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This device is intended for the subcutaneous injection of insulins.

This device is consisting of barrel, plunger, piston, cannula (which is tixed in the barrel nozzle lumen), top cap and cannula cap (orange color) with different gauges and cannula length.

The provided document describes the IMC Insulin Syringe, a Class II medical device, and its substantial equivalence to a predicate device (BD Insulin Syringe: K024112). The performance data section, which is crucial for understanding acceptance criteria and proof of device performance, focuses on two key characteristics: "Hub/needle bond strength" and "Graduation" (volume accuracy).

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

Acceptance Criteria and Device Performance for IMC Insulin Syringe

1. 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)

The document does not specify the sample size used for the test set for either the hub/needle bond strength or graduation tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not applicable and not provided as the tests relate to physical performance characteristics of a device (bond strength, volume accuracy) rather than diagnostic interpretations or expert consensus on patient data.

4. Adjudication method for the test set

This information is not applicable and not provided due to the nature of the tests (engineering performance metrics). Adjudication methods are typically relevant for subjective assessments or when discrepancies arise in expert interpretations of data.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. The IMC Insulin Syringe is a physical insulin delivery device, not a diagnostic or AI-powered system.

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

A standalone performance evaluation (as defined for AI algorithms) was not applicable and not done. This device does not involve an algorithm. The reported performance data (hub/needle bond strength, graduation) are intrinsic physical properties of the syringe.

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

The "ground truth" for the performance criteria is based on established international standards (ISO 7894:1993 for hub/needle bond strength and ISO 8537:1991(E) for graduation). These standards define objective, measurable physical properties and their acceptable limits.

8. The sample size for the training set

This information is not applicable and not provided. The IMC Insulin Syringe is a physical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

This information is not applicable and not provided for the same reason as point 8.

Summary of Study Proof:

The proof that the IMC Insulin Syringe meets the acceptance criteria is stated as "Meets Standard Criteria" for both the Hub/needle bond strength and Graduation (volume accuracy) tests. These tests were conducted according to international standards ISO 7894:1993 and ISO 8537:1991(E), respectively. The document asserts that the IMC Insulin Syringe's performance is substantially equivalent to the predicate device (BD Insulin Syringe K024112) based on these performance characteristics, along with similarities in intended use, materials, and other features. The specific raw data or detailed test reports, including sample sizes and statistical analysis, are not included in this 510(k) summary but would have been part of the full submission to the FDA.

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This device is intended for use in venous blood collection.

This device is intended for use in venous blood collection.

IMC blood collection needles are manufactured from stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is shorter end and is fitted with a protective rubber sleeve. And a needle cap. The opposite end of the needle is 1" or 1 ½" for withdrawing blood. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity.

IMC blood collection needles are a sterile single use disposable product. The needles are nontoxic and non-pyrogenic and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1 ½').

The document describes the acceptance criteria and performance of the IMC Blood Collection Needle, comparing it to the predicate device, VACUETTE VISIO PLUS blood collection needle (K061483).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample size used for the hub/needle bond strength test. It states "Meets Standard Criteria," implying that an adequate number of samples were tested to demonstrate compliance with the ISO 7894:1993 standard for each gauge. The data provenance is not specified, but given the submission for FDA approval, it is presumably from testing conducted by or for the manufacturer, International Medsurg Connection. The study is a prospective performance test designed to meet pre-defined criteria.

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

This information is not applicable to the type of device and test described. The "ground truth" for hub/needle bond strength is established by objective physical measurement against a specified international standard (ISO 7894:1993), not by expert opinion or interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The test involves direct physical measurement and comparison to quantitative criteria, not subjective assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data. The IMC Blood Collection Needle is a physical medical device, and its performance is evaluated through engineering and mechanical testing.

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

Not applicable. This device does not involve algorithms or human-in-the-loop performance in the context of diagnostic interpretation. The performance reported is that of the device itself.

7. The Type of Ground Truth Used:

The ground truth used is based on objective measurement against an international standard (ISO 7894:1993). The hub/needle bond strength is a quantifiable physical property, and the acceptance criteria are numerical thresholds defined by this standard.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of this device. The testing described is a performance validation test, not a machine learning model.

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

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

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This device is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

This device is consist of hub, cannula and protector and has difference hub color per each of gauges.

The provided text describes the IMC Hypodermic Needle and its substantial equivalence to a predicate device. It includes performance data for a single characteristic, "Hub/needle bond strength."

Here's an analysis of the acceptance criteria and study information:

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 the sample size used for testing, nor its provenance (e.g., country of origin, retrospective or prospective). It simply states "Meets Standard Criteria" for the IMC Hypodermic Needle performance.

