(167 days)
The intended use of the ACUSTIM is for use as an ELECTRO-ACUPUNCTURE DEVICE. It can be used by a Physician administering to his patients, or by a patient. It is a prescription device and should be used under continued medical supervision. It does not have curative value but stimulates appropriate auricular acupuncture points. It cannot be used transcerebrally, in the carotid sinus area or during pregnancy.
The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting wires to two electrodes which make contact with the skin of the outer ear of the patient. Switching the unit on generates low level electrical pulses the strength of which are controlled by the treatment strength control button.
The provided text is a 510(k) premarket notification for a medical device called ACUSTIM (later referred to as ACUSLIM). It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a study designed to prove the device meets those criteria in the way a typical AI/medical device performance study would.
However, based on the provided text, I can extract and infer some information, while explicitly stating what is not present.
Missing Information:
Crucially, this document is a regulatory submission for a device that delivers electro-acupuncture for non-curative stimulation. It is not for a diagnostic AI system or a device that produces a measurable outcome for which traditional performance metrics like sensitivity, specificity, or AUC would be applied. Therefore, many of the requested categories (like number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not relevant to this specific device and its submission type.
The "Performance Data" section mentions "Applicable performance testing criteria from the AAMI Standard Transcutaneous Electrical Nerve Stimulators NS4-1985" and "Clinical testing results both as a pilot study... and a double blind study". However, it does not detail these criteria or results.
Here's an attempt to answer the questions based on the available text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Regulatory Standard) | Reported Device Performance (Summary) |
|---|---|
| Compliance with AAMI Standard NS4-1985 for Transcutaneous Electrical Nerve Stimulators (TENS) electrical outputs and frequency, and rectangular waveform. | ACUSLIM uses four 1.5 volt batteries. Both ACUSLIM and predicate device ACUPLUS have similar electrical outputs and frequency and use a rectangular waveform. |
| Safety and efficacy in intended use (electro-acupuncture for stimulating auricular points). | Clinical testing results from a pilot study in a medical practice and a double-blind study under the University of Adelaide General Practice Department were included in the 510(k). (Specific results and acceptance criteria for these studies are not detailed in the provided text.) |
| Indications for Use: "for use as an ELECTRO-ACUPUNCTURE DEVICE. It can be used by a Physician administering to his patients, or by a patient. It is a prescription device and should be used under continued medical supervision. It does not have curative value but stimulates appropriate auricular acupuncture points. It cannot be used transcerebrally, in the carotid sinus area or during pregnancy." | The device has been reviewed and deemed substantially equivalent to a legally marketed predicate device (ACUPLUS K954334) for these indications, implying acceptable performance for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified in the provided text. The document only mentions "a pilot study in a medical practice environment, and a double blind study."
- Data Provenance: The "double blind study" was conducted "under the University of Adelaide General Practice Department," implying the data originated from Australia. Both studies appear to be prospective clinical trials by nature of being described as "clinical testing."
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. Given the device type (electro-acupuncture stimulator), "ground truth" would likely relate to physiological response or patient-reported outcomes rather than an expert interpretation of data like images. The clinical studies mentioned would have involved medical professionals overseeing the treatment and data collection, but their specific roles in establishing a "ground truth" for a diagnostic measure are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and is generally not applicable to this type of device submission. Adjudication methods are more commonly associated with expert interpretation of diagnostic imaging or clinical findings.
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 provided and is not applicable. The ACUSLIM is an electro-acupuncture stimulation device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not provided and is not applicable. The ACUSLIM is a physical device that delivers electrical pulses, not an algorithm. Its operation inherently involves a human (physician or patient).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Based on the device's function and the mention of clinical studies, the "ground truth" would most likely involve outcomes data or physiological responses related to "stimulating appropriate auricular acupuncture points," as assessed in the clinical studies. Specific details are not given.
8. The sample size for the training set
- This information is not provided and is not applicable. The ACUSLIM is not an AI/machine learning device that requires a training set in the conventional sense. Its performance is based on its physical and electrical characteristics and clinical validation.
9. How the ground truth for the training set was established
- This question is not applicable as the device does not employ machine learning or require a "training set."
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Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with three wavy lines extending from its head. The image is in black and white and appears to be a scan or photocopy.
JUN 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Dean Richards S.H.P. International Pty. Ltd. 5/212 Glen Osmond Road Fullarton, S.A. Australia 5063
Re: K014273 Trade/Device Name: ACUSTIM Regulation Name: Electro-Acupuncture Regulatory Class: Unclassified Product Code: BWK Dated: March 18, 2002 Received: March 29, 2002
Dear Dr. Richards:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abound in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Dr. Dean Richards
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark N. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510(k) Number (if known): 长۵14273
Device Name:_
Indications For Use:
The intended use of the ACUSTIM is for use as an ELECTRO-ACUPUNCTURE DEVICE.
It can be used by a Physician administering to his patients, or by a patient.
It is a prescription device and should be used under continued medical supervision.
It does not have curative value but stimulates appropriate auricular acupuncture points.
It cannot be used transcerebrally, in the carotid sinus area or during pregnancy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millman
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number
(Optional Format 3-10-98)
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ACUSLIM 510(k) Notification Page R
Koj4/273
510(K) SUMMARY
Submitters Information:
S.H.P. International Pty. Ltd 5/212 Glen Osmond Road Fullarton, S.A., 5064 Australia
6/12/02
Contact Person:
Dr. Dean Richards Telephone: +61 8 8379 0700
August 15, 2001
Device Name:
Date Summary Prepared:
Proprietary Name: Common or usual name: Classification name:
ACUSLIM
Portable transcutaneous electrical nerve stimulator. Transcutaneous electrical nerve stimulator, Class II, 882.5890.
Legally marketed device for substantial equivalence comparison: ACUPLUS K954 334.
Description of the Device:
The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting wires to two electrodes which make contact with the skin of the outer ear of the patient.
Switching the unit on generates low level electrical pulses the strength of which are controlled by the treatment strength control button.
Technological Characteristics:
ACUSLIM uses four 1.5 volt batteries as does the ACUPLUS. Both devices have similar electrical outputs and frequency and use a rectangular waveform.
Whereas the ACUPLUS has one gold electrode and a stainless steel grounding electrode, the ACUSLIM has a positive output from a gold electrode and a negative output from an adhesive conductive electrode using the same conductive adhesive gel as is common to most TENS devices.
Performance Data:
Applicable performance testing criteria from the AAMI Standard Transcutaneous Electrical Nerve Stimulators NS4-1985, were applied.
Clinical testing results both as a pilot study in a medical practice environment, and a double blind study under the University of Adelaide General Practice Department are included in the 510k.
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