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The AIK Sterile Acupuncture Needles for Single Use is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. Acupuncture needle is made up of needle handle and needle body. The body of needle uses 304 stainless steel wire (06Cr19Ni10). The handle is a body coil with stainless steel wire, the spiral loop of which is arranged symmetrically without gaps. The device can only be used by qualified practitioners of acupunctures. Qualified practitioners should already be knowledgeable on how to use the acupuncture needle and when not to use acupuncture in certain patient populations and medical conditions. Handle of acupuncture needle is a plain handle. Types of acupuncture needle (sterile acupuncture needle for single use) are: acupuncture needle without a guide tube and acupuncture needle with a guide tube.

Here's a breakdown of the acceptance criteria and study information for the AIK Sterile Acupuncture Needles for Single Use, based on the provided document:

This document describes a 510(k) premarket notification for a medical device called "AIK Sterile Acupuncture Needles for Single Use." This is not a study assessing the performance of an AI algorithm, but rather a submission for a traditional medical device (acupuncture needles) demonstrating substantial equivalence to a legally marketed predicate device. Therefore, many of the requested categories related to AI performance, ground truth establishment, and expert involvement are not applicable or directly addressed in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance data in a quantitative manner for most tests. Instead, it states that the device "meet[s] the requirements of its pre-defined acceptance criteria." For functional performance tests, it lists the test and a qualitative outcome indicating compliance.

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

The document does not explicitly state the specific "sample size" for each test. Non-clinical testing was conducted to evaluate performance. The provenance of the data is from CHANGCHUN AIK MEDICAL DEVICES CO., LTD in Jilin Province, China, as part of their submission to the FDA. The tests are non-clinical, likely laboratory-based, and therefore not strictly "retrospective" or "prospective" in the sense of patient data.

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

This is not applicable. The device is an acupuncture needle, and the "ground truth" for its performance is established by objective engineering and biocompatibility standards (e.g., ISO 17218, ISO 10993-1, ISO 11135, ISO 11607), not by expert human interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable, as "adjudication" typically refers to resolving discrepancies between human readers or between human readers and an AI system. The tests performed are objective, laboratory-based evaluations against pre-defined engineering standards.

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

No, an MRMC comparative effectiveness study was not done. This study is a 510(k) premarket notification for a Class II medical device (acupuncture needles), not an AI algorithm.

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

No, this is not applicable. The device is an acupuncture needle, not an algorithm. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used

The "ground truth" for the device's acceptable performance is defined by compliance with established international standards for medical devices, specifically:

• ISO 17218: Acupuncture needles for single use
• ISO 10993-1: Biological evaluation of medical devices (biocompatibility)
• ISO 11607: Packaging for terminally sterilized medical devices
• ISO 11135: Sterilization of health care products - Ethylene oxide
• ISO 10993-7: Ethylene oxide sterilization residuals

8. The Sample Size for the Training Set

This is not applicable, as this is not an AI/machine learning study and thus there is no "training set."

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

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

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Our acupuncture needles are devices used by licensed practitioners and are intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The acupuncture needles are sterile, thin needles which are inserted into specific points on the skin called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. Acupuncture is the stimulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles. The skin is sterilized, such as with alcohol, and the needles are inserted, frequently with a plastic guide tube for the user. Needles may be manipulated in various ways including spinning, flicking, or moving up and down relative to the skin. The Acuzone Acupuncture Needles and KSC DB Plus Acupuncture Needles are made of surgical stainless steel, a handle consisting of a flexible coiled copper handle with nickel plated for protection, or a surgical stainless steel or aluminum tube handle and may be provided with a plastic guide tube. (10pcs/pack, 1000pcs/box). Acuzone press tack needles (with micropore tape) are made with surgical stainless steel (10pcs/ pack, 100pcs/box). AcuZone Intradermal Needles are made with surgical stainless steel (5pcs/pack, 100pcs/box). Press tack and intradermal needles have same purpose for ear acupuncture point. The Acupuncture needles are available in nine diameters (0.12 ~ 0.35mm), five needle lengths (15 ~ 60mm), and tube lengths (30mm, 45mm, 55mm, 65mm and 75mm). Acuzone press tack needle is available in one diameter (0.20mm x 2mm x length (1mm). AcuZone Intradermal Needles is available in one diameter (0.12mm), one length (5mm).

