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The Universal Endoscope Tip Guard is intended to protect tip of the endoscope during transport and storage. It is not intended for use during sterilization.

The Andorate® Universal Endoscope Tip Guard is intended for single use. The universal endoscope tip guard is used to cover distal end of an endoscope prior to transportation and storage. The universal endoscope tip quard is individually packed in sealed package, and it is available both non-sterile and sterile.

The provided document describes the Andorate Universal Endoscope Tip Guard (K202838), which is intended to protect the tip of an endoscope during transport and storage. It is explicitly stated that it is not intended for use during sterilization.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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The Endoscope Tip Protector is intended to be used on the distal tip of an endoscope for the purpose of protecting the endoscope's delicate lens and the endoscope's bending rubber during transport and storage. It may also be used on the distal tip of medical/surgical instruments to protect delicate components/mechanisms.

The Endoscope Tip Protector is a single-use molded protective cover to be used to protect endoscopes and medical/surgical instruments. The design of the Endoscope Tip Protector:

• Is composed on non-porous plastic material that allows for air flow
• Has minimal contact points with the endoscope or medical/surgical instruments
• Fits a wide variety of devices: 4.9mm -15mm outer diameter
• Protects the distal tip of the endoscope or medical/surgical instrument during transport or storage.
  The Endoscope Tip Protector is available both non-sterile and sterile.

Based on the provided text, the Acceptance Criteria and Device Performance for the Endoscope Tip Protector are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each test (e.g., number of endoscope tip protectors tested, number of cycles for transport or attachment/detachment). The data provenance is also not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. It summarily states "Proposed Endoscope Tip Protector" and "PASS" for each criterion.

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

The document does not mention the use of experts to establish ground truth for this device's testing. The tests appear to be physical and biological performance tests rather than subjective evaluations requiring expert consensus.

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

There is no mention of an adjudication method, as the tests outlined are objective performance metrics (e.g., force, time, compliance with standards) rather than interpretations.

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 applicable. The device is a physical endoscope tip protector, not an AI-assisted diagnostic tool or system that would involve human readers or comparative effectiveness studies of AI assistance.

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

This is not applicable. As noted above, the device is a physical product, not an algorithm.

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

The "ground truth" for the tests appears to be defined by industry standards (ISO 10993-10, ISO 10993-5, ASTM standards) and defined physical/mechanical performance requirements (e.g., "minimal force," "reduce impact force," "remain on the endoscope for at least 7 days"). These are objective, measurable criteria rather than subjective interpretations requiring expert consensus or clinical outcomes data in the traditional sense.

8. The sample size for the training set:

This is not applicable. The device is a physical product, not a machine learning model that requires a training set.

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

This is not applicable, as there is no training set for this type of device.

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The Scope ProTech is a single-use, sterile endoscopic tip protector that is intended to be used during the transport and storage of endoscopes for the protection of these delicate instruments. The Scope ProTech is intended for the protection of the distal tip and the bending rubber of endoscopes with a diameter of 2.7mm-8.0mm and 8.7mm-14.7mm. The Scope ProTech will aid in the protection of distal end, the lens and other delicate components from damage. It is not intended for use during sterilization.

The Scope ProTech is a single-use, sterile endoscopic tip protector which provides a simple, safe, and highly effective method of protecting the delicate optics of an endoscope, while allowing the tip to 'breath' and thus not allowing biofilm to form. The Scope ProTech is available in two models to fit a range of scopes: INOV8-028S (Scope ProTech Small) for scope sizes 2.7 to 8mm and INOV8-028L (Scope ProTech Large) for scope sizes 8.7 to 14.7mm. The Scope ProTech is manufactured using injection moulding using a soft polypropylene.

The provided text describes the Meditech Endoscopy Ltd Scope ProTech, a device intended for protecting endoscope tips during transport and storage. The submission is a 510(k) premarket notification, establishing substantial equivalence to a predicate device rather than independently proving safety and effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies is presented in the context of this 510(k) submission.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state acceptance criteria with numerical targets in the way a clinical trial might, as it focuses on demonstrating substantial equivalence to a predicate device. Instead, it compares characteristics of the Scope ProTech to its predicate, the US Endoscopy Endo-Boot (K951104). The "Equivalence" column in the table below effectively serves as the acceptance criteria for a 510(k) submission.

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

• Sample Size: The document does not specify a numerical sample size for "test sets" in the context of human data. It states, "No clinical data was used in the submission." The testing described is non-clinical bench testing.
• Data Provenance: Not applicable, as no clinical human data was used.

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

• Not applicable. No human experts were used to establish ground truth from clinical test sets, as no clinical data was used. The substantial equivalence argument relies on comparison of device characteristics and bench testing.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set requiring adjudication was used.

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 physical endoscopic tip protector and does not involve AI or human "readers" or diagnostic interpretation.

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

• Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" for the substantial equivalence determination is primarily based on comparative characteristics with a legally marketed predicate device (Endo-Boot K951104) and bench testing results for mechanical performance, scope compatibility, retention performance, sterility, and shelf-life requirements. There is no "ground truth" derived from clinical outcomes or expert consensus on patient data.

8. The Sample Size for the Training Set:

• Not applicable. This is not a machine learning or algorithm-based device, so there is no training set in that sense.

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

• Not applicable. There is no training set.

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The Scope Guard protective sheath is intended for use during the transport, storage and sterilization of certain ACMI scopes for protection of these delicate instruments. It is not intended to be used alone for terminal sterilization but can be used in conjunction with an approved sterilization wrap to maintain sterility until the device is required for use. The ACMI scopes with Scope Guard can be wrapped, or placed into an approved sterilization tray for sterilization processing.

The Scope Guard Protective Sheath is a polymer tube in various widths and lengths with evenly distributed holes along the length of the shaft. It is designed to snap onto ACMI telescopes for protection during storage and sterilization.

Here's an analysis of the provided text regarding the Scope Guard™ Protective Sheath, focusing on acceptance criteria and study details:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it broadly states that "ACMI Scope Guards have been bench tested for durability, sterile efficacy and material compatibility with several sterilization methods." It then concludes that "The Scope Guard is substantially equivalent to the predicate described for the parameters tested."

To extract conceptual acceptance criteria and reported performance from the provided text, we can infer the following:

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

The document does not provide specific sample sizes for any test sets.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of the testing mentioned.

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

The document does not mention the use of experts to establish ground truth for a test set. The testing described appears to be bench testing for physical and sterilization properties, not involving interpretative assessments by human experts.

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

The document does not mention any adjudication method for a test set. This is consistent with the type of bench testing described, which typically involves objective measurements rather than expert consensus on subjective interpretations.

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

The document does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study. This device is a protective sheath, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

The document does not describe a standalone algorithm performance study. As mentioned, this is a physical medical device, not an algorithm.

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

For the bench testing described (durability, sterile efficacy, material compatibility), the "ground truth" would be established by:

• Durability: Objective physical measurements against engineering specifications or established industry standards.
• Sterile Efficacy: Microbiological testing results (e.g., sterility testing after sterilization cycles) against accepted sterility assurance levels.
• Material Compatibility: Visual inspection or material analysis after exposure to sterilization methods to detect degradation or incompatibility issues.

The document does not provide details on the specific methods used to establish these ground truths, but they would be based on objective scientific/engineering principles rather than expert consensus on medical images or pathology.

8. The sample size for the training set

The document does not mention any training set. As this is not an AI/machine learning device, the concept of a "training set" is not applicable.

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

Not applicable, as there is no training set for this device.

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