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This product is intended for the aspiration and preparation of medical fluid, not including injection.

The Filter Needle for Single Use is a single use, irradiation sterilized device that is designed to be used for use in conjunction with luer taper infusion sets conforming to EN ISO 80369-7 for the extraction, filtration and configuration of medicinal solutions and is not intended for injection purposes. Filter Needle for Single Use consists of cap, needle cannula, needle hub, sheath and filter. The cap, needle hub and sheath are made of polycarbonate (PC), the needle tube is made of medical stainless steel (SUS304), and filter is made of polyamide (PA).

The needle holder is a 6% standard tapered connector with good connectivity to the infusion apparatus.

The provided text describes the 510(k) premarket notification for a "Filter Needle for Single Use" (K233277) and its substantial equivalence to a predicate device. However, it does not contain information about a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, nor does it refer to performance metrics typically associated with AI/SaMD (e.g., sensitivity, specificity, AUC).

The document focuses on the substantial equivalence of a physical medical device (a filter needle) based on material, design, performance, biocompatibility, sterilization, and shelf-life testing, primarily against established international standards.

Therefore, I cannot extract the requested information regarding AI/SaMD acceptance criteria and studies from this document. The tables and study details you've asked for (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth establishment for training and test sets) are relevant to the validation of AI/SaMD, but are not present in this clearance document for a conventional medical device.

To directly answer your request based on the provided text, I must state that the information is not available.

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The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use.

The FilteredFlo warming blankets are used with the IOB Temperature Management System (previously cleared K231596) that draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the FilteredFlo Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient.

The FilteredFlo warming blankets in the submission are the following:

FF-243 ADULT/PACU BLANKET
FF-244 PEDIATRIC BLANKET
FF-246 INFANT UNDERBODY BLANKET
FF-247 LARGE PEDIATRIC UNDERBODY BLANKET
FF-248 ADULT UNDERBODY BLANKET
FF-443 UPPER BODY BLANKET
FF-442 LOWER BODY BLANKET
FF-344 TORSO BLANKET
FF-145 WARMING TUBE BLANKET

These blankets are single-use and disposable. Each blanket consists of two layers of nonwoven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The provided document is a 510(k) summary for a medical device called "FilteredFlo Warming Blankets." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information related to software, artificial intelligence (AI), diagnostic performance, or extensive clinical studies that would typically have the requested details about acceptance criteria for AI models, human reader studies, ground truth establishment, or training/test set sizes.

The "studies" mentioned are primarily non-clinical tests to demonstrate that the new warming blankets perform equivalently to existing ones in terms of physical characteristics and safety, not diagnostic accuracy or AI performance.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to AI or diagnostic performance, as these are not relevant to the "FilteredFlo Warming Blankets" device as described in this 510(k) submission.

Here's a breakdown of what can be extracted from the document, tailored as much as possible to your request, but highlighting the absence of AI/diagnostic-specific details:

Device: FilteredFlo Warming Blankets (models FF-243, FF-244, FF-246, FF-247, FF-248, FF-443, FF-442, FF-344, FF-145)

Intended Use: "The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use."

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

   Since this is a thermal regulating system and not an AI or diagnostic device, the "acceptance criteria" are related to physical and functional equivalence to a predicate device, specifically in terms of temperature uniformity, package integrity, and lack of leaks.

   Acceptance Criteria	Reported Device Performance
   Temperature Uniformity	All test results show temperature uniformity "equivalence" between the FilteredFlo Warming Blankets and the predicate at different IOB Warmer settings.
   Simulated Transport Testing (ASTM D4169)	No package damage was observed. All products held integrity after the transport testing.
   Bubble Testing (ASTM F2096) (Leakage)	No leakage was found.
   Biocompatibility	Tests for biocompatibility were reported in the previously cleared K231596 (predicate device's clearance). The proposed device is implicitly accepted as biocompatible based on previous clearance.
   Material Design and Indication for Use Equivalence	The proposed device's material design and Indications for Use are deemed "Substantially Equivalent" to the predicate device.

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

   • Sample Size: Not explicitly stated for each test, but implied to be a representative sample of the different blanket models. These are physical product tests, not data-driven studies with "test sets" in the AI sense.
   • Data Provenance: Not specified, but these are laboratory/bench tests performed by the manufacturer or their contractors.

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" in this context refers to established engineering standards and physical measurements, rather than expert diagnostic consensus.

