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These acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

DBC Press Acupuncture Needles are small, sterile disposable, surgical s/steel, press type acupuncture needles. The 2.0 mm dia ring handle is continous with the 1.0 mm or 1.5 mm long needle body. These needles are supplied in sealed packages on polystyrene plastic holders.

The provided documentation for Lhasa Medical, Inc.'s DBC Press Acupuncture Needles (K031250) states that substantial equivalence is NOT based on an assessment of performance data.

Therefore, the following information cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

Explanation:

The 510(k) summary explicitly states under section (b)(1)(2)(3) on page 6b: "Substantial equivalence is not based on an assessment of performance data."

Instead, the submission for the DBC Press Acupuncture Needles primarily relies on proving substantial equivalence in design and technological characteristics to predicate devices that were in commercial distribution prior to May 28, 1976, or that have previously received 510(k) approval (e.g., SEIRIN Pyonex Press Acupuncture Needles K-970254). The document indicates that the new device has "the same technological characteristics as the predicate device(s) identified in paragraph (a)(3). These needles use the same needle body lengths and gauges (needle thickness); handle design; method of insertion; and use the same packaging methods as these predicate devices."

This type of 510(k) submission does not typically involve the kind of performance studies or acceptance criteria that would be relevant for an AI/ML device or a device where performance claims are central to its safety and effectiveness.

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These acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Nano Tech and Super Nano Acupuncture Needles are sterile disposable, surgical s/steel acupuncture needles with rigid pipe type plastic handles. These needles are supplied in individual blister or bulk packages, with or without polypropylene insertion tubes.

The provided text is a 510(k) premarket notification summary for acupuncture needles. It explicitly states in section (b)(1)(2)(3) on page 6b: "Substantial equivalence is not based on an assessment of performance data."

Therefore, the document does not contain information on acceptance criteria or a study proving device performance in the way typically expected for a medical device with measurable performance metrics (e.g., accuracy, sensitivity, specificity). This submission is based on substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting where information is not present:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The submission explicitly states that substantial equivalence is not based on performance data.

2. Sample Size Used for the Test Set and Data Provenance: This information is not provided. No test set or performance evaluation study (in terms of clinical or analytical performance) was conducted or reported.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: This information is not provided. No test set or ground truth establishment based on expert review was conducted or reported.

4. Adjudication Method for the Test Set: This information is not provided. No test set or adjudication process was conducted or reported.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This information is not provided. No performance study involving human readers or AI assistance was conducted or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: This information is not provided. This device is a physical medical device (acupuncture needles), not a software algorithm, so a standalone algorithm study is not applicable.

7. Type of Ground Truth Used: This information is not provided. No ground truth was established for a performance study.

8. Sample Size for the Training Set: This information is not provided. The device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established: This information is not provided. Not applicable as the device is not an AI/ML algorithm.

Summary of the basis for clearance:

The Nano Tech and Super Nano Acupuncture Needles were determined to be substantially equivalent to legally marketed predicate devices based on design and technological characteristics, not on performance data. The key characteristics considered were:

• Same needle body lengths and gauges (thickness).
• Same handle design.
• Same packaging methods (single blister and bulk).
• Same method of insertion (with or without guide tubes).

The predicate devices cited are:

• DBC Acupuncture Needles (K-963300, 9/23/96)
• SEIRIN Acupuncture Needles (K-962809, 8/16/92)

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These acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Tai-Chi and Master acupuncture needles are sterile disposable, surgical s/steel acupuncture needles with spiral wound spring or rigid pipe type handles. These needles are supplied in individual blister or bulk packages. with or without polypropylene insertion tubes.

The provided text describes a 510(k) pre-market notification for Tai-Chi and Master Acupuncture Needles. It explicitly states that substantial equivalence is NOT based on an assessment of performance data. Instead, the equivalence is based on the devices having the "same technological characteristics" as predicate devices already on the market (K-003760 and K-962809).

Therefore, this document does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the other requested details regarding performance studies (sample sizes, ground truth, expert adjudication, MRMC, or standalone performance).

The only relevant information that can be extracted regarding the device and its regulatory pathway is:

Device Identification:

• Device Trade Name: Tai-Chi and Master Acupuncture Needles (other trade names may also be used)
• Common or Usual Name: Acupuncture Needles
• Device Classification Name: Needle, Acupuncture, Single Use
• Classification: Class II
• 510(k) Number: K-023787
• Indications for Use: These acupuncture needles are used to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Since no performance study was conducted or reported, the table of acceptance criteria and reported device performance cannot be generated. Similarly, all other requested information pertaining to study design and execution (sample sizes, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is absent from this document.

