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The Interlock™ Fibered IDC™ Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.

The Interlock Fibered IDC Occlusion System includes a coil (manufactured from platinum-tungsten alloy) that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock Fibered IDC Occlusion Coil is designed to be delivered under fluoroscopy with a 0.0 21 in (0.53 mm) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with one or two radiopaque (RO) tip markers. The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.

This document describes a medical device, the "Interlock™ Fibered IDC™ Occlusion System," and its premarket notification (510(k)) to the FDA. It details device characteristics, intended use, and non-clinical testing performed to establish its safety and substantial equivalence to a predicate device for regulatory clearance.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving performance:

The provided text is a 510(k) summary and FDA clearance letter for a medical device (Interlock™ Fibered IDC™ Occlusion System). It focuses on demonstrating substantial equivalence for regulatory clearance, not on providing a study that proves specific acceptance criteria for device performance in the way you've outlined for AI/diagnostic systems.

Therefore, I will extract the information available and explicitly state where information is not present in the provided document, as it pertains to a different type of evaluation.

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

• Acceptance Criteria: The document does not explicitly present a table of acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, the "acceptance criteria" were implied by the regulatory standard of demonstrating substantial equivalence to a predicate device (Fibered IDC™ Occlusion System, K060078) and meeting safety standards for its intended use, particularly regarding MRI compatibility.

  • For MRI compatibility, the acceptance criteria are implicit in the ASTM standards cited:
    • ASTM F2182-02a: Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging.
    • ASTM F2052-06e1: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
    • ASTM F2213-06: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
    • ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
  • The overall acceptance criterion for the 510(k) submission is that the new device presents "no additional risk to a patient" compared to gravitational and normal daily activities, or a feverish condition, in an MRI environment, and can be "scanned safely under a static magnetic field of 1.5 Tesla or 3.0 Tesla."

• Reported Device Performance:

  Performance Metric (Implied)	Reported Performance (Non-Clinical)
  MRI Safety (Heating)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2182-02a)
  MRI Safety (Displacement)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2052-06e1)
  MRI Safety (Torque)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2213-06)
  MRI Safety (Image Artifacts)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2119-07)
  Overall Risk Profile	"will not present additional risk to a patient during a MRI procedure"

Note: This is a physical medical device, not an AI/diagnostic software. The "performance" being evaluated here relates to mechanical and material safety under specific conditions, not diagnostic accuracy, sensitivity, or specificity.

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

• Sample Size: The document refers to "non-clinical testing" and does not specify a "sample size" in the context of patients or data points characteristic of diagnostic studies. The "test set" here would refer to the physical coils themselves that underwent MRI compatibility testing. The number of physical coils tested is not provided, and there is no patient data involved in this type of non-clinical testing.
• Data Provenance: Not applicable in the context of sensor data or patient data. The "tests" were conducted in a laboratory setting. No country of origin for data or retrospective/prospective nature is relevant.

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

• Not applicable. This is not a study requiring expert consensus or ground truth establishment for diagnostic purposes. The ground truth for MRI compatibility is established by the physical properties of the device and its interaction with magnetic fields, measured according to established ASTM standards by engineering/physics experts, not medical experts for diagnostic tasks.

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

• Not applicable. There is no adjudication method described as it's not a diagnostic study involving human interpretation or subjective assessment. The ASTM test methods likely have predefined pass/fail criteria that are objectively measured.

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 is a physical medical device, not an AI or diagnostic tool. No MRMC study was performed, nor is there any AI component involved to assist human readers.

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

• Not applicable. This is a physical medical device. There is no "algorithm only" performance to evaluate. The device functions as an embolization coil.

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

• The "ground truth" for the non-clinical MRI compatibility testing is defined by the physical performance measurements against established ASTM standards. For example, the maximum temperature rise measured must be below a certain threshold according to ASTM F2182-02a to be considered safe for MRI. This is an objective, quantitative ground truth.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable, as there is no training set.