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

   Not applicable. These are engineering and physical product tests, not qualitative assessments requiring adjudication. The results are based on objective measurements against defined criteria.

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 warming blanket, not an AI or diagnostic tool. No MRMC study was performed or is relevant.

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

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

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

   The "ground truth" for demonstrating performance is derived from established engineering standards (e.g., ASTM standards for transport and bubble testing) and physical measurements (e.g., temperature measurements for uniformity). Comparison to the predicate device's cleared performance serves as the benchmark for "equivalence."

8. The sample size for the training set

   Not applicable. This device does not involve a "training set" for an algorithm.

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

   Not applicable.

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Filter CareStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in pediatric (with a tidal volume between 100 and adult patients, depending on the respective device. Filter SafeStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult patients. Filter/HME TwinStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and for respiratory use, as well as heat and moisture exchanger for humidifying respired gases for the patient. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in adult, pediatric and neonatal patients, depending on the respective device.

The devices are breathing circuit filters used to filter the inhaled and/or the exhaled air of the patient against microbiological and particulate matter from the gases in the breathing circuit. They enclose a filter material in a housing that fits to standard breathing system connectors. Additionally, there are breathing system filters combined with a foam to function as HME (Heat and Moisture Exchangers) for passively humidifying the inspired air. The portfolio contains the following types of breathing circuit filters: - Filter CareStar Plus are electrostatic filters for use against contamination with microorganisms - . Filter SafeStar Plus are mechanical filters for use against contamination with microorganisms - Filter/HME TwinStar Plus are filters for use against contamination with microorganisms and for passive humidification of breathing gases

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

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

The provided document describes three devices: Filter CareStar Plus, Filter SafeStar Plus, and Filter/HME TwinStar Plus. The table below compiles the acceptance criteria and reported performance for these devices based on the "Summary of non-clinical testing" section (pages 18-19).

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 state the sample sizes used for each non-clinical test. It mentions that "The devices... have undergone extensive testing" but does not detail the number of units tested for each criterion. The data provenance is also not specified; however, given that the submitter is "Drägerwerk AG & Co. KGaA" based in "Lübeck, Germany" and they tested against international standards (ISO, ASTM, IEC), it is likely that the testing was conducted in a controlled laboratory environment, potentially in Germany or by a certified testing facility adhering to these standards. The testing appears to be prospective, specifically designed to verify the devices' adherence to the mentioned standards.

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

The document does not mention the use of experts to establish ground truth for the non-clinical test set. The validation relies on adherence to established international and national standards (e.g., ISO, ASTM, IEC) rather than expert consensus on a test set. This implies that the "ground truth" is defined by the objective metrics and methodologies outlined in these standards.

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

There is no mention of an adjudication method in the text for the non-clinical test set. Given the nature of the tests (physical and performance characteristics against standards), it's a pass/fail determination based on quantitative measurements against predefined criteria, not a subjective assessment 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

The document explicitly states "Summary of Clinical Testing N/A" (page 20). This indicates that no clinical studies, including MRMC comparative effectiveness studies involving human readers or AI assistance, were performed or submitted. The entire submission focuses on non-clinical performance and substantial equivalence based on technical characteristics and adherence to standards.

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

Since the devices are breathing circuit filters and not software or AI-powered devices, the concept of a "standalone (algorithm only)" performance study is not applicable. The device's performance is intrinsically mechanical and material-based, not algorithmic.

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

The ground truth for this submission is based on established international and national consensus standards (e.g., ISO 9360-1, ISO 5356-1, ISO 80369-7, IEC 60601-1, ISTA 3A, ISO 23328-1, ASTM F2101, ISO 10993, ISO 18562-1). The device's performance is measured against the quantitative requirements and methodologies specified within these standards.

8. The sample size for the training set

This question is not applicable. The document describes physical medical devices (filters), not machine learning or AI models that require a "training set."

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

This question is not applicable, as there is no training set for these devices.

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CareStar 30 and SafeStar 55 are Breathing System Filters which are designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems.

The products may either be used on the patient side or on the device side of the ventilator/ anaesthetic device and are used as a hygienic measure alternatively to decontamination of breathing system and/or breathing gas conveying parts of the ventilator.

TwinStar 55 is a Breathing System Filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchanger are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The products are the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since Heated Humidifiers are almost impossible to use.

The products mentioned above are designed for disposable use and should be changed at least every 24 hours.

