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Intended Purpose: The K-Pack Embrace™ Active Safety Needle, being a hypodermic needle with safety shield, is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The safety shield shall be manually locked (activated), after use, to cover the needle to minimize the risk of accidental needle stick.

Indications: The K-Pack Embrace™ Active Safety Needle is for general application – for treatment (injection of fluids) or diagnosis (withdrawal of fluids).

The K-Pack Embrace™ Active Safety Needle is a hypodermic single lumen needle, for single use consisting of stainless steel cannula that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The K-Pack Embrace™ Active Safety Needle is compatible for use with standard luer slip and luer lock syringes. The K-Pack Embrace™ Active Safety Needle is packed in a hard plastic container (cap and case) made of polypropylene and sealed with a label.

This device features a hinged safety shield, made of polycarbonate, attached to the needle hub. The safety feature is activated when the safety shield is manually pressed over the needle immediately after use and prior to disposal to minimize the risk of accidental needle stick injuries. The safety shield is activated with a one-handed operation, using the finger, thumb, or surface activation.

The K-Pack Embrace™ Active Safety Needle is sterilized by ethylene oxide.

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the K-Pack Embrace™ Active Safety Needle does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the way you've requested (e.g., details about AI studies, sample sizes for training/test sets, expert adjudication, MRMC studies, and nuanced ground truth establishment).

The document is a standard 510(k) clearance letter for a medical device (a hypodermic needle with a safety shield) that demonstrates substantial equivalence to a predicate device. The "Non Clinical Test" section focuses on:

• Performance testing: Verification of the device's design against recognized international standards (ISO 7864, ISO 9626, ISO 80369-7, ISO 6009, ISO 23908, ISO 11607-1, USP , and FDA guidance on sharps injury prevention). These standards define various physical and functional requirements for hypodermic needles and their safety features.
• Biocompatibility testing: Evaluation of the materials in contact with the body according to ISO 10993.
• Sterilization and shelf-life testing: Validation of the sterilization method (Ethylene Oxide) according to ISO 11135 and shelf-life studies according to ASTM F1980.

The document does not describe an AI/ML-based device or a study involving human readers, AI assistance, ground truth established by experts, or any of the elements typically associated with the kind of acceptance criteria you've detailed in your prompt (e.g., sensitivity, specificity, AUC for an AI model).

Therefore, I cannot populate the table or answer the specific questions related to AI/ML study design and expert review methodology based on the provided text. The device described is a physical medical device, not a diagnostic AI system.

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The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body.
The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable is used to inject fluids into, or withdraw fluids from, the body.
The Luer Lock Syringe (Low Dead Space) with Safety needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The Luer Lock and Slip Tip syringe (Low Dead Space) without Needle is a sterile, single-use, standard 3-piece piston hypodermic syringe.
The Luer lock and Slip Tip syringe (Low Dead Space) with exchangeable needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.
The Luer Lock Syringe (Low Dead Space) with Safety Needle is a Low Dead Space syringe in combination with a safety needle. The safety needle contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (syringes). It details the device description, indications for use, comparison to a predicate device, and summaries of non-clinical testing.

However, it does not contain information related to an AI/ML powered device, acceptance criteria or a study proving that an AI/ML meets these criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device (AI/ML based) meets the acceptance criteria using this document.

The document discusses performance testing against established ISO standards for medical devices like sterile hypodermic syringes and needles, biocompatibility testing, sterility, and shelf life for physical devices, not AI/ML model performance.

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The LDS Needle is intended for use with a luer-tip syringe for the administration of drugs.

The OcuSafe® LDS Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® LDS Needle is indicated for intravitreal use.

The SteriCap® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock'unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick.

The VitreJect® LDS Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® LDS Safety Needle has an integrated passive needle cap/shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle cap. The locked needle cap minimizes risk of accidental needle stick. The VitreJect® LDS Safety Needle is indicated for intravitreal use.

The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Safety Needle / SteriCap® LDS Safety Needle are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The Low Dead Space (LDS) needle has a decreased internal volume within the luer taper to reduce fluid volume loss. The LDS Needle and OcuSafe® LDS Needle have a removable cap that is removed prior to the needle's use. The SteriCap® LDS Safety Needle and VitreJect® LDS Safety Needle have a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The LDS Needle / OcuSafe® LDS Needle / VitreJect® LDS Needle / SteriCap® LDS Needle are single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect® LDS Safety Needle and OcuSafe® LDS Needle are suitable for intravitreal use.

