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The Remote Access Perfusion (RAP) femoral venous cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to six hours

RAP Femoral venous cannulae are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.

The device is composed of a cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the femoral vein till the vena cava. The cannula and the obturator are packaged within the same pouch and sold together.

The cannula is an open lumen PVC polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple holes at multiple stages to allow fluid flow. The clear proximal section is not reinforced to allow clamping; the proximal end terminates in a 3/8" to ½" barbed connector for standard cardiopulmonary bypass tubing.

The RAP femoral arterial cannulae are the modified version of the disposables currently marketed as the RAP Femoral Venous cannula (K052081).

This document, an FDA 510(k) Clearance Letter, is for a medical device (a cannula) and not for a software or AI-based medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and studies that prove a device meets acceptance criteria for an AI/software device.

The questions in your prompt are highly specific to AI/Machine Learning device validation, such as:

1. Acceptance criteria for AI performance: (e.g., sensitivity, specificity, AUC)
2. Sample size, provenance, expert ground truth, adjudication: These are standard for evaluating AI model performance.
3. MRMC study and effect size: How AI assists human readers.
4. Standalone performance: Algorithm without human input.
5. Type of ground truth: Pathology, outcomes, expert consensus.
6. Training set details: Sample size and ground truth establishment.

None of this information is relevant or present in the provided 510(k) clearance letter for the RAP Femoral Arterial Cannulae, which is a physical device subject to mechanical, material, and biocompatibility testing.

The document confirms the device meets acceptance criteria through:

• Non-Clinical Performance Data: Extensive verification and validation testing of the physical device components and function (e.g., visual inspection, connector testing, flow rate, kink test, pull strength, blood trauma characterization, biocompatibility tests).
• No Clinical Performance Data: The submission explicitly states "No clinical testing was conducted in support of the RAP Femoral venous cannulae, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."

Therefore, I cannot extract the information asked in your prompt from this particular document.

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Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant:
Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by premature and infant (birth to 2 years) patients in professional healthcare environments.

Hudson RCI® Comfort Flo® Plus Cannulas and Comfort Flo® Soft Plus Cannulas Extra Small:
Hudson RCI® Comfort Flo® Plus Cannulas and Comfort Flo® Soft Plus Cannulas Extra Small are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.

It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.

Hudson RCI® Comfort Flo Nasal Cannulas Premature, Infant
Hudson RCI® Comfort Flo Plus Cannulas Extra Small
Hudson RCI® Comfort Flo Soft Plus Cannulas Extra Small

This is a 510(k) clearance letter for a medical device (nasal cannula), not an AI/ML-driven device. Therefore, the information typically requested for AI/ML device validation (such as expert consensus, MRMC studies, or training/test set details) is not applicable.

The document describes the device, its intended use, and a summary of non-clinical testing performed to demonstrate substantial equivalence to predicate devices. It clearly states that no clinical testing was performed.

Here's a breakdown of the requested information based on the provided document, highlighting why many points are not applicable for this type of device clearance:

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

   • The document lists various non-clinical performance tests but does not provide a table of specific acceptance criteria with corresponding reported device performance values. Instead, it generally states that testing was conducted "to demonstrate substantial equivalence." For example, it lists "Relevant Humidity Output testing" but doesn't state the specific humidity output range considered acceptable or the measured output. This is typical for a 510(k) submission where broad equivalence is the goal rather than meeting precise performance thresholds for novel functionality.

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

   • Not applicable. This is a physical medical device. Testing involved bench tests on manufactured units, not data sets in the AI/ML sense. Data provenance, retrospective/prospective, and sample sizes for test sets (in the context of patient data) are not relevant as no human or clinical data was used for validation.

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. No "ground truth" was established by experts in the context of diagnostic performance, image interpretation, or similar AI/ML applications, as this is a physical medical device.

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

   • Not applicable. There was no test set requiring expert adjudication for performance evaluation.

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-assisted device, and no MRMC study was conducted. The document explicitly states "No clinical testing was performed."