The filters CareStar 30 and SafeStar 55 are designed to reduce possible air or liquid borne cross contamination with microorganisms via anesthetic or ventilator breathing systems. The strategic use of an effective breathing filter protects, bi-directionally, both the patient and equipment.

The filter CareStar 30 contains an electrostatic filter pad while the filter SafeStar 55 incorporates a mechanical pleated filter pad. Both filters consist of a plastic body which incorporates 22 female / 15 male connectors in accordance with EN ISO 5326 and a luer lock connector which may only be used for gas monitoring.

The Filter/HME TwinStar 55 is designed to combine the feature of reducing possible cross contamination with micro-organisms and an ideal heat and moisture return.

The Filter/HME TwinStar 55 consist of a plastic body which incorporates an electrostatic filter pad, 22 female / 15 male connectors in accordance with EN ISO 5326 and a gas luer lock connector which may only be used for gas monitoring.

Here's an analysis of the provided text regarding the Dräger Medical breathing system filters, focusing on the acceptance criteria and the study proving compliance.

It's important to note that this document is a 510(k) Summary, which typically provides a high-level overview of the device and its substantial equivalence to predicate devices, rather than a detailed study report. Therefore, specific details about study design, raw data, or comprehensive statistical analyses are often summarized or omitted.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance specifications for the devices, comparing them to generally accepted standards for breathing system filters. The "acceptance criteria" are implied by the listed performance values and the claim of substantial equivalence to predicate devices.

*BFE: Bacterial filtration efficiency; VFE: Virus filtration efficiency

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

The document states filtration efficiency tests were done "by Nelson Lab." Nelson Laboratories is a well-known contract research organization specializing in microbiology and material testing for medical devices.

• Sample Size for Test Set: Not explicitly stated in the provided document. Standard laboratory testing, especially for filtration efficiency, would involve a statistically significant number of samples, but the exact count is not given here.
• Data Provenance: The document implies the data comes from laboratory testing (Nelson Labs). This is not patient-specific clinical data. It is a prospective test of the physical properties and performance of the manufactured devices. The country of origin for Nelson Labs is the United States.

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

• This type of device (breathing system filter) does not typically involve human expert adjudication for its primary performance metrics like filtration efficiency or resistance to flow. These are objective, quantifiable physical properties measured by laboratory equipment.
• Therefore, the concept of "ground truth established by experts" in the way it applies to image-based diagnostics is not relevant here. The "ground truth" for the test results is established by the methods and standards used by Nelson Laboratories, which are highly specialized technicians and scientists in their field.

4. Adjudication Method for the Test Set

• Not applicable (see point 3). Performance metrics are determined by laboratory measurements according to established test standards (e.g., for BFE/VFE, resistance to flow, moisture loss).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

• No. This is a hardware medical device (breathing system filter), not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies and AI assistance are not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• No. This is not an algorithm or AI device. The performance data presented is the "standalone" performance of the physical device itself in a laboratory setting.

7. The Type of Ground Truth Used

• For physical performance metrics (filtration efficiency, resistance to flow, internal volume, moisture loss), the ground truth is derived from standardized laboratory testing methods and measurements. These methods are designed to objectively quantify the device's physical properties under controlled conditions. This is not pathology, expert consensus (in the clinical sense), or outcomes data.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's design and manufacturing processes are refined based on engineering principles and material science, not data training.

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

• Not Applicable. (See point 8).

Summary of the Study Proving Device Meets Acceptance Criteria:

The document states that the performance data for filtration efficiency was "[measured] by Nelson Lab." It also lists other performance characteristics such as resistance to flow, internal volume, and moisture loss. The study demonstrating that the device meets criteria is implicitly the laboratory testing conducted by Nelson Laboratories and Dräger Medical's internal R&D, which measured these specific physical and biological filtration properties of the filters.

The overall claim of the 510(k) submission is Substantial Equivalence. This means the applicant argues that the proposed devices (Filter CareStar 30, Filter SafeStar 55, Filter/HME TwinStar 55) are as safe and effective as existing, legally marketed predicate devices (listed in the document). The "study" isn't a comprehensive clinical trial but rather a comparison of key performance data to established values of predicate devices and relevant ISO/EN standards. The document states:

"The comparison of the data shows similar values for the key performance data. Proposed devices show similar values in filtration efficiency, dead space, resistance to flow and recommended tidal volumes when compared to the legally marketed devices."

