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SAFElife™ T-Cup Multi-Drug Urine Test Cup:

SAFElife™ T-Cup Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine at the cutoff concentrations of:

SAFElife™ T-Cup Multi-Drug Urine Test Cup offers any combinations from 1 to 19 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use.

The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.

SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx:

SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Fentanyl, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Opiates, Methadone, Norfentanyl, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids and Tramadol in human urine with below cutoff
concentrations and approximate detection time:

SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx offers any combinations from 1 to 19 drugs of abuse tests with or without on-board adulteration/specimen validity test (SVT) but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use.

The tests may yield positive results for the prescription drugs Buprenorphine, Fentanyl, Nortriptyline, Oxazepam, Secobarbital, Oxycodone and Tramadol when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) is the recommended confirmatory method.

SAFElife™ T-Cup Multi-Drug Urine Test Cup and SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Opiates, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids, 6-Monoacetylmorphine, Fentanyl, Norfentanyl, and Tramadol in human urine. Each SAFElife™ T-Cup Multi-Drug Urine Test Cup or SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx device consists of a test cup and a package insert. Each test cup is sealed with one sachet of desiccant in an aluminum pouch. SAFElife™ T-Cup Multi-Drug Urine Test Cup and SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx have a general identical design. The SAFElife™ T-Cup Multi-Drug Urine Test Cup is for over-the-counter (OTC) use and the SAFElife™ T-Cup Multi-Drug Urine Test Cup Dx is for professional use.

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The safety lancet is intended for capillary blood sampling.

The safety lancet is single use medical device, which is designed to collect capillary blood sample.

The intended users include Healthcare personnel, patients and lay persons.

Model XXXVI, the safety lancets consist of needle core, button, housing, protective cap and spring.

The sterile part of the safety lancet is the needle tip.

The sterile barrier is the needle sleeve and sterilized to a SAL of 10⁻⁶ by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. The purpose of this submission is to add two additional sizes (AMERI-TUFF Series 4000 XS and XXL) and additional series (AMERI-TOUCH Series 5000 XS through XXL) of SafeSource Direct Blue Powder-Free Nitrile Exam Glove

This document is a 510(k) Summary for a medical device (SafeSource Direct Blue Powder-Free Nitrile Exam Gloves) seeking FDA clearance. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (i.e., laboratory testing). It does not involve a study of an AI-powered device or a human-in-the-loop performance study.

Therefore, many of the requested elements related to AI/MRMC studies, expert ground truth adjudication, and training/test set details for AI models are not applicable to this document. I will focus on the acceptance criteria and the study that proves the device meets those criteria, as detailed in the provided text.

Here's a breakdown based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device under review includes two series of gloves: AMERI-TUFF Series 4000 and AMERI-TOUCH Series 5000. Not all tests explicitly differentiate between the series in the summary table, but chemotherapy permeation times are distinct.

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

The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for physical dimensions, watertightness, or chemotherapy permeation). However, it indicates compliance with recognized standards such as ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, and ASTM D6978-05, and ISO 10993 series. These standards typically specify the required sample sizes for testing.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective. Given this is a 510(k) submission for a medical device (gloves), the testing would be prospective laboratory testing conducted to demonstrate compliance with performance standards.

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

This information is not applicable. The "ground truth" for glove performance tests outlined here is based on objective laboratory measurements against established ASTM and ISO standards, not on expert interpretations or consensus of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically employed in studies involving human interpretation (e.g., radiologists reading medical images) to resolve discrepancies. The tests described are objective, physical, and chemical property measurements.

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 relevant for AI-powered devices where human readers are involved in diagnosis or intervention. This submission pertains to physical and chemical properties of examination gloves.

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

No, this is not an AI algorithm. The performance evaluation is based on standard laboratory testing of the physical and chemical properties of the gloves.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of these gloves is based on:

• Compliance with established industry standards: ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards provide specific methodologies and acceptance criteria for physical properties (dimensions, tensile strength, elongation), watertightness, powder content, and biocompatibility.
• Laboratory measurements: Objective measurements of the gloves' properties (e.g., length, width, thickness, force required to break, elongation percentage, breakthrough time for chemotherapy drugs) against predefined thresholds within the standards.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI model requiring a training set. The device is a physical product (gloves) whose performance is established through manufacturing processes and validated through standardized testing.

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

This is not applicable as there is no AI training set.

