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The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices, is intended for the delivery of continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.

The CIMPAX® C-CAT catheter kit is a sterile, single use, closed tip, multi-perforated catheter with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. The kit is intended for adult patients requiring the delivery of contiguous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management or as perineural delivery. Routes of administration may be intraoperative or percutaneous. The device is intended to be used in healthcare /hospital facilities.

The CIMPAX® C-CAT catheter is a multi-perforated catheter supplied in a kit which contains components for catheter placement. The drug infusion segment is placed between the blue tip of the catheter and the first blue marking after the tip. The catheter is designed with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. Attached to the catheter is a standard female luer lock that is compatible with and can be used with infusion pumps as well as with syringes for bolus injections with standard make luer connections.

The catheter is placed usually through an incision or wound in order to provide continuous or intermittent administration of local anesthetic to the area affected. This allows only the local nerve endings (pain receptors) to be anesthetized as opposed to giving a systemic pain relief medication to the patient.

The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the CIMPAX C-CAT Anaesthesia Catheter kit. This document is a regulatory submission for medical devices, demonstrating substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria for an AI/ML product.

Therefore, the document does not contain any information related to:

• Acceptance criteria for an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity, AUC).
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test sets or data provenance for AI/ML model evaluation.
• Number of experts, qualifications of experts, or adjudication methods for establishing ground truth in the context of AI/ML.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML model evaluation (e.g., pathology, outcomes data).
• Sample size for training sets or how ground truth was established for training sets in an AI/ML context.

The document discusses acceptance criteria and studies, but these relate to the physical and biological safety and performance of a medical catheter, not an AI/ML device. For example, it mentions:

• Non-Clinical Testing: Bench testing including mechanical and performance testing (e.g., peak tensile force, burst pressure, kink testing, liquid leakage under pressure, radiopacity, flow testing), biocompatibility, sterilization, packaging, and shelf-life testing.
• Biocompatibility Testing: According to ISO 10993-1 series, covering cytotoxicity, sensitization, irritation, systemic toxicity, Ames Test, in vitro mammalian chromosome aberration, hemolytic properties, and material mediated rabbit pyrogen.
• Flow Test: Performed according to DS/EN 1618, measuring water flow through the catheter.
• Tensile strength: Tested in accordance with ISO 10555-1.
• Packaging: Complies with ISO 11607-1:2014 and EN 865-5:2009.
• Stability: Tested according to ASTM F 1980 Accelerated Aging and ISO 11607-1:2009.
• Sterilization: Method is Ethylene Oxide (EO), complying with EN ISO 11135-1.

In summary, the provided text describes the regulatory process for a physical medical device (an anesthesia catheter) and outlines its non-clinical performance and safety testing to demonstrate substantial equivalence, not information relevant to the performance and acceptance of an AI/ML device.

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The Zip 4 Skin Closure Device is indicated for skin closure of minor lacerations. The Zip 4 Skin Closure Device may be sold direct to consumers (OTC).

The Zip® 4 Skin Closure Device is a single-use non-invasive skin closure device. A single Zip 4 device may be used to close wounds up to 4 cm (1.5 inches) in length from minor cuts or minor lacerations. The device is applied to clean, dry skin prior to skin closure, remains on the skin during wound healing, and may be removed by lifting one edge and peeling the device from the skin. The device is made of polymeric materials and utilizes a non-latex, pressure sensitive skin adhesive. The device contents are provided sterile in an intact and unopened package.

This document is a 510(k) Pre-market Notification for the Zip 4 Skin Closure Device. It focuses on demonstrating substantial equivalence to a predicate device rather than on clinical performance for novel AI/ML devices. Therefore, much of the requested information regarding acceptance criteria and performance against a ground truth is not directly applicable or available in this document.

However, I can extract the non-clinical performance data and the conclusion that supports the device's substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing conducted to demonstrate compliance with product requirements, but it does not specify quantitative acceptance criteria or corresponding reported performance metrics in a table format that typically applies to AI/ML model evaluations (e.g., sensitivity, specificity, AUC). Instead, it lists the types of tests performed and the standards met.

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

• Not Applicable. This document pertains to a medical device (skin closure device), not an AI/ML algorithm. Therefore, there is no "test set" in the context of an AI/ML model for data evaluation. The "human wear test" mentioned in the non-clinical performance data would involve human subjects, but the sample size and specific details are not provided in this summary.

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

• Not Applicable. As this is not an AI/ML device, the concept of establishing ground truth by experts for a test set is not relevant.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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

• No. This is not an AI/ML device, so no MRMC study or AI assistance evaluation was performed.