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The WS-501 Heat Lamp may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the WS-501 Heat Lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The WS-501 Heat Lamp is used to provide topical heating to the body. The WS-501 Heat Lamp is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 0.5 to 13,500 microns. The emission heating plate life ranges from 5,000 to 10,000 hours of usage. 110 volt power, 20 watts with hi and low switch. Hand held model also features a table top stand. Warm up time before use is 3 to 5 min.

This document does not contain information related to specific acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert qualifications, or adjudication methods for the WS-501 Heat Lamp.

The provided text is a 510(k) summary for the WS-501 Heat Lamp, which explicitly states:

• (b)(1)(2)(3) Substantial equivalence is not based on an assessment of performance data. (Page 6c)

This indicates that the device's pre-market notification was based on demonstrating substantial equivalence to existing predicate devices (WS Portable Infrared Heat Lamp, CAI Industries, 510k # K-954577; TDP CQ-27 Heat Lamp, Lhasa Medical, Inc, 510k #: K-003538; Firard II TDP Lamp, Helio Medical Supplies, 510k #: K-960036), rather than through a study evaluating specific performance criteria against predefined acceptance thresholds. The equivalence is based on similar design, indications for use, technological characteristics (heating plate method, power, output), function, and operation.

Therefore, I cannot populate the requested tables or answer the specific questions about acceptance criteria, performance data, or study methodologies.

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Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

The subject of this 510(k) application - the CW acupuncture needle - is a sterile, single use only acupuncture needle. The CW acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

The provided text is a 510(k) summary for an acupuncture needle, not a study evaluating an AI/ML device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, expert involvement, or AI performance metrics.

The document focuses on demonstrating substantial equivalence of the "CW acupuncture needle" to legally marketed devices, primarily by highlighting its sterile, single-use nature and its history of safe use. It explicitly states: "The CW acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture." However, it does not detail specific quantitative acceptance criteria or a formal study with a test set, ground truth, or expert review that would typically be associated with performance evaluation of an AI/ML device.

Therefore, I cannot provide the requested table and information as it is not present in the given text.

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Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

The subject of this 510(k) application - the TAKI acupuncture needle - is a sterile, single use only acupuncture needle. The TAKI acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

This 510(k) summary describes a pre-market notification for the TAKI acupuncture needle. However, it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria in the way a diagnostic AI algorithm study would. The document focuses on regulatory equivalence rather than a detailed performance study with quantitative metrics.

Therefore, I cannot provide a table of acceptance criteria vs. reported device performance, nor can I answer questions related to sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information provided for this device.

Here's what I can extract based on the provided text, heavily reinterpreting the "acceptance criteria" through a regulatory lens:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This document does not describe a test set or a study with quantitative performance metrics. The "performance" is based on the general lack of adverse events during real-world use and meeting general specifications.
• Data Provenance: The statement regarding no reported accidents or device failures since 1988 indicates historical, real-world usage data. The country of origin for this data is not specified, but the device was "imported and sold through interstate commerce in the USA since 1988," suggesting the absence of reports pertains to US usage. This would be considered retrospective observational data.

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

• Not applicable. There was no "test set" in the sense of a collection of cases requiring expert ground truth for performance evaluation of a diagnostic algorithm. The "ground truth" for this device is effectively its general acceptance, safety record, and functional equivalence.

4. Adjudication method for the test set

• Not applicable, as there was no test set or expert ground truthing process 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 is not a diagnostic AI device, and therefore, an MRMC study is irrelevant to this submission.

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

• Not applicable. This is not an algorithm.

7. The type of ground truth used

• The "ground truth" for this regulatory submission is based on several factors:
  • Historical Safety Record: The absence of reported adverse events over years of commercial distribution in the US.
  • General Acceptance/Longstanding Use: The statement that "Acupuncture needles have been used for the general practice of acupuncture in the United States for over 30 years" and that pre-amendment devices were non-sterile highlights the historical context and general understanding of acceptable performance for this device type.
  • Compliance with General Specifications: The device "meets the general specifications and criteria for an acupuncture needle." This implies adherence to established industry or regulatory standards for such devices, although specific standards are not listed.
  • Equivalence to Predicate Devices: The core of a 510(k) relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing a completely new "ground truth" for performance.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable.

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Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

The subject of this 510(k) application - the Hwa-To acupuncture needle - is a sterile, single use only acupuncture needle. The Hwa-To acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

The provided text is a 510(k) summary for an acupuncture needle (Hwa-To) and does not contain the detailed information required to answer the questions about acceptance criteria, study design, and performance metrics in the context of advanced AI/ML device evaluations. This document predates modern regulatory requirements for such detailed performance studies and focuses on demonstrating equivalence to predicate devices based on historical use and safety profiles.