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

   • Not applicable. This is not an algorithm-based device.

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

   • Not applicable. The concept of "ground truth" as it applies to AI/ML model validation is not relevant here. The device's performance was evaluated against engineering specifications and industry standards for physical device functionality (e.g., flow rates, material compatibility, strength).

8. The sample size for the training set

   • Not applicable. There is no AI/ML model, and thus no training set.

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

   • Not applicable. There is no AI/ML model, and thus no training set or ground truth establishment for it.

In summary, the provided document is a 510(k) clearance for a physical medical device, not an AI/ML-driven product. Therefore, most of the requested information related to AI/ML validation (ground truth, expert studies, training/test sets) is irrelevant to this submission.

The acceptance criteria for this device focus on:

• Biocompatibility: Meeting ISO standards (e.g., ISO 10993 series, ISO 18562 series) to ensure the materials are safe for patient contact and breathing gas pathways. The document lists the specific ISO standards used.
• Performance Bench Testing: Covering aspects like visual inspection, humidity output, thermal overshoot, connection strength, leak testing, headgear testing, shelf life, and useful life. While the specific numerical acceptance criteria for each test (e.g., "humidity output must be within X amount") are not explicitly listed in this summary, the document indicates these tests were performed and implicitly met the company's internal acceptance criteria for demonstrating substantial equivalence.
• Substantial Equivalence: The overarching acceptance criterion for a 510(k) is demonstrating that the device is "as safe and as effective" as a legally marketed predicate device, based on the non-clinical testing performed.

The "Study that proves the device meets the acceptance criteria" for this product consists of the various Non-Clinical Testing described on pages 16-17, primarily Biocompatibility Testing and Performance Testing (Bench), which were conducted to support the claim of substantial equivalence to the predicate devices.

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The cannulas, obturators, seals, and related accessories are intended to establish a port of entry for instruments, endoscopes, or accessories. They are intended to be used only in a medical facility by trained medical professionals in accordance with its associated user manual.

The subject device 8 mm and 12 mm Assist Cannulas are used as part of a trocar system to establish a port of entry into the surgical site. The 8 mm and 12 mm Assist Cannulas are intended to be used laparoscopically (independently of the da Vinci Systems), but may be used in conjunction with da Vinci systems to assist robotic procedures.
The cannula is a stainless steel hollow tube that serves as a port of entry for endoscopic instruments. A seal is attached to a cannula and an obturator is placed through the seal. The seal attaches to the top of the cannula to create an air-tight system that allows an insufflated body cavity to be maintained. The seal has an insufflation port with a universal luer fitting and stopcock which connects to the da Vinci Insufflator Tube Set with Smoke Evacuation.

This FDA 510(k) clearance letter pertains to medical devices (8 mm and 12 mm Assist Cannulas), not AI/ML software. Therefore, the information typically found for AI/ML device studies (such as acceptance criteria for algorithm performance, sample sizes for test sets, expert consensus, MRMC studies, or training set details) is not present in this document.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing relevant to surgical cannulas, such as dimensional measurements, mechanical and functional verification, biocompatibility, and sterilization.

Here's a breakdown of the available information related to performance and testing, framed to align with your request where applicable, but noting the absence of AI/ML-specific details:

Device: 8 mm Assist Cannula; 12 mm Assist Cannula

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated numerically. The performance data section vaguely mentions "bench and animal" testing. The human factors evaluation refers to "post-market data and the MAUDE database" and "formative usability evaluations." Specific numbers for test units or subjects are not provided.
• Data Provenance:
  • Bench and Animal Testing: Implied to be conducted internally or by a testing facility, but no specific country of origin is mentioned. These are typically prospective tests.
  • Human Factors Evaluation: "Post-market data and the MAUDE database" is retrospective data from device adverse event reporting. Formative usability evaluations are prospective. No country of origin is specified for these studies.

