/algorithm-based device that requires a training set.

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The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes for sterilization in any of the following sterilization machines/cycles:

• STERRAD 100NX sterilization system using the Express cycle .
• . STERRAD 100S sterilization system using the Standard cycle
• Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles ●
• Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles .
• Steris V-PRO 1 using the V-PRO/Lumen cycle

The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 8.9 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated. FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

The Endoscope Sterilization Tray (P/N: 400490) is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is intended for use to encase and protect compatible da Vinci Xi endoscopes (Model #'s 470026, 470027) during the transport and sterilization process.

The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight; it is the same tray as no changes were made to these parameters.

This document is a 510(k) premarket notification for an Endoscope Sterilization Tray (K180964). It asserts substantial equivalence to a previously cleared predicate device (K170640). The core argument is that the subject device is identical to the predicate device in design, materials, and manufacturing processes, with only a minor change to the reprocessing instructions related to where specific endoscope model numbers are referenced.

Therefore, the information you've requested about acceptance criteria and a study proving the device meets those criteria is largely absent because the submission relies on a claim of identity to a previously cleared device, not new performance data.

Here's an attempt to fill in the requested information based on the provided text, with many fields indicating "Not Applicable" or "Not Provided" due to the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The only change made from the predicate's IFU was the removal of specific da Vinci Xi Endoscope model numbers (PNs: 470026 and 470027) from the IFU Statement. These model numbers are now referenced within the reprocessing instructions to clarify usage. The device is still explicitly stated to be used only with these specific da Vinci Xi Endoscope models. |
| Sterilization Process | Compatibility with specified sterilization machines/cycles and maintained effectiveness of the sterilization process. | "Additionally there are no changes to the sterilization process parameters between the subject device and the predicate device; therefore sterilization validation testing was not repeated." This implies that the previous validation for the predicate device is considered applicable. |
| Cleaning | Device must be cleanable. | "Cleaning...testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device." Implies compliance based on predicate device data. |
| Biocompatibility | Materials used in the device must be biocompatible. | "Biocompatibility...testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device." Implies compliance based on predicate device data. |
| Bench Testing | Device performance and protection capabilities must be demonstrated through bench testing. | "Bench testing were not repeated as the subject device design, materials, and manufacturing processes are identical to the predicate device." Implies compliance based on predicate device data. |
| Physical/Chemical Properties | Physical/chemical properties must be identical to the predicate device. | "The physical/chemical properties of the subject device are identical to the predicate device, since there are no changes to the tray features and materials." |

Regarding the study that proves the device meets the acceptance criteria:

The provided document does not describe a new study to demonstrate that the subject device (K180964) meets specific acceptance criteria. Instead, it relies entirely on the assertion of substantial equivalence to a previously cleared predicate device (K170640). The fundamental premise is that because the device itself is identical to the predicate (same design, materials, weight, manufacturing processes), and the only change is in the documentation (where specific model numbers are referenced), no new performance testing (cleaning, biocompatibility, sterilization validation, bench testing) was deemed necessary.

Therefore, the "study" is effectively the original substantial equivalence determination for the predicate device (K170640), which would have included such testing. This current submission leverages that prior clearance.

Additional Requested Information (based on provided text):

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

• Sample Size: Not Applicable / Not Provided (no new testing performed for this submission)
• Data Provenance: Not Applicable / Not Provided (no new testing performed)

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

• Number of Experts: Not Applicable / Not Provided (no new testing performed and no ground truth establishment relevant to this specific submission)
• Qualifications of Experts: Not Applicable / Not Provided

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

• Not Applicable / Not Provided (no new testing performed)

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 / Not Provided. This device is a physical sterilization tray, not an AI or diagnostic device.

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

• Not Applicable / Not Provided. This device is a physical sterilization tray, not an algorithm.

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

• Not Applicable / Not Provided. For the predicate device, the ground truth would have been established through validated sterilization efficacy, cleaning efficacy, and biocompatibility testing according to relevant standards.

8. The sample size for the training set:

• Not Applicable / Not Provided. This is not an AI/machine learning device.

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

• Not Applicable / Not Provided. This is not an AI/machine learning device.