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The Safecare Urinary Tract Infection Test is for the qualitative detection of Leukocytes (LEU,white blood cells) and nitrite (NIT) in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use.

Urinary Tract Infection Test is in vitro diagnostic test device for qualitative detection of leukocyte and nitrite in urine. The device is composed of two-color pads aligned on a strip. One pad is employed for testing leukocyte and the other for nitrite by visually reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Safecare Urinary Tract Infection Test are for the qualitative detection of Leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a Urinary Tract infection (UTI). It is intended for over-the-counter home use only.

This document, particularly the "510(k) Summary" section, details the performance characteristics of the Safecare Urinary Tract Infection Test. While it doesn't present a formal "acceptance criteria" table in the typical sense of a pre-defined set of numerical thresholds for device performance, the data provided in the "Lay user Study" serves as the proof that the device meets the necessary performance for its intended use, especially for over-the-counter home use, by demonstrating high agreement with a predicate device.

Here's a breakdown of the requested information based on the provided text:

Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the agreement rates deemed acceptable for an over-the-counter device intended for screening, where high agreement with a physician-used predicate device signifies adequate performance for lay users. The study aimed to demonstrate that lay users could achieve results comparable to healthcare professionals using a predicate device.

Note: For the Leukocytes, "Agreement (+/- Color Block)" was 100% for all grades, indicating excellent performance when allowing for slight variations in visual interpretation around the color block, which is common in visual assays.

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

• Sample Size: 154 lay users with UTI symptoms.
• Data Provenance: The document does not explicitly state the country of origin for the lay user study data. It was conducted at "Three (3) sites." Given the applicant is Safecare Biotech (Hangzhou) Co., Ltd. in China, it is plausible the study was conducted in China, though this is not confirmed. The study was prospective, as it involved recruiting participants to test their own urine samples in real-time.

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

• Number of Experts: The ground truth was established by "healthcare professionals" using the predicate device. The exact number of individual healthcare professionals is not specified, but it implies a standard clinical practice setting where trained personnel perform the testing.
• Qualifications of Experts: They are referred to as "healthcare professionals." Their specific qualifications (e.g., medical technologists, nurses, physicians) and years of experience are not detailed in this summary.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The ground truth was established by "healthcare professionals using the predicate device." It appears to be a direct comparison between the lay user's result on the Safecare device and the healthcare professional's result on the predicate device, implying the predicate device's result, as performed by a healthcare professional, was taken as the reference.

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 document describes a diagnostic test strip for visual interpretation (Urinary Tract Infection Test). It does not involve AI assistance or a comparison of human reader performance with and without AI. It focuses on the ability of lay users to correctly interpret the visual results compared to healthcare professionals using a predicate device.

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

• Not Applicable. This device is a visual test strip intended for human (lay user) interpretation. There is no automated algorithm or standalone performance without human input.

7. The Type of Ground Truth Used

The ground truth for the lay user study was established by comparison to a legally marketed predicate device (Healgen URS Test Strips, K231045) as interpreted by healthcare professionals. This serves as a clinical reference standard for diagnostic performance in the context of this 510(k) submission.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of a machine learning model, as this is a traditional in-vitro diagnostic test strip. However, if "training set" refers to the data used for internal development, optimization, or early analytical studies, the following information is provided:

• Precision and Reproducibility Study: "A total of forty-five (45) assays results on each of eight levels of control were obtained." This involved three (3) clinical sites, two (2) operators per site, three (3) replicate assays over five (5) days.
• Analytical Specificity Interference: "Potentially interfering substances were added to negative urine with different leukocyte and nitrite concentrations. These samples were tested with three lots of the Safecare Urinary Tract by three different operators (one operator per lot)."
• Assay Cut-off/Sensitivity Study: "Urine samples were spiked to known concentrations of each analyte. These samples were then diluted to the lowest positive concentrations...Each sample was tested in 30 replicates with three (3) different operators."

These analytical studies use controlled samples and protocols to define the device's inherent performance characteristics, prior to the lay user study which demonstrates real-world applicability.

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

For the analytical studies (which might be considered analogous to a "training/development" phase for traditional IVDs):

• Precision and Reproducibility: Ground truth involved preparing "eight levels of control" which are presumably well-characterized, spiked samples with known concentrations.
• Analytical Specificity Interference: Ground truth involved "negative urine with different leukocyte and nitrite concentrations" and then spiking them with "potentially interfering substances" at known concentrations.
• Assay Cut-off/Sensitivity: Ground truth involved "Urine samples...spiked to known concentrations of each analyte." This means the true concentration of the analytes was known by design. Readings were taken by multiple operators and likely compared against these known concentrations to define the lower limits of detection and appropriate cut-offs.

