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The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set.

The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.

Sterilization Cycle Parameters

Method: Steam Cycle: Pre-vacuum Temperature: 132ºC Exposure: 4 minutes Drying Time: 30 minutes

or

Method: Steam Cycle: Gravity Temperature: 132ºC Exposure: 15 minutes Drying Time: 80 minutes

The POGO Screw Instrumentation Tray is a custom autoclavable, compartmentalized, and perforated tray with a locking lid. It is intended to enclose and protect medicel device instrumentation, and to facilitate the sterilization process by allowing sterilant peneration and air removal. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap.

The POGO Screw Instrumentation Tray is a device designed to enclose and protect medical device instrumentation, facilitate the sterilization process by allowing sterilant penetration and air removal, and maintain the sterility of the internal components when used with an FDA-cleared sterilization wrap. The device's performance was validated through sterilization validation testing, demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample size for the test set used in the sterilization validation. However, it indicates Sterilization Validation was conducted. The data provenance is not specified, but it would typically be prospective testing performed by the manufacturer, FxDEVICES, in a controlled lab environment to assess the device's ability to withstand and facilitate sterilization effectively.

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

This information is not provided in the document. For sterilization validation, the "ground truth" is typically established through recognized industry standards (e.g., ISO 11134) and validated laboratory protocols, rather than expert consensus on individual cases. The expertise lies in the validation engineers and microbiologists conducting the testing and interpreting the results against established sterilization efficacy parameters.

4. Adjudication Method for the Test Set:

Not applicable in this context. Sterilization validation involves objective measurements of sterility assurance levels (SAL) based on challenge tests (e.g., biological indicators) and physical parameters, not subjective 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 an instrumentation tray for sterilization, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

Not applicable. This device is a physical product, not an algorithm. Its performance is assessed through its physical properties and its ability to facilitate a sterilization process.

7. The Type of Ground Truth Used:

The ground truth for sterilization validation is based on:

• Sterility Assurance Level (SAL): Objective, quantifiable evidence that the sterilization process has achieved a predefined probability of a single viable microorganism being present on an item after sterilization (typically 10^-6 for critical devices).
• Compliance with Industry Standards: Adherence to recognized standards like ISO 11134 for steam sterilization, which outlines the requirements for the development, validation, and routine control of a sterilization process for medical devices. This involves using biological indicators and physical parameter monitoring.
• Predicate Device Equivalence: The performance of the new device is compared to a legally marketed predicate device (PolyVac Tray K040223) that has already demonstrated safety and effectiveness for the same intended use.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.

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

Not applicable. This is not an AI/ML device.

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The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.

Dovice Bels.ipness are comprised of various size cannulated screws for the fixation of bone fractures. POGO screws are made of 316LVM Stainless Steel conforming to ASTM F138. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.

The provided text describes a 510(k) premarket notification for a medical device called the "POGO Screw." This submission aims to demonstrate substantial equivalence to an already legally marketed predicate device (K080649), rather than proving the device meets specific acceptance criteria through clinical or even extensive bench performance studies with stated numerical targets.

Therefore, the requested information regarding acceptance criteria, study details like sample sizes, expert involvement, ground truth establishment, and comparative effectiveness with AI assistance is largely not applicable or not present in the provided document.

Here's an explanation of why and what information is available:

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

• Not applicable/Not provided. The document states "Bench testing was conducted to support equivalency" but does not detail specific acceptance criteria (e.g., minimum tensile strength, fatigue life thresholds) or the numerical results of this testing. The focus is on demonstrating "substantial equivalence" to a predicate device, meaning it performs similarly, not necessarily meeting a predefined set of numerical performance targets.

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

• Not applicable/Not provided. This type of information is typically associated with clinical studies or extensive performance testing with defined test sets. For a 510(k) demonstrating substantial equivalence based on bench testing (as implied), these details are not usually required or disclosed in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. There is no mention of human expert involvement in establishing a "ground truth" for the testing in this submission, as it focuses on material and design equivalency, not diagnostic or clinical interpretation.

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

• Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here.

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 bone fixation screw, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

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

• Not applicable. As a physical medical device (bone screw), there is no "algorithm only" performance to evaluate.

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

• Not applicable/Not provided. Since no specific "test set" and outcome evaluation in the clinical sense is detailed, there's no ground truth type mentioned. The "truth" in this context is the performance of the predicate device, to which the new device is compared.

8. The sample size for the training set

• Not applicable. The concept of a "training set" applies to machine learning models. This device is a mechanical implant, not an AI system.

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

• Not applicable. See point 8.

Summary of available information from the document that is tangentially related to "performance":

• Study type: Bench testing was conducted to support equivalency with a predicate device.
• Predicate Device: POGO Screw cleared under K080649.
• Equivalency Statement: "The POGO Screw is substantially equivalent in design, materials, construction and intended use as those of the predicate."
• Safety and Efficacy: The risk analysis and test results demonstrate that the POGO Screw is substantially equivalent to the predicate device and is capable of safely and effectively performing the stated intended use.
• Device Description (relevant to equivalency): The device consists of various size cannulated screws for bone fracture fixation, made of 316LVM Stainless Steel conforming to ASTM F138. Available in 55mm to 130mm lengths, provided sterile or non-sterile.
• Intended Use: General management of fractures and reconstructive surgery.

In essence, the entire document serves as evidence of substantial equivalence to a device already on the market, not as a detailed report of a study proving a device meets specific, pre-defined quantitative acceptance criteria with associated ground truth from experts or large datasets.

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The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.

The POGO Screws are comprised of various size cannulated screws for the fixation of bone fractures. The components are manufactured from 316 surgical stainless steel. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.

The POGO Screw is a medical device designed for the fixation of bone fractures and reconstructive surgery.

Here's an analysis of its acceptance criteria and the study conducted to prove it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The documentation provided does not describe a test set with explicit sample sizes for clinical data, patient cases, or imaging. The evaluation of the POGO Screw for 510(k) clearance was based on bench testing and a comparison of its technological characteristics to predicate devices. Therefore, the concept of "data provenance" related to human data (e.g., country of origin, retrospective/prospective) is not applicable in this context.

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

This information is not applicable as the clearance was based on bench testing and comparison to predicate devices, not on the evaluation of a test set with human-labeled ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there was no test set involving human-labeled ground truth or 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

An MRMC comparative effectiveness study was not performed. This device is a bone fixation screw, not an AI-powered diagnostic or assistive technology.

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

This information is not applicable. The POGO Screw is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the POGO Screw's performance was established through:

• Bench Testing Data: This involved engineering tests to evaluate mechanical properties, strength, and other physical characteristics of the screw. While specific test types and results are not detailed in the summary, "Bench testing was conducted to support equivalency."
• Comparison to Predicate Device Specifications: The key "ground truth" was that the POGO Screw's design, materials, and intended use were demonstrably the same or highly similar to legally marketed predicate devices (Smith and Nephew Cannulated Screws and Stryker Medical Asnis III). This effectively meant the established safety and efficacy of the predicate devices served as a benchmark for the POGO Screw.

8. The Sample Size for the Training Set

This information is not applicable. There was no "training set" in the context of machine learning or AI for this device. The development process would have involved engineering design, material selection, and manufacturing, followed by bench testing and comparison to established standards and predicate devices.

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

This information is not applicable as there was no "training set." The understanding of "ground truth" for a device like the POGO Screw is developed through engineering principles, material science, biomechanical testing, and clinical experience with similar devices (the predicate devices).

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