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The Celerity System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including:

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker-Driven Rhythm
• Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of an additional method is necessary to confirm catheter tip location.

The Celerity™ ECG Cable Accessory Pack consists of a sterile remote cover and a specialized alligator PICC clip. The Celerity™ ECG Cable Accessory Pack is designed to be used in conjunction with the Celerity™ System to provide a continuous display of electrocardiograph waveforms to guide placement of peripherally-inserted central catheters in the patient's right atrium of the heart.

This document describes the Celerity™ ECG Cable Accessory Pack, an accessory product used with the Celerity™ System for positioning Peripherally Inserted Central Catheters (PICC). The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K142889).

Here's an analysis of the provided information, focusing on the requested criteria:

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

Based on the provided regulatory document, the acceptance criteria are primarily focused on demonstrating substantial equivalence to the predicate device K142889 for an accessory pack consisting of an ECG cable and remote cover. The performance reported is that the accessory pack does not raise new or different questions of safety and effectiveness and performs identically to the predicate device's components.

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 primarily describes bench/performance/non-clinical testing for an accessory pack, not a clinical study involving patients. Therefore, traditional "test set" and "data provenance" as applied to clinical data are not fully applicable here.

• Sample size for non-clinical testing: The document does not specify exact sample sizes for each test listed (e.g., how many alligator clips were subjected to accelerated aging). It lists the types of tests performed.
• Data Provenance: The data provenance is from internal non-clinical testing conducted by the manufacturer, Medical Components, Inc. (dba Medcomp®). No country of origin is explicitly stated for the testing, but the manufacturer is based in Harleysville, Pennsylvania, USA, implying the testing likely occurred in the USA or through US-based labs. The tests are non-clinical (bench testing).

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 section is not applicable as the submission is for an accessory pack and relies on non-clinical, bench testing to demonstrate substantial equivalence. There is no clinical "test set" requiring expert ground truth establishment in the context of diagnostic accuracy. The ground truth for the non-clinical tests would be defined by engineering specifications and standards for electrical conductivity, material integrity, and aging performance.

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

This section is not applicable. Since there is no clinical test set requiring human interpretation or diagnosis, there is no need for an adjudication method.

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 section is not applicable. The device is an ECG cable accessory pack, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.

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

This section is not applicable. The device is a physical accessory pack that facilitates the existing Celerity System's ECG-based tip confirmation technology. It does not involve a standalone algorithm.

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

For the non-clinical testing conducted, the "ground truth" would be objective engineering and performance specifications. For example:

• Functional performance: The ability of the alligator clips and remote cover to conduct an ECG signal accurately and reliably.
• Durability/Aging: Ability to withstand accelerated aging simulation for 1 and 3 years without compromising function or integrity.
• Shipping Integrity: Ability of the packaged accessory pack to withstand shipping stresses (ISTA 2A).
• Material Composition: Conformance to specified material compositions.

These "ground truths" are established by engineering standards and internal quality control, not by expert clinical consensus, pathology, or outcomes data, as this is a non-clinical submission for an accessory.

8. The sample size for the training set

This section is not applicable. This submission is for a physical accessory product and describes non-clinical testing to demonstrate substantial equivalence to a predicate. There is no machine learning or AI component requiring a "training set."

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

This section is not applicable for the same reasons as point 8.

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The Medcomp® Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.

Medcomp®s Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter into a vein or artery. The Vessel Dilators range in size from 4F to 24F with lengths of either 15cm (6.0 inches) or 20cm (8.0 inches), are either single or dual taper, and can use guidewire sizes .025", .035", and .038". The Medcomp® Vessel dilators are offered in two different tubing materials (polyethylene or polypropylene) attached to an HDPE hub. Vessel dilators are supplied sterile, for use in an aseptic technique and can only be used once.

The provided text is a 510(k) summary for the Medcomp Vessel Dilator, a medical device for percutaneous entry into a vessel to enlarge the opening for catheter placement. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study involving AI.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and training set details for an AI-powered device is not applicable or present in this document.

