(57 days)
The PS-1 is indicated for use as an adjunct in the treatment of high and low anorectal malformations. The PS-1 is used to identify striated muscles to be used in anal reconstructions.
The PS-1 Peña Muscle Stimulator, addressed in this premarket notification, has the same technological characteristics as the commercially available Radionics Model 433-A General Hospital Stimulator and the P. B. Services Model A-200 Constant Current Peripheral Nerve Stimulator. Like these devices, the PS-1 is intended to be used as a stimulator.
The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria.
Instead, the document is a 510(k) premarket notification for the Model PS-1 Peña Muscle Stimulator, demonstrating its substantial equivalence to existing predicate devices (Radionics Model 433-A General Hospital Stimulator and P.B. Services Model A-200 Constant Current Peripheral Nerve Stimulator).
Here's a breakdown of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states "The system and unit testing results provided in this premarket notification verify that the Model PS-1 Peña Muscle Stimulator is safe and reliable." However, it does not specify what those "testing results" were, what the acceptance criteria for "safe and reliable" were, or the quantitative performance metrics achieved. The basis for substantial equivalence is primarily technological characteristics being similar to predicate devices, not specific performance against defined criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. No information on sample size or data provenance is provided. The document focuses on technological equivalence with predicate devices.
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)
- Missing. This type of information is not relevant to a substantial equivalence determination based on technological characteristics and safety/reliability claims without explicit performance studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. See point 3.
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
- Missing. This device is a muscle stimulator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing. This device is a physical muscle stimulator, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Missing. No ground truth establishment is described because no specific performance study against a "truth" is detailed. The assessment revolves around the device's design, safety features (audio indicators, battery test), and similarity to predicate devices.
8. The sample size for the training set
- Missing. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Missing. See point 8.
Summary of available information related to "acceptance criteria" and "study":
The document primarily relies on the concept of substantial equivalence to predicate devices.
- "Acceptance Criteria" (Implied): The implied "acceptance criteria" for this 510(k) submission are that the device shares the same technological characteristics as the predicate devices and that its design raises no new safety or effectiveness concerns. Specific, quantifiable performance criteria are not explicitly stated. Safety is highlighted through intrinsic features like audio indicators and a battery test function.
- "Study" (Implied Verification): The document mentions "The system and unit testing results provided in this premarket notification verify that the Model PS-1 Peña Muscle Stimulator is safe and reliable." However, the details of this verification ("study") are not provided. It seems to refer to internal testing performed by the manufacturer to ensure basic functionality and safety features are working as intended, rather than a formal clinical or comparative performance study against pre-defined statistical endpoints. The basis for safety and effectiveness is largely similarity to already approved devices.
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Model PS-1 Peña Muscle Stimulator 510(k)
APR - 3 1998 980448
Appendix A: Summary of Safety and Effectiveness
General Information
| Classification: | Class II |
|---|---|
| Common Name: | Muscle Stimulator |
| Device Trade Name: | Model PS-1 Peña Muscle Stimulator |
| Intended Uses: | Used to identify striated muscle in thetreatment of high and low anorectalmalformations |
| Predicate Devices: | Radionics Model 433-A General HospitalStimulatorP.B. Services Model A-200 |
| Establishment Name andAddress: | Radionics, Inc.22 Terry AvenueBurlington, MA 01803 |
| Contact Name and Phone | Nichole Riek, (781) 272-1233 ext. 274 |
| Establishment RegistrationNumber: | 1222895 |
| Performance Standards: | None established under Section 514 |
Substantial Equivalence Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
Safety Summary
The system and unit testing results provided in this premarket notification verify that the Model PS-1 Peña Muscle Stimulator is safe and reliable. Audio indicators inform the user that the unit is properly functioning. In addition, a battery test function allows the user to check the batteries prior to use.
General Safety and Effectiveness Concerns
The device labeling contains Instructions for Use which include indications for use, cautions and warnings as well as the general operating instructions required for proper use of the device. This information promotes safe and effective use of the device.
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Description of the Device and Basis for Substantial Equivalence
The PS-1 Peña Muscle Stimulator, addressed in this premarket notification, has the same technological characteristics as the commercially available Radionics Model 433-A General Hospital Stimulator and the P. B. Services Model A-200 Constant Current Peripheral Nerve Stimulator. Like these devices, the PS-1 is intended to be used as a stimulator.
Radionics' opinion with regards to substantial equivalence is based on the fact that the PS-1 complies with the same or equivalent requirements or standards as the above predicate devices. The design of the stimulating circuitry raises no new safety or effectiveness concerns. Radioncs believes that the information and testing provided in this premarket notification clearly describe the PS-1 Peña Muscle Stimulator and demonstrate that it is as safe and effective as the aforementioned predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 1998
Ms. Nichole Riek Regulatory Associate Radionics, Inc. P.O. Box 438 22 Terry Avenue 01803 Burlington, Massachusetts
K980448 Re: Model PS-1 Peña Muscle Stimulator Requlatory Class: II Product Code: IPF Dated: February 3, 1998 February 5, 1998 Received:
Dear Ms. Riek:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with manne the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Nichole Riek
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
S. Celia M. Whitton, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Model PS-1 Peña Muscle Stimulator 510(k)
Indications for Use Section II:
Indications for Use:
The PS-1 is indicated for use as an adjunct in the treatment of high and low anorectal The FS-I is indicated for be as an adjurier in the aboutinated muscles to be used in anal reconstructions.
Prescription Use
(Per 21 CFR 801.109)
Acosta
(Division Sign-Off) Division of General Re 510(k) Numbe
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).