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The InZone Detachment System is intended for use with all versions of Stryker Neurovascular detachable coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Stryker Neurovascular's InZone® Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular Detachable Coils. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.

Here's an analysis of the provided text regarding the InZone Detachment System, focusing on acceptance criteria and the supporting study:

The provided document (K212455) is a 510(k) summary for modifications to the InZone Detachment System. It does not describe a study involving human readers or AI. Instead, it focuses on bench testing and software verification to demonstrate substantial equivalence to a predicate device after firmware modifications. The device is a medical instrument used for detaching coils in neurovascular procedures, not an AI or imaging diagnostic tool. Therefore, many of the requested points related to AI, ground truth establishment, expert consensus, and MRMC studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly treats the successful completion of the listed verification tests as meeting acceptance criteria, demonstrating the modified device functions as intended and is substantially equivalent to the predicate.

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

The document does not specify a "test set" in the context of patient data or clinical images. The testing described is primarily bench-top testing of the device's firmware and physical characteristics. Therefore, there is no mention of country of origin or whether data was retrospective or prospective in the clinical sense. The "test cases" for software and bench-top testing would refer to specific scenarios and conditions the device was put through. The number of iterations or specific samples for each bench test (e.g., how many coils were detached for detachment consistency) is not provided.

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

Not applicable. This device is an instrument, not an AI diagnostic tool requiring expert interpretation of medical data for ground truth. Ground truth for the device's functionality would be established by engineering specifications, proper electrical readings, and functional verification, typically performed by engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in the context of expert review. The device's performance is objectively measured against engineering specifications.

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 not an AI diagnostic device, and no MRMC study was performed. The device is a tool used by interventionalists, and the study focuses on its functional performance, not its impact on human reader effectiveness for diagnosis.

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

This refers to the performance of the device itself (the "algorithm" being its firmware). The "Verification Testing" detailed in the table above is a standalone assessment of the device's performance. It evaluates the device's ability to perform its functions (detachment, detection, safety features) without human intervention beyond initiating the process.

7. The Type of Ground Truth Used

The ground truth used for the verification testing (standalone performance) is based on engineering specifications and expected functional outcomes. For example:

• Detachment cycle time: Should fall within a defined range.
• Max voltage/current output: Must not exceed specified limits.
• Low battery detection: Must accurately signal when battery is low.
• Fault detection: Must correctly identify and signal specified faults.
• Delivery wire compatibility and detection: Must correctly identify and interface with different coil types.

These ground truths are derived from existing design requirements, safety standards (e.g., ISO 14971, EN 62304), and the established performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI system that undergoes "training" with data in the conventional machine learning sense. Its firmware is programmed based on design specifications and engineering principles.

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

Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the device's design and programming comes from established medical device standards, functional requirements for electrolytic detachment, and the performance characteristics of the previously cleared predicate device.

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The InZone Detachment System is intended for use with all versions of Stryker Neurovascular detachable coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

The Stryker Neurovascular InZone Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular Detachable Coils. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.

This document, K160096, is a 510(k) premarket notification for the Stryker Neurovascular InZone Detachment System. It concerns modifications to existing firmware and hardware. However, a table of acceptance criteria and reported device performance derived from a study that specifically tested against such criteria is not present in the provided text. The document refers to "Verification Testing," which describes the tests performed and the areas assessed, but it doesn't provide a direct comparison table for acceptance criteria against performance metrics for a specific clinical or diagnostic AI/ML product.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The provided document is a 510(k) summary for a medical device (a detachment system for coils used in embolization of intracranial aneurysms), not an AI/ML-based diagnostic device. The "Verification Testing" mentioned in section {8} details general engineering and software tests (e.g., detachment cycle time, maximum detachment time, detachment consistency, max voltage/current output, battery detection, fault detection, etc.), and risk assessment, rather than performance metrics related to diagnostic accuracy, sensitivity, or specificity that would typically be associated with AI/ML products and their acceptance criteria in a clinical setting.

The device is a physical system that performs an electrolytic detachment process, and the testing described is engineering verification to ensure the system functions as intended and safely, not a study to evaluate algorithmic performance against a ground truth in a diagnostic context.

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The InZone Detachment System is intended for use with all versions of Stryker Neurovascular detachable coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

The Stryker Neurovascular InZone Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular Detachable Coils. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.

Here's an analysis of the provided text regarding the acceptance criteria and study for the InZone® Detachment System:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a Special 510(k) for firmware modifications to an already cleared device (K103008). Therefore, the "acceptance criteria" discussed are primarily related to verifying the impact of these changes and demonstrating substantial equivalence, rather than establishing initial performance benchmarks for a new device.