However, I can extract information related to the bench/performance data/non-clinical testing that demonstrates the device's substantial equivalence to its predicate and reference devices.

Here's the relevant information based on the provided text:

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

The document does not present specific acceptance criteria in a table format with corresponding reported performance values for an AI device. Instead, it states that "The proposed device, Vessel Dilators, meets the performance criteria of design verification as specified by ISO standards, guidance documents, and internal test protocols." It also mentions "The results of performance testing, in conjunction with the substantial equivalence claims, effectively demonstrate the proposed device, Medcomp® Vessel Dilator, is equivalent to the reference device, Cook® Dilator, preamendment."

The performance data mentioned includes:

• Compliance with ISO 11070:2014 (Sterile single-use intravascular introducers, dilators and guidewires)
• Compliance with ISO 10555-1:2013 (Sterile, single-use intravascular catheters - part 1: general requirements) - described as "Bench Testing"
• Compliance with AAMI / ANSI / ISO 10993-1:2009/(R) 2013 (Biological evaluation of medical devices -- Part 1: evaluation and testing within a risk management process) - described as "Biocompatibility"
• Compliance with ISO 11135:2014 (Sterilization of health-care products - ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices) - described as "Sterility"
• Compliance with AAMI / ANSI / ISO 10993-7:2008(R) 2012 (Biological evaluation of medical devices - part 7: ethylene oxide sterilization residuals) - described as "Sterility"
• Compliance with ISO 14971:2007 (Medical devices - application of risk management to medical devices)

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

This information is not provided. The document describes non-clinical performance testing and biocompatibility studies, not a test set related to AI performance.

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 document is not about an AI device or a study requiring expert ground truth for image interpretation.

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

This information is not applicable.

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

This information is not applicable. The document is about a physical medical device (vessel dilator) and its substantial equivalence, not an AI-powered image analysis tool.

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

This information is not applicable.

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

For the non-clinical performance testing, the "ground truth" would be the established specifications and requirements outlined in the referenced ISO standards and internal test protocols. For biocompatibility, it's the biological response against predefined safety limits. This isn't "ground truth" in the context of an AI diagnostic device.

8. The sample size for the training set

This information is not applicable.

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

This information is not applicable.

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The Medcomp® Pro-Lock CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp Pro-Lock CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.

The 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to aid in the prevention accidental needle sticks when manually activated during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A nonremovable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged. The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Pro-lock™ CT Safety Infusion Set). It focuses on demonstrating substantial equivalence to a predicate device through performance testing and biocompatibility.

Therefore, many of the requested criteria, such as those related to AI algorithm performance studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device submission. This document describes a physical medical device, not an AI/ML software device.

However, I can extract information related to the device's acceptance criteria and studies to demonstrate its performance where applicable from the document.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the listed tests and the demonstration of substantial equivalence to the predicate device. The document does not explicitly state quantitative acceptance limits for each test in a table, but rather lists the tests performed to ensure the device meets relevant standards and performs similarly to the predicate.

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

The document does not specify the exact sample sizes (number of units tested) for each of the performance and biocompatibility tests. It only lists the tests performed and the relevant standards. These tests are laboratory-based, non-clinical tests.

• Data Provenance: The tests are "bench / performance data / non-clinical testing" conducted by the manufacturer, Medcomp®, located in Harleysville, Pennsylvania, USA. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate the device's characteristics.

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

This question is not applicable. The "ground truth" here is established by the accepted international and internal test methods and standards (e.g., ISO, ASTM), not by expert consensus in a clinical scenario. The tests are designed to objectively measure physical, chemical, and biological properties.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials, particularly for imaging studies where subjective interpretation is involved. These are objective, quantitative, non-clinical laboratory tests where the results are measured against defined criteria within the standard.

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 question is not applicable. This is a physical medical device (an infusion set), not an AI/ML diagnostic or assistive device. No human-in-the-loop study with AI was performed.