This document is a 510(k) Summary for AcuZone Acupuncture Needles, KSC DB Plus Acupuncture Needles, AcuZone Press Tack Needles, and AcuZone Intradermal Needles. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for the performance tests. Instead, it refers to the outcomes of tests as meeting "requirements of those standards" or being "substantially equivalent" to predicate devices. The performance data presented focuses on comparisons with predicate devices and compliance with relevant ISO standards.

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

The document does not provide specific sample sizes for the performance tests (visual inspections, pull-out force, elasticity, biocompatibility, sterilization, dimensional conformance). It generally refers to "the Acupuncture Needle" or "all devices" when discussing testing.

Data Provenance: The data appears to be prospective as it describes testing conducted specifically for this 510(k) submission. The country of origin of the data is not explicitly stated, but the testing was conducted to support a submission by a U.S. corporation (K. S. Choi Corporation in Los Angeles, California) to the U.S. FDA.

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

This information is not provided in the document. The testing described (mechanical, visual, biocompatibility, sterilization) would typically be performed by laboratory technicians or engineers following established protocols, not by medical experts establishing "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set

This information is not applicable to the type of testing described (physical and chemical properties, sterilization) for acupuncture needles. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation where human expert consensus is required for complex decisions.

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

An MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of an acupuncture needle, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

This is not applicable. The device is an acupuncture needle, a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through physical and chemical characterization, and compliance with recognized standards. This includes:

• Microscopic examination for surface quality.
• Mechanical testing (pull-out force, elasticity) against quantifiable parameters.
• Biocompatibility testing against ISO 10993 series standards.
• Sterilization validation against established protocols (e.g., for EO sterilization and residuals).
• Dimensional conformance to specifications.
• Comparison to the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

This is not applicable. The device is an acupuncture needle, not a machine-learning algorithm; therefore, there is no "training set" in the context of AI.

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

This is not applicable as there is no training set mentioned or implied for an acupuncture needle.

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The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the deliyery of acupuncture treatment.

The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the deliyery of acupuncture treatment.

This document is a 510(k) clearance letter from the FDA for several brands of acupuncture needles. It does not contain information about the acceptance criteria or a study proving that an AI device meets such criteria. Therefore, I cannot provide the requested information based on the given text.

The document discusses:

• Device Name: Eacu, Zagu, Jocu, Eaku, Balance, Tempo, Acuzone, Smart, Prime, Acuking, Myotech Dry, Red Coral Premium, Red Coral J-type, Red Coral Natural Acupuncture Needles
• Regulation Number: 21 CFR 880.5580
• Regulation Name: Acupuncture Needle
• Regulatory Class: II
• Product Code: MQX
• Indications for Use: The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the delivery of acupuncture treatment.

There is no mention of any AI device, performance criteria, study data, sample sizes, expert ground truth, or comparative effectiveness studies.

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This KM Needles (Acupuncture Needle) is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the state regulations.

The KM Needles (Acupuncture Needle) are simple stainless steel pins that are used by an acupuncture practioner in the treatment of various conditions. Acupuncture is the timulation of specific acupuncture points along the skin of the body involving various methods such as penetration by thin needles or the application of heat, pressure, or laser light. Clinical practice varies depending on the country. Traditional acupuncture involves needle insertion, moxibustion, and cupping therapy. It is a form of alternative medicine and a key component of traditional Chinese medicine (TCM).

The KM Needles (Acupuncture Needle) are constructed of stainless steel, with pin body diameters ranging from 0.16 to 0.70 mm and vary in length from 15 to 135 mm. Each acupuncture needle has a handle for the practioner to manipulate the needle. The handle is also made from stainless steel and range in length from 20-30 mm.

The manufacturer, K.M.S. Inc., states that the KM Needles (Acupuncture Needle) are substantially equivalent to the Dong Bang Acupuncture Needles (K972659). The performance data section describes bench testing for tensile strength and sterility testing.

Here's the breakdown of the information requested:

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

2. Sample sized 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 used for each of the bench tests (tensile strength, biocompatibility, sterilization, packaging, accelerated aging). It only mentions that "Bench testing was performed" and "Sterility testing was performed."