Ask a specific question about this device

The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in any of the following sterilization machines/cycles:

• · STERRAD 100NX sterilization system using the Express cycle
• · STERRAD 100S sterilization system using the Standard cycle
• · Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• · Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
• · Steris V-PRO 1 using the V-PRO/Lumen cycle
  The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 8.9 lbs. The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

The Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi Endoscopes during the sterilization process. It is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and the lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope.

This document is a 510(k) premarket notification for an "Endoscope Sterilization Tray" (K170640) and does not contain detailed information about acceptance criteria and the comprehensive study that proves the device meets them in the context of the requested questions. This type of FDA filing primarily establishes substantial equivalence to a predicate device, rather than providing granular performance data or detailed study methodology as would be included in a clinical trial report.

However, based on the provided text, I can extract the following information relevant to device performance and testing:

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

The document mentions that "Performance test data demonstrates that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements."
The testing mentioned is:

• Cleaning Validation
• Human Factors Validation

No specific quantitative acceptance criteria or reported device performance metrics are provided in this document. The overall "performance" is stated as being "substantially equivalent" to the predicate.

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

This information is 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)

This information is not provided in the document. The device is a sterilization tray, not a diagnostic or AI device that would typically involve expert ground truth generation.

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

This information is not provided in the document. As addressed above, this type of adjudication is typically for diagnostic interpretation, not for validating a sterilization tray.

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 type of study is not applicable and was not performed for this device. This device is an Endoscope Sterilization Tray, not an AI-assisted diagnostic tool.

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

This is not applicable and was not performed for this device. This device is an Endoscope Sterilization Tray, not an AI algorithm.

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

For "Cleaning Validation," the ground truth would likely be established through standardized laboratory testing methods to detect residual soil or microbial load, adhering to relevant industry standards (e.g., AAMI, ISO).
For "Human Factors Validation," the ground truth would typically be observations of user interactions and assessment against usability criteria, often involving user tasks and satisfaction surveys.
Specific details are not provided in the document.

8. The sample size for the training set

This information is not provided and is not applicable as this is not an AI/ML device.

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

This information is not provided and is not applicable as this is not an AI/ML device.

In summary: The provided FDA 510(k) document focuses on establishing substantial equivalence for a physical medical device (sterilization tray) and, as such, does not contain the detailed performance study information typically requested for AI/ML or diagnostic devices. The performance data mentioned relates to cleaning and human factors validation, but specific results, sample sizes, and detailed methodologies are not included in this summary.

Ask a specific question about this device

The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in any of the following sterilization machines/cycles:
• STERRAD 100NX sterilization system using the Express cycle
• STERRAD 100S sterilization system using the Standard cycle
• Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
• Steris V-PRO 1 using the V-PRO/Lumen Cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of tray and endoscope is 8.9 lbs.
The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

The Endoscope Sterilization Tray is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) during transport and sterilization. The tray is compatible with the STERRAD 100NX (Express cycle), STERRAD 100S (Standard cycle) and the following Steris low temperature hydrogen peroxide gas sterilization systems:

• o Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
• o Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
• Steris V-PRO 1 using the V-PRO/Lumen Cycle o
  The subject Endoscope Sterilization Tray and predicate tray are identical in terms of design, materials, dimensions and weight. The purpose of this 510(k) is to update the Indications for Use to reflect that the tray can accommodate a heavier endoscope. The previous Indications for Use reflected that the tray could accommodate a maximum of 7.7 lbs for the combined weight of the endoscope and tray, while the Indications for Use in this 510(k) reflect that the tray can accommodate a maximum of 8.9 lbs for the combined weight of the endoscope and tray.

This document describes a 510(k) premarket notification for an "Endoscope Sterilization Tray" (K151450) from Intuitive Surgical, Inc. The purpose of this submission is to update the Indications for Use for an existing, legally marketed predicate device (K142937) to accommodate a heavier endoscope.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative manner as one might expect for a diagnostic or AI-driven device. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its ability to accommodate a heavier endoscope and maintain sterilization efficacy.

The key performance aspect being validated is the ability of the tray to facilitate sterilization with the specified sterilizers, even with an increased maximum weight. The "acceptance criteria" can be inferred from the "Performance Data" section.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the "sterilization validation and bench testing." It generally refers to "testing conducted."
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission from a US-based company (Intuitive Surgical, Inc., Sunnyvale, CA 94086), the testing would typically be conducted according to US regulatory standards and likely in a controlled laboratory environment. It is a retrospective evaluation against a predicate device.