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

This information is not applicable as the described device is a physical medical device (hypodermic needle) and the performance data pertains to a mechanical bond strength test, not an AI or diagnostic imaging device requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Mechanical testing does not involve human adjudication in this context.

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

This information is not applicable as the described device is a physical medical device, not an AI or diagnostic imaging system that would involve human readers or comparative effectiveness studies with AI assistance.

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

This information is not applicable as the described device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance data (Hub/needle bond strength) is established by objective mechanical testing against the specified force thresholds outlined in the ISO 7894:1993 standard. This is a direct physical measurement, not based on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic devices.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical device and does not involve AI or machine learning that would require a training set.

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

This information is not applicable for the same reason as point 8.

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International Medsurg Connection's piston syringe is intended for the injection of fluids into, or withdraw of fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger. The intended use is the same as the intended use on IMC piston syringe sold by International Medsurg Connection, Reference K022159.

This submission includes piston syringe that will be sold both sterile and non-sterile syringes are to be sold to OEMs for EtO sterilization according to their validated process per ANSVAMMISO 11135. Sterile syringes are to be sold directly to users after EO sterilization validation per ANSVAMMI/ISO 11135

The device consists of a calibrated hollow barrel and a movable plunger with piston. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into or withdraw fluids from, the body.

The provided text describes a 510(k) submission for an IMC Piston Syringe and does not contain information about an AI/ML device. Therefore, it does not fit the typical structure of an acceptance criteria and study report for such a device. This document is a regulatory submission for a medical device (piston syringe) claiming substantial equivalence to a predicate device.

However, I can extract the relevant "performance data" and "acceptance criteria" presented in the context of this device's submission, along with other requested information where applicable.

Here's the information based on the provided text, adapted to your request format:

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

Note: For this traditional medical device, "acceptance criteria" means meeting the requirements of the specified ISO standards, and "reported device performance" indicates that the new device meets those requirements.

2. Sample sized used for the test set and the data provenance

The document does not specify the sample size used for testing the piston syringes. It also does not explicitly state the provenance (e.g., country of origin, retrospective/prospective) of the data. The tests are referenced by ISO standards, implying laboratory testing.

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

This section is not applicable as the device is a physical medical instrument (piston syringe), not an AI/ML device requiring expert ground truth for classification or diagnosis. Performance is evaluated against objective engineering standards (ISO 7886-1).

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert-dependent tasks, typically in AI/ML performance evaluation where human experts might disagree. The syringe's performance is determined by objective physical tests according to ISO 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 section is not applicable. This is a submission for a physical medical device (piston syringe), not an AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this document.

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

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

7. The type of ground truth used

The "ground truth" for the device's performance is established by objective engineering standards and test methods defined in ISO 7886-1. The device is deemed to meet its performance criteria if it passes these standardized tests, indicating functional equivalence to the predicate device.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This section is not applicable for the same reasons as above.

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These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile.

Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSIIAMMIIISO 11135. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSIIAMMIIISO 11135

The IMC Surgical Drape devices are patient protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is made of non-latex rubber.

The Bladder Suspension Drape, the GYN Drape and the TUR drape have the same features and same materials but have different dimension of drape and aperture.

The provided text describes a 510(k) submission for the IMC Surgical Drape and focuses on establishing substantial equivalence to predicate devices. It does not present a study designed to evaluate the device's performance against specific acceptance criteria in the context of clinical or diagnostic accuracy. Instead, it outlines the device's characteristics and compares them to predicate devices, referencing performance tests for material properties.

Therefore, many of the requested details about acceptance criteria and study design are not applicable to the information provided.

Here's a breakdown of what can be extracted and what cannot:

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

The document lists performance characteristics and test methods for material properties, demonstrating that the IMC Surgical Drape "Meets Intended use" for each. These are implicitly the acceptance criteria for those specific material properties, equating to being "acceptable for the intended use" or meeting the specified standard.

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

• Sample Size: Not specified for the performance tests. The document only states that "These materials were tested." It does not detail how many samples of each material were tested.
• Data Provenance: Not specified. It's likely that the testing was conducted by the manufacturer or a contracted lab, but the location or whether it was retrospective/prospective is not mentioned.

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. This device is a surgical drape, not a diagnostic or AI-driven device requiring expert-established ground truth for a test set. The "ground truth" for material properties is determined by standardized test methods and their defined pass/fail criteria (e.g., Class I for flammability, meeting "intended use" for hydrostatic pressure).