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

• Not Applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used:

• Not Applicable / Indirect. For a physical device, "ground truth" would relate to its physical properties, biocompatibility, and functional performance as determined by established engineering standards, biological assessments, and usability. The "ground truth" is established through adherence to the listed ISO and ASTM standards, which provide validated methods for testing these aspects.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. See point 8.

Summary regarding the device's "study" and "acceptance criteria":

The "study" for the Zip 4 Skin Closure Device was a series of non-clinical performance tests designed to show that the device meets its product requirements and complies with relevant international and national standards.

The acceptance criteria are implicitly defined by compliance with these standards (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization dose, ASTM D 4169 for packaging, ASTM F 2096 for leak detection, and IEC/EN 62366 for usability). The document states that performance testing, including dimensional, mechanical, and human wear tests, was "conducted on the subject Zip 4 Skin Closure Device to demonstrate compliance with the product requirements specification either by design analysis or functional testing."

The conclusion states, "The successful completion of the performance testing further supports the subject Zip 4 Skin Closer Device's substantial equivalence to the predicate device. The usability testing that was successfully performed shows that the proposed device can be marketed for over-the-counter use. No issues of safety or effectiveness are raised by the Zip 4 Skin Closure Device." This indicates that the device met the implicit acceptance criteria by passing these non-clinical tests.

Important Note: This 510(k) summary is for a traditional medical device and explicitly states, "No clinical testing was deemed necessary to support the substantial equivalence." Therefore, it does not contain the types of AI/ML-specific performance metrics or study designs typically requested for AI/ML devices.

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The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep™ Antegrade Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow® NextStep™ Antegrade catheter is intended for use in adult patients.

The Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter is a 15 Fr, 2 lumen, one piece Carbothane catheter with a preloaded stylet and step tip designed for antegrade placement. The catheter is available in multiple lengths. The procedure kit includes the necessary accessories to correctly insert the catheter.

The provided 510(k) summary for the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238) does not describe a study that uses AI/algorithm performance. Instead, it focuses on demonstrating the substantial equivalence of a medical device (a catheter) to a predicate device through traditional engineering and biological performance testing.

Therefore, many of the requested categories related to AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context.

Here's a breakdown of the information that is available based on your request, adapted for a medical device rather than an AI/algorithm:

Acceptance Criteria and Device Performance for Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheter (K102238)

This submission describes a medical device, a chronic hemodialysis catheter, and its performance is assessed through laboratory testing to demonstrate substantial equivalence to a predicate device, not through an AI/algorithm performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion from Submission: "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices. Based on the indications for use, design, safety and performance testing, the Arrow® NextStep™ Antegrade Chronic Hemodialysis Catheters met the requirements that are considered adequate for its intended use and is substantially equivalent to the predicate devices."

The following points are not applicable (N/A) as the submission describes a physical medical device and not an AI/algorithm:

2. Sample size used for the test set and the data provenance: N/A (This was a physical device performance study, not a data-driven test set.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth is not relevant for physical device testing this context; performance is measured against physical standards/benchmarks.)
4. Adjudication method for the test set: N/A (Not applicable for physical device testing.)
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (This is not an AI-assisted device.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is not an algorithm.)
7. The type of ground truth used: N/A (For physical devices, performance is measured against engineering specifications, industry standards, and predicate device performance, not "ground truth" derived from expert consensus or pathology in the sense of an AI model.)
8. The sample size for the training set: N/A (This is not an AI/algorithm that requires a training set.)
9. How the ground truth for the training set was established: N/A (Not applicable.)

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Centurion® SorbaView® OTC dressings are intended for medical purposes to cover and protect wounds, hold together the skin edges of a wound, support an injured part of the body, or to secure objects to the skin.

This device is intended for lay or prescription use by pediatric or adult patients.

Sorba View® dressings are highly permeable, self-adhesive, transparent film dressings that are of multi-layer construction. The multi-layer construction consists of:

• Polyurethane film, .
• . Solvent-spun cellulose,
• . Medical grade adhesive,
• ◆ Non-woven fabric, and
• Kraft liner with silicone release coating. .

This is a 510(k) premarket notification for a medical device (dressing), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and human/AI performance is not applicable.

The provided document describes the Centurion® SorbaView® OTC dressing and its substantial equivalence to predicate devices (Centurion® SiteGuard® Transparent Dressing K945977 and 3M Tegaderm™ + Pad K811291).

Here's a summary of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance: This section is designed for AI/ML performance metrics. For this device, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various tests.