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

• This information is not provided in the document. The nature of the device (sterilization tray) doesn't typically involve expert interpretation of medical images or conditions for establishing "ground truth" in the way a diagnostic AI device would. The "ground truth" here is the physical ability to hold the endoscope and allow for effective sterilization, which is assessed through laboratory testing and engineering specifications.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple experts. For this device, the "acceptance" is based on meeting technical specifications and demonstrating equivalency through validation tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study was not done. This device is an endoscope sterilization tray, which is a physical medical device, not a diagnostic or AI-assisted system that involves human readers or interpretation of cases. Therefore, the concept of "human readers improving with AI" is not relevant here.

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

• Not applicable/Not done. This device is a physical product, not an algorithm. The concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this device is based on engineering and performance specifications related to the physical dimensions of the tray, its material properties, and its ability to withstand and facilitate sterilization processes.
  • Weight Capacity: The actual measured weight of the endoscope and tray against the specified maximum.
  • Sterilization Efficacy: Demonstrated through validation tests that confirm the sterilizer cycles achieve the required sterility assurance level (SAL) when the endoscope is contained within the tray. This would involve standard microbiology tests, not expert consensus on medical images or pathology.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable/Not provided. As there is no training set for an AI/ML algorithm, there is no ground truth established for a training set. The relevant "ground truth" for this medical device's function (sterilization and protection) is established through established scientific and engineering principles and validated testing protocols.

Ask a specific question about this device

The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in any of the following sterilization machines/cycles:
STERRAD 100NX sterilization system using the Express cycle
STERRAD 100S sterilization system using the Standard cycle
Steris V-PRO maX using the Non Lumen, Flexible, or Lumen cycles
Steris V-PRO 1 Plus using the Non Lumen or Lumen cycles
Steris V-PRO 1 using the V-PRO/Lumen Cycle
The sterilization cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci Xi Endoscope. The length of the da Vinci Xi Endoscope is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of tray and endoscope is 7.7 lbs.
The Endoscope Sterilization Tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared STERRAD and Steris compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

The Endoscope Sterilization Tray is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Steroscope Sterilization Tray is designed to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) during transport and sterilization. The tray is compatible with the STERRAD 100NX (Express cycle), STERRAD 100S (Standard cycle), and the following Steris low temperature hydrogen peroxide gas sterilization systems:
Steris V-PRO maX using the Non Lumen, Flexible, or Lumen Cycles
Steris V-PRO 1 Plus using the Non Lumen or Lumen Cycles
Steris V-PRO 1 using the V-PRO/Lumen Cycle
The Endoscope Sterilization Tray is the same tray previously cleared for sterilizing the endoscopes in STERRAD sterilizers. The tray is now validated for use in the Steris sterilization systems and the Indications for Use are being modified to reflect that capability.

Based on the provided text, the document is a 510(k) premarket notification for an Endoscope Sterilization Tray. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new, innovative device (like an AI algorithm).

Therefore, much of the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, effect size of human improvement with AI, standalone performance, training set details) is not applicable to this document, as it is related to the validation of a medical device involving software or AI, particularly for diagnostic or interventional tasks.

The document discusses the performance data in terms of sterilization validation and limits of reuse testing for the sterilization tray, demonstrating its functionality and safety. The acceptance criteria here are related to ensuring the tray effectively facilitates sterilization and maintains its integrity over multiple uses, making it equivalent to the predicate device.

Here's an attempt to extract relevant information and explain why other parts of your prompt are not present in this document:

Acceptance Criteria and Device Performance (as inferred from the document)

The core "acceptance criteria" for this device, as per a 510(k) pathway, is to demonstrate substantial equivalence to a predicate device. This is achieved by showing that the subject device is as safe and effective, and performs at least as safely and effectively, as the predicate.

For a physical device like a sterilization tray, this typically involves demonstrating:

• Ability to encase and protect the endoscope: This is a fundamental design function.
• Compatibility with specified sterilization systems/cycles: The primary focus of this 510(k) is to expand compatibility to additional Steris V-PRO systems.
• Maintenance of structural integrity and functionality over multiple uses (limits of reuse): Ensuring the tray remains effective after repeated sterilization cycles.
• Cleaning effectiveness: Ensuring the tray can be adequately cleaned.
• Biocompatibility: Ensuring the materials are safe for use in a medical context.