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

This information is not applicable and not provided in the document as this is a traditional medical device (surgical cannula) clearance, not an AI/ML device that requires expert-established ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This concept is typically relevant to the establishment of ground truth in AI/ML diagnostic studies through expert review.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating human reader performance with and without AI assistance for diagnostic tasks, which is not relevant for a surgical cannula.

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

No, this is not applicable. The device is a physical surgical tool and does not involve an algorithm.

7. The Type of Ground Truth Used

For the physical device, "ground truth" would correspond to engineering specifications and safe/effective performance. This was established through:

• Design Input Requirements: The pre-defined criteria for the device's function and performance.
• Bench Testing: Direct physical measurements and functional tests against specifications.
• Animal and Cadaver Models: Simulated use to confirm performance in a biological context.
• Biocompatibility Standards: Adherence to ISO 10993-1.
• Sterilization Standards: Confirmation of steam sterilization methods.
• Human Factors Analysis: Identification and mitigation of use-related risks through analysis of historical data and usability assessments.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train AI/ML algorithms. This device does not use an AI/ML algorithm.

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

Not applicable, as there is no AI/ML training set for this device.

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OPT94X Model:
The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway.

This device is designed to be used in a hospital, sub-acute facility or long-term care facility by appropriately qualified healthcare professionals.

MYOPT9X Model:
The F&P Optiflow+ is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (3 years and older) to adult patients who would benefit from receiving high flow warmed and and humidified respiratory gases to the upper airway.

This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.

The F&P Optiflow+ Nasal Cannula range is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy.

The F&P Optiflow+ Nasal Cannula range is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.

The provided FDA 510(k) clearance letter and summary for the F&P Optiflow+ Nasal Cannula Range does not contain specific acceptance criteria or an analytical study proving the device meets those criteria.

This submission is for a labeling change only. The document explicitly states:

• "The modification in scope of this 510(k) submission is to change the labeling of the subject device only, specifically to the Indications for Use statement."
• "The subject device's technological characteristics, material composition, and intended use remain identical to those of the predicate device."
• "No new performance or biocompatibility testing was conducted on the subject device since the device design is identical to the predicate device."

Therefore, the information requested regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets cannot be extracted from this document because such studies were not conducted for this specific 510(k) submission.

The clearance is based on the device being substantially equivalent to a previously cleared device (F&P Optiflow+ Nasal Cannula range, K162553), with the only change being an updated Indications for Use statement to be more defined and aligned with current labeling requirements. The original predicate device (K162553) would have had performance data supporting its clearance, but that data is not detailed in this particular document.

Summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance: Not provided in the document as no new performance testing was conducted. The document states the device's characteristics and performance are identical to the predicate device.
2. Sample Size for Test Set and Data Provenance: Not applicable, as no new performance testing was conducted.
3. Number of Experts and Qualifications: Not applicable, as no new clinical study requiring expert review was conducted.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no new clinical study was conducted.
6. Standalone Performance (Algorithm only): Not applicable, as this is a medical device (nasal cannula), not an AI/algorithm-based device.
7. Type of Ground Truth Used: Not applicable, as no new performance testing was conducted.
8. Sample Size for Training Set: Not applicable.
9. How Ground Truth for Training Set Established: Not applicable.

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GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.

GPS Advanced is a sterile, single use dispenser for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The dispenser has a ratcheted plunger that advances with each squeeze of its handle. The 5 cc GPS Advanced Cannula ("GPS Advanced Cannula") is available individually packaged and can be attached to the dispenser.

GPS Advanced is provided sterile via irradiation and GPS Advanced Cannula is provided sterile via ethylene oxide.

The GPS Advanced Cannula is provided empty and needs to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.

Based on the provided FDA 510(k) clearance letter for "GPS Advanced and GPS Advanced Cannula," it's important to understand that this device is a piston syringe used for delivering a bone graft substitute. As such, the "acceptance criteria" and "study that proves the device meets acceptance criteria" are focused on the mechanical and functional performance of the syringe as a medical device, rather than the performance of an AI/ML algorithm or diagnostic tool.

