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The Detachable Silicone Balloon (DSB) is intended for artificial embolization of the internal carotid artery in the presence of certain intracranial aneurysms in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.

The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.

This is not an AI/ML device, therefore, the mentioned acceptance criteria and studies are not applicable.

The Detachable Silicone Balloon (DSB) is a medical device for artificial embolization. Device testing included biocompatibility testing and functional bench testing. Functional bench testing included cycle testing, rupture testing, pressure-volume testing, detachment force testing, inflation-deflation cycle rate testing, and catheter insertion valve testing. The results of these tests demonstrated the DSB to be safe for its intended use.

This device was determined to be substantially equivalent to predicate devices based on intended use, materials, manufacturing, design parameters, method of delivery, and method of deployment.

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The DSB is intended for artificial embolization of symptomatic carotid cavernous fistulae in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.

The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.

The provided document describes the FDA 510(k) submission for the Detachable Silicone Balloon (DSB) Artificial Embolization Device. The submission focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for AI/software devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for an AI-like device is not applicable to this 1998 medical device submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device testing mentioned in the document is primarily bench testing and biocompatibility testing, not performance metrics based on clinical outcomes relevant to AI. Acceptance criteria are implied by successful completion of these tests to demonstrate safety and functional validity for its intended use and substantial equivalence to predicate devices. Specific quantitative acceptance criteria or reported device performance in a clinical context were not provided in detail.

2. Sample Size for the Test Set and Data Provenance

Not applicable. The submission describes bench testing and biocompatibility testing, not a clinical study with a "test set" of patient data in the context of an AI device.

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

Not applicable. This is not a study involving expert review of images or data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI device, and no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness relies on successful completion of biocompatibility and functional bench tests, and the demonstration of substantial equivalence to existing predicate devices. This is a regulatory pathway, not a data-driven ground truth for an AI algorithm.

8. Sample Size for the Training Set

Not applicable. There is no AI model or "training set" for this physical device.

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

Not applicable.

Summary of Relevant Information from the Document:

• Device Name: Detachable Silicone Balloon (DSB) Artificial Embolization Device
• Intended Use: Artificial embolization of symptomatic carotid cavernous fistulae in patients for whom other medical or neurosurgical means would not be indicated.
• Testing Performed:
  • Biocompatibility testing
  • Functional bench testing: cycle testing, rupture testing, pressure volume testing, detachment force testing, inflation-deflation cycle rate testing, and catheter insertion valve testing.
• Outcome of Testing: Demonstrated the device to be safe for its intended use.
• Regulatory Pathway: 510(k) premarket notification, where the primary focus is demonstrating substantial equivalence to legally marketed predicate devices.
• Predicate Devices:
  • Target Therapeutics Detachable Platinum Coil (GDC)
  • Target Therapeutics (ITC) Radiopaque Spherical Emboli (RSE)
  • Target Therapeutics (ITC) Contour Emboli (CE)
  • Target Therapeutics (ITC) Occlusion Balloon Catheter (mentioned conceptually, but not in the detailed comparison)
• Substantial Equivalence: Claimed based on equivalence/identity in intended use, materials, manufacturing, design parameters, method of delivery, and method of deployment to the predicate devices. The comparison chart specifically details similarities in general description, indications, device function, material (though DSB is silicone, GDC is platinum/tungsten, RSE is silicone, CE is Polyvinyl Alcohol), delivery, and deployment methods.

This document clearly outlines a 510(k) submission for a physical medical device, not a software or AI-driven device. Therefore, the questions tailored for AI/software performance studies do not directly apply.

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The Retriever II is indicated for use in the retrieval of intravascular occlusion coils misplaced during interventional radiological procedures in peripheral and neurovasculature.

The Retriever II (R-II) is a single use, disposable endovascular Snare. The R-II consists of a flexible core wire, radiopaque coils at the distal end of the corewire facilitate fluoroscopic visualization. Fiber strands are attached to the distal tip of the core wire. A platinum tip marker is attached at the distal end of the fibers to facilitate fluoroscopic visualization. The fibers, when manipulated, work to ensnare the misplaced coil.