The data provenance is not specified beyond being generated by K.M.S. Inc. for the K.M.S Inc. device. There is no information regarding country of origin of data, or if it was retrospective or prospective.

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 information is not applicable. The device is an acupuncture needle, and the testing involves physical and biological properties rather than diagnostic accuracy requiring expert interpretation of results. The "ground truth" for these tests would be established by validated scientific methods and international standards (e.g., ISO, AAMI, ASTM), rather than expert consensus on diagnostic imaging.

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

This information is not applicable as the study involves bench testing of physical and biological properties, not a clinical study requiring adjudication of expert interpretations.

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 a medical instrument (acupuncture needle), not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be conducted.

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 not an algorithm or AI system.

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

The "ground truth" for the performance claims of the KM Needles is based on established international standards and validated scientific testing methodologies. For example:

• Tensile Strength: Objective measurement against specified physical limits.
• Biocompatibility: Evaluation against the requirements of ISO 10993 series standards, which define acceptable biological responses.
• Sterilization: Demonstration of a sterility assurance level (SAL) of $10^{-6}$ using validated methods like ISO 1137-2 concerning radiation sterilization.
• Packaging: Compliance with AAMI ANSI ISO 11607 series standards for maintaining sterility.
• Accelerated Aging: Compliance with ASTM F1980-07 for determining package integrity over time.

8. The sample size for the training set:

This information is not applicable. This is not a study involving machine learning or AI where a "training set" would be used. The testing described is verification and validation of a physical medical device.

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

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

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SMC ACUPUNCTURE NEEDLE is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Acupuncture Needles are sterile, hair thin needles which are inserted into specific points on the skin, called "acupuncture points". The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation and/or ethylene oxide.

The Acupuncture Needles are available in nine needle diameters (0.16 to 0.70 mm), ten needle lengths (15-135 mm), and ten tube lengths (30-160 mm).

This document is a 510(k) Premarket Notification for the SMC Acupuncture Needle, comparing it to a predicate device, the WOOJEON ACUPUNCTURE NEEDLE (K111392). The information provided focuses on demonstrating substantial equivalence rather than a detailed study proving the device meets strict acceptance criteria in the way a clinical trial for a novel, complex diagnostic or therapeutic AI device would.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or not provided in this type of regulatory submission, as it's for a relatively simple medical device (acupuncture needle) and relies on demonstrating equivalence to an already marketed device.

However, I can extract the relevant information regarding performance and "acceptance criteria" as implied by the comparison to the predicate device and the non-clinical testing.

Here's the breakdown of the available information:

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

The acceptance criteria are implicitly defined by the characteristics of the predicate device and relevant international standards (like ISO 10993 for biocompatibility) as well as general performance expectations for acupuncture needles. The comparison table below highlights how the new device's attributes align with or expand upon the predicate.

Study Details:

The primary "study" described is a non-clinical performance and comparison study to demonstrate substantial equivalence to a predicate device, not a human clinical trial against specific acceptance criteria for diagnostic accuracy or treatment efficacy.

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

• Sample Size for Test Set: Not specified in terms of a "test set" for performance metrics like sensitivity/specificity. The testing involved dimensional conformance, visual inspections, design verification, and biocompatibility on representative samples of the device. The exact number of units or samples for each test is not provided.
• Data Provenance: Not applicable in the context of clinical data provenance (country, retrospective/prospective) for this type of device and submission. The non-clinical tests were likely conducted by the manufacturer, SMC, or their designated testing laboratories.

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

• This is not applicable. The "ground truth" for this device relates to its physical and biological safety characteristics, which are assessed through engineering tests and biocompatibility standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

• This is not applicable. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation or subjective assessments, which are not relevant for the non-clinical testing of an acupuncture needle.

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

• This is not applicable. An acupuncture needle is a physical tool, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

• This is not applicable. This device is not an algorithm.

7. The type of ground truth used

• The "ground truth" for this submission is based on:
  • Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed WOOJEON ACUPUNCTURE NEEDLE (K111392).
  • International Standards: Compliance with relevant standards like ISO 10993 series for biocompatibility.
  • Engineering Specifications: Conformance to pre-defined dimensional, material, and manufacturing specifications for acupuncture needles.