In summary, the "ground truth" for the analytical and development phases was established through controlled laboratory experiments using precisely prepared and characterized samples with known analyte concentrations.

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The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

This document is a 510(k) summary for a medical device called "Safety Winged Blood Collection Sets" (K243806) from Promisemed Hangzhou Meditech Co., Ltd. It declares substantial equivalence to a predicate device (K211293).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance in the format usually seen for AI/ML performance. This is because the device is a physical medical device (blood collection set), not an AI/ML diagnostic system. The "acceptance criteria" here are implied by adherence to recognized international standards and successful completion of non-clinical tests.

However, based on the provided text, we can infer some "acceptance criteria" and "performance" statements related to the modifications made (specifically the addition of model RBC and changes in needle sizes/materials).

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

• Sample size: The document does not specify a numerical sample size for any of the non-clinical tests conducted. Statements like "Visual inspections were conducted on unit packaging" and "Full performance was tested" indicate tests were performed but don't provide the number of units tested.
• Data provenance: The data provenance is from the manufacturer's internal non-clinical testing. It is implicitly "prospective" in the sense that the tests were conducted specifically to demonstrate the performance of the modified device for this 510(k) submission. No specific country of origin for the data is mentioned other than the manufacturer's location in China.

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 this is a 510(k) for a physical medical device (blood collection set), not an AI/ML device that generates diagnostic outputs requiring expert interpretation or ground truth labeling in that sense. The "ground truth" for these types of devices is established by adherence to engineering specifications and international performance standards.

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

This is not applicable for the same reason as above. No "adjudication" or consensus reading by experts is required for the non-clinical performance and design verification tests reported.

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

This is not applicable as the device is not an AI/ML system, nor does it involve human readers or cases in an interpretive diagnostic context.

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

This is not applicable as the device is not an algorithm or AI system.

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

The "ground truth" for this medical device is adherence to established technical specifications, engineering drawings, and relevant international performance standards (ISO 6009, ISO 8536-4, ISO 9626, ISO 23908). Biocompatibility is "ground-truthed" by ISO 10993 series testing (e.g., in vitro cytotoxicity).

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm requiring a training set.

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

This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.

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Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Safety Lancet could be divided into Model XA Pro and Model ZF.Each model has sharps protection features that it can reduce the occurrence of accidental needle sticks. The device is sterilized by Co-60 or e-beam gamma ray and for single use.The shelf life is 5 years. Model XA Pro has four versions according to the different three penetration depths, version XA1 Pro,version XA3 Pro,version XA5 Pro and version XA11 Pro. Model ZF also has four versions according to the different need type and material of slider, version ZF1,version ZF2,version ZF1 Blade and version ZF2 Blade.

Model XA Pro is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions.There is an integrated automatic inactivation system to prevent lancet reuse. When the back cover is pressed down, it drives the rear spring to compress downwards. The back cover support legs are flush with the inclined surface of the protruding line head of the housing. The needle is rotated and slided downwards under the force of the rear spring until it is disengaged from the inclined surface and fired forward for blood sampling, while compressing the front spring. The needle will be retracted automatically back into the housing after the puncture due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.

Model ZF lancet is composed of spring, three-facet needle or blade, housing, and slider. The needle body with needle or blade is concealed within housing/slider. The lancets of different specifications are in different colors. There is an integrated automatic inactivation system to prevent lancet reuse. The spring is fixed at the bottom of the housing, and when the slider is pressed down, which drives the spring to compress downwards.The two locking points(blocked the needle) on the slider will be opened along the slope of the housing, the needle will be released to fire under the force of the spring for blood sampling. After the puncture is completed, the spring retracts to a relaxed state and synchronously pulls the needle body back into the housing. Therefore, the device cannot be re-used.

The provided document is a 510(k) summary for a "Safety Lancet" (K242627). It details the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device (K222090).

Here's a breakdown of the requested information:

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 individual test within the "Performance Test" section. It broadly states that "All non-clinical bench testing performed on the subject device is to demonstrate the substantial equivalence to the predicate devices."

