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The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

The Oral/Enteral Syringe with ENFit connector is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. The Oral/Enteral Syringe with ENFit connector consists of plunger, gasket/piston, barrel with ENFit connector, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The proposed syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

This document is a 510(k) premarket notification for an Oral/Enteral Syringe with ENFit connector, seeking substantial equivalence to a predicate device. As such, it does not describe a study to prove a device meets acceptance criteria in the way a clinical trial or performance study for a novel diagnostic algorithm might. Instead, it demonstrates substantial equivalence by showing that the device meets relevant performance standards and has similar technological characteristics to a predicate device.

Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test/training set, training set sample size) are not applicable in the context of this 510(k) submission for a non-active medical device like a syringe.

However, I can extract the acceptance criteria where applicable (i.e., performance standards and biocompatibility) and report the device's performance against those standards as described in the document.

Acceptance Criteria and Device Performance (Oral/Enteral Syringe with ENFit connector)

Device Under Review: Oral/Enteral Syringe with ENFit connector (K222772)
Predicate Device: Oral/Enteral Syringe with ENFit connector (K211025)

1. Table of Acceptance Criteria and Reported Device Performance

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This product is intended for use in neonatal and pediatric patients to provide nutrition via nasal or orogastric placement. The Polyurethane Feeding Tube is not intended for use beyond 30 days. The PVC Feeding Tube is not intended for use beyond 24 hours.

The Feeding Tube consists of the following main components: a feeding tube single lumen catheter and an enteral only connector hub with integral tethered connection closure plug. The catheter tubing is made of Polyurethane or PVC. The catheter tubing has an orange or purple radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration. The proposed Feeding Tube is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

This document is a 510(k) premarket notification decision letter from the FDA to Anhui Tiankang Medical Technology Co., Ltd. regarding their "Feeding Tube" device. It primarily focuses on the device's substantial equivalence to a predicate device and outlines the non-clinical performance data provided to support this claim.

Based on the provided text, the device is a medical feeding tube, and the "acceptance criteria" and "proof" relate to demonstrating its safety and effectiveness through non-clinical performance testing and biocompatibility testing, rather than a study involving human subjects or an AI algorithm. Thus, many of the typical elements of AI/ML device acceptance criteria (e.g., sample size for test set, expert adjudication, MRMC studies, standalone algorithm performance, training set details) are not applicable here as this is a traditional medical device submission.

Here's an analysis of the acceptance criteria and the study (non-clinical testing) that proves the device meets them, based only on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to recognized international standards and successful completion of specific physical and biological tests. The "reported device performance" indicates that the subject device met these standards and test requirements.

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The Pre-Filled Normal Saline Flush Syringe is intended to be used only for the flushing vascular access devices.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device called "TK Pre-Filled Normal Saline Flush Syringe."

The letter acknowledges the submission of a premarket notification and states that the device is substantially equivalent to legally marketed predicate devices. It also outlines regulatory requirements but does not include details about performance testing, study designs, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot generate the requested table and information based on the given input.

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The Bifurcated Needle is intended for use in administering vaccines by the scarification method or administering epidermal allergens.

The proposed Bifurcated Needle have two prongs. A small drop of smallpox vaccine was placed between the prongs and approximately fifteen punctures would be made into the skin. The needles were sterilized by EO to achieve a SAL of 10-6 and supplied sterile in packaging with a shelf life of five years.

The provided document is a 510(k) summary for a "Bifurcated Needle" and primarily focuses on proving substantial equivalence to a predicate device based on material properties, manufacturing processes, and adherence to performance standards. It explicitly states that "No clinical study is included in this submission." Therefore, the document does not contain information regarding a study that proves the device meets acceptance criteria related to AI/algorithm performance, human reader improvement, or clinical effectiveness.