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

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

7. The Type of Ground Truth Used

The "ground truth" or basis for evaluation is defined by:

• Established Industry Standards: ISO and ASTM standards (e.g., ISO 10555-1, ISO 10993 series, ASTM F2052, etc.) that specify test methods and acceptable limits for medical devices of this type.
• Internal Test Methods: Where no specific external standard exists, internal test methods are used, and their validity is implicitly accepted by the FDA's clearance.
• Substantial Equivalence: The primary "ground truth" for 510(k) clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device (K132880) through comparison of design, materials, indications for use, and performance testing.

8. The Sample Size for the Training Set

This question is not applicable. This device does not involve a "training set" for an AI/ML algorithm.

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

This question is not applicable, as there is no training set for an AI/ML algorithm.

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The Dignity® Dual Port is a power injectable implantable infusion port that is indicated for patient therapies requiring repeated access to the vascular system. The Dignity® Dual Port can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with a power injectable needle, the Dignity® Dual Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

The Dignity® Dual power injectable implantable infusion port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a power injectable needle only. The Dignity® Dual Port device consists of two primary components: an injection port with a self-sealing septa and a radiopaque catheter. The Dignity® Dual Ports can be identified subcutaneously by feeling the top of the septum and the top rim of the port housing. Power Injectable Implantable Infusion Ports can be identified by the letters "CT" under radiographic imaging.

The Dignity® Dual Port will be marketed in four kit configurations, which are listed below:

• 9.5F Standard Port Kit (Catalog number MRDP95ADN)
• 9.5F Port Kit with Micro-Stick (Catalog number MIDP95ADN)
• 9.5F Standard Port Kit with Silicone Filled Suture Holes (Catalog number MRDP95ADS)
• 9.5F Port kit with Silicone Filled Suture Holes and with Micro-Stick (Catalog number MIDP95ADS)

The Dignity® Dual Port is comprised of a polysulfone cap (with silicone filled suture holes, or open suture holes), two silicone septa, and a polysulfone base assembly with a titanium tube that provides a channel from the stem to the distal reservoir. The reservoir is plastic (polysulfone). The Dignity® Dual catheter locking assembly (makrolon/pellethane) locks the chronoflex lumen to the plastic stem of the Dignity® Dual Port.

The provided text describes the "Dignity® Dual Port," a power injectable implantable infusion port. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to pre-existing devices. Therefore, the "study" referred to is a demonstration of equivalence through functional and material comparisons, rather than a traditional clinical study with human patients and outcomes data.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial with a distinct human "test set."

• Test Set: No independent human "test set" in the context of a clinical trial is described. The "testing" involves bench testing, material comparisons, and a comparison matrix against a predicate and reference devices.
• Data Provenance: The data provenance is primarily from bench/performance data and comparison to previously FDA-cleared devices (predicate K090512, reference K070003, K120281). This is not data from human subjects or from a specific country of origin in the way a clinical trial would generate it. All data would be generated in a lab setting by Medcomp® or its contracted testing facilities.

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

• Ground Truth Establishment: Not applicable in the context of this 510(k) summary. The "ground truth" for the current device's acceptability is established by demonstrating its equivalence to predicate devices that have already been determined safe and effective by the FDA. The performance standards are derived from established industry standards (e.g., ISO, ASTM) and the performance characteristics of the predicate device.
• Experts: No external experts are described as establishing "ground truth" for the test set. The submission itself is prepared by Medcomp®'s regulatory associate, Ms. Courtney Nix, and reviewed internally by Medcomp® and externally by the FDA (specifically the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" of patient data requiring adjudication. The assessment is a comparison of design, materials, and performance data against established standards and predicate device specifications.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic imaging devices where human readers interpret results with and without AI assistance. The Dignity® Dual Port is an implantable infusion port, a physical medical device, not an imaging or diagnostic AI system.

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

• Standalone Performance: Not applicable. The device is a physical implantable infusion port, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the submission is the established safety and effectiveness of the legally marketed predicate device (C.R. Bard PowerPort©, K090512) and reference devices (Medcomp® Pro-Fuse®, K070003; Medcomp® Dignity® Power Injectable Titanium Port, K120281), as interpreted through FDA regulations and consensus standards (ISO, ASTM). The equivalence is demonstrated through comparative analysis of specifications, materials, and bench test results against these established benchmarks.