No, the provided document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document is a 510(k) summary and the FDA's clearance letter for the Retriever II Endovascular Snare Device. It states that:

• "TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION: The results of bench testing (tensile, turns to failure, tip flexibility, fiber retention), animal studies, and Biocompatibility testing support the substantial equivalence claims of the R-II for its intended use."
• "Results of the bench testing, animal studies, and Biocompatibility testing in conjunction with the substantial equivalence claims as outlined in this premarket notification, effectively demonstrate that the R-II is substantially equivalent to the predicate device."

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Details of a standalone (algorithm only) performance study (as this is a medical device, not an AI/algorithm-based device).
7. Type of ground truth used (again, this is physical device testing).
8. Sample size for training set (not applicable for this type of device submission).
9. How ground truth for the training set was established (not applicable).

The document focuses on demonstrating substantial equivalence to a predicate device (Retriever-18) through general descriptions of bench testing, animal studies, and biocompatibility, rather than presenting a detailed performance study against specific acceptance criteria.

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See table below

Please refer to Table 1 (Page 10)

The provided text is a 510(k) summary for various medical devices by Target Therapeutics. It primarily focuses on demonstrating substantial equivalence to predicate devices based on functional, chemical, biocompatibility, and sterile barrier tests.

This document does not contain information on acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.

Instead, it details laboratory-based testing for physical and chemical properties and refers to section 6 of the submission for further details on these tests. There is no mention of a study involving human readers, ground truth established by experts, or AI performance metrics.

Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria and studies based on the provided text. The document is for a traditional medical device submission, not an AI/ML-driven one.

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The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature.

Spinnaker Infusion Catheter is a single lumen device with a graded shaft stiffness, ranging from a highly flexible tip to a semi-rigid proximal section that allows ease of advancement by the physician. A lure fitting located on the catherer hub is used for the attachment of accessories. Spinnaker is manufactured with HYDROLENE®, a hydrophilic surface coating that reduces friction during manipulation in the vessel.

The Spinnaker Infusion Catheter will be made available as a system consisting of a Spinnaker Infusion Catheter, a stylet with a torque device attached, and a steam shaping mandrel.

SPINNAKER with HYDROLENE Infusion Catheter (SPINNAKER) is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guiding catheter. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section allows ease of advancement by the physician. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip and body facilitate fluoroscopic visualization. SPINNAKER is manufactured with HYDROLENE, a hydrophilic surface that reduces friction during manipulation in the vessel. The stylet accompanying the SPINNAKER is used to increase rigidity of the distal section during introduction into the guiding catheter. The steam shaping mandrel packaged with the SPINNAKER is used when the physician desires to shape the catheter's distal end.

The provided text describes a medical device, the SPINNAKER™ Infusion Catheter, and its substantial equivalence to predicate devices based on performance and biocompatibility testing. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device evaluations (e.g., sensitivity, specificity, accuracy, or comparative effectiveness with human readers).

The document focuses on:

• Device Description: Physical characteristics, materials, and components.
• Intended Use: Facilitating access through vasculature and infusion of diagnostic agents.
• Predicate Devices: Balt Magic Infusion Catheter, Zephyr Infusion Catheter.
• Testing for Substantial Equivalence: Flow rates, tip flexibility, tensile, static rupture, coefficient of friction, and biocompatibility.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study details because this information is not present in the provided text.

The 'testing in support of substantial equivalence' mentioned refers to engineering and bench testing relevant to the physical and functional aspects of a catheter, not clinical performance metrics typically associated with AI/ML diagnostic devices.

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Berenstein Coils are intended for the embolization of vascular malformations of the peripheral and neuro vasculature.

The Berenstein Coil is an occlusion coil designed to be delivered by injection through either Target Therapeutics Infusion Catheters or Balt Magic 1.5F and 1.8F catheters. These coils are radiopaque.

