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The Zephyr™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or leg, including: radial, dorsalis pedis, or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in anticoagulation therapy.

The Zephyr™ Vascular Compression Devices are external compression devices deployed on a patient's arm or leg to promote hemostasis at a puncture site in a blood vessel. The Zephyr™ devices are single-use, sterile, individually pouched inflatable devices, deployed onto a skin surface by clinicians to help achieve hemostasis for vascular puncture sites in post-procedure patients. Zephyr is available in different lengths, with and without a separate cuff balloon. The strap measures approximately 1.5" x 8.25" (small) or 9.5" (large) and is composed of biocompatible multiple-layer PVC film and PVC tube, and a syringe and valve made of biocompatible thermoplastics. Hook and loop material is used to secure the strap in position. Only the PVC film comes into contact with broken skin.

The provided text describes a 510(k) summary for the Zephyr™ Vascular Compression Devices. However, the document focuses on establishing substantial equivalence to predicate devices and does not detail specific acceptance criteria or the comprehensive study design and results that would typically be associated with proving these criteria.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All testing passed acceptance criteria and demonstrated that the performance of the Zephyr™ Vascular Compression Devices is equivalent to the predicate devices." However, specific numerical acceptance criteria and corresponding reported device performance values are not provided in this document.

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

The document mentions "Zephyr Vascular Compression devices were subjected to inspections and tests," but it does not specify the sample size of devices used for any of the performance or preclinical testing.
The data provenance is also not explicitly stated beyond being part of the manufacturer's internal testing processes. It does not mention country of origin, nor whether the tests were retrospective or prospective.

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

This section is not applicable to the type of testing described. The tests are for device performance and biocompatibility, not for interpreting medical images or clinical outcomes that would require expert "ground truth."

4. Adjudication Method for the Test Set:

This section is not applicable as there is no mention of expert review or adjudication in the context of the device performance or preclinical tests.

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

No, an MRMC comparative effectiveness study was not done. The document describes preclinical and performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

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

This question is not applicable as the Zephyr™ Vascular Compression Device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the performance and preclinical testing, the "ground truth" was established by engineering specifications and established testing protocols to confirm the device's functionality (e.g., inflation, compression, syringe function). For biocompatibility, the ground truth was based on ISO 10993 standards, which define acceptable levels of cytotoxicity, sensitization, and irritation.

8. The Sample Size for the Training Set:

This question is not applicable as the Zephyr™ Vascular Compression Device is a physical medical device, not an AI system that requires a training set.

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

This question is not applicable for the same reason as number 8.

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The RadAR™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm or leg, including: radial, brachial, dorsalis pedis or tibial blood vessels, arterial or venous line or sheath removal, hemodialysis, and in patients on anticoagulation therapy.

The RadAR™ Vascular Compression Devices consist of a strap with a housing with controls for device securement and adjustment, and a compression pad. The product is designed to reduce blood flow in the subject blood vessel compressed by the pad, while allowing blood flow in other vessels in the arm or the leg to promote hemostasis at the vascular puncture site. The user can delicately control the compression applied by the device without unfastening it. This allows gradual release of compression as hemostasis occurs and, at the user's discretion, permits blood flow into the compressed blood vessel during puncture site hemostasis. This device is not life supporting or life sustaining. The product is provided individually packaged. It is a sterile, single use device.

This FDA 510(k) summary for the RadAR™ Vascular Compression Devices (K142122) explicitly states that no new testing was deemed required, and no performance testing or clinical evaluations were submitted for this 510(k).

The basis for the device's acceptance is its substantial equivalence to previously cleared predicate devices, specifically:

1. The RadAR™ Vascular Compression Devices cleared under 510(k) K092503 (itself).
2. The HemoBand® manufactured by Innovations for Access, Inc. (K081740).

Therefore, based on the provided document, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance: No new performance data was presented.
2. Sample size used for the test set and the data provenance: No new test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set was used.
4. Adjudication method for the test set: Not applicable as no new test set was used.
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 a physical medical device, not an AI/software device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable as no new testing was performed for this submission.
8. The sample size for the training set: Not applicable as no new testing was performed for this submission.
9. How the ground truth for the training set was established: Not applicable as no new testing was performed for this submission.

The document indicates that the current 510(k) submission (K142122) is primarily to revise the indications for use for the RadAR™ Vascular Compression Devices. The manufacturer leveraged information and testing from the previous clearance (K092503) for the same device to support the substantial equivalence claim for the expanded indications.

Conclusion stated in the document:
"Previous testing on the submitted RadAR™ Vascular Compression Device has demonstrated that this device is as safe and as effective as the predicate devices."

This means the acceptance criteria and performance data for this device are implicitly tied to the previous 510(k) clearances and the performance characteristics of the predicate devices. The current submission did not involve new studies to generate new performance data.