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

   • Sample Size: Not specified in the provided summary. For a physical device like this, test samples would be units of the sterilization tray itself subjected to various tests.
   • Data Provenance: The tests would have been performed in a laboratory setting by the manufacturer (Intuitive Surgical, Inc.). The document doesn't specify if the testing was retrospective or prospective in the sense of clinical studies, but it would be prospective lab testing for device validation.

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

   • N/A. This device does not involve expert interpretation or ground truth establishment in the context of diagnostic performance (e.g., radiology images). The "ground truth" for a sterilization tray is its measurable physical performance and its ability to facilitate sterilization, which is determined through engineering and microbiology testing.

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

   • N/A. No adjudication method is applicable for the validation of this type of device.

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:

   • N/A. This device is not an AI software and does not involve human readers for diagnostic interpretation.

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

   • N/A. This is a physical medical device, not an algorithm.

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

   • The "ground truth" for this device's performance would be established by:
     • Standardized sterilization efficacy tests: e.g., using biological indicators or thermocouples to verify sterility within the tray after a cycle.
     • Mechanical and material property tests: e.g., stress testing, dimensional stability measurements, visual inspection for damage after reuse cycles.
     • Biocompatibility standards: Confirmation that materials meet established safety standards.

7. The sample size for the training set:

   • N/A. This is not an AI/ML device, so there is no "training set."

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

   • N/A. Since there is no training set, this is not applicable.

Ask a specific question about this device

The Intuitive Surgical Endoscope Sterilization Tray is intended for use to encase and protect da Vinci Xi endoscopes (Model #'s 470026 and 470027) for sterilization in the STERRAD 100NX sterilization system using the Express cycle and in the STERRAD 100S sterilization system using the standard cycle. The sterilization cycle parameters of the sterilizers are preset by the manufacturer and are not adjustable. The maximum product load per tray is 1 da Vinci Xi Endoscope. The max weight of tray and endoscope is 7.7 lbs.

The Intuitive Surgical Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

The Endoscope Sterilization Tray is a thermoformed plastic tray with silicone inserts and a clear lid. The tray and lid contain perforations to allow sterilization gases to penetrate the tray and sterilize the endoscope. The Endoscope Sterilization Tray is designed to encase and protect da Vinci endoscopes during transport and sterilization. The tray is compatible with the STERRAD 100NX and 100S sterilization systems.

This document is a 510(k) Summary for the Intuitive Surgical Endoscope Sterilization Tray (K133942), which is a Class II device. It primarily details a comparison to a predicate device to demonstrate substantial equivalence, rather than providing a detailed study of its own performance against pre-defined acceptance criteria for an AI/CADe device.

Therefore, many of the requested sections for AI/CADe device studies, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies, are not applicable to this document. This document describes a medical device used for sterilization, not an algorithm or AI system.

However, I can extract the general "performance data" claims from the document as it relates to demonstrating substantial equivalence.

Here's an attempt to answer based solely on the provided text, acknowledging that it does not contain the specific details typically found in AI/CADe performance studies.

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

The document does not explicitly state quantitative acceptance criteria in a table format for performance beyond "dimensional measurements" and "functional verification." It concludes that the device "meets the design input requirements."

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

This information is not provided in the document. The document refers to "Performance test data (bench, cleaning, and sterilization tests)" but does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective nature).

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 as this is not an AI/CADe device and no "ground truth" in the context of expert review for medical image analysis is described. The device's performance is assessed through physical, chemical, and biological tests related to cleaning and sterilization.

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

This information is not applicable as this is not an AI/CADe device and no adjudication method for expert review of a test set is described.

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. An MRMC study is relevant for AI/CADe devices to assess the impact on human reader performance. This document concerns a physical medical device (sterilization tray).

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

This information is not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant for a sterilization tray.

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

This information is not applicable in the context of AI/CADe devices. For this device, the "truth" or "success" of performance would be determined by objective measurements and standardized test methods for cleaning and sterilization effectiveness (e.g., microbial kill, absence of residues, structural integrity).

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/CADe device.

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

This information is not applicable. There is no "training set" or corresponding "ground truth" for this type of medical device.