The document lists "Physical and Performance Characteristics" that describe the device, but these are not explicitly presented as "acceptance criteria" with quantitative targets and reported performance. Instead, the "Verification Testing" section outlines the types of tests performed to confirm the modifications did not negatively impact the device or raise new safety/effectiveness questions.

2. Sample Size for the Test Set and Data Provenance

The document provides no specific sample sizes for "test sets" in the traditional sense of clinical or even large-scale performance testing using patient data. The verification testing described is primarily bench-top and firmware test case modeling.

• Sample Size: Not specified quantitatively. The text refers to "software (firmware) test case model" and "bench top testing." This typically implies a systematic set of tests covering various scenarios and parameters, but not a large statistical sample of physical units or clinical cases. For a firmware change, test cases would be numerous but not necessarily represent a "sample size" in the conventional sense.
• Data Provenance: Not applicable as it's not a clinical study. The testing is internal to Stryker Neurovascular ("bench top") and software-based.

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

Not applicable. This is not a study involving human interpretation of data where ground truth would be established by experts. The "ground truth" for firmware and bench testing would be the expected functional behavior and performance defined by the design specifications.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication method as no expert-derived ground truth or human assessments were involved. The testing is objective and based on engineering verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe any MRMC comparative effectiveness study. It's a technical submission for firmware modifications to a detachment system, not an imaging-based AI diagnostic device requiring human reader assessment studies.

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

Yes, in essence. The verification testing conducted (software/firmware test case model and bench top testing) assesses the device's performance in a standalone manner. The device, which automates a detachment process based on embedded firmware, acts as an "algorithm only" system in this context. The study did not involve human-in-the-loop performance modification.

7. The Type of Ground Truth Used

The ground truth used for this type of verification testing is based on:

• Design Specifications: The intended behavior and performance parameters defined during the device's design and development.
• Predicate Device Performance: The established and cleared performance of the original InZone Detachment System (K103008). The firmware modifications aim to improve specific aspects (e.g., wire detection time, detachment success for Target coils) while maintaining overall safety and effectiveness.
• Industry Standards: Compliance with relevant standards like ISO 14971:2009 for risk management.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm in the context of data training. The "firmware" is a program with predefined logic and parameters, not something that "learns" from a training set.

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

Not applicable, as there is no training set for this type of firmware update.

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The InZone™ Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Boston Scientific's InZone™ Detachment System is a sterile, handheld, single-patient use device designed for use with Boston Scientific Detachable Coils. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.

The provided text describes Boston Scientific's InZone Detachment System, which is intended for use with detachable coils for embolization procedures. This document details a 510(k) premarket notification for modifications to an already cleared device, not an initial market clearance study. Therefore, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel acceptance criteria through a comprehensive clinical study.

Given the nature of the submission (modifications to an existing device), the "acceptance criteria" primarily relate to the functional performance of the modified components and ensuring that the modifications do not negatively impact the safety and effectiveness of the device compared to the predicate. The "study" proving this largely consists of verification testing.

Here's an attempt to extract and present the information as requested, acknowledging the limitations of the provided document in the context of a typical standalone clinical study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the way one might expect for a new device's clinical performance. Instead, the focus is on functional verification that the modified device still performs as intended and is substantially equivalent to its predicate. The "performance" reported is primarily the successful completion of these verification tests and the unchanged fundamental scientific technology.

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

• Sample Size: The document does not specify a distinct "test set" sample size in terms of clinical cases or patient data. The verification testing mentioned (functional testing, software verification) would have involved specific numbers of devices, components, and possibly simulated detachments. This is a technical (benchtop and software) verification, not a clinical trial.
• Data Provenance: Not applicable in the context of clinical data. The data provenance is from internal Boston Scientific verification testing, software analysis, and risk assessments.

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

• This information is not provided. Given that the study is primarily device verification (functional, software, risk assessment) rather than a clinical study requiring expert interpretation of patient data, formal "ground truth" established by external clinical experts would typically not be a primary component. Internal engineering and quality assurance personnel would be involved in assessing the verification test results against design specifications.

4. Adjudication Method for the Test Set

• Not applicable. This was not a study requiring adjudication of expert interpretations of medical images or patient outcomes.

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. This document describes a medical device (a coil detachment system that is a power supply), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• No. This is a physical medical device. While it has firmware (an "algorithm"), its performance is always in conjunction with human use during a medical procedure, albeit as a tool rather than an interpretive system. A standalone "algorithm only" performance study, as understood in diagnostic AI, is not applicable.