8. The Sample Size for the Training Set

• Training Set: Not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

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The PTFE Super Sheath Introducers are intended to obtain central venous access to facilitate catheter insertion or placing pacing leads into the central venous system.

The PTFE Super Sheath Introducer 2.1 is a catheter introducer. The sole difference between the predicate device (K130855; Super Sheath 2.0) and the proposed device is the material change to dilatory. The dilator material that was approved in the predicate 510K submission was nylon, the proposed has a dilator composed of a nylon/Pebax blend.

The provided text is a 510(k) premarket notification for a medical device (PTFE Super Sheath Introducer 2.1) and does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.

The document discusses substantial equivalence to a predicate device (PTFE Super Sheath Introducer 2.0, K130855) for a physically manufactured medical instrument, not a software-based AI/ML device. The "Bench / Performance Data" section lists in-vitro tests performed, but these are for the physical properties of the introducer, such as liquid leakage, air leakage, force at break, simulated use, and equipment interaction. There is no mention of an algorithm, AI, or machine learning model.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth details) because the provided text is not about an AI/ML medical device study.

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The C3 Wave System is indicated for use as a supplemental aid in positioning for Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.g., Chest X-Ray, Fluoroscopy). Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P wave: atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and cronic obstructive pulmonary disease (COPD). Such patients are easily identified prior to PICC insertion. Use of additional confirmation method is necessary to confirm catheter tip location.

The C3 Wave system includes the iPad® monitor running the mobile application software, the C3 hub (a battery and power supply cord for the hub), a remote control, and an ECG clip cable (alligator clip). Procedural accessories include the ECG snap leads, ECG patient cable, ECG electrodes, remote cover, and prep pads which are provided as a convenience to the clinician.

The provided text describes the C3 Wave device and its regulatory submission, but it does not contain the detailed study information required to fully answer your request.

Specifically, the document states:

• "Design verification and validation activities were performed in accordance with Design Control requirements per 21 CFR 820.30 and demonstrate that the subject C3 Wave system meets predetermined performance specifications."
• "The performance evaluation plan included testing per the following recognized standards to assess conformance to IEC 60601-1 (3rd Edition). IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety - IEC 60601-1-2 Medical Electrical Equipment - Part 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard Electro Magnetic Compatibility - Requirements and Test"

However, it does not provide:

• A table of acceptance criteria for its core function (PICC tip location) and the reported device performance against those criteria.
• Details on the sample size for any clinical test set or its provenance.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• Whether MRMC, standalone, or training set studies were performed, or the details of these if conducted.
• The type of ground truth used for assessing PICC tip location accuracy.

The document focuses on regulatory compliance, electrical safety standards (IEC 60601 series), and biocompatibility testing for materials that may contact the patient. These are important for device safety and general performance but do not detail the clinical performance validation for its primary "PICC tip location" function.

Therefore, I cannot fully complete the table or answer all your questions with the provided text.

Here's what can be extracted and what is missing:

Acceptance Criteria and Study Details for C3 Wave System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document mentions performance testing relating to electrical safety (IEC 60601 series) and biocompatibility (ISO 10993-1), which the device passed. However, it does not provide acceptance criteria or performance data for the primary function of "real-time catheter tip location information by using the patient's cardiac electrical activity" in terms of accuracy or precision relative to a ground truth.

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

• Test Set Sample Size: Not specified for clinical efficacy.
• Data Provenance: Not specified for clinical efficacy.

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

• Not specified.

4. Adjudication method for the test set:

• Not specified.

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 specified. The device is for "real-time catheter tip location information" and acts as a "supplemental aid," but no details of human-in-the-loop performance studies are provided.

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

• Not specified for clinical performance. The functional descriptions imply standalone capability to detect P-wave changes, but explicit standalone clinical accuracy metrics are not provided.

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

• Not specified for clinical efficacy. The Indications for Use state, "Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.g., Chest X-Ray, Fluoroscopy)," implying these might be used as ground truth in a clinical study, but no study details are provided.