For the "Performance of Clinical Simulated Use Testing for Sharps Injury Protection," it states: "Select the most widely sold in the market of each model as typical product for study." This suggests a limited sample size focused on representative models, but the exact number isn't provided.

The data provenance is not explicitly stated as originating from a specific country or being retrospective/prospective. Given the manufacturer is Ningbo Medsun Medical Co., Ltd. in China, it's highly likely the testing was conducted in China. The "non-clinical bench testing" and "clinical simulated use testing" imply a prospective testing approach dedicated to this submission.

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

The document does not involve expert-established ground truth in the traditional sense for diagnostic AI/software. The testing described is for a physical medical device (safety lancet) and focuses on engineering and performance criteria. The "ground truth" for the performance tests would be objective measurements and observations against pre-defined engineering and safety standards. No human expert consensus for a diagnostic outcome is relevant here.

4. Adjudication method for the test set

Not applicable. This is not a diagnostic study requiring human adjudication for interpretation. The performance tests involve objective physical and chemical measurements.

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 submission for a physical medical device (safety lancet), not an AI-powered diagnostic tool, and therefore an MRMC study is not relevant.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

The ground truth used for these tests are the pre-defined technical specifications, engineering requirements, and safety standards (e.g., ISO 23908:2011, ISO 10993 series, and 21 CFR 801). The "Passed" results indicate that the device met these objective criteria.

8. The sample size for the training set

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

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

Not applicable. There is no training set for a physical safety lancet.

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SafePath Suturing System - Silk Suture: The SafePath Suturing System is intended for use in placement of a silk suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polyamide (Nylon) Suture: The SafePath Suturing System is intended for use in placement of a nylon suture in the skin and subcutaneous tissues.
SafePath Suturing System - Polypropylene Suture: The SafePath Suturing System is intended for use in placement of a polypropylene suture in the skin and subcutaneous tissues.

The silk suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of the organic protein, fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. The silk suture is silicone coated, braided and dyed (black) with logwood extract. The silk suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP size 2-0. The suture is provided as a 36 in. Jength, swaged on a single-armed 1½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

The nylon suture provided with the SafePath Suturing System is a nonabsorbable, sterile, surgical suture composed of long chain aliphatic polymers - nylon 6,6. SafePath nylon sutures are dyed with Logwood extract, FDA approval number §73.1410. The nylon suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a singlearmed ½ circle. 26 mm reverse cutting needle. The suture is pre-loaded in a handheld, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

The polypropylene suture provided with the SafePath Suturing System is a monofilament synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula is (C3H6)n. The Safepath suture is dyed with [Phthalocyaninato(2-)] copper, FDA approval number §74.3045. The polypropylene suture meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture and is available in USP sizes 2-0 and 3-0. The suture is provided as a 36 in. length, swaged to a single-armed ½ circle, 26 mm reverse cutting needle. The suture is pre-loaded in a hand-held, manually operated suturing device. When the suturing device is actuated a single stitch is placed through the tissue and the needle is automatically captured and reset for placement of an additional stitch.

Finished devices may be packaged individually, or in multi-unit cartons or procedure packs. The SafePath Suturing System is designed to place a suture in skin and subcutaneous tissue.

This document discusses the FDA clearance for the SafePath Suturing System, which includes silk, polyamide (nylon), and polypropylene sutures. However, the provided text does not contain information about a study based on AI/ML. All the performance criteria and testing mentioned relate to the physical and biological properties of the sutures and the suturing system, not to an AI component.

Therefore, I cannot answer your request with the specific details about acceptance criteria and studies related to AI/ML performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document highlights the following non-clinical performance criteria and testing for the sutures:

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

2. Sample size used for the test set and the data provenance: Not applicable as this is a non-AI/ML device. The testing was physical and biological, not based on data sets.

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 a non-AI/ML device. Ground truth as typically understood in AI/ML is not relevant here.

4. Adjudication method for the test set: Not applicable as this is a non-AI/ML device.

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 as this is a non-AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a non-AI/ML device.

7. The type of ground truth used: For physical testing, ground truth would be established by the specifications of the USP standards. For biocompatibility, it's about meeting pre-defined safety thresholds as per recognized standards (e.g., ISO 10993).