8. The sample size for the training set

• This is not applicable. There is no "training set" in the context of an AI/machine learning device. For manufacturing, routine quality control involves statistical process control, but this is not what is typically meant by a "training set" in medical device studies that involve algorithms.

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

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

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The TeWa Acupuncture Needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Not Found

This document is a 510(k) clearance letter for TeWa Acupuncture Needles and does not contain the requested information regarding acceptance criteria and performance study details. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the specific details you've asked for, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for test sets.
• Information on MRMC studies or standalone algorithm performance.
• The type of ground truth used or details about training sets.

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WOOJEON ACUPUNCTURE NEEDLES is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states

The our needles are sterile which are inserted into specific points on the skin, called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation.

The Acupuncture Needles are available in 78 models as per diameters (0.16 to 0.40 mm) and 78 needle tube models as per lengths (8-60mm)

The "WOOJEON ACUPUNCTURE NEEDLE" 510(k) submission [K111392] provides information about the device's technical characteristics and claims of substantial equivalence but does not describe a study that establishes acceptance criteria or proves the device meets specific performance thresholds in a clinical or standalone evaluation.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (ASIA-MED Single use, Acupuncture Needle, K052085) based on technical characteristics and intended use.

Here's an analysis of the information provided, addressing your specific points where applicable, and highlighting what is not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not define specific numerical acceptance criteria (e.g., "pull-out force greater than X Newtons") but rather compares the device's performance to that of the predicate device or general observations.

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

The document does not report a specific "test set" in the context of a clinical performance study. The listed evaluations (microscopic, pull-out, elasticity) are likely laboratory-based tests on samples of the manufactured needles. The sample size for these manufacturing tests is not specified.

Data provenance (country of origin, retrospective/prospective) is not applicable as there is no clinical study described. The manufacturer is based in South Korea, so the device manufacturing and testing would presumably be conducted there.

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

Not Applicable. The described evaluations are technical/mechanical tests (microscopic, pull-out, elasticity) performed on the device itself, not clinical assessments requiring expert ground truth for interpretation of patient data.

4. Adjudication Method for the Test Set

Not Applicable. There is no clinical test set or subjective assessment requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. The submission does not describe any study involving human readers or assessing improvement with AI assistance (as it is a physical medical device, not an AI-enabled diagnostic tool).

6. If a Standalone Study Was Done

The "studies" mentioned are laboratory tests of the device's physical properties:

• Microscopic examination of surfaces (smoothness and defects)
• Quantification of pull-out force
• Evaluation of elasticity properties

These are standalone technical evaluations of the device's characteristics against its predicate, but they are not a clinical standalone performance study in the typical sense (e.g., evaluating diagnostic accuracy or clinical outcomes). The document states these tests were performed to establish substantial equivalence.

7. The Type of Ground Truth Used

For the technical characteristics evaluated:

• Microscopic Examination: Ground truth is visually determined by inspection against a standard of "smooth and free of visible defects."
• Pull-out Force: Ground truth is the quantitative measurement of force, compared against the "average values reported for the predicate devices."
• Elasticity Properties: Ground truth is the measured elastic behavior, compared for "substantial equivalence" to the predicate.

These are engineering/material property ground truths derived from direct measurement and comparison, not clinical outcomes, pathology, or expert consensus on patient data.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device. There is no AI model or "training set" in the context of machine learning. The manufacturing process of acupuncture needles is the "training" for consistent quality, not data training.

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

Not Applicable. As there is no training set as understood in AI/machine learning, this question does not apply.

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Biomate Sterile Acupuncture Needle, Model: Nano, Nano-PI, Nano-EI is intended to be used to pierce the skin in the practice of acupuncture (by qualified practitioner of acupuncture) as determined by the States.

Not Found

This is a 510(k) premarket notification letter for a medical device (acupuncture needles) and does not contain the information requested regarding acceptance criteria and a study proving device performance. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information based on the given text.

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The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Acupuncture Needles are sterile, hair thin needles which are inserted into specific points on the skin, called "acupuncture points." The Acupuncture Needles are manufactured from stainless steel and sterilized with gamma irradiation. The Acupuncture Needles are available in eleven diameters (0.14 to 0.50 mm), nine needle lengths (15-60mm), two stick lengths (20 and 30 mm), and nine tube lengths (30-145 mm).