The request asks for details typically found in submissions for AI/ML-driven medical devices or diagnostic tools, which involve evaluating algorithm performance, human-in-the-loop studies, and the establishment of "ground truth" for test and training sets. Since this document is for a physical, non-AI medical device (a bifurcated needle for administering vaccines), these types of studies were not conducted or presented.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance in the context of AI/ML or diagnostic accuracy.
• Sample sizes for a test set for AI performance or data provenance.
• Number of experts or their qualifications for establishing ground truth for AI.
• Adjudication methods for AI test sets.
• MRMC comparative effectiveness studies.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data) for AI performance.
• Sample size for training set for AI.
• How ground truth for training set was established for AI.

The "performance data" section in the document refers to biocompatibility, sterilization, shelf life, and general physical performance testing for the needle itself, against standards like ISO 10993, ISO 11135, and ASTM standards. This is for the device's physical properties and safety, not for diagnostic or AI/ML performance.

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The Disposable Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.

The proposed Syringes include Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration (TKSPN01) and the Safety Syringe with permanently attached needle has two kinds of product configurations (TKSSPN01 and TKSSPN02).

The proposed syringes are available in different combination of syringe volumes and/or needle sizes. The syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10f . The proposed device has a shelf life of three years.

The provided text is a 510(k) Premarket Notification for medical devices, specifically Disposable Syringes with permanently attached needles and Safety Syringes with permanently attached needles. This document focuses on demonstrating substantial equivalence to predicate devices, not on proving overall safety and effectiveness through clinical trials or the type of performance studies typically associated with AI/ML-driven devices.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., ground truth
establishment, adjudication methods, MRMC studies, effect sizes of human reader improvement with AI) are not applicable to this submission.

This document describes the safety and performance testing for a physical medical device (syringes) based on established international and national standards and biocompatibility testing. The "acceptance criteria" here are compliance with these recognized standards and demonstrated equivalence to existing predicate devices.

Here's an attempt to extract the relevant information based on the provided document, addressing the requested points where applicable and noting when information is not present or not relevant to this type of submission:

Device: Disposable Syringe with permanently attached needle; Safety Syringe with permanently attached needle

Regulatory Pathway: 510(k) Premarket Notification (demonstrates substantial equivalence to predicate devices)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for traditional medical devices like syringes are generally defined by compliance with recognized consensus standards and successful completion of specific performance and safety tests. The document doesn't present a "performance table" in the typical sense of AI/ML device metrics (e.g., sensitivity, specificity). Instead, it lists the standards the devices adhere to and states that testing was performed and found acceptable.

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: Not explicitly stated for each specific test. For medical devices like syringes, testing often involves a defined number of units per batch or per test series to meet statistical requirements of the standards (e.g., 30 samples for a particular mechanical test). The document confirms that various tests were "performed" according to the relevant standards, which implies the use of appropriate sample sizes as defined by those standards.
• Data Provenance: The tests are non-clinical (laboratory/bench testing, material analysis, sterility validation). The manufacturer is Anhui Tiankang Medical Technology Co., Ltd. in Tianchang City, Anhui, China. The data would originate from their internal testing or qualified third-party labs, but the specific country of origin for each test data set is not detailed beyond the manufacturer's location. The studies are by nature prospective in the sense that they are conducted specifically to support this regulatory submission, but they are not clinical studies.

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

• Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus and adjudication is typically relevant to AI/ML devices where the "truth" for image interpretation or diagnosis needs to be established by human experts. For syringes, the "truth" is determined by objective measurements, chemical analyses, and adherence to physical performance specifications outlined in the referenced ISO/ASTM standards. The "experts" involved would be qualified laboratory technicians, engineers, and quality assurance personnel performing the tests according to the standard operating procedures.

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

• Not Applicable. See point 3. This concept is for AI/ML device performance evaluation methods, not for physical medical 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

• Not Applicable. This device is a manual syringe, not an AI-assisted diagnostic tool. No human reader involvement or AI assistance is mentioned or 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, not an algorithm.