7. The Type of Ground Truth Used

• For the verification testing described, the "ground truth" would be the engineering design specifications and expected functional performance parameters of the device. For example, successful detachment (yes/no), correct LED signal behavior, proper grounding detection, and adherence to software requirements. It does not involve "expert consensus, pathology, or outcomes data" in the clinical sense for this specific submission.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "firmware" is programmed based on engineering design, not trained on data.

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

• Not applicable, as there is no "training set." The software/firmware's "ground truth" is defined by its design specifications and functional requirements established during the device's development process.

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Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Target Coils are indicated for endovascular embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature

Boston Scientific's InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Boston Scientific Corporation's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Boston Scientific's InZone™ Detachment System (sold separately).

Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.

Boston Scientific's InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

The provided text describes Boston Scientific Corporation's Target Detachable Coils and InZone Detachment System. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods is not present in the provided document.

However, based on the available information, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it states that "Verification testing has demonstrated Target Detachable Coils are substantially equivalent to the current legally marketed predicate devices" and similarly for the InZone Detachment System, electrical safety testing "has demonstrated the devices to be substantially equivalent to the current legally marketed predicate device."

The "performance" reported is that the devices are substantially equivalent to their respective predicate devices. This implies that their performance, in terms of safety and effectiveness for their intended use, is considered comparable to already approved devices.

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

The document states "Verification testing has demonstrated..." and "Verification testing of the InZone Detachment System, including electrical safety testing in accordance with applicable parts of the EN 60601-series of standards, has demonstrated..."

This indicates that pre-clinical verification testing was performed. However, specific sample sizes for these tests are not provided. The data provenance is also not specified, but given this is pre-clinical bench and electrical safety testing, it would largely be laboratory-generated data, not human patient data in the context of geographical origin or retrospective/prospective nature.

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

This information is not provided and is generally not applicable to a 510(k) submission for this type of device, which relies heavily on bench testing and comparison to predicate devices, rather than human expert evaluation of clinical cases or images.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable in the context of the reported verification 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:

This is not applicable. The device (embolization coils and their detachment system) is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in interpretation.

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

This is not applicable. The device is a physical medical device.

7. The Type of Ground Truth Used:

For the "verification testing," the ground truth implicitly used would be established engineering specifications, performance standards (like EN 60601 for electrical safety), and the known characteristics/performance of the predicate devices. For example, if testing tensile strength, the "ground truth" would be the specified strength range for safe performance.

8. The Sample Size for the Training Set:

This information is not provided and is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set.

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

This information is not provided and is not applicable for the same reason as point 8.

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Boston Scientific's InZone™ Detachment System is intended for use with all versions of BSC Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Boston Scientific's InZone™ Detachment System is a sterile. handheld, single-patient use device designed for use with Boston Scientific Detachable Coils. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes preloaded with two AAAA (1.5 VDC) batteries.

Boston Scientific's IZDSTM Connecting Cable is a 180 cm cable intended for use with the InZone Detachment System in the detachment of Boston Scientific's GDC® Detachable Coils and Matrix2® Detachable Coils. The cable completes the connection between the InZone unit and a patient return electrode (a 20 or 22 gauge uncoated stainless-steel hypodermic needle) inserted subcutaneously at the patient's groin.

The provided 510(k) summary for the Boston Scientific InZone™ Detachment System and IZDS™ Connecting Cable (K092666) does not contain a typical "study" that would prove device performance against numerical acceptance criteria. Instead, it relies on a demonstration of substantial equivalence to a previously cleared predicate device (K021494).

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly mention a "test set" in the context of clinical data or comparative performance against specific metrics. The testing referred to is primarily verification testing (e.g., electrical safety, material compatibility, firmware function, sterilization validation). These are engineering and quality assurance tests, not typically clinical trials with 'test sets' of patient data. Therefore, details like sample size for clinical data or data provenance are not applicable or provided in this 510(k) 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):
This information is not applicable as the submission focuses on substantial equivalence through verification testing and risk assessment rather than a clinical study requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring expert adjudication is 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 MRMC comparative effectiveness study was conducted or described. This device is an electro-mechanical system for detaching coils, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm, but a hardware system used by a clinician during a medical procedure.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the verification testing, the "ground truth" would be established engineering specifications, safety standards (e.g., EN 60601), and the performance characteristics of the predicate device. It's not clinical "ground truth" in the sense of gold-standard diagnoses or patient outcomes.

8. The sample size for the training set:
Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established:
Not applicable.

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