Acupuncture Needles (K092240) - Acceptance Criteria and Performance Study

The K092240 submission concerns Acupuncture Needles manufactured by HaengLim SeoWon Medical Co. The primary study presented aims to demonstrate substantial equivalence to predicate devices rather than establishing novel safety and efficacy criteria through a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size in terms of a "test set" in the traditional sense of a clinical or in vivo study. The evaluation appears to be a bench-top comparison between the subject device and two predicate devices.

• Test Set: The "test set" consisted of the Acupuncture Needle (subject device) and two predicate devices (Dong Bang Acupuncture Needle, K972659 and C & G Acupuncture Needle, K043277).
• Data Provenance: The study was a retrospective bench-top comparison performed on the devices themselves. No details on the origin of the specific samples (e.g., country of origin for the tested devices) are provided, beyond the manufacturing location of the subject device (Korea) and the listed applicants of the predicate devices.

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

The study does not involve human observers or interpretation of medical images, thus the concept of "experts" establishing ground truth for a test set is not applicable in the traditional sense. The "ground truth" for the mechanical and microscopic properties was based on direct measurement and observation by the individuals conducting the testing. Their qualifications are not specified, but it's presumed they were technicians or engineers competent in microscopy and mechanical testing.

4. Adjudication Method for the Test Set

No adjudication method was used, as the study involved direct physical and mechanical testing rather than human interpretation requiring consensus.

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

No MRMC comparative effectiveness study was conducted. This device is an acupuncture needle, and the study focuses on its physical and mechanical properties compared to legally marketed predicate devices, not on the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical medical instrument (acupuncture needle), not an algorithm or AI-powered system.

7. Type of Ground Truth Used

The ground truth used was based on direct physical and mechanical measurements and microscopic observations. This includes:

• Visual assessment under magnification for surface defects.
• Quantitative measurement of pull-out force.
• Qualitative assessment of elasticity (return to original shape after loading).

8. Sample Size for the Training Set

Not applicable. There was no "training set" as this was a physical device comparison study, not a machine learning or AI context.

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

Not applicable. As there was no training set, there was no ground truth for a training set to be established.

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Jiajian Acupuncture Needle is intended to piece the skin in the practice of acupuncture therapy by qualified practitioners or acupuncture doctors as determined by the states.

Jiajian brand Acupuncture Needle consists of a stainless steel wire (ASTM 304) as the needle body, with a stainless steel wire handle, a copper wire handle or polystyrol handle. The handles make the needles easier to manipulate and place. The acupuncture needle is sterilized and disposable. The diameter of the needle is 0.140.80mm; the length of the needle is 7100mm; the invasive length is 2~47mm.

The provided text is a 510(k) Premarket Notification Summary for the Jiajian Acupuncture Needle. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies with acceptance criteria and statistical analysis typical of software or AI/ML medical devices. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed performance metrics. The primary "performance" demonstrated is the substantial equivalence to predicate devices. This means the device is considered as safe and effective as the predicate devices.

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

No test set for performance evaluation in the typical sense (e.g., a dataset of images for an AI model) is described. The device is a physical acupuncture needle.

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

Not applicable, as no such test set or ground truth determination process is described for this physical medical device.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. The "ground truth" for this submission is establishing that the device's design, materials, and intended use are similar enough to existing legally marketed devices.

8. The sample size for the training set

Not applicable, as this is a physical device and not an AI/ML model requiring a training set.

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

Not applicable.

Summary of Device and Substantial Equivalence Information (from the provided text):

The Jiajian Acupuncture Needle is a single-use acupuncture needle made of stainless steel wire with various handle options. It is sterilized by Co-60 irradiation and intended for use by qualified practitioners for acupuncture therapy.

The manufacturer claims substantial equivalence to two predicate devices:

• DN Acupuncture Needles (K983800)
• Singer Acupuncture Needles (K974616)

Similarities claimed between the Jiajian Acupuncture Needle and predicate devices:

1. Similar materials composition and structure.
2. Same intended use.
3. All are sterile.
4. All are used as prescription.

Differences:

1. Different sizes scale (This difference was not deemed significant enough to preclude substantial equivalence).

The FDA concurred with the substantial equivalence determination.

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