The acceptance criteria are therefore implicitly defined by the performance benchmarks set by these predicate devices and relevant industry standards (like EN ISO 5326 and ISO 9360), which the new devices' laboratory test results must meet or demonstrate equivalence to. The FDA's clearance (K072002) signifies their agreement that this substantial equivalence has been demonstrated.

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The FilterWire EZ™ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral vasculature, peripheral vessels other than carotid arteries, or in treating native coronaries, including acute myocardial infarction.

The Boston Scientific FilterWire EZ System (3.5 mm - 5.5 mm) is a temporary intra-vascular 0.014" guide wire filtration system that is placed distal to the vessel lesion to be treated by interventional procedures. The system consists of a Protection Wire, an EZ Delivery Sheath, an EZ Soft Tip Retrieval Sheath and accessories. A separately packaged EZ Bent Tip Retrieval Sheath is also available as an alternate tool for retrieving the FilterWire EZ Protection Wire. The 190 cm wire is compatible with the Boston Scientific extension wire (K970376 cleared June 6, 1997) for overthe-wire catheter exchanges.

The FilterWire EZ System is delivered via the EZ Delivery Sheath. Once the Protection Wire is across the lesion, the filter bag is expanded in the artery lumen by removing the EZ Delivery Sheath. After treating the lesion, all interventional devices are removed, and the EZ Soft Tip Retrieval Sheath or EZ Bent Tip Retrieval Sheath is advanced to the proximal end of the filter and the filter loop is retracted into the EZ Retrieval Sheath, trapping any emboli caught during the procedure. The EZ Retrieval Sheath and Protection Wire are then removed from the patient simultaneously.

This document describes the Boston Scientific FilterWire EZ™ Embolic Protection System.

Acceptance Criteria and Device Performance

Due to the nature of the device (a physical medical device for embolic protection), the provided 510(k) summary does not contain specific quantitative acceptance criteria or detailed device performance metrics in the format of a typical AI/software device. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and a clinical trial.

Summary of Device Performance and Verification:

Note on Quantitative Data: The provided text does not offer numerical percentages, sensitivities, specificities, or other quantitative performance data often associated with acceptance criteria for AI/software devices. The "acceptance criteria" for this physical device are implicitly met by passing various engineering, biological, and clinical studies to demonstrate substantial equivalence to legally marketed predicate devices.

Study Information

The primary clinical evidence referenced is the CABERNET Trial.

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in this 510(k) summary. The document mentions the CABERNET Trial's results were used to support the NexStent PMA (P050025). To obtain the exact sample size, one would need to refer to the PMA for the NexStent Carotid Stent.
   • Data Provenance: The study was a "carotid artery stenting clinical trial (CABERNET) sponsored by EndoTex™ Interventional Systems, Inc." This indicates it was a prospective clinical trial, likely involving multiple sites (though not explicitly stated) and would have predominantly included data from the country/countries where the trial was conducted. The specific country of origin is not mentioned.

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

   • This information is not provided in the 510(k) summary. For a clinical trial of a physical device, "ground truth" would typically be established through clinical outcomes, imaging assessments adjudicated by a clinical events committee (CEC), or other objective medical findings, rather than expert consensus on interpretive data (as would be common for AI/diagnostic software).

3. Adjudication method for the test set:

   • This information is not explicitly stated in the 510(k) summary. Clinical trials often employ a Clinical Events Committee (CEC) for endpoint adjudication, where multiple experts review cases. However, the specific method (e.g., 2+1, 3+1) is not detailed here.

4. 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 device is a physical medical device (embolic protection system), not an AI-based diagnostic or assistive software. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable.

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

   • Not applicable. This is a physical medical device, not an algorithm or software requiring a standalone performance evaluation.

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

   • For a clinical trial evaluating the safety and effectiveness of an embolic protection system, the "ground truth" would primarily be clinical outcomes data, such as rates of stroke, death, myocardial infarction, and other adverse events, as well as procedural success and device-related complications. Imaging data (e.g., degree of revascularization, evidence of embolization) would also contribute.

7. The sample size for the training set:

   • Not applicable. This device is a physical medical device undergoing a clinical trial for safety and effectiveness, not a machine learning model that requires a training set. The "in-vitro testing," "in-vivo testing," and "clinical evaluation" serve to validate the physical device.

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

   • Not applicable. As a physical device, there is no "training set" in the context of machine learning.

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The FilterWire EZ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts. The diameter of the artery at the site of filter loop placement should be between 2.25 mm and 5.5 mm.

