Search Results

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

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

• Sample Size: Not explicitly stated for each test, but standard test methods were followed. The number of devices required for each standard (e.g., ISO 7886-1, ISO 80369-3) would dictate the sample sizes.
• Data Provenance: The tests are non-clinical (bench testing, material testing, biocompatibility testing) performed on the manufactured device. The location of testing labs is not specified, but the applicant is based in China. The data is prospective for the purpose of this submission (i.e., new tests performed on the specific device for this submission).

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 non-clinical device submission. "Ground truth" in the diagnostic/AI sense is not relevant. Performance is measured against established international and harmonized standards.

4. Adjudication method for the test set:

• Not Applicable. This refers to clinical assessments or expert review, which is not part of this type of submission. Testing involves laboratory measurements against predefined criteria in standards.

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

• Not Applicable. This is a non-clinical syringe, not an AI-enabled diagnostic device.

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

• Not Applicable. This is a non-clinical syringe, not an AI-enabled diagnostic device.

7. The type of ground truth used:

• Not Applicable. For this type of device, performance is evaluated against objective, measurable criteria defined in international scientific and engineering standards (e.g., ISO, ASTM). There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of a diagnostic product.

8. The sample size for the training set:

• Not Applicable. This is a non-AI device submission; there is no "training set."

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

• Not Applicable. This is a non-AI device submission; there is no "training set" or ground truth for it.

Summary of Study (Based on Submitted Information):

The "study" in this context is a collection of non-clinical performance evaluations and testing conducted to demonstrate that the Anhui Tiankang Medical Technology Co., Ltd. Oral/Enteral Syringe with ENFit connector is substantially equivalent to its predicate device. This involves:

• Biocompatibility Testing: Evaluating the device's materials for cytotoxicity, irritation, and sensitization according to ISO 10993 series. The device reported "No Cytotoxicity; No Irritation; No Sensitization."
• Sterilization Validation: Confirming the Ethylene Oxide (EO) sterilization process meets ISO 11135 standards and an SAL of 10-6, along with EO and ECH residue testing per ISO 10993-7. The device was found to comply.
• Shelf Life Determination: Performing accelerated aging tests according to ASTM F1980-16 to support a 3-year shelf life.
• Package Integrity Testing: Conducting tests like seal strength (ASTM F88/F88M-15), blue dye penetration (ASTM F1929-2015), and visual inspection (ASTM F1886/F1886M-16) to ensure packaging maintains sterility. All packaging was deemed acceptable.
• Product Performance Testing: Evaluating the syringe against specific functional standards:
  • Dose accuracy according to ISO 7886-1:2017.
  • Enteral connector compatibility and performance according to ISO 80369-3:2016.
  • General connector requirements and common test methods from ISO 80369-1:2018 and ISO 80369-20:2015.
  • Material properties referenced by ASTM D638-22 and ASTM D790-17.

The submission concludes that the non-clinical testing demonstrates the device's safety, effectiveness, and performance are comparable to the legally marketed predicate device, thereby establishing substantial equivalence. No clinical studies were included or deemed necessary for this type of device.

Ask a specific question about this device

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.

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

The document does not specify the exact sample sizes (number of units tested) for each non-clinical performance and biocompatibility test. It simply states that the tests were "performed" according to the relevant standards.
Data provenance is not directly addressed in terms of "country of origin for data" or "retrospective/prospective" as these are non-clinical, in-vitro/bench tests, not clinical studies. The testing would have been conducted by the manufacturer or a contracted lab to demonstrate compliance.

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

Not applicable. Ground truth, in the context of device performance, is established by adherence to codified international standards and test methods (e.g., ISO, ASTM). These tests are objective measurements, not subjective evaluations requiring expert consensus from human readers or assessors.

4. Adjudication method for the test set

Not applicable. As described above, these are objective physical and biological tests, not human assessments requiring 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 device is a physical medical device (feeding tube), not an AI/ML diagnostic or assistive device for human readers. No MRMC study was performed or is relevant to this submission.

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

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used

The "ground truth" for this device's acceptance is established by international standards and validated test methodologies. For example, a successful biocompatibility test result (per ISO 10993) is the "ground truth" that the material is biocompatible. Similarly, meeting specified force or leakage requirements (per ISO 80369-3, ISO 20695) constitutes the "ground truth" for mechanical performance.

8. The sample size for the training set

Not applicable. This device is a physical medical device and does not involve AI/ML requiring a training set.

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

Not applicable. As above, no training set is relevant for this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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<788>. 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<788>). 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.

Ask a specific question about this device