The provided text describes a 510(k) submission for several needle devices, primarily focusing on the addition of a "low dead space (LDS)" specification. The submission claims substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The primary new acceptance criterion mentioned is for "Low Dead Space (LDS)".

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

• Low Dead Space (LDS) Testing:

  • Sample Size: 58 samples (for 95% confidence and 95% reliability)
  • Data Provenance: Not specified (country/retrospective/prospective)

• Other Testing (Biocompatibility, Performance, Sterilization, etc.): The specific sample sizes for each of these tests are not provided in the summary. The text implies these tests were conducted as part of the overall validation process, often following international standards (ISO, USP, AAMI, ASTM). No information about data provenance (country, retrospective/prospective) is given for these tests. The text states these characteristics "did not change from devices under the respective previously cleared 510(k)s," suggesting that much of this data might be carried over from previous submissions for very similar devices.

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 device is a physical medical needle, not an AI or imaging device that requires expert interpretation for a "ground truth" establishment in the traditional sense of clinical studies. The "ground truth" for the performance characteristics (e.g., dead space volume, material strength, biocompatibility endpoints) is established through standardized laboratory testing and measurement against pre-defined engineering and biological criteria outlined in the referenced ISO, USP, AAMI, and ASTM standards. The summary does not specify the number or qualifications of individuals conducting these laboratory tests.

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

Not applicable. This is not a study requiring expert adjudication of diagnoses or findings. The "test set" here refers to physical samples undergoing laboratory 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 medical device (needle) and does not involve AI assistance or human readers for diagnostic interpretation.

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

Not applicable. This is a medical device (needle) and does not involve an algorithm.

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

The "ground truth" for verifying the device's characteristics is based on:

• Direct Measurement/Quantitative Analysis: For specifications like low dead space volume (≤ 5µL), needle length, gauge.
• Standardized Laboratory Tests: For biocompatibility endpoints (e.g., cytotoxicity, endotoxin levels), material properties, sterilization efficacy, and packaging integrity. These tests compare results against established thresholds defined by international standards (ISO, USP, AAMI, ASTM).
• Engineering Specifications: For physical characteristics and design integrity.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described in this summary.

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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The Luer Lock Syringe with Exchangeable Needle is used to inject medicines and vaccines into, or withdraw fluids from. the body.

The Luer Lock Syringe with Safety Needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The Luer Lock Syringe with Blunt Fill Needle is used for aspiration from multi-dose medicine vials.

The Luer Lock Syringe with Exchangeable Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.

The Luer Lock with Safety Needle is a syringe and needle combination with the safety needle. It contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Safety needle can be pre-attached or aside the syringe.

The Luer Lock Syringe with Blunt Fill Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. It is used for aspiration from multi-dose medicine vials.

The proposed devices are offered in various gauge sizes and length.

The proposed devices are available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.

The device is for medical professionals use only and for prescription use only.

• Luer Lock Syringe with Safety Needle (Syringe range: 1ml, 3ml, 5ml,10ml; Needle range: 20G, 21G, 23G, 25G; Needle length from 5/8" to 1 1/2"). The Safety needle can be pre-attached or aside the syringe.

• Luer Lock Syringe with Exchangeable Needle (Syringe range: 3ml, 5ml, 10ml, Needle range: 20G, 21G, 22G, 23G, 25G; Needle length from 5/8" to 1 1/2").

• Luer Lock Syringe with Blunt Fill Needle (Syringe range: 3ml, 5ml, 10ml, Needle: 18G, Needle length:1 1/2").

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the typical sense of algorithm performance. The device referenced is a "Luer Lock Syringe with Safety Needle: Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle."

Therefore, most of the requested information (sample size, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, training set details) is not applicable as this is a physical medical device clearance, not an AI/algorithm-driven device.

However, I can extract the acceptance criteria (standards the device complies with) and the reported device performance (test results indicating compliance).

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests detailed in the "8. Performance Data" section. These tests were conducted on representative samples of the proposed devices to demonstrate compliance with the listed international and ASTM standards and USP monographs.