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

• The "ground truth" for this device's performance is established by objective measurements against defined specifications in international and national consensus standards (e.g., ISO, ASTM, USP). This includes:
  • Physical and Mechanical Performance: e.g., plunger force, needle pull-out force, fluid leakage, needle sharpness, volume accuracy based on ISO 7886-1, ISO 7864, ISO 9626.
  • Material Properties and Biocompatibility: Chemical analysis, in vitro and in vivo biological tests (Cytotoxicity, Hemolysis, Skin Sensitization, etc.) as per ISO 10993 series for specific material components.
  • Sterility Assurance: Sterility testing, bacterial endotoxin testing, and ethylene oxide residue testing according to ISO 11135 and USP standards.
  • Shelf-Life Stability: Accelerated aging and real-time stability studies confirming physical properties, sterility, and package integrity over time per ASTM standards.

8. The sample size for the training set

• Not Applicable. This is a traditional medical device, not an AI/ML model that requires training data.

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

• Not Applicable. See point 8.

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The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The Surgical Face Masks are single use, three-layer, flat –folded masks with ear loops/tie coverall and nose clamp. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ties/ear loops are held in place over the users' mouth and nose by two ties/ear loops welded to the facemask. The loops are made of Nylon and spandex and the ties are made of polypropylene nonwoven. The nose clamp in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PP coated steel wire. The Surgical Face Masks will be provided in blue. The Surgical Face Masks are sold non- sterile and are intended to be single use, disposable devices.

The provided document describes the acceptance criteria and the study that proves the device meets those criteria for a Surgical Face Mask (K212368) manufactured by Anhui Tiankang Medical Technology Co., Ltd.

Here's the requested information:

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

• Level 1: pass at 80mmHg
• Level 2: pass at 120mmHg
• Level 3: pass at 160mmHg | Pass |
  | Particulate Filtration Efficiency ASTM F2299 | Demonstrate particulate filtration | 29 out of 32 pass
• Level 1: pass at ≥95%
• Level 2: pass at ≥98%
• Level 3: pass at ≥98% | Pass |
  | Bacterial Filtration Efficiency ASTM F2101 | Demonstrate bacterial filtration | 29 out of 32 pass
• Level 1: pass at ≥95%
• Level 2: pass at ≥98%
• Level 3: pass at ≥98% | Pass |
  | Differential Pressure (Delta P) EN 14683 Annex C | Demonstrate breathability | 29 out of 32 pass
• Level 1: pass at ≤ 5.0 mmH₂0/cm²
• Level 2: pass at ≤ 6.0 mmH₂0/cm²
• Level 3: pass at ≤ 6.0 mmH₂0/cm² | Pass |
  | Flammability 16 CFR 1610 | Demonstrate flame resistance | Class I | Pass |
  | Cytotoxicity ISO 10993-5 | Demonstrate cytotoxic biocompatibility | Under the conditions of the study, the device is non-cytotoxic. | Pass |
  | Skin Irritation ISO 10993-10 | Demonstrate non-irritability | Under the conditions of the study, the device is non-irritating. | Pass |
  | Skin Sensitization ISO 10993-10 | Demonstrate non-sensitization | Under the conditions of the study, the device is non-sensitizing. | Pass |

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

The sample sizes for the functional performance tests (Synthetic Blood Penetration, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure) were 32 samples for each test. For these tests, the acceptance criteria are generally "≥ 29 samples out of 32 pass".

The document does not explicitly state the country of origin for the studies, nor if they were retrospective or prospective. However, given that these are non-clinical performance tests for a device submitted to the FDA by a company in China, it is highly likely that the tests were conducted in a laboratory setting, potentially in China or a certified testing facility elsewhere. They are by nature prospective tests, performed specifically to evaluate the device.

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 as the described studies are non-clinical performance tests of a physical product (surgical face mask), not diagnostic or interpretative studies requiring human expert ground truth.

4. Adjudication method for the test set

This information is not applicable for these types of mechanical and biological compatibility tests. The results are typically objectively measured by instruments or laboratory methods.

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

There was no MRMC study conducted. This document describes the performance testing of a physical medical device (surgical face mask), not an AI-powered diagnostic tool.