8. The sample size for the training set:

• Not specified.

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

• Not specified.

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The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The CT Midlines are designed for peripheral vein catheterization and power injection of contrast media, available in 4Fx20cm single-lumen or 5Fx20cm double-lumen configurations. Fundamentally, the proposed device is physically identical to the predicate K 121094 aside from the clamp, which is now colored purple to indicate power injection.

The provided document is a 510(k) summary for the Medcomp CT Midline device, indicating that it is being submitted for substantial equivalence to existing predicate devices, K121094 (Midline) and K091953 (Pro-PICC CT). The primary focus of the submission is to demonstrate that the CT Midline, while otherwise identical to predicate K121094, is also safe and effective for power injection, an indication shared with predicate K091953.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly labeled as such but are derived from the performance data presented for the proposed CT Midline and compared against the predicate devices, particularly the Pro-PICC CT (K091953) for power injection capabilities. The document asserts that the proposed device is "substantially equivalent" to predicate devices. For mechanical performance, specifically power injection, the CT Midline is compared to the Pro-PICC CT.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a nonclinical performance test study. It specifically focused on the power injection capabilities, as this was the key performance difference between the proposed CT Midline and the primary predicate (K121094).

The document states: "The following tests were performed to establish the device's equivalence to the relevant predicate device: o Power Injection Flow Rate o Max Static Burst. These tests highlight the relevant difference between the proposed device and predicate K121094 by testing for the safety and effectiveness of the proposed device with regard to the expanded indication for use of power injection."

The reported performance data for the CT Midline in the table above demonstrates that for both 4F and 5F configurations, the proposed device achieved equal or higher flow rates and burst pressures compared to the predicate Pro-PICC CT (K091953) for power injection. This indicates that the CT Midline meets or exceeds the power injection performance of the predicate device with that indication.

For air leakage, liquid leakage, biocompatibility, and sterility, the claims of substantial equivalence are based on either being identical in materials to a cleared predicate or passing relevant ISO standards, which implies meeting the acceptance criteria set by those standards.

The remaining information requested is largely not applicable (NA) or not explicitly provided in the given excerpts, as this is a 510(k) summary for a medical device (catheter), not an AI/software device or a clinical study in the typical sense that would involve human readers, ground truth consensus, or training data for an algorithm.

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

• Sample Size: The exact sample sizes for the power injection and static burst tests are not explicitly stated as "n=X". However, for the Max Static Burst, the standard deviation and range are provided (e.g., "302±5psi," "range of burst pressures was 292-312 psi"), which implies multiple tests were performed on multiple units to generate an average and range. Without the full Section 18 (reference testing summaries and protocols), the specific number of units tested is unknown.
• Data Provenance: This is an in-vitro nonclinical performance test, conducted by the manufacturer (Medcomp). Therefore, it is a prospective test conducted on manufactured devices, likely in a laboratory setting. Country of origin of the data is the US, where Medcomp is located.

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):

• NA. This is a hardware device performance test. There are no human experts establishing ground truth for image interpretation or diagnosis. The "ground truth" is defined by the physical properties of the device and its performance under specified testing conditions as measured by instruments.

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

• NA. There is no adjudication method as this is a physical performance test, not a subjective judgment task.

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:

• NA. This is not an AI or imaging device subject to MRMC studies.

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

• NA. This is not an algorithm. Standalone performance refers to the device's functional attributes (e.g., flow rate, burst pressure) under test conditions as measured by equipment.

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

• For the nonclinical performance tests (power injection, static burst, leakage, biocompatibility), the "ground truth" is defined by the measured physical properties and performance characteristics of the device under controlled laboratory conditions, verified against established ISO standards and the performance of legally marketed predicate devices.

8. The sample size for the training set:

• NA. This is a physical device, not an algorithm that requires a training set.

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

• NA. This is a physical device, not an algorithm that requires a training set and its associated ground truth establishment.

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The Celerity System is intended to provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the superior vena cava.

The Celerity System is indicated for use as a supplemental aid in positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. Confirmation of tip placement should be verified according to clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy).

