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Ultraflex™ Esophageal NG Stent System (non-covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.

Ultraflex™ Esophageal NG Stent System (covered) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

The proposed Ultraflex Esophageal NG Stent System allows for the placement of a selfexpanding metallic stent within the esophagus. The systems consist of a flexible delivery catheter preloaded with an expandable stent. The stent is offered either bare or covered and with either a proximal release or distal release delivery system. The stent may be placed fluoroscopically using radiopaque markers as a guide or endoscopically using the visual marker on the delivery catheter. The proposed device also incorporates two adhesive material changes and the addition of a visual marker on two models.

The provided text describes a 510(k) premarket notification for a medical device called the Ultraflex™ Esophageal NG Stent System. This submission is a "Special 510(k)," which typically means minor changes have been made to a previously cleared device. As such, the emphasis is on demonstrating substantial equivalence to the predicate device rather than presenting new clinical performance data for acceptance criteria and a detailed study proving performance.

Here's an analysis based on the provided text, addressing your points:

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

Rationale: The 510(k) summary (Section 7) states that "In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." This confirms that the device meets its internal design specifications and performance requirements for in-vitro tests, which are used to demonstrate substantial equivalence, especially for a Special 510(k). However, specific acceptance criteria for clinical outcomes (e.g., success rates, complication rates) are not provided, as this type of submission usually relies on the predicate device's established clinical profile. The "acceptance criteria" here are implicitly that the device performs equivalently to the predicate in all relevant aspects, supported by in-vitro testing for the changes made.

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

• Sample Size for Test Set: Not applicable / Not provided.
• Data Provenance: The performance data described is "In-vitro testing." This suggests laboratory-based testing rather than patient-derived data (e.g., retrospective or prospective clinical studies). Therefore, there is no country of origin for patient data.

Rationale: The submission explicitly states "In-vitro testing." This means the testing was likely conducted in a lab environment using physical devices or models, not on a patient population. Consequently, there's no patient data, sample size for test sets (in a clinical sense), or data provenance from a geographical perspective.

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.
• Qualifications of Experts: Not applicable.

Rationale: Since the performance data is derived from "in-vitro testing" and not clinical studies involving diagnostic accuracy or treatment efficacy evaluated by experts, there is no need for experts to establish ground truth in the context of this submission. The "ground truth" for in-vitro tests is typically defined by engineering specifications and objective measurements.

4. Adjudication method for the test set

• Adjudication Method: Not applicable.

Rationale: As there are no human-interpreted results or clinical outcomes requiring independent review or consensus, an adjudication method is not relevant to "in-vitro testing."

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

• MRMC Study: No, an MRMC study was not done.
• Effect Size: Not applicable.

Rationale: This device is an esophageal stent system, which is a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not applicable.

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

• Standalone Performance Study: Not applicable.

Rationale: This device is a physical stent system and does not involve an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The type of ground truth used

• Type of Ground Truth: Engineering specifications and objective measurements for in-vitro performance.

Rationale: For "in-vitro testing," the ground truth is typically established by predetermined performance specifications, material properties, and objective measurements (e.g., mechanical strength, deployment characteristics, fatigue resistance) that the device must meet.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable.

Rationale: There is no mention of "training" in the context of an algorithm or statistical model. The testing described is performance testing of a physical device.

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

• How Ground Truth for Training Set was Established: Not applicable.

Rationale: As there is no "training set" in the context of an algorithm, the concept of establishing ground truth for it does not apply.

In summary:

This 510(k) submission for the Ultraflex™ Esophageal NG Stent System is a "Special 510(k)," indicating minor changes to a previously cleared device. The primary method of demonstrating performance and substantial equivalence relies on in-vitro testing to show that the modified device's components and full systems meet all required specifications. The submission does not present clinical performance data (e.g., patient-based studies, expert evaluation, or AI algorithm performance) to establish acceptance criteria or prove effectiveness in the way one might expect for a novel device or an AI/diagnostic software product. The "acceptance criteria" are implicitly met by showing the new device performs identically to or within acceptable limits of the predicate device through laboratory testing.

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The Orthocon OrthoStat™ Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.

Orthocon OrthoStat™ Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the management of bleeding from the cut surface of bone. The material is a mixture of calcium stearate (a wax-like tamponade), Vitamin E Acetate (for handling properties) and alkylene oxide copolymer (a dispersing agent). The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application and does not soften appreciably at body temperature. When applied manually to surgically incised or traumatically broken bone, OrthoStat Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and absorbed within a period of 60 days.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria in the way typically expected for a diagnostic AI/ML device.

The document is a 510(k) summary for a medical device called "OrthoStat™ Hemostatic Bone Putty." It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than proving diagnostic performance against specific metrics with a test set, ground truth, or expert review.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Device Type: OrthoStat™ Hemostatic Bone Putty is a hemostatic agent (a physical barrier to stop bleeding), not an AI/ML diagnostic tool or a device that interprets data for diagnosis. Therefore, the concepts of "acceptance criteria for device performance" in terms of accuracy, sensitivity, specificity, etc., or "expert ground truth" as applied to diagnostic image interpretation, do not apply.
• Study Focus: The "studies" mentioned are typically engineering tests, biocompatibility assessments, and functionality/efficacy testing to show the device performs its intended mechanical function (stopping bleeding) and is safe. These are not comparative effectiveness studies with human readers or standalone algorithm performance studies.
• "Acceptance Criteria" in this Context: For a device like bone putty, "acceptance criteria" likely refer to successful outcomes in non-clinical tests (e.g., in vitro or animal models) showing it effectively stops bleeding, is absorbed within a specified timeframe, and is biocompatible. These are not explicitly detailed here with numerical targets as would be for a diagnostic tool.

Therefore, I cannot provide the requested table and information because the document describes a different type of medical device and regulatory submission where those specific performance metrics, study designs, and ground truth methodologies are not applicable or detailed.

The document states:

• "The 510(k) Notice contains summaries of physical test results, functionality (efficacy testing) results, absorption testing and biocompatibility testing."
• "The data presented demonstrate that the device is biocompatible and is suitable for its indicated use."

This indicates that these tests were performed to support the "suitability for indicated use" and "biocompatibility," which are the operational criteria for this type of device. However, the specifics of these results and their acceptance criteria are not presented in the provided text.

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