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The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 moxa is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "PREMIO 10 moxa," which is an infrared lamp. This type of document typically confirms that a device has been cleared for market based on substantial equivalence to a predicate device, but it does not include detailed information about the acceptance criteria, study design, or performance metrics that would be found in a clinical study report or a detailed premarket submission.

Specifically, the document does not provide any information on:

1. Acceptance criteria or reported device performance
2. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or type of ground truth used for a test set.
3. Sample size or ground truth establishment for a training set.

The letter focuses on regulatory compliance and substantial equivalence, not on the results of a performance study with detailed acceptance criteria and study methodologies.

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The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states. The device consists of a solid, titanium needle.

The device consists of a solid, titanium needle.

This document is an FDA 510(k) clearance letter for acupuncture needles. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the given input. The categories in your request are relevant to the evaluation of AI/ML-driven medical devices, which this document is not about.

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

ASP Type needles consists of a short "tack-like" solid stainless steel needle contained in a plastic injector to introduce the needle in the epidermis, to facilitate the delivery of acupuncture treatment. ASP needles are sterile devices for single use only. The "ASP Gold needle" is an "ASP needle" which has been gold plated (an intermediate laver of copper is added between stainless steel and gold). The ASP needles are offered in a single size.

The provided text is a 510(k) premarket notification for the SEDATELEC ASP Acupuncture Needles. It does not describe an acceptance criteria study or report device performance against specific criteria in the way typically expected for an AI/CADe device. Instead, it demonstrates substantial equivalence to a predicate device, which is a common regulatory pathway for medical devices.

Therefore, many of your requested points are not directly applicable or cannot be extracted from this document, as the focus is on demonstrating similarity to an already approved device rather than proving novel performance against predefined criteria through a clinical study.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance

This document does not present acceptance criteria or reported device performance for the ASP Acupuncture Needles in terms of specific metrics like sensitivity, specificity, or accuracy. The demonstration of safety and effectiveness relies on substantial equivalence to a legally marketed predicate device (Seirin - S & Seirin - Pionex acupuncture needles).

Substantial Equivalence Comparison (Excerpted from the document):

The core "acceptance criteria" here is that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective.

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

This information is not applicable to a 510(k) submission based on substantial equivalence for a physical device like an acupuncture needle. There isn't a "test set" of data in the context of an AI/CADe algorithm. The evaluation is based on manufacturing processes, materials, intended use, and general device characteristics compared to a known safe and effective predicate.

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

Not applicable. This type of expert review for ground truth is associated with AI/CADe performance studies.

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. This is not an AI/CADe device.

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

Not applicable. This is not an AI/CADe device.

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

For this type of 510(k) submission, the "ground truth" for safety and effectiveness is established by the legally marketed predicate device. The fundamental premise is that if the new device is sufficiently similar in design, materials, and intended use to an existing device, it can be presumed to be equally safe and effective without requiring a full de novo approval process.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device.

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

Not applicable. This is not an AI/CADe device.

Summary based on the document:

The SEDATELEC ASP Acupuncture Needles were approved based on substantial equivalence to existing legally marketed acupuncture needles (Seirin - S & Seirin - Pionex). The FDA determined that the device is as safe and effective as the predicate device because it shares similar technological characteristics (materials, intended use, sterilization method (though different, it is validated), and basic design). There was no need for a clinical "acceptance criteria" study in the context of AI/CADe performance, as the device is a simple, physical medical instrument.

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

The DN needle consists of a solid stainless steel needle with a copper wire wrapped around the stainless steel needle shaft. The copper wire acts as a handle which facilitates the delivery of acupuncture treatment by making the needles easier to manipulate and place. DN needles are sterile devices for single use only. The needles are made from 302 grade stainless steel meeting ASTM F899-84 standards. No lubricant is used on the needles.

The provided document describes a 510(k) premarket notification for the SEDATELEC DN Acupuncture Needles (K983800). This submission aims to demonstrate substantial equivalence to a predicate device, the CARBO MicroClean acupuncture needle (K961339), rather than presenting a performance study against specific acceptance criteria. Therefore, the information requested in the prompt regarding acceptance criteria, device performance, and a study proving said performance is largely not applicable in the context of this 510(k) submission.

Here's an breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in this 510(k) submission. The submission's goal is to establish substantial equivalence to a predicate device, implying that if the DN Acupuncture Needles are sufficiently similar to the legally marketed CARBO MicroClean acupuncture needle, they are presumed to be safe and effective. There are no specific performance criteria or a study demonstrating achievement of those criteria detailed in this document.

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

Not applicable. This is not a performance study involving a test set. The submission relies on a comparison table of device features to demonstrate equivalence.

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

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring adjudication is described.

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

Not applicable. This is not a comparative effectiveness study involving human readers or AI assistance.

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

Not applicable. This device is an acupuncture needle, not an algorithm or AI system.

7. The type of ground truth used:

Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" in a 510(k) submission is effectively the established safety and effectiveness of the predicate device.

8. The Sample Size for the Training Set:

Not applicable. There is no training set mentioned as this is not a study involving machine learning or similar methodologies.

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

Not applicable. As there is no training set, there is no corresponding ground truth establishment process.

Summary of Relevant Information from the Document (if interpreted for "equivalence" as the "criterion"):

The submission argues for substantial equivalence to the CARBO MicroClean acupuncture needle (K961339) based on the following:

• Identical Intended Use: Both devices are "Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states."
• Similar Design Features:
  • Device Type: Both are considered "DN Type" (DN Equivalent for the predicate).
  • Needle Tip Shape: Both are "Taper."
  • Needle Shape: Both are "Stylet."
  • Biocompatibility: Both use "ASTM 302 surgical stainless steel" (Standard specifications for stainless steel billet, bar, and wire for surgical instruments F899-84).
• Similar Materials: The needle material is surgical stainless steel for both. The handle material differs (copper for the SEDATELEC device vs. silver-plated metal for the CARBO device), but this difference is not presented as affecting equivalence for the intended use.
• Labeling: Both have comparable labeling requirements for identification and statements (e.g., sterile, single use, lot number, manufacturer, gauge, length, quantity).
• Sterilization: Both are sterilized devices. The SEDATELEC needles are sterilized by Gamma radiation at a validated dose level of 25kGy to achieve a sterility assurance level of 10^-6, in accordance with ISO 11737-1, EN552, and ISO 11137 standards. The predicate's sterilization method is listed as "Ethylene oxide gas sterilization" in its labeling, which is a different method but both are acceptable for sterilization.
• Dimensions: While there are differences in the range of invasive lengths (SEDATELEC: 18-47mm; CARBO: 13-75mm) and diameters (SEDATELEC: 0.25-0.40mm; CARBO: 0.20-0.30mm), these variations are considered within acceptable limits for acupuncture needles and do not preclude substantial equivalence.

Conclusion stated in the document: "Based on the design, function, intended use and materials of the DN Needles, substantial equivalence is evident. The referenced CARBO brand needles are functionally identical. The anticipated safety and effectiveness of both devices is or may be expected to be the same."

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