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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 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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To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision Acupuncture Needles, Alpha Acupuncture Needles, Fine Point Acupuncture Needles, Chi Acupuncture Needles and Zen Acupuncture Needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture Needles meet the general specifications and criteria for an single use acupuncture Needles and is effective for the practice of acupuncture.

This 510(k) premarket notification for acupuncture needles (K061517) is a submission for a Class II medical device, and as such, it relies on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance as would be expected for novel, high-risk devices. The notification focuses on showing that the new acupuncture needles are as safe and effective as already legally marketed acupuncture needles.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the traditional sense for this 510(k). The "acceptance criteria" here are met by demonstrating the substantial equivalence of the new devices to existing, legally marketed predicate devices. The performance is therefore implicitly accepted as being equivalent to these predicates.

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

Not applicable. There is no specific "test set" of patient data or clinical samples mentioned for evaluating the performance of the new acupuncture needles against predefined metrics. The assessment is based on a comparison of device characteristics to predicate devices and a general safety review of existing acupuncture needles.

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

Not applicable. Ground truth, in the sense of expert-validated diagnostic classifications or outcomes, is not established for this type of submission. The safety assessment relies on publicly available incident reports for similar devices.

4. Adjudication Method for the Test Set

Not applicable. No test set of data is described.

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 an acupuncture needle, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This device is an acupuncture needle and does not involve an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this submission is the established safety and effectiveness of legally marketed predicate acupuncture needles. This is primarily based on:

• Prior FDA 510(k) clearances: The document states, "FDA had issued 510(K)s to 47 different single use acupuncture Needless brand and them have I DA had issued 9 ro(11)3 wire in the United States since 1996." This indicates a history of regulatory acceptance for similar devices.
• Absence of reported safety issues with predicate devices: The search of consumer safety websites for adverse events ("no serious or life-threatening accidents involving acupuncture Needless") serves as a form of "negative ground truth" supporting the safety profile of the device category.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI component requiring a training set.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of the Study (Demonstration of Substantial Equivalence):

The study presented in this 510(k) is not a traditional performance study with empirical data generated from the new devices. Instead, it is a demonstration of substantial equivalence. The manufacturer, Prime Herbs Co., is asserting that their various acupuncture needles (Precision Press Tack / Intraderm Needle, Precision Seven Star Needle, Präzision Acupuncture Needle, Alpha Acupuncture Needle, Fine Point Acupuncture Needle, Chi Acupuncture Needle, and Zen Acupuncture Needle) are as safe and effective as predicate devices already on the market.

The "study" or justification for this claim involves:

• Identification of Predicate Devices: While not explicitly named in the provided text, the submission implicitly references all existing 510(k)-cleared acupuncture needles as predicates.
• Comparison of Intended Use: The intended use of piercing the skin for acupuncture by qualified practitioners is identical to that of predicate devices.
• Comparison of Technological Characteristics: The submission asserts that the new needles' "design, material used, sterility and biocompatibility... meet the general specifications and criteria for a single use acupuncture Needles" and are "effective for the practice of acupuncture." This implies a comparison to the known characteristics of predicate devices.
• Safety Review of Device Category: The search of government consumer safety websites for adverse events associated with any acupuncture needles serves to support the general safety profile of this device type, thereby reinforcing the argument for the substantial equivalence of the new devices.

In essence, the "study" is a regulatory argument, not a scientific experiment with the new devices themselves. The FDA's letter confirms that they have reviewed this argument and determined the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market.