Note: Limiting, but not contraindicated, situations for this technique, are patients where cardiac rhythms may change presentation of the P wave.

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker driven rhythm
• Chronic obstructive pulmonary disease (COPD)
  Such patients are easily identified prior to PICC insertion. Use of additional confirmation method is necessary to confirm catheter tip location.

The Celerity System includes the Celerity Monitor/Software, ECG Patient Cable, Remote Control Cable, Battery, Power Supply Cord and ECG Clip Cable (alligator clip). Procedural accessories including ECG Snap Leads, ECG Electrodes, Cable Cover and Prep Pads are provided as a convenience for the clinician.

The Medcomp Celerity System is a device intended to provide real-time tip location information of a central venous catheter by utilizing ECG to observe P-wave changes as the tip approaches the right atrium. The device's performance was evaluated through design verification and validation activities in accordance with 21 CFR 820.30 and testing per IEC 60601 standards.

Here's the breakdown of the acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific numerical acceptance criteria for device performance (e.g., accuracy percentages, sensitivity/specificity thresholds for tip location). Instead, it states that "Design Verification and Validation activities were performed in accordance with Design Control requirements per 21 CFR 820.30 and demonstrate that the subject Celerity System meets predetermined performance specifications."

The performance evaluation focused on demonstrating safety and essential performance through compliance with recognized electrical safety and electromagnetic compatibility standards.

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

The document does not explicitly state the sample size used for any specific performance test set related to the accuracy of P-wave changes or tip location. It broadly mentions "Design Verification and Validation activities" and "safety and performance testing."

Furthermore, there is no information provided regarding the country of origin of the data or whether the data was retrospective or prospective.

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

This information is not provided in the document. The document refers to "clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy)" for confirming tip placement, but it does not detail how ground truth was established for the device's own performance evaluation.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the test set.

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 is mentioned in the document. The Celerity System is described as a "supplemental aid" to assist clinicians in positioning PICCs using ECG, but there's no study comparing human performance with and without the device. The device itself is not an "AI" in the modern sense but rather a real-time monitoring system.

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

The document describes the Celerity System as providing "real time tip location information" by utilizing ECG to observe P-wave changes. While this implies a standalone algorithm for processing ECG data and identifying P-wave changes, there is no separate "algorithm only" performance study detailed with specific metrics for accuracy or reliability of its ECG analysis in isolation from a clinical user. Its function is inherently presented as an aid for the clinician.

7. The Type of Ground Truth Used

The document states that "Confirmation of tip placement should be verified according to clinical judgment and established hospital protocol (e.g., chest x-ray, fluoroscopy)." This suggests that the ultimate ground truth for actual tip location in clinical practice (and presumably in any validation studies) would be based on imaging methods (chest x-ray, fluoroscopy) and expert clinical judgment. However, the specifics of how this ground truth was applied to prove the device meets its acceptance criteria are not detailed.

8. The Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This type of information is typically associated with machine learning or AI algorithms, which are not explicitly mentioned for the Celerity System's core function.

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

As no training set is mentioned, information on how its ground truth was established is not applicable.

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The Medcomp® Gen III Power Injectable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the power injectable infusion port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle.

The Medcomp® Gen III Power Injectable Port includes the Dignity® Mini. Low Profile and Pro-Fuse® Low Profile and Standard are subcutaneously implantable single fluid reservoir port offered with a choice of a silicone or polyurethane cather either pre-attached by the manufacturer or attachable for application by the inserting physician. The Pro-Fuse® product line offers a round base while the Dignity® product line offers a shovel nose concaved sides and smooth contours. The Dignity® product line is offered in Midsize. which has a smaller base than the predicate, K070003. The Dignity® product line is offered in Low Profile, which is a smaller base than the Midsize therefore is smaller than predicate, K070003. The Dignity® product line is offered in Mini, it is the smallest offered profile.

Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. The port can be anchored with sutures in the port pocket for secure seating. The catherer lock provides securement of the catheter to the port stem. The port is accessed by inserting needle through the skin into the self-sealing septum.