The Berenstein Coil is available in a helical shape, in 0.008 or 0.016 inch primary wind diameter (Berenstein Coil - 10 and Berenstein Coil - 18, respectively), and in a variety of lengths. The Berenstein Coil comes loaded in a sheath-like introducer for easy transfer into a catheter.

An adapter, manufactured by Target Therapeutics, is required when Berenstein Coil - 10 Occlusion Devices are used with Balt Magic catheters. The Adapter may be supplied with the Berenstein Coil or may be available separately.

The provided text is a 510(k) summary for the Berenstein Coil, a medical device. It describes the device, its intended use, and predicate devices. Crucially, it does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for evaluating device performance.

Therefore, I cannot fulfill your request for specific details regarding acceptance criteria and study data as this information is not present in the provided input. This document is a regulatory submission summary, not a detailed clinical study report or performance evaluation.

To answer your request, you would need a document that describes:

• The specific performance metrics and their acceptance thresholds.
• The design and results of a study (e.g., a clinical trial, a bench test, and animal study) that evaluated the device against those criteria.
• Details about the data used (sample size, provenance), expert involvement, and ground truth methodology.

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The Patient Return Electrode is indicated for use only with Target Therapeutics GDC System as the patient return electrode.

Target Therapeutics' Patient Return Electrode (PRE) is a single use, disposable, non-sterile electrode. The PRE is intended to be used as an alternative patient return electrode for Target Therapeutics GDC system (K951256 & K960705). A hypodermic needle is currently used as the patient return electrode. The PRE is applied to the skin on the patient's upper arm (deltoid). The PRE is being made available for patient comfort and has no effect on the safety or efficacy of the GDC system as functional testing indicates.

A small Prep pad is included with the PRE to exfoliate the skin prior to applying the PRE.

This is a 510(k) premarket notification for a medical device (Patient Return Electrode). This type of submission generally does not contain detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies as would be expected for AI/ML device evaluations. The focus of a 510(k) is to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested fields cannot be directly answered from the provided text. I will extract the information that is available and note when information is not present.

Here's a breakdown based on your request:

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

Based on the provided text, specific quantitative acceptance criteria and their corresponding reported device performance values (like sensitivity, specificity, AUC) are not explicitly stated as they would be for an AI/ML device. The document mentions "functional testing" and "bench testing" but does not provide specific metrics or thresholds.

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

• Sample size for the test set: Not specified. The document mentions "bench testing," "animal studies," and "biocompatibility testing" but does not give sample sizes for these tests.
• Data provenance: Not specified. (e.g., country of origin, retrospective/prospective).

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 specified. For this type of device (Patient Return Electrode), ground truth is established through physical/electrical measurements and biological responses, not expert interpretation of data.
• Qualifications of experts: Not applicable/Not specified.

4. Adjudication method for the test set

• Adjudication method: Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used when human interpretation of data (e.g., medical images) is involved in establishing ground truth. This is not pertinent to the evaluation of a Patient Return Electrode.

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 is relevant for AI/ML diagnostic devices where human readers interpret medical images or data. This is not applicable to a Patient Return Electrode.
• Effect size of human reader improvement: Not applicable.

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

• Standalone performance: Not applicable in the context of AI/ML algorithms. The device itself (Patient Return Electrode) is a standalone component; its performance is evaluated in direct physical/electrical tests and biological studies, not as an algorithm.

7. The type of ground truth used

For this device, the "ground truth" would be established by:

• Physical/Electrical measurements: For the Tensile Test and Impedance Test, ground truth is based on engineering specifications and physics.
• Biological responses: For animal studies and biocompatibility testing, ground truth is based on observed physiological reactions and histological analyses against established safety standards.

8. The sample size for the training set

• Sample size for the training set: Not applicable. This document does not describe the development or evaluation of an AI/ML algorithm, so there is no concept of a "training set" in the sense of machine learning.

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

• How ground truth was established for the training set: Not applicable (as there is no training set for an AI/ML algorithm).