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

• Not Applicable. As above, this is a material property evaluation, not an interpretation task requiring adjudication by experts.

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

• Not Applicable. This is not an AI-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm.

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

• Material Standard Compliance: For the performance characteristics listed, the "ground truth" is adherence to established industry standards and test methods (e.g., 16 CFR Part 1610 for flammability, AATCC 127-2008 for hydrostatic pressure, ISO 10993-x for biocompatibility). The claim is that the materials "were found to be acceptable for the intended use" based on these tests.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device requiring a training set.

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

• Not Applicable. This is not an AI/machine learning device.

In summary: The provided 510(k) summary for the IMC Surgical Drape focuses on demonstrating substantial equivalence to predicate devices through comparisons of material composition, design features, and performance characteristics as measured by established material testing standards. It is not an AI-driven or diagnostic device, and therefore, many of the requested details related to "acceptance criteria" in a clinical/diagnostic context and associated study methodologies (like expert review, sample sizes for test/training sets, MRMC studies) are not pertinent to this submission.

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This device is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The IMC Surgical Face Mask devices are surgical apparel intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The surgical masks feature either tie-on or ear loop attachment mechanisms. This device is a flat pleated 3 ply mask. The inner and outer layer of the mask is made of polypropylene, sandwiching a middle layer made of melt-blown polypropylene filter media. The outer layer of the mask is offered in a yellow color.

Here's an analysis of the provided text regarding the IMC Surgical Face Mask, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the performance tests (e.g., how many masks were tested for each characteristic). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The tests are described as being conducted "in accordance with" specific ASTM and MIL standards, implying standard laboratory testing rather than clinical studies with human subjects.

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

This information is not applicable to the type of device and testing described. The "ground truth" for the performance characteristics of a surgical mask (e.g., fluid resistance, filtration efficiency) is established by the specified test methods and their defined parameters, not by expert consensus or interpretation of imagery.

4. Adjudication Method for the Test Set

Not applicable. The performance testing of a surgical mask involves objective measurements against established standards, not interpretation by multiple experts requiring adjudication.

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

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This document describes the performance characteristics of a physical product (a surgical mask).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is not an algorithm or AI system. The performance studies are laboratory tests of the physical mask's material properties.

7. Type of Ground Truth Used

The ground truth used for this device's performance evaluation is established by objective test standards and defined acceptance criteria. These are standardized test methods (ASTM F1862, ASTM F2299, ASTM F2101, MIL-M36945C, 16 CFR Part 1610) that measure specific physical properties of the mask. The "ground truth" is that a mask either meets or does not meet the specified quantitative threshold for each characteristic (e.g., ≥98% for particulate filtration efficiency).

8. Sample Size for the Training Set

Not applicable. This device is a physical product and not an AI/ML algorithm that requires a "training set" of data.

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

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

Study That Proves the Device Meets the Acceptance Criteria:

The device's compliance with the acceptance criteria is demonstrated through a series of performance characteristic tests conducted according to recognized industry standards. The summary states that for each performance characteristic (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability), the "IMC Surgical Face Mask K100846" was found to "Meets Standard Criteria" or "Class 1" (for Flammability).

The predicate devices (Medline K991559 and Crosstex K012602) are also listed as meeting the "Same" standards, indicating that the new device replicates the performance of already legally marketed devices. The document implies that reports from these tests were submitted to the FDA to demonstrate substantial equivalence to the predicate devices. The listed Test Methods are the studies that prove the device meets the acceptance criteria.

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This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

International Medsurg Connection's Surgical Drape is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures. This submission includes drapes that will be sold both sterile and non-sterile. Non-sterile drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile drapes are to be sold directly to users according to current sterilization process.

This document is a 510(k) premarket notification for "IMC-Surgical Drapes - Various Types, Sizes and Configurations." As such, it does not contain information related to the performance of an AI/ML powered device, or a study to prove such performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria because the provided text does not describe such a device or study.

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This device is intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures.

Surgical Drapes including various sizes and configurations of table covers, flat drape sheets, Lap drapes, cardiovascular drapes, head & neck drapes, general use drapes, cysto drapes, c-section drapes, orthopedic drapes and specialty drapes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the International Medsurg Connection Surgical Drape:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly lists the tests and the standards they adhere to, implying that meeting these standards constitutes the acceptance criteria. The phrase "All material used in the fabrication of the IMC Surgical Drapes were evaluated for" followed by the list of tests strongly suggests that the device met the requirements of these standards. However, specific quantitative performance data for each test (e.g., actual hydrostatic pressure achieved) is not provided in this summary.