The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-coming needle at a maximum recommended infusion rate of 5 ml/s.

The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion.

The provided text describes the Medcomp® Gen III Power Injectable Port and its 510(k) submission (K132177). This document focuses on demonstrating substantial equivalence to a predicate device (K070003) rather than a standalone study proving device performance against specific novel acceptance criteria.

The acceptance criteria are implicitly defined by the safety and performance requirements for implantable infusion ports and are primarily demonstrated through comparison to the predicate and established international standards (ISO 10555-1, ISO 10993).

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding performance results for each criterion. Instead, it lists various "Bench / Performance Data" tests performed and states that the "results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003."

Essentially, the acceptance criterion for each test is that the new device's performance is equivalent to, or meets the established safety and performance characteristics of, the predicate device and relevant ISO standards.

• Power Injection Simulation
• Elongation & Tensile
• Priming Volume
• Gravity Flow
• Stem Break Force
• Cap/Base Bond Integrity
• Catheter Lock Integrity
• Clearance Volume
• Needle Insertion/Extraction Force
• Reservoir Pressure
• Static Burst Pressure | "In vitro testing was performed on the Power Injectable. Implantable Infusion Port to assure reliable design and performance in accordance with the FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990."
  "Verification testing and performance testing performed according to the referenced standards as well as in accordance with in-house protocols."
  "The following testing was performed on all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini. in accordance with requirements of ISO 10555-1 for all configurations listed in pursuant of this application to market."
  "The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003."
  No specific numerical performance values are provided, only an assertion of equivalence. |
  | Biocompatibility in accordance with ISO 10993 | "Testing for all materials used for the Power Iniectable Infusion Port has been submitted in previously cleared Medcomp device predicate K070003. All biocompaibility testing demonstrals used meet the requirements of ISO 10993." |
  | Substantial Equivalence to Predicate K070003 | "The proposed devices meet the performance criteria of design verification as specified by ISO standards, guidance documents and internal test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate devices." |

2. Sample sizes 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 (number of units or batches tested) for the "Bench / Performance Data" tests. It mentions "all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini" were tested, indicating multiple product variants were included.

The data provenance is implied to be from in vitro testing performed by the manufacturer (Medcomp®) in the US, as it's a submission to the FDA. It is prospective for the Gen III device, as these tests were conducted on the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this type of submission. This is a premarket notification for a medical device (implantable port) based on substantial equivalence and bench testing, not an algorithmic diagnostic device requiring expert interpretation of clinical images for ground truth establishment.

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

This is not applicable. Adjudication methods are typically used in studies involving human interpretation or performance, often for diagnostic accuracy, which is not the nature of this submission. The "ground truth" for the performance tests would be the measured physical properties of the device against engineering requirements or 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

This is not applicable. An MRMC comparative effectiveness study is specific to diagnostic imaging devices or AI algorithms where human reader performance is a key metric. This submission is for an implantable infusion port.

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

This is not applicable as this is a physical medical device, not an algorithm or AI system. The "standalone" performance here relates to the device's physical and mechanical properties, which were tested in a "standalone" manner (i.e., the device itself was subjected to bench tests).

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

The "ground truth" for the bench tests are:

• Engineering specifications and measurements: For parameters like priming volume, burst pressure, tensile strength, etc.
• Compliance with international standards: ISO 10555-1 for performance and ISO 10993 for biocompatibility.
• Performance of the predicate device (K070003): The new device's performance is shown to be equivalent to the previously cleared predicate.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable for the same reason as above.

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The Valved Tearaway Introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.

Valved Tearaway Introducer Generation II

I am sorry, but the provided text from the FDA 510(k) letter for the "Generation II Valved Tearaway Introducer" does not contain information about acceptance criteria, study details, or performance data for a device in the context of an AI or diagnostic algorithm.

The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as product codes, regulations, and general controls, but it does not include any technical or clinical study details that would allow me to answer your specific questions regarding acceptance criteria, sample sizes, ground truth establishment, or AI performance metrics.

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

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