Therefore, many of the typical questions asked about AI/ML device studies (like MRMC studies, standalone algorithm performance, AI training/test sets, ground truth establishment for AI) are not applicable to this type of device.

Here's a breakdown of the acceptance criteria and performance data as inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Inferences:

• The document explicitly states that "The performance data for the subject devices consists of the following evaluations: Biological Risk Assessment, Sterilization Validation, Packaging and Shelf-Life Testing, including functional evaluation." These evaluations implicitly define the acceptance criteria for those aspects.
• The statement about "consistent with those of the primary predicate and reference device" implies that the new device must perform comparably to previously cleared devices in terms of its core technological characteristics and function.

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

This information is not explicitly detailed in the provided 510(k) summary. For a mechanical device like a syringe, "sample size" typically refers to the number of units tested for various validations (e.g., how many syringes were subjected to sterilization, packaging, or functional tests). The document does not specify these numbers.

• Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here refers to test results from various engineering and biological validations of the device itself.

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

This concept is not applicable to this device. "Ground truth" in this context is established through engineering specifications, validated test methods (e.g., sterility testing, material biocompatibility standards), and direct functional testing, not by expert consensus on clinical images or interpretations.

4. Adjudication Method for the Test Set

This concept is not applicable to this device, as there's no "interpretation" or "diagnosis" being made that requires human adjudication. Device performance is determined by objective measurements and validation against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The GPS Advanced and GPS Advanced Cannula is a delivery device, not an AI diagnostic tool.

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

No, a standalone algorithm performance study was not done. This concept applies to AI/ML algorithms that perform a task independently (e.g., detecting a lesion on an image). The GPS Advanced and GPS Advanced Cannula is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective scientific and engineering standards and tests:

• Sterility Validation: Demonstration that the device meets established sterility assurance levels (e.g., SAL of 10^-6).
• Biocompatibility Standards: Compliance with ISO 10993 series for medical device biocompatibility.
• Functional Specifications: Ability to successfully deliver the specified volume of material, maintain pressure, resist leakage, and operate smoothly.
• Packaging Integrity Standards: Ability of the packaging to maintain sterility and physical integrity under specified conditions.
• Shelf-Life Parameters: Demonstration that the device retains its functional and sterile properties over its specified shelf-life.

8. The Sample Size for the Training Set

This concept is not applicable for this device. "Training set" refers to data used to train AI/ML algorithms. The GPS Advanced and GPS Advanced Cannula is a mechanical device, not an AI/ML system.

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

This concept is not applicable for this device, as there is no "training set" in the AI/ML sense.

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This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.

The MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula models feature wire wound polyvinyl chloride (PVC) bodies with side ports in the distal tip, a ported atrial basket drainage site located along the length of the cannula body, and a 3/8-inch (0.95 cm) to 1/2-inch (1.27 cm) connection site. The overall length of each cannula body is approximately 15¼ inch (38.7 cm). Insertion depth marks are provided to aid in positioning of the cannula. Each cannula is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide.

This document is a 510(k) clearance letter for a medical device: the MC2™ Two-Stage Venous Cannula and MC2X™ Three-Stage Venous Cannula. It does not contain any information about an AI/ML-driven medical device, nor does it discuss acceptance criteria, test sets, ground truth establishment, or human reader studies related to AI performance.

The clearance is for a physical device used in cardiopulmonary bypass surgery, and the summary of performance data refers to pre-clinical bench testing related to material formulation changes, not algorithmic performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt asks for details about AI/ML device performance, which are entirely absent from this 510(k) clearance.

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The Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q are intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.

The Single Use 2-Lumen Cannula V PR-V614M is intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.

The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series is comprised of nine (9) sterile, single-use, cannulas designed to inject contrast medium in the biliary or pancreatic duct when used in conjunction with a compatible endoscope.