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

The provided text does not include information on:

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

The tests listed are material property tests rather than clinical studies on patient data.

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

This information is not applicable to the type of testing described. The tests are laboratory-based material property assessments against established industry standards (ISO, AATCC, ASTM, CFR). Ground truth in this context is defined by the specifications and methodologies within these standards, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable. As discussed above, the tests are objective laboratory evaluations against material standards, not analyses requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not relevant for this type of device (surgical drapes). This device is a physical barrier, not an AI or diagnostic tool that would involve human readers interpreting data.

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

No, a standalone study (in the context of an algorithm's performance) was not done. This device is a physical product, not a software algorithm. The tests performed are for material properties.

7. The Type of Ground Truth Used

The ground truth used for these tests is scientific and engineering standards and specifications. For instance:

• ISO 10993 (Biocompatibility): Standards define acceptable levels of cytotoxicity, irritation, and sensitization based on established biological safety principles.
• 16 CFR Part 1610 (Flammability): Federal regulations specify flammability performance requirements for textiles.
• AATCC (Textile Chemistry): Standards provide methodologies and criteria for properties like hydrostatic pressure and impact penetration.
• ASTM (Materials Testing): Standards outline methods for evaluating tensile strength.

The "ground truth" is adherence to these widely accepted and documented industrial standards.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (surgical drapes), not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for this device.

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International Medsurg Connection's Fluid Collection Under Buttocks Drape is intended to be used as Fluid Collection and by placing under a patient's buttocks in obstetrics procedure (with absorbent pad).

The International Medsurg Connection Fluid Collection Under Buttocks Drape.

The International Medsurg Connection Fluid Collection Under Buttocks Drape was tested for biocompatibility to demonstrate its safety. The acceptance criteria and the device performance are shown in the table below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each biocompatibility test. It indicates that "International Medsurg Connection Fluid Collection Under Buttocks Drape were tested," implying a sufficient number of samples were used to meet the requirements of the standards. The data provenance is not specified, but these are standard in-vitro and in-vivo biocompatibility tests, typically performed in a laboratory setting.

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

For biocompatibility testing according to ISO 10993 standards, "ground truth" is established by adherence to standardized protocols and interpretation by trained laboratory technicians and toxicologists. The document does not specify the number or specific qualifications of these experts, but it is implied they are qualified to conduct and interpret tests according to international standards.

4. Adjudication method for the test set:

Not applicable in the context of standard biocompatibility testing. The results are typically objectively measured and interpreted according to the specific criteria of each ISO standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or algorithms where human readers interpret results, and it is not relevant for a fluid collection drape.

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

Not applicable. This device is a fluid collection drape, not an algorithm or a diagnostic tool. The performance evaluated here is related to its material safety.

7. The type of ground truth used:

The ground truth used for these tests is based on established biological safety endpoints and objective measurements defined by the ISO 10993 series of standards for biological evaluation of medical devices. For example:

• Cytotoxicity: Cell viability and morphology compared to controls.
• Skin Sensitivity: Presence or absence of delayed hypersensitivity reactions.
• Skin Irritation: Erythema and edema scores compared to controls.
• Systemic Toxicity: Clinical observations, body weight, organ weights, and histopathology.

8. The sample size for the training set:

Not applicable. Biocompatibility testing does not involve training sets in the same way machine learning algorithms do. The tests are designed to assess the intrinsic biological properties of the material.

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

Not applicable, as there is no training set in the context of these biocompatibility tests. The "ground truth" for evaluating the safety of the device's materials is established by the well-defined methodologies and criteria specified in the ISO 10993 standards.

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This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.

The International Medsurg Connections Irrigation Sets.

This is a 510(k) premarket notification for a medical device (Irrigation Sets), not an AI/ML device. Therefore, the questions related to AI/ML performance, ground truth, expert adjudication, and training/test sets are not applicable.

The document describes the device's characteristics and its substantial equivalence to a predicate device based on intended use, configurations, and materials. It also outlines a summary of testing conducted to ensure the materials and components meet certain standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a list of evaluations performed on the "Joined Tubing 5" and 20"" and "Irrigation Sets*". These can be considered the acceptance criteria for material and component properties. The document states that "All materials used in the fabrication... were evaluated for" these characteristics, implying they met specified acceptance levels, although the specific performance values or pass/fail thresholds are not detailed in this summary.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study or a test set in the context of AI/ML evaluation. The "testing" refers to material and component evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device, and no "ground truth" for diagnostic or predictive performance is being established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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: Not applicable. This device is an irrigation set, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be engineering specifications and material standards.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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