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

• Sample Size: Not explicitly stated for each test. The document mentions "representative samples" were used.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As these are bench tests and biocompatibility assessments for a physical device, the concept of "country of origin of data" in the AI sense is less relevant. The studies were non-clinical performance and biocompatibility tests conducted to industry standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This is a clearance for a physical medical device, not an AI/algorithm-driven device requiring expert consensus for ground truth. The "ground truth" here is compliance with established performance standards for syringes and needles.

4. Adjudication Method for the Test Set:

• Not Applicable. As above, this is for a physical device. Test results are typically objective measurements against a standard, not subjective expert adjudication.

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

• No. This type of study is relevant for AI/imaging algorithms, not for physical syringes and needles. The document explicitly states: "No data from human clinical studies have been included to support the substantial equivalence of the proposed device."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Not Applicable. This is a physical device; there is no embedded algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this device is compliance with internationally recognized scientific and engineering standards and biological safety standards as listed (e.g., ISO 7886-1, ISO 10993 series, ASTM, USP). The tests performed (e.g., cytotoxicity, pyrogenicity, seal strength, fluid dynamic performance) provide objective measurements against these predefined standards.

8. Sample Size for the Training Set:

• Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

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

• Not Applicable. (See point 8).

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Sterile Disposable Syringe is intended to be used to withdraw solutions into patient's body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient's body. Sterile Disposable Syringe with safety needle is intended to be used with a luer slip or luer lock syringe to withdraw solutions into patient's body. 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 needlestick.

The Sterile Disposable Syringe consists of barrel, plunger and piston. The proposed device is available in luer slip or luer lock connector types which are intended to be connected with a hypodermic needle. The Sterile Disposable Syringe with Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The proposed device is also available with fixed needle 25-26 gauge and 1/2 – 1 inch length. The Sterile Disposable Syringe with Safety Needle is available in 18-19, 21-26 gauge and 3/8 – 2 inch lengths. The safety cap will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. All subject device are operated manually.

This document is a 510(k) Premarket Notification summary for a Sterile Disposable Syringe, Sterile Disposable Syringe with Needle, and Sterile Disposable Syringe with Safety Needle. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information related to the acceptance criteria and study proving device performance in the context of an AI/ML device. This is a clearance for a traditional medical device (syringes), and the evaluation is primarily based on equivalence to existing devices and adherence to relevant ISO standards and ASTM tests.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device and regulatory submission described in the provided text.

The "studies" mentioned are non-clinical (bench) tests to verify compliance with standards like ISO 7886-1 for syringes, ISO 7864 for needles, and ISO 10993 for biocompatibility. These are standard engineering and materials tests, not AI model evaluations.

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The SteriCap Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The SteriCap Safety Needle has an integrated passive needle shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle shield. The locked needle shield minimizes risk of accidental needle stick.

The VitreJect Safety Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect Safety Needle is indicated for intravitreal use.

The VitreJect Safety Needle has an integrated passive needle shield that covers the needle prior to use and automatically activates to cover the needle immediately after use. A lock mechanism can be manually activated to lock/unlock the needle shield. The locked needle shield minimizes risk of accidental needle stick.

The SteriCap Safety Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen hypodermic needle intended for use with a luer-tip syringe. The SteriCap Safety Needle has a spring-actuated, non-removable sliding cap that moves along the axis of the needle hub during clinical use and automatically re-covers the needle tip after use. The needle cap can be manually locked/unlocked. The SteriCap Safety Needle is intended for manual use by health care professionals for administration of drugs. The SteriCap Safety Needle is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas.

The VitreJect Safety Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen hypodermic needle intended for use with a luer-tip syringe. The VitreJect Safety Needle has a spring-actuated, non-removable sliding cap that moves along the axis of the needle hub during clinical use and automatically re-covers the needle tip after use. The needle cap can be manually locked/unlocked. The VitreJect Safety Needle is intended for manual use by health care professionals for administration of drugs. The VitreJect Safety Needle is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Safety Needle is suitable for ophthalmic use.

This document details the acceptance criteria and supporting studies for the OcuJect SteriCap Safety Needle and VitreJect Safety Needle.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OcuJect SteriCap Safety Needle and VitreJect Safety Needle are based on conformance to recognized international and internal standards, and performance against these standards. The subject devices are described as having "identical" characteristics where they match the predicate devices, and "meet design specification and conforms to standard" or "Passed bench testing for sharps injury prevention feature activation, access in the safe mode, and destructive force, and demonstrate 0% injury rate" for performance features.