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

This information is not applicable as the device is a physical surgical face mask, not an algorithm.

7. The type of ground truth used

The ground truth used for these tests is based on objective measurements and chemical/biological assays as defined by recognized international and national standards (ASTM, EN, ISO, CFR). For example:

• Synthetic Blood Penetration: Measured resistance to fluid penetration at specific pressures.
• Particulate/Bacterial Filtration Efficiency: Measured percentage of particles/bacteria filtered.
• Differential Pressure: Measured breathability in mmH₂0/cm².
• Flammability: Determined by specific flame resistance classifications.
• Biocompatibility (Cytotoxicity, Skin Irritation, Sensitization): Determined by laboratory assays evaluating cellular responses or skin reactions under specified conditions.

8. The sample size for the training set

This information is not applicable as the described device is a physical product and not an AI/machine learning model that requires a training set.

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

This information is not applicable as the described device is a physical product and not an AI/machine learning model.

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The AUTO DISABLE SYRINGE is intended for use in the suction of vaccine for medical purposes. Additionally , after injection to the body, the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.

The AUTO DISABLE SYRINGE is designed for the hypodermic injection of the intended micro scale solution. It has the automatic function in the structure of the syringe which after injection of an intended fixed dose locks the syringe to prevent re-use of the syringe. It can be widely used for injection of vaccine for the immunization.
The syringe consists of a calibrated hollow barrel, a movable plunger, a rubber stopper (piston) assembled at end of the plunger, and a steel clip installed between the barrel and the plunger that functions to prevent re-use of the syringe.
At the end of the barrel, a fixed an unmovable needle is installed, and a needle cap covers the needle. The zero line and nominal capacity line are printed outside of barrel. The main materials are PP, latex free (polyisoprene rubber) and stainless steel.

This document describes the regulatory approval for an "Auto Disable Syringe" (K210464). The acceptance criteria are essentially the compliance with various international standards, and the "study" that proves the device meets these criteria is a series of non-clinical, functional performance, sterility, shelf-life, and biocompatibility tests.

Here's the breakdown of the requested information:

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

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

The document does not explicitly state the specific sample sizes for each test mentioned (e.g., how many syringes were tested for flow rate, or how many were used in biocompatibility studies). It broadly states that the "AUTO DISABLE SYRINGE described in this summary were tested".

Regarding data provenance:

• Country of Origin: The manufacturer is Anhui Tiankang Medical Technology Co., Ltd. from Tianchang, Anhui, China. It is highly probable that the non-clinical testing was performed in China or by labs commissioned by the Chinese manufacturer.
• Retrospective or Prospective: The testing described (functional performance, sterility, shelf-life, biocompatibility) is typically prospective and conducted specifically for regulatory submission to demonstrate compliance with standards and safety/effectiveness of the device.

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

This is a medical device (syringe), not an AI/diagnostic imaging device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image interpretation (e.g., radiologists) does not apply. The "ground truth" for this device's performance is established by objective measurements against recognized international standards through laboratory testing.

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

Not applicable. As noted above, this device's performance is determined by objective physical, chemical, and biological tests against established standards, not by human interpretation that would require adjudication.

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

Not applicable. This is a physical medical device (syringe), not a diagnostic imaging device utilizing AI.

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

Not applicable. This is a physical medical device (syringe), not an algorithm or AI.

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

The "ground truth" for this device is established by objective measurements and pass/fail criteria defined by recognized international standards (e.g., ISO, ASTM, USP). For example:

• Functional performance: Measurements of flow rate, penetration force, bonding strength, tolerance on nominal capacity, etc., against predefined limits in standards like ISO 7864, ISO 7886, ISO 9626.
• Sterility: Demonstrated sterile assurance level (SAL) of 10-6 per ISO 11135.
• Biocompatibility: Absence of cytotoxic, sensitizing, irritating, systemic toxic, pyrogenic, or hemocompatible effects as determined by tests outlined in ISO 10993 series.
• Shelf-life: Maintenance of package integrity and device functionality over a specified period (5 years) as per ASTM F1980.