Each device has two sections: the handle (proximal portion) and the insertion portion. The insertion portion is introduced into the biliary or pancreatic ducts through an endoscope. The distal end of the insertion portion is designed for smooth cannulation of the papilla of Vater or the minor papilla. All models are visible under fluoroscopy and feature a distal marking system.

The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series models are to be used with compatible endoscopes.

The provided 510(k) Premarket Notification document describes a medical device, the "Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series," and its comparison to a predicate device for demonstrating substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of device performance as typically expected for software-enabled devices or those with diagnostic capabilities.

This submission is for a physical medical device (cannulas) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of its physical properties and biocompatibility. Therefore, many of the requested categories (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to the information provided.

Based on the document, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance data that was provided to demonstrate substantial equivalence, rather than specific and quantitative acceptance criteria with reported numerical device performance against those criteria. The "Analysis" column in the comparison table broadly states "Substantially equivalent" or "Identical," but doesn't provide the detailed numbers that would typically be associated with acceptance criteria for a diagnostic or algorithmic device.

Acceptance Criteria and Reported Performance (General statement from the document):

The document states: "Non-clinical testing demonstrates that the slight differences in device design do not alter the safety, efficacy, or performance of the subject devices when compared to the predicate devices." and "The non-clinical data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the identified predicate device." This is a qualitative conclusion of meeting equivalence rather than presenting specific numerical acceptance criteria.

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

• Sample Size for Test Set: Not specified in the provided document. The performance data refers to various non-clinical tests, and the sample size for these individual tests (e.g., number of cannulas tested for insertion force) is not detailed.
• Data Provenance: Not applicable in the context of clinical data. The tests are non-clinical (laboratory/bench testing).

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

• Not applicable. Ground truth as typically understood for diagnostic performance (e.g., disease presence/absence) is not relevant for these non-clinical, physical device performance tests. "Human Factors Testing" is mentioned, which would involve experts, but the number and qualifications are not provided, nor is it the type of "ground truth" establishment usually refers to in the context of diagnostic AI.

4. Adjudication method for the test set:

• Not applicable. This is typically used for clinical study endpoints or image interpretation, not for physical performance tests of a cannula.

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 physical cannula, not an AI or diagnostic imaging system.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable in the conventional sense. The "ground truth" for the non-clinical tests would be the physical properties and functional performance measured against predefined specifications or predicate device performance.

8. The sample size for the training set:

• Not applicable for a physical device where "training set" doesn't apply in the context of machine learning.

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

• Not applicable for a physical device.

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Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Bard® Temporary Pacing Electrode Catheters:
Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device. Certain catheters may incorporate a lumen for balloon inflation.

Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.

Needle / Cannula (Introducer):
The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits.

The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter.

The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle is then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

The provided FDA 510(k) clearance letter and summary describe the Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer). The submission is a "Special 510(k)" primarily focused on removing a warning label related to unknown electromagnetic compatibility (EMC) with low-frequency emissions.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The core of this Special 510(k) is the demonstration of electromagnetic compatibility, specifically concerning immunity to proximity magnetic fields, to justify the removal of a previous warning label.

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

• Sample Size: The document does not explicitly state a numerical sample size (e.g., "N=X devices were tested"). It refers to "representative external pulse generator equipment and the sample Temporary Pacing Electrode devices." This typically implies a limited number of devices/systems sufficient to represent the product line for EMC testing as per regulatory guidelines for in-vitro/bench testing.
• Data Provenance: The study was a bench (in-vitro) test performed to a recognized international standard (IEC 60601-1-2). There is no patient data involved, so there is no country of origin or retrospective/prospective distinction.

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

Not applicable. This was a bench-top engineering test evaluating electromagnetic compatibility against a defined international standard (IEC 60601-1-2). "Ground truth" in the clinical sense (e.g., diagnosis by experts) is not relevant here. The "ground truth" is the established test methodology and performance limits defined by the IEC standard.