• Internal Standards: The document refers to "Internal Standards" for certain performance aspects, particularly for the Sharps Injury Prevention Feature.
• Bench Testing Results: Demonstrating specific quantifiable performance metrics such as "0% injury rate" for the sharps injury prevention feature.
• Post-market data: Mentioned as recording a "0% injury rate" for the predicate devices.

8. Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument, not a machine learning model, and therefore does not involve a training set in the context of AI/ML.

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

This question is not applicable, as there is no training set for a physical medical device.

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Shina Safety Needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of skin. Shina Safety Needle is compatible for use with standard syringes.

Shina Safety Needle has safety shield that covers the needle after using the product to prevent reuse and accidental needle sticks.

Shina Safety Needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of skin. Shina Safety Needle is compatible for use with standard syringes.

Shina Safety Needle has safety shield that covers the needle after using the product to prevent reuse and accidental needle sticks.

This document is a 510(k) clearance letter for the Shina Safety Needle, a hypodermic single lumen needle. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about the acceptance criteria or a study that proves the device meets those criteria, nor does it include details about AI/ML performance, ground truth, or study methodologies that are typically found in a clinical study report or a more detailed section of a 510(k) submission.

The document focuses solely on:

• The FDA's decision regarding substantial equivalence.
• General regulatory requirements for the device.
• Indications for Use for the Shina Safety Needle.

Therefore, I cannot provide the requested information based on the input text. The information requested typically comes from performance testing reports, clinical studies, or AI/ML validation studies, none of which are detailed in this regulatory clearance letter.

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The Medline Sure-Snap Safety Syringe is intended for use in the aspiration and injection of fluids for medical purposes. 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 Medline Sure-Snap Safety Needle is intended for use with a luer-lock syringe for aspiration and injection of fluids for medical purposes. 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 Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe comprises hypodermic single lumen luer-lock safety needles alone (Identified in this submission as Medline Sure-Snap Safety Needles) and a combination of hypodermic single lumen luer-lock safety needles with luer-lock piston syringes (identified in this submission as Medline Sure-Snap Safety Syringes).

The provided text describes a 510(k) premarket notification for the Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical efficacy study. Therefore, much of the requested information regarding clinical study design (sample size, expert ground truth, MRMC studies, training set details) is not applicable or explicitly stated in this document because the regulatory pathway chosen focuses on device characteristics and bench testing.

However, based on the document, here's what can be extracted regarding acceptance criteria and the study performed, focusing on the "Performance Testing (Bench)" and "Usability Testing" sections as these are the closest to performance evaluation.

Acceptance Criteria and Device Performance (Summary based on available information)

The primary "acceptance criteria" from a regulatory perspective for this 510(k) submission is to demonstrate substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. Performance is evaluated through a series of bench tests and a simulated clinical use study as recommended by FDA guidance.

Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence and non-clinical testing, explicit numerical "acceptance criteria" and "reported device performance" are presented as compliance with established standards and successful outcomes of specific tests, rather than clinical efficacy metrics.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Simulated Clinical Use Study for Sharps Injury Prevention): 1,000 safety needles were tested (500 per "safety needle type" – though the document details multiple configurations, it doesn't specify if "safety needle type" refers to Sure-Snap Safety Needle vs. Sure-Snap Safety Syringe types or different gauge sizes).
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission, the studies would typically be conducted prospectively as part of the premarket submission process, and are likely to be conducted under a quality system by the manufacturer (Medline Industries, Inc. in Northfield, Illinois, USA).

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

   • For the simulated clinical use study (usability testing), "Participating healthcare professionals assessed the function of the safety needle with a pass/fail criteria and provided feedback." The specific number of professionals or their detailed qualifications (e.g., years of experience, specific role like nurse, phlebotomist) are not specified in the document.

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

   • The document implies a direct "pass/fail criteria" assessed by the participating healthcare professionals during the simulated clinical use study. It does not mention any formal adjudication method (like 2+1 or 3+1 consensus) for the results, suggesting a direct observation of the device's functional activation.

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

   • No. This is a medical device (syringe and needle) and not an AI/imaging device. Therefore, an MRMC comparative effectiveness study is not applicable and was not conducted.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm. Bench tests evaluate the physical properties and functional aspects of the device itself (e.g., needle sharpness, sheath activation), which could be considered a form of "standalone" performance testing for a physical object.