8. The sample size for the training set

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

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

Not applicable. As there is no training set for a physical medical device.

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The TK Insulin Syringe with Safety Retractable Device is a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

The TK Insulin Syringe is a sterile, single-use, disposable, insulin syringe intended for injection of U-100 insulin into the body.

The TK Insulin Syringe with/without Safety Retractable Device are similar devices except one has a safety feature and the other is a standard insulin syringe.

The TK Insulin Syringe with/without Safety Retractable Device is an integrated needle and piston syringe with an anti-needle-stick mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn and snapped off which renders the needle unusable and prevents accidental needle sticks. The used syringe is then discarded into a sharp's container.

The subject devices are sterile, single-use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.

The provided text describes a 510(k) premarket notification for the "TK Insulin Syringe with/without Safety Retractable Device." The submission aims to demonstrate substantial equivalence to a predicate device, the "U&U Insulin Syringe with/without Safety Retractable Device."

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

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

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance values. Instead, it relies on demonstrating conformance to established international and national standards. The implicit acceptance criteria are defined by these standards, and the reported performance is that the device "conforms" to them.

Here's a summary of the standards the device was tested against, which serve as the implicit acceptance criteria:

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

The document does not specify the sample sizes used for any of the non-clinical tests performed on the subject device (e.g., number of syringes tested for performance standards, number of samples for biocompatibility).

The data provenance for these tests is that they were "performed on the subject device" by the manufacturer, Anhui Tiankang Medical Technology Co.,Ltd. The origin of the data would be associated with the manufacturing and testing facility in Tianchang City, Anhui, China. The studies are by nature prospective, as they involve testing the newly manufactured device against established criteria.

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 to this type of device submission. The "ground truth" for insulin syringes and needles is established by internationally recognized performance and safety standards (e.g., ISO, USP), not by expert consensus on individual test instances in the way one might evaluate an AI diagnostic tool. The compliance with these standards is objectively measurable through predefined test methods.

4. Adjudication method for the test set

This information is not applicable. Since the evaluation is based on conformance to objective standards with predefined test methods, there is no need for expert adjudication of results in the traditional sense of a clinical or image interpretation study. The interpretation of test results against the specified criteria of the standards would be straightforward.

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

This information is not applicable. The device is an insulin syringe, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or performed.

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

This information is not applicable. The device is a physical medical device (an insulin syringe), not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance and safety is derived from established international and national standards for medical devices, specifically:

• Performance Standards: ISO 8537, ISO 7864, ISO 9626, ISO 23908.
• Biocompatibility Standards: ISO 10993 (various parts).
• Other Quality Standards: USP (Particulate Matter), 21 CFR Part 801 (Labeling).

8. The sample size for the training set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by established engineering principles and prior knowledge from similar devices, but not by a data training set.

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

This information is not applicable for the same reasons as #8.

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The TK Intravascular Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

The TK Intravascular Administration Set is a gravity single use device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. The device includes the following components: Protective cap of spike, Spike, Micron filter, Air inlet, Drip chamber, Fluid filter, Tubing, Slide clamp, Pinch clamp, Flow regulator, Roller, Male luer lock, Stopcock (without needleless luer access valve), 4.0mm Connector, Y-site (access by needle), Rotating luer lock, Back check valve, Luer lock cap.

The provided document is a 510(k) summary for the "TK Intravascular Administration Set". This document primarily focuses on establishing substantial equivalence to a predicate device (U&U Intravascular Administration Set, K151151) rather than detailing a specific clinical study with acceptance criteria and reported device performance directly.

The document lists "Non Clinical Performance Testing" and references various ISO standards and FDA guidance documents. These standards likely define the acceptance criteria for physical, chemical, and biological properties of the device. However, the document does not explicitly list a table of acceptance criteria alongside reported device performance for these non-clinical tests. It states that evaluations were performed using industry consensus standards and evaluated per the performance requirements of the device, and that the results for pyrogenicity and sterility were in line with requirements.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this 510(k) summary, as it is a premarket notification for a Class II medical device focused on substantial equivalence to a predicate, not a detailed clinical study report.