Therefore, I cannot extract the following information from the provided text:

• Acceptance criteria and reported device performance table: The document states the device "meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture," but it does not provide specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, AUC) for the device's function as an AI/ML product.
• Sample size and data provenance for the test set: Not applicable for this type of device and submission. The "test set" in this context refers to the real-world use of acupuncture needles.
• Number of experts and qualifications for ground truth: Not applicable. Ground truth for acupuncture needles involves their physical characteristics and safety in use, not diagnostic interpretations.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
• Standalone performance: Not applicable. This is a physical medical device.
• Type of ground truth used: The ground truth for an acupuncture needle relates to its manufacturing quality, sterility, and safe function, not clinical outcomes in a specific diagnostic context.
• Sample size for the training set: Not applicable. This is not an AI/ML device that undergoes training.
• How the ground truth for the training set was established: Not applicable.

Summary of what can be inferred from the document regarding "acceptance" in its context:

The document primarily focuses on demonstrating the substantial equivalence of the Hwa-To acupuncture needle to legally marketed predicate devices, which is the core principle of a 510(k) submission for this type of medical device.

Acceptance Criteria (Implicit from the document's structure and claims):

1. Sterility: The device is sterile.
2. Single-Use: The device is for single use only, enhancing safety over older reusable needles.
3. General Specifications and Criteria for Acupuncture Needles: The device meets these unspecified general standards.
4. Effectiveness for Acupuncture Practice: The device is suitable for its intended purpose.
5. Safety Profile: No serious accidents, life-threatening incidents, or device failure claims reported since 1986.
6. Equivalence to Predicate Devices:
   • Equivalent to pre-May 28, 1976, acupuncture needles (which were non-sterile, reusable).
   • Equivalent to other sterile, single-use acupuncture needles currently on the market.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The "study" here is not a formal clinical trial with specific performance endpoints, but rather a combination of:

• Historical Data/Absence of Adverse Events: The document states, "Since 1986, no accidents or device failure claims have been reported as a result of using the Hwa-To brand acupuncture needle." It also notes no serious incidents involving acupuncture needles in general over 30 years.
• Manufacturing Standards and Controls (Implied): While not explicitly detailed, the claims of "sterile" and "single use" imply adherence to relevant manufacturing and quality control standards.
• Comparison to Predicate Devices: The core of the 510(k) is the argument that "The Hwa-To needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976. Also, the Hwa-To needle is equivalent to other acupuncture needles which are currently being sold through interstate commerce." This comparison likely involves evaluating material, design, intended use, and sterility against currently marketed devices and historical practice.

The provided document is a regulatory submission from 1996 for a basic medical device (acupuncture needle), which falls under a different regulatory and evaluative framework than complex AI/ML-driven diagnostic devices.

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Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

The subject of this 510(k) application - the DBC acupuncture needle - is a sterile, single use only acupuncture needle. The DBC acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.

This document is a 510(k) Pre-Market Notification for an acupuncture needle. It does not contain the type of detailed performance criteria and study results typically found for devices that involve AI, image analysis, or complex diagnostic functions.

Here's why the requested information cannot be extracted from the provided text:

• Device Type: Acupuncture needles are relatively simple medical devices. Their primary function is to pierce the skin for acupuncture. The "performance" in this context is about sterility, single-use, and general functionality, not diagnostic accuracy or expert interpretation.
• Lack of AI/Algorithm: The document makes no mention of AI, machine learning, image analysis, or any algorithm. Therefore, concepts like acceptance criteria for AI performance (sensitivity, specificity, AUC), ground truth establishment by experts, training/test sets, or MRMC studies are not applicable.
• Focus of the 510(k): This 510(k) is focused on demonstrating substantial equivalence to predicate devices already on the market. The criteria for acceptance are primarily related to safety (sterility, single-use) and general functionality, not on analytical or clinical performance metrics that would require expert-adjudicated studies.

Therefore, I cannot fulfill your request for the specific points because the provided document does not contain information about:

1. A table of acceptance criteria and reported device performance related to AI/diagnostic accuracy.
2. Sample sizes for test sets, data provenance, number of experts, or adjudication methods for diagnostic performance.
3. Multi-reader, multi-case comparative effectiveness studies.
4. Standalone algorithm performance studies.
5. Type of ground truth (expert consensus, pathology, etc.) related to diagnostic accuracy.
6. Sample size for a training set or how ground truth was established for a training set.

The document's "acceptance criteria" are implied to be meeting the safety and functionality standards for acupuncture needles and demonstrating equivalence to existing devices. The "study" proving this is essentially the information provided in the 510(k) application, highlighting its sterility, single-use nature, and lack of adverse event reports over years of use.

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