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

   • For the simulated clinical use study, the "ground truth" for the device's safety feature activation was based on direct observation of its functional activation against pre-defined pass/fail criteria by "participating healthcare professionals." It's a performance truth based on observed mechanical function in a simulated setting, rather than a diagnostic truth like pathology or outcome data.
   • For other performance tests (e.g., biocompatibility, functional performance under ISO standards), the "ground truth" is defined by the requirements and test methods specified in the cited international consensus standards. Compliance with these standards indicates the device performs as expected for its class.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" for an algorithm. All listed tests are for device verification/validation.

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

   • Not applicable. As there is no training set for an AI model.

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The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. 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 sticks.

The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.

The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle gauges and lengths. The safety needle is compatible for use with a luer slip and luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle.

Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism.

The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

Compared with Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle.

The proposed devices are 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 5 years.

The provided document describes the 510(k) premarket notification for "Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle" (K221247) by Jiangsu Kangbao Medical Equipment Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K170651) based on non-clinical testing.

Here's a breakdown of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various international and ASTM standards that the device was tested against. The acceptance criterion for each standard is implicit within the standard itself (e.g., "complies with the requirements of related standards," "no cytotoxicity," "no hemolysis"). The reported performance consistently states that the proposed device met these criteria.

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

The document does not specify the exact sample sizes for each non-clinical test performed on the test set. It mentions "non clinical tests were conducted to verify that the proposed device met all design specifications" and that "Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device." Similarly, for biocompatibility and packaging tests, it states "The proposed device was evaluated for the following tests" and "Sterile barrier packaging testing were performed on the proposed device."

The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Jiangsu Kangbao Medical Equipment Co., Ltd. from China. The studies are non-clinical, meaning they are lab-based and not involving human subjects. They are inherently prospective in nature as they test the new device against established standards.

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

This information is not applicable to this submission. The "ground truth" for non-clinical performance and biocompatibility is established by adherence to recognized international and national standards (e.g., ISO, ASTM, USP). These standards define the test methods and acceptance criteria, and the device's performance is measured against these objective criteria rather than expert consensus on a clinical outcome.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the tests are against objective engineering and biological standards, there is no need for an adjudication method typically used in clinical studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The submission focuses on non-clinical performance, biocompatibility, and substantial equivalence to a predicate device based on these non-clinical tests. Therefore, there is no effect size reported for human readers with or without AI assistance.

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

This question is not applicable as the device is a physical medical instrument (syringe and needle), not an algorithm or AI-powered system. No standalone "algorithm only" performance was evaluated.

7. The type of ground truth used:

The type of "ground truth" used for this submission is based on established international and national standards and their defined acceptance criteria. For example:

• Biocompatibility: Absence of cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, complement activation, and thrombogenicity as defined by the respective ISO and USP standards.
• Physical/Mechanical/Chemical Performance: Compliance with the specifications and performance requirements outlined in ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, and USP .
• Packaging Integrity: Maintenance of sterility barrier as per ASTM F1886/F1886M-16, ASTM F88/F88M-15, and ASTM F1929-15.
• Sterilization: EO/ECH residue within limits (ISO 10993-7), endotoxin limit (USP ), and sterile assurance level (SAL) of 10-6.
• Safety Feature: Meeting pre-established criteria as per FDA Guidance and ISO 23908:2011.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" to establish.

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

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

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The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for use in the aspiration and injection of fluids for medical purpose. 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 needlesticks.

The Sterile Hypodermic Syringes for Single Use with Safety Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size.

The provided text describes the regulatory clearance (510(k)) for the "Sterile Hypodermic Syringes for Single Use with Safety Needles" by Sichuan Prius Biotechnology Co., Ltd. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report for AI-powered medical devices. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable or present in this given text.

However, I can extract the acceptance criteria and performance data for the non-clinical functional and safety aspects of the device, as well as general information about testing methodologies.

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

The following questions are not applicable as the document describes a traditional medical device (syringes with safety needles) and not an AI/ML-powered device:

2. Sample size used for the test set and the data provenance: Not applicable. The testing described is for physical characteristics and biological safety, not a "test set" in the AI/ML context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This refers to expert review for AI/ML model training/validation.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI context. For physical device testing, "ground truth" is established by the specified ISO/ASTM standards and their associated test methods for measuring properties (e.g., strength, sterility, dimensions).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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