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To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Lyra Acupuncture Needles." It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory requirements the manufacturer must adhere to (e.g., registration, labeling, good manufacturing practice).
• Stating the intended "Indications For Use" for the device, which is "To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided 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 Device is defined as prescription device intended to to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. The Device consists of a solid stainless steel needle with handle attached to facilitate the delivery of acupunture treatment. The material for the Device is stainless steel wire 0Cr19Ni9, which complies with the Chinese National Standard GB2024-94 for acupuncture needles. The handles of the Device are in flat, ring, flower or tube shape and are made of different materials including copper, stainless steel, aluminum, and plastic. The length of the Device conforms to GB2024-94, which meets the needs for depth of insertion and manipulation. The diameters of the needle come in 0.16mm, 0.18mm, 0.25mm, 0.30mm, 0.35mm, 0.40mm, and 0.45mm, depending on the needs. The point of the needle is round, straight, and smooth and complies with GB2024-94. Each acupuncture needle is individually packaged, with or without a guide (insertion) tube. The Device is sterilized with Ethylene Oxide, whose residue on the surface of needle body meets clinical health requirements. The Device package is confirmed to remain stainless and aseptic in two years of shelf life at room temperature, normal pressure, and ≤80%RH. The Device is sterile, disposable, and for single use only. The material, sterility, and biocompatibility of the Device meet the general specifications and the criteria for single use acupuncture needle. In addition, the Device is designed such that it is compatible with the current acupuncture needles produced by other major acupuncture needle manufacturers.

The provided text is a 510(k) summary for acupuncture needles. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, it does not include information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way a clinical trial or performance study would for an AI/ML device.

Acupuncture needles, as described here, are physical medical devices, and their evaluation for market clearance (via 510(k)) focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through material composition, manufacturing processes, sterility, and biocompatibility, rather than performance metrics derived from complex data analysis.

Therefore, many of the requested categories (like effect size of human readers with AI, standalone algorithm performance, training set details, etc.) are not applicable to this type of device and submission.

Here's the information that can be extracted or derived from the provided document, framed as close as possible to your request for acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Details (Based on 510(k) Substantial Equivalence Determination)

For this type of device (acupuncture needle), the "study" is primarily a comparison to predicate devices and adherence to recognized standards, rather than a prospective clinical trial with human subjects testing performance criteria directly.

1. Sample Size used for the test set and the data provenance: Not directly applicable in the conventional sense of a "test set" for algorithm performance. The evaluation is based on comparing the device's design, materials, manufacturing processes, and sterilization to those of legally marketed predicate devices and relevant industry standards (e.g., Chinese National Standard GB2024-94). The "data" provenance would be the technical specifications, material certifications, and manufacturing process documentation provided by the manufacturer.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this is established by adherence to engineering specifications, material standards, biocompatibility testing (often outsourced to labs), and sterilization validation rather than expert consensus on interpretive data. The FDA reviewers are the "experts" who evaluate the submission against regulatory requirements and established-predicate device characteristics.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant to interpreting ambiguous clinical data, not the characterization of a physical product.

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: Not applicable. This relates to AI/ML devices influencing human interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

6. The type of ground truth used:

   • Engineering specifications and standards: GB2024-94 for material, dimensions, and needle point.
   • Material certifications: For 0Cr19Ni9 stainless steel.
   • Sterilization validation data: To demonstrate efficacy of Ethylene Oxide sterilization and confirm residue levels.
   • Biocompatibility testing reports: To ensure the materials are safe for patient contact.
   • Shelf-life stability data: To support the 2-year claim.
   • Comparison to predicate devices: The "ground truth" for substantial equivalence is the known safety and effectiveness of the existing predicate devices.

7. The sample size for the training set: Not applicable. This device does not use machine learning with a training set.

8. How the ground truth for the training set was established: Not applicable.

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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 a handle attached to the needle for ease of acupuncture treatment.

The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle for ease of acupuncture treatment.

This document is a 510(k) clearance letter from the FDA for an acupuncture needle. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device.

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

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Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Not Found

The provided text is a 510(k) premarket notification approval letter for acupuncture needles. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, or training set details) from the provided document.

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To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Helio Medical Supplies, Incorporated regarding their Press Tack/Intradermal Acupuncture Needles. This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving device performance as typically understood for medical device AI/algorithm submissions.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:

• Device Name: Press Tack/Intradermal Acupuncture Needles
• Regulatory Classification: Class II
• Product Code: MQX
• Submission Date and Receipt Date: February 3, 2005 / February 7, 2005
• FDA Determination: Substantially equivalent to a legally marketed predicate device.
• Indications for Use: To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
• Prescription Use status: Prescription Use.

To address your request, I would need a document that presents a clinical or performance study for a medical device, ideally one involving an AI or algorithmic component, which would then detail its acceptance criteria and the results of the study.

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