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The AVD Left and Right Radial Drapes are single use sterile devices intended for use by medical professionals as a protective patient covering, such as to isolate a site of surgical incision or vascular puncture from microbial and other contamination. The drapes are attached to the patient in proximity to a vascular puncture site to isolate vascular access punctures from microbial and other contamination during procedures including angiographies and percutaneous interventions.

The AVD Radial Drapes are composed of a fluid-resistant film layer, an absorbent barrier layer, and an adhesive material that bonds the two layers. The surgical site is accessed through an oval opening in the drape that is surrounded by an adhesive tape to keep the drape in position over the surgical or vascular puncture site. The AVD Drapes are supplied sterile and for single use only. The Drapes are available in both a Left Radial and a Right Radial configuration. They may be sold singly or as part of a procedure pack.

Here's an analysis of the provided 510(k) summary regarding the AVD Radial Drapes, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance for AVD Radial Drapes (K131571)

The AVD Radial Drapes are a Class II surgical drape indicated for isolating surgical incision or vascular puncture sites from microbial contamination. The submission primarily relies on demonstrating substantial equivalence to a predicate device (HVO Various Disposable Non-Sterile Drapes, K050508) and performing non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance tests conducted on the AVD Radial Drapes. The "acceptance criteria" for many of these appear to be "Pass" or "Acceptable" based on adherence to specific standards.

Note: For parameters where the predicate device's performance was "Not stated" or "Not available," the AVD Drapes demonstrated performance against recognized standards, contributing to the claim of substantial equivalence. The predicate device was non-sterile, so sterilization validation and EO residuals were not applicable to it.

2. Sample Size and Data Provenance

The document does not specify the sample sizes used for each of the non-clinical tests (e.g., how many drapes were tested for tensile strength or tear resistance). However, these are typically laboratory tests performed on a representative sample of manufactured products.

• Test Set Sample Size: Not explicitly stated for any of the non-clinical tests.
• Data Provenance: The non-clinical tests were conducted specifically for this submission (prospective testing) and are laboratory-based, without reference to human or animal data for these specific performance metrics. The country of origin of the data is not stated, but the submission is to the US FDA, and the submitter is based in Milwaukie, OR, USA.

3. Number of Experts and Qualifications for Ground Truth

• Ground Truth Establishment: Not applicable in the traditional sense for this submission. The "ground truth" for the non-clinical tests is established by the specified international and national standards (e.g., ISO, ASTM, ANSI/AAMI, CFR). These standards define the methodology and acceptance criteria for measuring material properties and performance. There isn't a panel of clinical experts establishing a ground truth for device performance in this context, as it's a materials and functional performance evaluation.

4. Adjudication Method

• Adjudication Method: Not applicable. Non-clinical tests follow established, standardized protocols with objective measurements, rather than requiring expert adjudication.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The AVD Radial Drape is a physical medical device (surgical drape), not a diagnostic imaging AI.

6. Standalone Performance Study

• Standalone Performance Study: Yes, in essence, the non-clinical testing described in Section G constitutes standalone performance evaluations for the AVD Radial Drapes against specified standards. The results for parameters like Barrier Protection, Tensile Strength, Tear Resistance, Flammability, and Biocompatibility (cytotoxicity, sensitization, irritation, EO residuals) were obtained directly from testing the AVD Drapes themselves, without human intervention as part of the performance metric. This is "algorithm only" in the sense that the device's inherent physical and biological properties were evaluated.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the ground truth is established by objective technical standards and regulatory requirements. For example, "Barrier Level 4" is an objective classification defined by ANSI/AAMI PB70, not by expert consensus or clinical outcomes. Similarly, "Non-cytotoxic" is determined by a specific laboratory assay described in ISO 10993-5.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set." The performance is based on the physical and chemical properties of the materials and design, evaluated through standard non-clinical tests.

9. How Ground Truth for Training Set was Established

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

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To monitor relative blood flow changes distal to the occlusion of a brachial, ulnar, or femoral artery.

From the physician history and clinical findings, the person has pain, claudication, or changes in blood flow to the extremity.

The FloChec Plethysmograph Device (PPG) is similar to the PPG portion of the Hokanson EC-6 but does not include a strain gauge PPG function that is included in the EC-6. The FloChec Sensor is similar to that of the Parks' Mini-Lab which used a single wave length IR emitter in the sensor. The device is not sterile. Use of the FloChec device by a medical practitioner allows visualizing of the blood flow wave forms in the extremities. In viewing the effects on the wave forms as a result of events such as direct external pressure being applied proximal to the sensor.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria for the FloChec Photoplethysmography Device.