The safety and effectiveness of this device as an embolic protection system has not been established in cerebral, carotid and peripheral vasculature or in treating native coronaries, including acute myocardial infarction.

The subject FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) consists of the same four main components as the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984. These components are:

• · A Protection Wire (0.014 in. [0.36 mm] guide wire and integrated filter loop) that incorporates a circular/oval-shaped structure (filter loop assembly), which supports a thin, porous, filter membrane designed to contain and remove embolic material while maintaining blood flow.
• · An EZ Delivery Sheath, a low-profile sheath that constrains the filter on the protection wire for delivery to the site of filter loop placement. It is prepackaged with the protection wire for coaxial delivery and has a slit for easy removal in a peel-away fashion.
• · An EZ Retrieval Sheath is intended to negotiate through the anatomy over the protection wire to retrieve the filter. The sheath is designed to track easily to the filter without catching on obstacles such as stents. The sheath has a radiopaque marker and is silicone coated.
• · A tool kit containing one peel-away introducer, one wire torquer and one hemostasis valve dilator

This is a 510(k) premarket notification for a medical device, the Boston Scientific FilterWire EZ Embolic Protection System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with defined acceptance criteria for a new AI/software device.

Therefore, the requested information about acceptance criteria, study details, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance metrics are not applicable to this regulatory document.

The document states that the new device is substantially equivalent to a previously cleared device (K051984) and that "Non-clinical tests conducted for the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) showed the device met its design-input criteria, and is safe and effective for its intended use." However, it does not provide specific acceptance criteria or detailed study results in the format requested for an AI/software device.

Here's an attempt to structure the available information, noting the inapplicability of many requested fields:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission for a non-software medical device. The submission focuses on demonstrating substantial equivalence to a predicate device and meeting "design-input criteria" through non-clinical testing. Specific quantitative acceptance criteria and performance metrics for the device's function (e.g., filter efficiency, guidewire flexibility) are not detailed in this summary.

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

Not applicable as this is not an AI/software device requiring a test set of data. Non-clinical (in-vitro and in-vivo) testing was performed, but specific sample sizes for these tests are not provided in this summary.

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

Not applicable. This device is not an AI/software system that uses ground truth labels established by experts on a test set.

4. Adjudication Method for the Test Set

Not applicable.

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

No. This is not an AI/software device, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study?

No. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

Not applicable.

8. Sample Size for the Training Set

Not applicable. This device does not involve a training set as it's not an AI/software device.

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

Not applicable.

Summary of Relevant Information from the Document:

While the specific details requested for an AI/software device are not present, the document provides the following:

• Device: Boston Scientific FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm)
• Purpose of Submission: To demonstrate substantial equivalence to a predicate device (FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984).
• Performance Evaluation: "Non-clinical tests conducted for the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) showed the device met its design-input criteria, and is safe and effective for its intended use."
• Testing Types Mentioned: In-vitro testing, in-vivo testing, biocompatibility, and packaging.
• Compliance: Where appropriate, testing conformed to the requirements of 21 CFR Part 58, Good Laboratory Practices (GLP).

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The FilterWire EZTM Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in coronary saphenous vein bypass grafts. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm.

• The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature.
• The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
• The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.

The Boston Scientific FilterWire EZ (2.25 mm - 3.5 mm) Embolic Protection System is a temporary intra-vascular 0.014" guide wire filtration system that is placed distal to the vessel lesion to be treated by interventional procedures. The system consists of a Protection Wire (190 cm or 300 cm length), an EZ Delivery Sheath, an EZ Retrieval Sheath and accessories. The 190 cm long wire is compatible with the Boston Scientific Add Wire® Extension Wire (K970376 cleared June 6, 1997) for over-the-wire catheter exchanges. The Filter Wire EZ (2.25 mm - 3.5 mm) Protection Wire is delivered via the EZ Delivery Sheath. Once the Protection Wire is across the lesion, the filter bag is expanded in the artery lumen by removing the EZ Delivery Sheath. After treating the lesion, all interventional devices are removed, and the EZ Retrieval Sheath or EZ Bent Tip Retrieval Sheath is advanced to the proximal end of the filter and the filter loop is retracted into the EZ Retrieval Sheath, trapping any emboli caught during the procedure. The EZ Retrieval Sheath and EZ Protection Wire are then removed from the patient simultaneously.