However, I can extract the information that is present and indicate where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table with explicit acceptance criteria and corresponding reported performance results for a device study. Instead, it outlines the non-clinical tests performed to demonstrate substantial equivalence to the predicate device, relying on compliance with recognized standards.

Implicit Acceptance Criteria (based on referenced standards) and Partial Reported Performance:

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

• Test Set Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: The tests are non-clinical (laboratory/bench testing) of the device components and entire product in China, performed by the manufacturer, Anhui Tiankang Medical Technology Co., Ltd.

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

• Not applicable as this is a 510(k) summary for a Class II medical device, focusing on non-clinical performance and substantial equivalence. There is no mention of a "test set" requiring expert-established ground truth in a clinical context. The "ground truth" for the non-clinical tests would be the established scientific/engineering principles and performance requirements outlined in the referenced ISO standards.

4. Adjudication Method for the Test Set

• Not applicable. As described above, there is no clinical "test set" requiring adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI systems where human readers interpret patient cases. The "TK Intravascular Administration Set" is a physical medical device (infusion set), and a clinical study with human readers would not be relevant in this context.

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

• No, a standalone (algorithm only) performance study was not done. This device is a physical medical administration set, not an algorithm or AI-powered system that would have a "standalone" or "human-in-the-loop" performance.

7. Type of Ground Truth Used

• The "ground truth" for the non-clinical performance evaluations described (biocompatibility, sterility, pyrogenicity, etc.) is based on recognized international standards (e.g., ISO, ASTM, USP) and FDA guidance documents. These standards define the acceptable limits and methodologies for testing.

8. Sample Size for the Training Set

• Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The product design and manufacturing processes are likely informed by engineering principles, material science, and regulatory requirements, not by training data in the AI sense.

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

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

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TK Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TK Safety Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.

The TK Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use.

The provided text describes a 510(k) submission for the "TK Safety Needle," which is a single lumen hypodermic needle with a safety shield. The submission aims to demonstrate substantial equivalence to a predicate device, the "TM Safety Needle" (K142765).

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

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

The provided document details non-clinical testing performed against recognized ISO standards. These standards implicitly contain the acceptance criteria for various functional and safety aspects of a hypodermic needle. The report states that the device was "demonstrated to be in conformance" with these standards.

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 explicitly state the sample sizes for the functional, sterility, or biocompatibility tests. It only indicates that "the sterile, single lumen hypodermic needles described in this summary were tested." The data provenance is implied to be from Anhui Tiankang Medical Technology Co., Ltd. in China, as they are the submitter and manufacturer. The testing described is prospective, as it was conducted specifically for this submission to demonstrate conformance.

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

This type of device (hypodermic needle) does not typically involve human expert interpretation for "ground truth" in the way an AI diagnostic device would. The "ground truth" for the tests performed is based on the objective measurements and pass/fail criteria defined by the cited ISO standards and USP. Therefore, no experts in the sense of medical diagnosticians were used to establish ground truth.

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

Not applicable. As noted above, the assessment of these types of medical devices against performance standards involves objective measurements and predefined pass/fail criteria, not subjective interpretation requiring an adjudication method.

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

No. The TK Safety Needle is a physical medical device, not an AI-powered diagnostic tool, and therefore an MRMC comparative effectiveness study is not relevant or applicable.

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

Not applicable. As a physical medical device, this question is not relevant.

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

The "ground truth" in this context refers to the defined specifications and limits set by the referenced international standards (e.g., ISO 7864, ISO 80369-7, ISO 10993, USP). For example, the fragmentation test would have a specific maximum allowable fragmentation, and the flow rate test would have a specified range of acceptable flow rates. The device's performance is measured against these objective, predefined criteria.

8. The sample size for the training set

Not applicable. This device is a physical product and does not utilize a "training set" in the context of machine learning or AI.

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

Not applicable for the same reason as above.

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