Instead, the document is a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to predicate devices rather than proving performance against pre-defined acceptance criteria through a specific study.

Here's what the document does state and what is missing:

The document states:

• Intended Use: To provide visualization and evaluation of the blood flow wave form in an extremity.
• Testing Conclusion: "It was concluded that the FloChec is equivalent to the predicate device."
• Indications for Use: To monitor relative blood flow changes distal to the occlusion of a brachial, ulnar, or femoral artery, for persons with pain, claudication, or changes in blood flow to the extremity, based on physician history and clinical findings.
• Device Type: Photoplethysmograph (PPG)

Missing Information (regarding acceptance criteria and performance study):

1. Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document claims equivalence to a predicate device but does not provide specific performance metrics or thresholds for the FloChec device.
2. Sample Size for Test Set and Data Provenance: Not mentioned.
3. Number of Experts to Establish Ground Truth and Qualifications: Not mentioned.
4. Adjudication Method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. There is no information about human readers or their improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study: Not mentioned.
7. Type of Ground Truth Used: Not explicitly stated, though the context implies comparison to the predicate device's output.
8. Sample Size for Training Set: Not mentioned. This device is an analog measurement device, not an AI or deep learning model, so a "training set" in that sense would not apply.
9. How Ground Truth for Training Set Was Established: Not applicable given the device type.

In summary, the provided text asserts that the FloChec device is "equivalent to the predicate device" in providing a visual representation of PPG waveforms, but it lacks the detailed study information (acceptance criteria, performance metrics, ground truth establishment, sample sizes, etc.) that would typically be found in a comprehensive clinical or performance study report. This document is focused on regulatory clearance through substantial equivalence.

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The RADAR™ Vascular Compression Devices are indicated for use by medical professionals to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, hemodialysis, and in patients on anticoagulation therapy.

The RadAR " Vascular Compression Devices are compression devices used on the arm. Each device consists of a strap with a housing, a screw permanently inserted into the housing, and a movable compression pad. The product is designed to reduce blood flow in the blood vessel compressed by the pad while allowing blood flow in other vessels in the arm. The user can delicately control the compression applied by the device without unfastening it. This allows gradual release of compression as hemostasis occurs and, at the user's discretion, permits blood flow in the compressed vessel during puncture site hemostasis. The product is provided individually packaged. It is a sterile, single-use device.

This submission does not provide information on acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it states:

"Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

Therefore, I cannot populate the requested information regarding acceptance criteria, device performance, study details, training set, or ground truth.

The document mainly focuses on establishing substantial equivalence to predicate devices based on design and intended use, rather than presenting a performance study with acceptance criteria.

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This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.

The PressureMate™ Compression Assist Handle mates with the SuperComfort™ Discs (K040615) to provide an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following fernoral vascular catheterization procedures.

The PressureMate™ handle itself is an aluminum handle with stainless steel stem. The stem ends in a female connection which mates to the male connector located on the SuperComfort Discs. The handle can not be used without a Disc.

The PressureMate™ comes in two designs: i) symmetrical, with both ends symmetrically tapering down at each end and centrally located stem or ii) asymmetrical, with one end tapered smaller than the other end and the stem slightly off center. The handle designs, round with tapered ends, enable better fit to an operator's hand.

Use of the handle and disc by a medical practitioner avoids prolonged direct contact with bodily fluids, and alleviates bio-mechanical stress which may occur during traditional direct digital compression of the femoral artery post-cardiac catheterization.

The provided text describes the PressureMate™ Compression Assist Handle, a device designed to assist with hemostasis following femoral vascular catheterization procedures. Here's an analysis of the acceptance criteria and the study information available:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical or performance testing on subjects/patients. The reported performance refers to a device design and material strength test.

• Test Set Description: The test involved evaluating the device's ability to withstand a specific mechanical force.
• Sample Size: Not explicitly stated for this mechanical test, but implies multiple units were tested to ensure consistency.
• Data Provenance: Not applicable as it's a mechanical test, not clinical data from patients.

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

Not applicable. The "ground truth" for the mechanical test is the physical capacity of the device to withstand 35 pounds, which is a manufacturing specification, not an expert assessment.

4. Adjudication Method for the Test Set

Not applicable. This was a mechanical engineering test, not a clinical study requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical handle for manual compression, not an AI-assisted diagnostic tool or an imaging device that would typically involve MRMC studies.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

No, a standalone study focusing on an algorithm's performance was not done. This device is a manual assist tool, not an algorithm or software.

7. Type of Ground Truth Used

The "ground truth" for the reported performance criterion (withstanding 35 pounds) is a physical/mechanical specification and measurement. It's a measure of the device's structural integrity and strength, rather than a clinical outcome or expert judgment.