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The proposed Pelvic Floor Repair System is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

The proposed device is a sterile, single use kit, consisting of two synthetic mesh assemblies and a needle holder. Each mesh assembly consists of a polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the Capio™ Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement. The proposed mesh configurations were designed for performing vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs.

The provided text pertains to a 510(k) summary for a medical device called the "Pelvic Floor Repair System" (Tradename: TBD, later identified as Pinnacle Pelvic Repair Kit). A 510(k) submission is a premarket notification demonstrating that a medical device is at least as safe and effective as a legally marketed device (predicate device). This type of submission relies on demonstrating substantial equivalence, not necessarily on new clinical trials or detailed performance study reports with specific acceptance criteria that one would find for a novel device or a Premarket Approval (PMA) application.

Therefore, the document does not contain the acceptance criteria and a study proving the device meets those criteria in the way you've outlined. This is because the 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and intended use, rather than fulfilling specific performance metrics from a new, independent study with pre-defined acceptance criteria.

The document indicates that substantial equivalence was demonstrated by comparing key characteristics of the proposed device to predicate devices (K071957 and K081048, both also "Pinnacle Pelvic Floor Repair Kit"). It states: "A direct comparison of key characteristics demonstrates that the proposed mesh is substantially equivalent to the predicate mesh in terms of intended use, technological characteristics, and performance characteristics tested. The proposed device is as safe, as effective, and performs as well as the predicate device."

Without a new performance study being conducted for this specific 510(k) submission, the requested information (acceptance criteria, sample size, ground truth, MRMC study details, etc.) cannot be extracted from this document. The "performance characteristics tested" mentioned likely refer to bench testing or material characterization to ensure similarity to the predicate, rather than a clinical study with human subjects.

Therefore, I cannot populate the table or answer the specific questions because the detailed information about a study proving the device meets acceptance criteria is not present in this 510(k) summary. The summary focuses on showing equivalence to existing devices.

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The proposed Boston Scientific power injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The proposed PICC is designed for intravenous therapy and for use with power injectors at settings of 300 psi for the administration of contrast media for imaging studies (including, but not limited to, CT scans, MRIs). The proposed PICC is an open ended, non-valved catheter with proximally located luer lock hub(s), extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL); with a reverse tapered shaft to aid in staunching bleeding at the insertion site; and usable length of 45 cm lengths for the 4 Fr SL, 5 Fr DL lengths and 55 cm lengths for the 4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL. The radiopaque catheter is marked with depth indicators every 1 cm along its length and with a "0" indicator to serve as a reference during catheter insertion and for user convenience in catheter sizing. The lumens are differentiated by proximally located colored clamps and hubs that indicate lumen size. Maximum power injection flow rates are indicated on the clamp(s). As is the predicate device, the proposed BSC PICC will be offered in convenience kits with other legally marketed products.

This document, K070002, is a 510(k) summary for the Boston Scientific Peripherally Inserted Central Catheter (PICC). It focuses on substantial equivalence to a predicate device, rather than a standalone performance study with acceptance criteria.

Therefore, it does not contain the information required to populate the fields related to acceptance criteria and device performance as it pertains to AI/algorithm performance. The device described in this document is a physical medical device (PICC), not an AI algorithm.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. This document demonstrates substantial equivalence through a comparison of technological characteristics and performance characteristics tested to a predicate device, not by defining and meeting specific acceptance criteria for a new, AI-based functionality.
2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI algorithm with a test set of data.
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. Ground truth establishment is irrelevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

• Device Name: Boston Scientific Peripherally Inserted Central Catheter (PICC)
• Predicate Device: AngioDynamics, Inc. Morpheus™ CT PICC (K041420 and K060887)
• Intended Use: Short or long-term peripheral access to the central venous system for intravenous therapy (fluids, medications, nutrients, blood sampling) and power injection of contrast media.
• Substantial Equivalence Basis: Comparison of intended use, technological characteristics, and performance characteristics tested to the predicate device. The document states a "direct comparison of key characteristics demonstrates that the proposed device is substantially equivalent." However, the specific results of these characteristic tests or the defined criteria for "substantial equivalence" regarding measured performance are not detailed in this summary.