8. The sample size for the training set: Not applicable as this is a non-AI/ML device.

9. How the ground truth for the training set was established: Not applicable as this is a non-AI/ML device.

The study described is a non-clinical performance testing study that evaluated the physical and biocompatibility characteristics of the sutures and the suturing system. The conclusions state that the device met or exceeded USP criteria for physical properties and met the test criteria for a battery of biocompatibility evaluations. The safety evaluation for the nylon and polypropylene sutures leveraged information from a previously cleared device (K180701) and used identical raw materials, packaging, and sterilization conditions as the predicate devices.

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Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

• · Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
• Pre-vacuum steam at 132℃ (270°F) for 4 minutes; 20 minutes dry time
• · Pre-vacuum steam at 134℃ (273°F) for 3 minutes; 20 minutes dry time
• Pre-vacuum steam at 135℃ (275°F) for 3 minutes; 16 minutes dry time
• Ethylene Oxide (EO) with a concentration of 735 mg/L at 55℃ (131°F) and 50% relative humidity for 60 minutes. Aeration time of 8 hours at 60℃ (140°F).
• The recommended hydrogen peroxide vapor sterilization cycle is :
• · Standard Cycle of STERRAD® 100S
• Standard cycle and Advanced cycle of STERRAD® NX
• · Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX
• · Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX

The steam and EO device are not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen listed below:

• Standard Cycle of STERRAD® 100S
• inside diameter ≥ 1 mm and length ≤ 125 mm
• inside diameter ≥ 2 mm and length ≤ 250 mm
• Standard cycle of STERRAD® NX
• · Single channel stainless steel lumens with:
• Inside diameter ≥ 1 mm and length ≤ 150 mm
• Inside diameter ≥ 2 mm and length ≤ 400 mm
• · Single channel PE/PTFE tubing with:
• Inside diameter ≥ 1 mm and length ≤ 350 mm
• Advanced cycle of STERRAD® NX
• · Single channel stainless steel lumens with:
• Inside diameter ≥ 1 mm and length ≤ 500 mm
• · Single PTFE lumen tubing with:
• Inside diameter ≥ 1 mm and length ≤ 1000 mm
• · Single channel PE/PTFE flexible endoscopes with:
• Inside diameter ≥ 1 mm and length ≤ 850 mm
• Standard cycle of STERRAD® 100NX
• · Single channel stainless steel lumens with:
• Inside diameter ≥ 0.7 mm and length ≤ 500 mm
• Single channel PE/PTFE instruments with:
• Inside diameter ≥ 1 mm and length ≤ 1000 mm
• Flex cycle of STERRAD® 100NX
• Single channel PE/PTFE flexible endoscope with:
• Inside diameter ≥ 1 mm and length ≤ 850 mm
• Lumen Cycle of V-PRO® maX
  △ Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.
  △ Medical devices, including single, dual and triple channeled rigid endoscopes, with the following configurations:
• Single channeled devices with a stainless lumen that is > 0.77mm internal diameter (ID) and < 500mm in length
• Dual channeled devices with stainless steel lumens that are ≥ 0.77mm ID and ≤ 527mm in length
• · Triple channeled devices with stainless steel lumens that are
• ≥1.2 mm ID and ≤ 275 mm in length
• ≥1.8 mm ID and ≤ 310 mm in length
• Or
• ≥2.8 mm ID and ≤ 317 mm in length
• Flexible Cycle of V-PRO® maX
  △ Two flexible endoscopes with a light cord (if not integral to the endoscope) and mat with no additional load. The flexible endoscopes may contain either:
• · A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
• · Or two lumens with:
• One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
• And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length
• △ One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. The flexible endoscopes my contain either:
  ● A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length
• Or two lumens with:
• One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
• And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length

The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam, EO, or hydrogen peroxide sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple or from Pink to Cocoa after exposure to steam, from yellow to brown or from Blue to Brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.

The paper version of the pouch is for Steam and EO. The Tyvek version of the pouch is for hydrogen peroxide sterilization only.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 5 years(for paper pouch) and 2 years(for Tyvek pouch) from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6).

The subject device is intended and has been validated to maintain sterility of the enclosed devices for 12 months after steam sterilization and 24 months after EO sterilization(for paper pouch), and, 2 years after hydrogen peroxide sterilization (for Tyvek Pouch).

The maximum validated pouch load is 2.64 pounds (1.2kg).

The device is made from porous material printed chemical indicator thermally sealed to a plastic film, additionally Self-Seal has medical double side tape.