   Acceptance Criteria (Implied)	Reported Device Performance
   Biocompatibility: Non-cytotoxic, non-sensitizing, negligible irritant	Results of testing validate SorbaView® is non-cytotoxic, non-sensitizing, and a negligible irritant.
   Barrier effectiveness against viral contaminants	Effective against penetration of viral contaminants (ASTM F 1671-97b).
   Barrier effectiveness against blood contaminants	Effective against penetration of blood contaminants (ASTM F 1671-97b and 107098).

2. Sample Size and Data Provenance: Not applicable for a non-AI/ML device. The testing conducted was for biocompatibility and barrier effectiveness, likely using standardized laboratory samples.

3. Number of Experts and Qualifications: Not applicable. Human experts are not involved in establishing ground truth for biocompatibility or barrier effectiveness tests in the same way they would be for an AI diagnostic.

4. Adjudication Method: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant for a medical dressing.

6. Standalone Performance Study: Not applicable in the context of an "algorithm only" performance. The device itself (the dressing) was tested for its properties (biocompatibility, barrier effectiveness).

7. Type of Ground Truth Used: For biocompatibility, the ground truth is established by standardized biological assays. For barrier effectiveness, the ground truth is established by physical testing against viral and blood contaminants according to ASTM standards.

8. Sample Size for Training Set: Not applicable. There is no training set for a medical dressing.

9. How Ground Truth for Training Set was Established: Not applicable.

In conclusion, the provided document details the safety and effectiveness testing of a transparent film dressing, demonstrating its substantial equivalence to existing products through standardized biological and physical tests, rather than through AI/ML performance evaluation.

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Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

The Subdural Evacuating Port System Cranial Access Kit is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the Subdural Evacuating Port System Cranial Access Kit's "SEPS Components" are designed to promote gradual brain reexpansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. The completeness of the Subdural Evacuating Port System Cranial Access Kit saves time and eliminates the need to gather supplies; this convenience can be critical in an emergency situation.

The Subdural Evacuating Port System Cranial Access Kit is available in three (3) kit configurations:

1. SEPS-CA, Catalog # 11-0401-CA (Standard Kit)
2. SEPS-CAL, Catalog # 11-0401-CAL (Standard Kit with Lidocaine w/epinephrine)
3. SEPS-CAND, Catalog # 11-0401-CAND (Standard Kit without Lidocaine, ChloraPrep® One-Step, or PVP (Povidone-Iodine) ointment -- no drugs).

The provided text describes a 510(k) submission for the Subdural Evacuating Port System Cranial Access Kit (SEPS Cranial Access Kit). This is a medical device, not an AI/ML algorithm or software that would typically have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested categories in the prompt are not applicable to this type of traditional medical device submission. The 510(k) process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a study with clearly defined statistical endpoints for sensitivity/specificity.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present or relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated for the current device. The submission refers to "successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)." This implies that the data relied upon was from studies previously conducted for the predicate device.
• Data Provenance (country of origin, retrospective/prospective): Not provided in this summary. The data provenance would relate to the predicate device's studies.

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

• Number of Experts: Not applicable/Not provided. The 510(k) submission for this device type does not involve establishing ground truth through expert reads of images for performance evaluation in the way an AI diagnostic device would. Performance is demonstrated through substantial equivalence to existing devices.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not provided. Adjudication is typically used in studies involving human readers or AI output where discrepancies need resolution, which is not the primary assessment method described for this device.

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

• MRMC Study Done: No. This type of study is specifically designed for evaluating the impact of AI assistance on human reader performance, which is not relevant for this physical medical device.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: No. This device is a physical surgical kit, not a software algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable/Not provided in the context of typical AI performance evaluation. For this device, the "ground truth" for demonstrating safety and effectiveness is primarily established through the regulatory approval of the predicate device(s) and their associated clinical performance data. The current submission relies on the established safety and performance of the predicate.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical medical kit and does not involve AI model training.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of Performance Testing (as per document):

The manufacturer (Medical Designs, LLC) states that the Subdural Evacuating Port System Cranial Access Kit is "substantially equivalent to the Subdural Evacuating Port System Kit (Predicate Device #1) based on the successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)."

This means that the current device's safety and effectiveness were demonstrated by showing that it is essentially the same as a device already approved by the FDA, which had its own performance testing and clinical data submitted previously. No new specific clinical trials or performance studies unique to the "SEPS Cranial Access Kit" itself (as described in the 510(k) summary) were conducted beyond demonstrating its equivalence to the predicate. Biocompatibility was also confirmed by noting that components are FDA approved or substantially equivalent to approved components.

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The CURAD® Silver Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.

The CURAD® Silver Bandage is an adhesive bandage that includes silver in the wound pad. The bandage covers the wound to create a protected environment. At the same time, silver ions reduce bacterial growth in the wound pad.