This document is a 510(k) premarket notification for the Boston Scientific FilterWire EZ™ Embolic Protection System (2.25 mm – 3.5 mm). The study described is not for an AI/ML device, but rather a traditional medical device. Therefore, much of the requested information (e.g., number of experts, adjudication methods, MRMC study, standalone performance, training set details) is not applicable.

However, based on the provided text, here is an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The primary acceptance criterion for the clinical study was likely to demonstrate non-inferiority in the 30-day MACE rate compared to the predicate GuardWire Plus device in the specified vessel diameter range.

2. Sample Size and Data Provenance

• Test Set (Clinical Study):
  • FilterWire EZ Group (BLAZE II): 131 registry patients, 8 roll-in patients, 1 compassionate use patient (total 140 enrolled, but performance analysis focuses on "131 registry patients").
  • GuardWire Plus Control Group (FIRE Trial subset): 169 patients treated within the 2.25 mm - 3.5 mm vessel diameter range.
• Data Provenance: Prospective, multi-center study (BLAZE II) for the FilterWire EZ device. The comparator data (GuardWire Plus) was from a subset of a previously completed study (FIRE Trial). The countries of origin of the data are not explicitly stated, but it's a multi-center study.

3. Number of Experts and Qualifications

This information is not applicable as the submission describes a traditional medical device with a clinical trial, not an AI/ML device where expert consensus is typically used to establish ground truth for a test set.

4. Adjudication Method

This information is not applicable for a traditional clinical trial measuring clinical outcomes like MACE. MACE (Major Adverse Cardiac Events) are defined clinical endpoints.

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

• Not Applicable. This is a study for a traditional medical device (embolic protection system), not an AI/ML diagnostic or assistive device that would involve human readers.

6. Standalone Performance

• Not Applicable. This device is an interventional tool, and its performance is inherently linked to human use during a procedure. "Standalone performance" as often understood for AI algorithms (i.e., algorithm only without human-in-the-loop) is not relevant here. However, the study focuses on the device's technical success, clinical success, and impact on patient outcomes (MACE) when used by clinicians.

7. Type of Ground Truth Used

• Clinical Outcomes Data: The primary ground truth for the clinical study was the occurrence of Major Adverse Cardiac Events (MACE) at 30 days post-procedure, as well as device success, clinical success, and final TIMI 3 flow. MACE is a composite of clinically defined adverse events (e.g., all-cause death, myocardial infarction, target vessel revascularization). The presence of non-Q wave MI was assessed via CK-MB levels.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning. The device design and specifications are based on engineering principles and preclinical testing.

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

• Not Applicable. See point 8.

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The FilterWire EZ Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

The Boston Scientific FilterWire EZ Embolic Protection System is a temporary intra-vascular 0.014" guide wire filtration system that is placed distal to the vessel lesion to be treated by interventional procedures. The system consists of a protection wire in 190 and 300 cm lengths, an EZ Delivery Sheath, an EZ Soft Tip Retrieval Sheath and accessories. A separately packaged EZ Bent Tip Retrieval Sheath will also be available as an alternate tool for retrieving the FilterWire EZ protection wire. The 190 cm wire is compatible with the Boston Scientific extension wire (K970376 cleared June 6, 1997) for over-the-wire catheter exchanges. The FilterWire EZ protection wire is delivered through a low profile delivery sheath, which allows free rotational movement of the guide wire component. The tip of the protection wire and the filter loop are radiopaque. The filter is deployed distal to the lesion, and the delivery sheath removed, leaving only the filter and filter loop at the end of a standard 0.014" guide wire. Interventional devices, which are 0.014" guide wire compatible, may then be tracked over the FilterWire guide wire to treat the lesion. After treating the lesion, all interventional devices are removed, and a retrieval sheath is advanced to collapse the filter loop, trapping any emboli caught during the procedure. The retrieval sheath and FilterWire are then removed from the patient simultaneously.

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the Boston Scientific FilterWire EZ Embolic Protection System, primarily describing the device, its intended use, and its substantial equivalence to a predicate device.

It details:

• Device Description: What the FilterWire EZ Embolic Protection System is and how it functions.
• Intended Use: The specific medical procedures and patient populations for which the device is indicated.
• Labeling Changes: Minor updates to contraindications.
• FDA Communication: The FDA's determination of substantial equivalence for market clearance.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study proving it meets acceptance criteria.
• Information on sample sizes for test sets or training sets.
• Data provenance, expert qualifications, adjudication methods, or MRMC studies.
• Standalone algorithm performance or the type of ground truth used.

Therefore, I cannot provide the requested information based on the text provided.

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