They are divided according to porous material to paper pouch and Tyvek pouch. Paper Pouch are constructed from uncoated medical paper and plastic film; it can be used with steam and EO sterilization. Tyvek Pouch are constructed from an uncoated Tyvek and plastic film, , it can be used with hydrogen peroxide sterilization.

The device is preformed sterile barrier systems, sealed 2 sides (roll for left and right) or 3 sides(pouch for left, right and top). The remaining edges can be Heat-Sealed or Self-Sealed to form a sealing system. The Self-Seal pouch permits sealing of the pouch without Heat-Sealing equipment, whereas the Heat-Sealable pouches must be Heat-Sealed prior to the cycle.

The pouches and rolls are used to enclose medical devices that are to be sterilized by a healthcare provider following manufacturer's instructions. The medical devices are inserted into Pouches or rolls and sealed.

The devices contain chemical process indicator intended to demonstrate that the device has been exposed to the steam, EO and vapor hydrogen peroxide Sterilization.

The provided text describes the regulatory clearance for "Safe Secure Sterilization Pouches and Rolls" and details non-clinical testing performed to establish its substantial equivalence to a predicate device. It is not an AI/ML medical device, and therefore, the requested information regarding AI/ML-specific acceptance criteria and study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies) is not present in this document.

The document focuses on the physical and chemical performance of sterilization pouches, not on an algorithm's diagnostic or predictive capabilities.

However, I can extract the general acceptance criteria and reported device performance from the "Summary of Non-Clinical Testing" table provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Points 2-9 are not applicable/available based on the provided text, as this document pertains to a physical medical device (sterilization pouches) and its physical and chemical properties, not a software-based AI/ML medical device.

• 2. Sample sized used for the test set and the data provenance: Not applicable. Testing involves physical units of pouches and rolls. The data provenance is laboratory testing rather than patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective measurements and established standards (e.g., integrity, strength, color change), not expert consensus on interpretations of complex data like medical images.
• 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 is not an AI/ML device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on established engineering and materials science standards for sterile barrier systems (e.g., seal strength, dye penetration for integrity, microbial ingress for sterility maintenance, chemical color change for indicator function).
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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The SafeCross Vascular System is a Steerable Balloon Introducer System with Access Dilator used for introducing various cardiovascular catheters into the vasculature including the heart. In addition, the device can be used for monitoring intracardiac pressures, sampling blood, and infusing solutions.

The SafeCross Vascular Introducer System is used to introduce various cardiovascular catheters into the vasculature including the heart. Unlike the predicate device, it does not include an RF Puncture Member and is not intended to cross the atrial septum. The subject device system includes three (3) components: the Steerable Introducer Sheath (SIS), a Long Access Dilator (LAD), and a Short Access Dilator (SAD). In the subject device, the SIS and LAD are identical to their respective corresponding components of the predicate device (K203459). The Vascular SIS features a compliant, specially shaped, atraumatic overhanging Positioning Balloon on its distal end to facilitate the accurate positioning and stability of the SIS while navigating the patient's vasculature. The physician is able to bi-directionally deflect the distal segment in a range of 0° to 180°. The subject device includes a new component, the SAD (12 Fr, 20 cm in length).

The provided text describes a 510(k) submission for the SafeCross Vascular Introducer System, claiming substantial equivalence to a predicate device. However, it does not contain a study that describes acceptance criteria for device performance or provides detailed results from such a study.

The document primarily focuses on:

• Device Description: What the SafeCross Vascular Introducer System is, its components (Steerable Introducer Sheath - SIS, Long Access Dilator - LAD, Short Access Dilator - SAD), and its intended use.
• Comparison to Predicate Device: How the subject device is similar to and different from the SafeCross Transseptal Puncture Device and Introducer (TSP/I) System (K203459). Key differences include the removal of the transseptal puncture indicator, the addition of a Short Access Dilator (SAD), and expansion of the indication to include peripheral vasculature.
• Reference Device: Use of the Oscor Destino™ Reach Steerable Sheath (K151951) as a reference for assessing safety and effectiveness, particularly for the expanded vascular access.
• Performance Testing Mentioned:
  • Leveraging prior testing from the predicate device due to similar geometry and functionality of common components (SIS and LAD).
  • A "new specification for the SIS deflection angle (149.6°)" was retroactively applied to existing predicate device testing, and it was stated that "Testing was not repeated" because the identical SIS component met this new specification. This indicates a specification change based on a risk assessment related to extended navigation pathways, not a new performance study.
  • Biocompatibility testing was performed only on the newly introduced Short Access Dilator (SAD) due to its new material.