The provided text describes a 510(k) premarket notification for the CURAD® Silver Bandage, which is an adhesive bandage containing silver in its wound pad. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.

However, the provided document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Instead, it refers to general performance testing.

Here's a breakdown of the information presented, highlighting why a full acceptance criteria study cannot be extracted as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

• Missing Details: The document does not specify the quantitative or qualitative "acceptance criteria" for "acceptable" or "satisfactory" in terms of silver release, antimicrobial effect, or biocompatibility. It also does not provide the specific numerical results obtained during testing.

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

The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for any of its performance testing.

3. Number of Experts and Qualifications:

The document does not provide information on the number of experts used to establish ground truth or their qualifications. This is not typically part of a 510(k) submission for this type of device, which focuses on device performance rather than interpretation of complex medical images or data by experts.

4. Adjudication Method for the Test Set:

The document does not provide information on any adjudication method.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more relevant for diagnostic imaging devices where human interpretation is a key factor.

6. Standalone (Algorithm Only) Performance:

The document does not describe any standalone (algorithm only) performance. This device is a physical product, not an algorithm.

7. Type of Ground Truth Used:

For the performance testing mentioned (silver release, antimicrobial effect, biocompatibility), the "ground truth" would be established through laboratory testing and established scientific standards/methods for measuring these properties. The specific details of these methods are not provided in this 510(k) summary.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this physical medical device. This term is used for machine learning algorithms.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no "training set" for this device.

In summary, the provided 510(k) summary for the CURAD® Silver Bandage indicates that performance testing for silver release, antimicrobial effect, and biocompatibility was conducted and yielded "acceptable" or "satisfactory" results. However, it lacks the detailed quantitative acceptance criteria, specific study designs, sample sizes, and expert involvement that would be present in a comprehensive study report for certain types of medical devices, particularly those involving diagnostics or complex algorithms. The submission aims to demonstrate substantial equivalence to existing predicate devices based on technological characteristics and general performance, rather than providing detailed clinical trial data with expert agreement and specific statistical metrics often seen for higher-risk devices or software as a medical device.

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The Baxter Emergency Relief TM System consists of color-coded mini first aid kits. Each kit is intended to be used as a basic first aid treatment for various emergency situations, while seeking further professional medical assistance.

The Baxter Emergency Relief ™ System is designed as one large unit which houses various first aid kits Each mini kit contains various individual components traditionally used for first aid treatment. Each individual component is a finished good with an established regulatory path where applicable. All components are purchased as finished goods and packaged in the appropriate mini kit, including direction for use inserts. All direction for use inserts correspond to the instruction manual accompanying the system.

The provided text does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria. The document is a summary of safety and effectiveness for the Baxter Emergency Relief™ Kit System, detailing its components, classification, intended use, and substantial equivalence to predicate devices. It explicitly states: "Testing of the system was deemed not applicable as all regulated devices has an established regulatory path and is obtained in finished good form." This indicates that no specific performance study was conducted for the overall kit system as its components are already approved finished goods.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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Not Found

Tape and Bandage, Adhesive

This document (K955270) describes a Class I medical device, a "Cutaneous Compression Device for General Hospital Use," which is essentially an adhesive tape and bandage. As a Class I device, it is exempt from many requirements seen in higher-risk devices.

Based on the provided information, the device is considered substantially equivalent to a predicate device (K951973, a "Cutaneous Compression Device for Hemodialysis"), indicating that its safety and effectiveness have been established by comparison to an already legally marketed device.

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

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

For a Class I device like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device. This typically means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Specific performance metrics are generally not required for Class I devices where substantial equivalence is the primary pathway.

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 for Test Set: Not applicable/Not provided. For Class I devices demonstrating substantial equivalence, formal clinical studies with "test sets" as understood in AI/performance studies are typically not required. The substantial equivalence argument relies on the inherent characteristics of the device and its predicate.
• Data Provenance: Not applicable/Not provided.

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" establishment by experts, as typically seen in AI/diagnostic device studies, is mentioned or required for this type of device.

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

• Not applicable. There is no mention of a formal adjudication process or test set in the context of this Class I device submission.

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 passive physical compression device, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

• Not applicable. This device is not an algorithm or software. It is a physical medical tape/bandage.

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

• Not applicable. For this Class I device, the "ground truth" (if it could even be conceptualized) is its physical properties and intended use, which are assumed to be safe and effective based on its predicate and general knowledge of such products. No specific "ground truth" labels like pathology or expert consensus are generated.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or any form of "training set."

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

• Not applicable. (See #8)

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