8. Sample Size for the Training Set

Not applicable. As this device is a physical, manual compression assist handle and not an AI/software product, there is no "training set" in the context of machine learning or algorithms.

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

Not applicable for the same reason as above. There is no training set for this type of medical device.

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This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.

This device handle is similar to the Compass handle, but of a different shape. The ComfortPress device provides an alternative to the use of mechanical clamping systems or direct hand holding pressure to obtain hemostasis following femoral vascular catheterization procedures. The ComfortPress handle mates with the SuperComfort™ Disc, one of which is provided with each handle. The device is provided as sterile, with a SuperComfort disc attached. The handle with the disc is manually positioned at the femoral vascular access site. The medical practitioner then applies holding force sufficient to obtain hemostasis.

The provided document is a 510(k) summary for the ComfortPress™ Vascular Compression Assist Handle. It describes the device and its intended use, and states that it is substantially equivalent to a predicate device. However, it does not contain the detailed acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or performance study report typically would.

The "testing" mentioned is very limited and focused on mechanical fit and applying pressure, rather than broader clinical effectiveness.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, sample sizes, expert involvement, or comparative effectiveness with AI assistance, as this information is not present in the provided text.

Here's what I can extract based on the limited information provided:

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

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

• Sample size used for the test set: Not specified.
• Data provenance: Not specified. The document states "Market testing determined that the use of a handle and disc for holding manual pressure...was more comfortable and less stressful to the care giver," implying some form of user feedback, but no details on the participants or methodology.

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 specified.

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

• Not specified.

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 study was done, and AI assistance is not mentioned or relevant to this device.

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

• This is a mechanical device; a standalone algorithm study is not applicable.

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

• The "ground truth" for the equivalence claim appears to be based on the assessment that it effectively performs the same mechanical function (applying pressure and fitting the disc) as the predicate device. For the "more comfortable and less stressful" claim, the ground truth was "Market testing" which likely involved user feedback, but the specifics are not provided.

8. The sample size for the training set

• Not applicable/not specified. There's no mention of a training set in the context of an algorithm or machine learning.

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

• Not applicable/not specified.

Summary of Device Performance Test and Conclusion:

The document states: "Testing was conducted to determine that the ComfortPress device provides mechanical fit to the CompressAR SuperComfort™ Disc and may be used to apply pressure. It was concluded that the ComfortPress Compression Assist Handle, used with the SuperComfort™ Disc, is equivalent to the predicate device."

This suggests the testing was a functional assessment of the device's ability to mate with its intended consumable and to physically allow pressure application. The conclusion of equivalence is based on these functional aspects being comparable to the predicate device, the Compass™ Compression Assist Handle. No detailed study protocols, results, or statistical analyses are provided in this 510(k) summary.

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This device is indicated for use to provide hemostasis of the femoral vascular access site during and following catheterization or cannulation procedures.

The CompressAR® SuperComfort™ Disc provides an elastomeric insert in the compression pad, and is used with a modified attachment to the CompressAR @ StrongArm™ System to provide a two-step friction fit connection. The elastomer insert contacts the patient skin providing increased friction against the skin.

The disk and supporting stand provide a mechanical means of holding external pressure at or near the site of femoral vascular access. Direct pressure is used to obtain and maintain hemostasis, in a similar fashion to direct hand pressure on the access site or at a pressure point.

The provided text describes a 510(k) summary for the CompressAR® SuperComfort™ Disc and StrongArm™ SuperComfort™ System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance data in the format requested.

Therefore, many of the requested details are not explicitly present in the provided text.

Here's an attempt to extract and infer information based on the given text:

1. Table of acceptance criteria and the reported device performance:

The document states: "Testing was conducted to determine that the modified device provides mechanical clamping and holding functions, similar to the predicate device. It was concluded that the CompressAR & SuperComfort™ Disc and StrongArm™ System is equivalent to the predicate device."

This implies that the acceptance criterion was demonstrating "similar" mechanical clamping and holding functions to the predicate device. The reported performance is that the device met this criterion, as it was concluded to be "equivalent."

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Testing was conducted."

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

• Not specified. The assessment appears to be based on engineering or performance testing against the predicate device rather than expert-derived ground truth.

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

• Not specified.

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 device is a mechanical medical device, not an AI or diagnostic imaging tool.

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

• This question is not applicable as the device is a mechanical hemostasis device, not an algorithm. However, the testing conducted would be considered "standalone" in the sense that it doesn't involve human interpretation of output from the device, but rather the device's direct mechanical function.

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

• The ground truth (or more accurately, the benchmark) was the performance of the predicate device (CompressAR® Universal System CompressAR® Comfort™ Disc). The study aimed to show that the new device's mechanical functions were "similar" to this established predicate.

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.

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

• Not applicable (no training set for this type of device).

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