Ask a specific question about this device

The FinESS Endoscope Sterilization Tray is intended for use to encase and protect the FinESS Endoscope for sterilization in STERRAD 100NX using the standard cycle setting and NX Sterilization Systems using the advanced cycle setting.

• The sterilization cycle parameters of the STERRAD sterilizers are preset by the manufacturer and are not adjustable.
• The maximum product load per FinESS Endoscope Sterilization Tray includes 1 FinESS Endoscope and 2 light post adapters.
  The FinESS Endoscope Sterilization Tray is intended to be used with legally marketed, FDA-cleared STERRAD compatible sterilization wrap in order to maintain sterility of the enclosed endoscope.

The FinESS Endoscope Sterilization Tray is comprised of a bottom, a clear lid, and silicone inserts designed to secure the FinESS Endoscope in place. The lid is clear and secured to the tray with a snap fit mechanism. The FinESS Endoscope Sterilization Tray contains perforations in the base and lid to allow the sterilant to penetrate. The use of commercially available sterilization wrap allows the tray to maintain sterility after sterilization.

The FinESS Endoscope Sterilization Tray (K103213) is intended to encase and protect the FinESS Endoscope for sterilization.

1. Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a specific sample size for each test (design verification, biocompatibility, sterilization efficacy).
The data provenance is not specified (e.g., country of origin, retrospective or prospective), but given the context of a 510(k) submission, it would be laboratory-generated data from the manufacturer (Entellus Medical, Inc.).

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

This information is not explicitly provided. For sterilization efficacy, ground truth (SAL of 10⁻⁶) is typically established through standardized microbiological testing methods, often performed by trained microbiologists or specialists in sterilization science within a testing laboratory.

4. Adjudication method for the test set:

Not applicable. The performance testing involves objective measures (e.g., material integrity, microbiological kill rates) rather than human interpretation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a sterilization tray and does not involve AI or human "readers" or diagnostic interpretations.

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

Not applicable. This device is a physical medical device (sterilization tray), not an algorithm or AI system.

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

The ground truth for the performance testing included:

• Design Verification: Established standards for material stability and device integrity after sterilization cycles.
• Biocompatibility: Established toxicological and irritation thresholds in accordance with relevant standards (e.g., ISO 10993 series).
• Sterilization Efficacy: A Sterility Assurance Level (SAL) of 10⁻⁶, which is a universally accepted standard for sterilization, demonstrating a one in a million chance of a non-sterile unit. This is determined through biological indicator testing and D-value calculations.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, and the testing described is performance validation, not machine learning model training.

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

Not applicable. There is no training set involved as this is not a machine learning or AI device.

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The KARL STORZ-ENDOSKOPE Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD 100S and NX Sterilization Systems, as indicated. STERRAD Sterilization Systems are pre-set and the cycle parameters can not be adjusted.

The KARL STORZ-ENDOSKOPE Sterilization Trays are intended only for use to encase and protect specific KARL STORZ reusable medical devices for sterilization in STERRAD 100S and NX Sterilization Systems, as indicated.

The provided text describes a 510(k) premarket notification for Karl Storz-Endoscope Sterilization Trays. It primarily focuses on the regulatory approval and the intended use of the sterilization trays with specific sterilization systems.

Unfortunately, the document does not contain the detailed information requested regarding the acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, or adjudication methods that would typically be found in a clinical study report or a detailed validation study.

The document is a letter from the FDA confirming substantial equivalence and an "Indications for Use" statement, with a table showing compatibility with specific sterilization systems and maximum product loads. These are statements of intended function and compatibility, not a report of performance metrics or specific study results against acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be provided based on the text:

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

The document does not explicitly state quantitative "acceptance criteria" for device performance in terms of efficacy or safety from a study. Instead, it provides a "Sterilization Compatibility and Max Load" table, which acts as a statement of intended performance under specific conditions.

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 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)

This information is not provided in the document. The document describes a medical device, not an AI or diagnostic tool that relies on expert interpretation for ground truth.

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

This information is 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

This information is not applicable/provided. The device is a sterilization tray, not an AI-assisted diagnostic tool.

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

This information is not applicable/provided. The device is a sterilization tray, not an algorithm.

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

This information is not provided within this document. For a sterilization tray, "ground truth" would likely relate to efficacy studies (e.g., microbial kill rates, material compatibility, maintenance of sterility) conducted as part of the validation process, but these details are not in the FDA letter.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

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