Therefore, based on the provided text, a detailed study with specific acceptance criteria and performance results (as would be expected for a typical device performance study) for the entire SafeCross Vascular Introducer System is not present. The information available is limited to:

1. Biocompatibility testing for the SAD: This is the only new performance testing explicitly mentioned.

I will provide the information based on what is available in the document, and explicitly state what is not present.

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

Note: The document explicitly states: "While no new design verification or validation testing was performed on the subject device..." This indicates that performance data beyond what was inherited from the predicate (and new biocompatibility for the SAD) is not presented as new testing.

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

• SIS Deflection Angle: Not explicitly stated. The text only mentions "bench deflection angle testing" and that the predicate device's SIS "met the 149.6° specification" without re-testing the subject device.
• Biocompatibility for SAD: Not explicitly stated. Biocompatibility tests are typically performed on samples of the device material. The data provenance is implied to be from laboratory testing performed according to ISO 10993-1.

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

• Not applicable/Not mentioned. The testing described (SIS deflection and biocompatibility) does not involve expert ground truth establishment in the context of diagnostic performance.

4. Adjudication method for the test set:

• Not applicable/Not mentioned.

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 vascular introducer system, not an AI or diagnostic imaging device.

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

• Not applicable. This device is a vascular introducer system, not an algorithm.

7. The type of ground truth used:

• Not applicable for the reported mechanical and biocompatibility testing. The "ground truth" would be the measured mechanical properties meeting engineering specifications and biocompatibility tests meeting ISO 10993-1 criteria.

8. The sample size for the training set:

• Not applicable. This device is a vascular introducer system, not a machine learning model.

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

• Not applicable.

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Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.

Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years. Product Structure of the Safety Lancet are summarized in the table below: Model XY is composed of a protective cap, slider, front spring, housing, needle body with a tri-bevel edge needle or blade, a rear spring, and a back cover. The needle body is hidden inside the housing/slider, and the housing is color-coded for different versions. Model XH is composed of a protective cap, front spring, housing, needle body, rear spring, and back cover. Model XA is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions. There is an integrated automatic inactivation system to prevent lancet reuse. When the slider is pressed, the slider pushes the two bosses of the needle holder backwards. The bosses move backwards over the short rib on the inner side of the housing, and the rear spring is pressed and activated to launch the needle forwards for blood sampling. The needle retracts automatically back into the housing after the puncture, due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.

The provided text describes a 510(k) submission for a Safety Lancet, demonstrating its substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, detailed study results, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, or MRMC study information that you requested.

The document states that the device meets certain performance criteria through "non-clinical bench testing" and adherence to ISO standards, but it only lists the types of tests performed, not the quantitative acceptance criteria or the specific results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Details: The document only states that these tests were "verified" or "meet requirements." It does not provide specific quantitative acceptance criteria for each test (e.g., what is the acceptable range for penetrating force, or the specific dimensions) nor does it provide the numerical results for the device's performance against these criteria. It simply generally affirms that the design was "verified."

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

• Sample Size for Test Set: Not specified. The document only mentions "non-clinical bench testing."
• Data Provenance: Not specified. It's implied this testing was conducted by the manufacturer, Ningbo Medsun Medical Co., Ltd., in China, as part of their design control process. The data is likely retrospective in the sense that it was collected during product development/verification prior to this submission.

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

• Number of Experts: Not applicable. This is a non-clinical device (Safety Lancet), not an AI/software device that typically requires expert-established ground truth for performance evaluation in a clinical context. The "ground truth" here is adherence to engineering specifications and international standards.
• Qualifications of Experts: N/A for the reasons above.

4. Adjudication method for the test set

• Adjudication method: Not applicable. This is a non-clinical device. The verification is based on objective measurements against defined specifications and standards, not subjective expert judgment.

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

• MRMC Study: No. This is a physical medical device (Safety Lancet), not an AI-powered diagnostic or assistive tool.

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

• Standalone Performance: Not applicable. This device does not involve an algorithm.

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

• Type of Ground Truth: The "ground truth" for this device's performance primarily relies on engineering specifications, direct physical measurements, and adherence to established international standards (e.g., ISO 9626, ISO 7864, ISO 10993 series).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable. No training set is used.

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