4. Adjudication Method for the Test Set

Not applicable. As a bench test against objective standards, there is no expert adjudication process like those used in clinical studies for diagnostic accuracy. The results are objectively measured against the specified limits of the IEC standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a passive pacing electrode catheter and introducer, not an AI-powered diagnostic or therapeutic tool with a human-in-the-loop component.

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

Not applicable. The device is a medical hardware component, not an algorithm. The testing focused on the physical and electrical compatibility of the hardware with relevant external equipment.

7. The Type of Ground Truth Used

The "ground truth" for this study is compliance with international consensus standards for electromagnetic compatibility, specifically IEC 60601-1-2 (Edition 4.1): 2020, with particular focus on Clause 8.11 and the methods specified in IEC 61000-4-39 (2017). This standard defines objective tests and acceptance limits for device performance under various electromagnetic conditions.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

Not applicable, as there is no training set.

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The ACE Cannula is intended to inject fluids intradermally.

The ACE Cannula is provided as a single-use, sterile device. It is comprised of needles, hub and cap. This device comes in a variety of needle gauges and lengths. This device offers AN type and B type within the package. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub. The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector(hub) designed to mate with a male connector(nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/medications/drugs to a patient.

The provided document is a 510(k) summary for a medical device called the "ACE Cannula." It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence, rather than providing the results of a clinical study or performance data based on human-in-the-loop or standalone AI performance.

Therefore, most of the requested information regarding acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment (for training and test sets) is not applicable to this type of submission. This document outlines bench testing for physical characteristics, material safety (biocompatibility), and sterility, all of which are laboratory-based and do not involve patient data or expert reader studies in the way you've described for AI/CADe devices.

Here's an analysis based on the information that is present in the document:

Device: ACE Cannula
Purpose: Intended to inject fluids intradermally.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACE Cannula are based on compliance with international standards for medical devices, specifically hypodermic needles and cannulas, and biocompatibility. The "reported device performance" is the manufacturer's assertion that the device "Pass"ed all these tests.

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

• This is a 510(k) submission for a conventional medical device (a cannula), not an AI/CADe device. The "test set" here refers to samples of the device undergoing laboratory bench testing according to various ISO standards.
• The document does not specify the exact sample size for each individual bench test (e.g., how many cannulas were tested for bond strength). However, it implies that sufficient samples were tested to demonstrate compliance with the relevant standards.
• Data Provenance: The tests were conducted by Ace Medical Industry Co., Ltd. (Korea, as per company address in the 510(k) summary) or a qualified third-party lab under their direction. These are prospective tests performed on newly manufactured devices to demonstrate compliance.

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

• Not applicable. This device's performance is evaluated through physical, chemical, and biological laboratory tests against pre-defined, objective engineering and safety standards (e.g., ASTM, ISO standards). It does not involve subjective human interpretation of data (like medical images), so no human experts are needed to establish "ground truth" for a test set in the clinical sense.

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

• Not applicable. As above, the testing is objective and based on engineering/scientific measurements, not subjective human assessments 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:

• Not applicable. This relates to AI/CADe devices assisting human clinicians. The ACE Cannula is a physical, sterile, single-use device for fluid injection, not an AI or imaging device.

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

• Not applicable. This relates to the performance of an AI algorithm. The ACE Cannula does not have an "algorithm" in this context. Its "performance" is its mechanical, material, and biological properties.

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

• For the tests performed, the "ground truth" is defined by the objective pass/fail criteria established within the referenced international standards (e.g., ISO, USP, ASTM). For example, "pass" for patency of lumen means the lumen was unobstructed as per the standard's definition; "pass" for cytotoxicity means the extracts did not cause a cytotoxic effect beyond the acceptable limits defined in ISO 10993-5. It is based on objective, measurable criteria rather than expert consensus or clinical outcomes data relevant to AI/CADx devices.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of device. The device is manufactured and then tested for compliance with established standards. There is no machine learning model being trained.

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

• Not applicable. As there is no training set for an AI model, there is no ground truth established for it. The product's design and manufacturing rely on engineering principles, material science, and established quality control practices.

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