To obtain specific performance data and acceptance criteria for a physical device like a PICC, one would typically need to review the full 510(k) submission, which would include detailed testing protocols and results (e.g., burst pressure, flow rates, material compatibility, functional durability). This summary document does not provide those specifics.

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The Boston Scientific Express™ Biliary SD Premounted Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

The Express Biliary SD Premounted Stent System is available in the models indicated in Table 4.3. A brief description of the device components follows. The Express Biliary SD stent is a balloon expandable metallic stent intended to maintain patency of biliary strictures produced by malignant neoplasms. The stent will be available in a variety of sizes to address clinician needs. The Express Biliary SD stent is made from 316L surgical grade stainless steel. The stent geometry is a laser-cut pattern consisting of large and small sinusoidal bands connected by axial struts. Additional struts are provided to reinforce the three connector rows of the proximal stent end, resulting in additional scaffolding designed to reduce tumor in-growth at the proximal stent end. The delivery system for the Express Biliary SD Premounted Stent System consists of a Monorail™ catheter with a stent crimped on a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The distal segment of the balloon catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon. The wire lumen permits the use of guidewires (≤0.018 in / 0,46 mm) to facilitate advancement of the catheter to and through the stricture to be dilated.

This document is a 510(k) Summary for the Boston Scientific Express Biliary SD Premounted Stent System. It primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison of technological characteristics and non-clinical testing.

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 list "acceptance criteria" in a quantitative way with corresponding numerical performance results for the device. Instead, it outlines a series of non-clinical tests performed to demonstrate that the device functions as intended and is comparable to the predicate device. The implied acceptance criterion for each test is that the device performs acceptably and is substantially equivalent to the predicate.

The Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the document is a non-clinical (in-vitro) testing program designed to demonstrate substantial equivalence to a predicate device. The summary states: "Based on a comparison of intended use, design, and results of in-vitro testing, the Express Biliary SD Premounted Stent System is adequate for the intended use and is considered substantially equivalent to the legally marketed Johnson & Johnson Corinthian IQ Transhepatic Biliary Stent with Delivery Catheter."

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 "test set" in terms of how many devices or components were used for each non-clinical test. The testing appears to be based on engineering verification and validation of the device's physical and functional characteristics.
• Data Provenance: The data provenance is non-clinical/in-vitro testing conducted by the manufacturer, Boston Scientific, Inc. No information regarding country of origin of the data or whether it was retrospective or prospective is applicable as it's not a clinical study.

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

• This information is not applicable to this type of submission. The "ground truth" for non-clinical engineering tests is based on established engineering standards, specifications, and comparison to the predicate device's known characteristics, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

• This is not applicable to the non-clinical testing described. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for interpreting medical images or clinical outcomes, which is not the nature of the testing 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

• No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a medical device (stent and delivery system), not an AI/ CAD (Computer-Aided Detection/Diagnosis) software. Therefore, the concept of human readers improving with or without AI assistance is irrelevant here.

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

• No, this is not applicable. This device is a physical medical device (stent and delivery system), not an algorithm or software.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" is based on engineering specifications, design requirements, and comparison to the characteristics of the legally marketed predicate device.
  • For example, for "expanded stent length," the ground truth would be the specified design length. For "compression resistance," it would be the required radial force. For biocompatibility, it would be compliance with ISO standards for medical device materials.

8. The Sample Size for the Training Set

• This is not applicable as this is a physical medical device, not a machine learning or AI model. Therefore, there is no "training set."

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

• This is not applicable for the same reason as above (no training set for a physical medical device).

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