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The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: a)very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The provided text describes a medical device (Guglielmi Detachable Coil - GDC) and its intended use, as well as compares its indications for use with predicate devices. It is a summary of safety and effectiveness, likely from a regulatory submission, but it lacks the specific details requested regarding performance studies.

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Berenstein Coils are intended for the embolization of vascular malformations of the neuro vasculature.

The Berenstein Coil is an occlusion coil designed to be delivered by injection through either Target Therapeutics Infusion Catheters or Balt Magic 1.5F and 1.8F catheters. These coils are radiopaque.

The Berenstein Coil is available in a helical shape, in 0.008 or 0.016 inch primary wind diameter (Berenstein Coil - 10 and Berenstein Coil - 18, respectively), and in a variety of lengths. The Berenstein Coil comes loaded in a sheath-like introducer for easy transfer into a catheter.

An adapter, manufactured by Target Therapeutics, is required when Berenstein Coil - 10 Occlusion Devices are used with Balt Magic catheters. The Adapter may be supplied with the Berenstein Coil or may be available separatelv.

The provided text describes a medical device (Berenstein Coil) and its equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets specific performance criteria as typically understood in the context of AI/ML or diagnostic device performance.

The document is a 510(k) summary for a Class III medical device (Berenstein Coil). It focuses on demonstrating "substantial equivalence" to existing predicate devices, rather than establishing specific diagnostic performance metrics (like sensitivity, specificity, AUC) against a defined ground truth.

Therefore, I cannot provide a response based on your requested structure, as the necessary information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, or training set details is not present in the provided text.

The "Testing in Support of Substantial Equivalence Determination" section describes:

• In-vitro, in-vivo, and biocompatibility testing: These are general categories of testing to ensure safety and effectiveness comparable to predicate devices.
• Functional bench testing:
  • Force required to deliver coils through catheters.
  • Coil/catheter compatibility.
    These are engineering/design validation tests, not clinical performance metrics against a ground truth.

In summary, the provided text does not contain the type of study data (e.g., diagnostic accuracy metrics against a ground truth, reader study results) that your request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic devices would typically require.

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The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: a)very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovencus fistulae of the neuro vasculature.

The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.

The provided text describes a medical device (Guglielmi Detachable Coil - GDC) and its intended use, but it does not contain information regarding acceptance criteria, a specific study proving the device meets those criteria, or any details about AI/algorithm performance. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical trial results with specific performance metrics and acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text.

Here's what I can infer from the given document, which is limited to the device description and intended use:

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

• Not applicable / Not provided in the text. The document does not describe specific acceptance criteria (e.g., success rates, complication rates, embolization effectiveness metrics) or report performance against such criteria.

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 in the text. No "test set" in the context of algorithm evaluation is mentioned. The document describes expanding indications for an existing device.

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 in the text. No mention of ground truth establishment by experts for a test set. The document refers to "treating neurosurgical team" determining suitability for the GDC, but this is clinical decision-making, not ground truth for an AI study.

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

• Not applicable / Not provided in the text.

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 in the text. No AI or algorithm is mentioned.

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

• Not applicable / Not provided in the text. No AI or algorithm is mentioned.

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

• Not applicable / Not provided in the text.

8. The sample size for the training set:

• Not applicable / Not provided in the text. No AI or algorithm training is mentioned.

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

• Not applicable / Not provided in the text. No AI or algorithm training is mentioned.

Summary of what the document does describe:

• Device Name: Guglielmi Detachable Coil (GDC)
• Device Description: Consists of a remote power supply and an occlusion coil attached to a delivery wire, detached electrolytically. Coils are platinum.
• Intended Use: Embolizing certain intracranial aneurysms (high risk or inoperable) and other vascular malformations (AVMs, AVFs) of the neuro vasculature.
• Expanded Indications: The document indicates an expansion of use to "other vascular lesions such as arteriovenous malformations (AVM) and arteriovenous fistulas (AVF)." This expansion is being sought based on substantial equivalence to predicate devices (other GDCs and Cook Occlusion Coils) already marketed for similar vascular lesions.

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