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Automator 2000 has the control circuitry, drive components, and battery contained in a single housing. The compact and entirely self contained design of Automator 2000 simplifies the installation of the product. Automator 2000's machined aluminum housing is a robust design that comfortably accommodates the axial force and impact load requirements of the device. Additionally, the conductive aluminum housing has been designed to preclude radio frequency interference. Automator 2000's design has retained the CF Automator's redundant self diagnostic and circuitry controls to assure that the telescoping rod may move only the amount it is intended to move, and only when it is intended to move. Since each Automator 2000 device has its own control circuitry, the complexity built into the CF Automator circuitry for controlling multiple drive units has been removed. Since Automator 2000 is programmed using switches on the control board rather than through an IR communication link to a doctor's master computer, further communication circuitry has also been rendered unnecessary. Consequently, Automator 2000 has a more simplified circuit board and software package. Automator 2000 has 7 rate setting to chose from and the movement amount per increment is held constant at 1/360th mm. Both systems have been designed to use the final drive gear as an encoder to verify the position of the telescoping rod. Each system will error if the encoder does not verify that distraction is progressing within tolerable accuracy. Both systems check current on the motor circuit to verify the motor runs only when it is supposed to, and furthermore, check current during motor pulses to verify that current is not higher than expected, Both motor circuits have switches that remain open between motor pulses to prevent the motor from receiving current. Both systems use a watch-dog circuit to confirm software operation nearly continuously. Both systems have redundant audio and visual alarms. Furthermore, both units use the same design telescoping rod, which may be used to make manual lengthening adjustments at any time.
This FDA clearance letter (K981426) for the STAT Profile Ultra F, G, H, I, J, K and L Analyzers from Nova Biomedical, issued in 1998, primarily focuses on establishing substantial equivalence to predicate devices. It does not contain detailed information about specific acceptance criteria and the results of a study proving the device meets those criteria, nor does it describe AI-related performance or ground truth establishment.
The document is an FDA clearance letter for a medical device (analyzers), not a study report or clinical trial summary. Therefore, the requested information, which pertains to the detailed results of a performance study, is not present in the provided text.
Based on the provided text, I can only state what is not available:
- A table of acceptance criteria and the reported device performance: Not present. The letter indicates the device is substantially equivalent but doesn't list performance metrics or criteria explicitly.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not present. This document predates widespread AI in medical devices, and no mention of AI is made.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Again, no mention of AI or algorithm-only performance.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
The letter confirms the device's classification and substantial equivalence to pre-1976 marketed devices, allowing it to proceed to market under general controls. It also mentions potential CLIA complexity categorization and refers to regulations like GMP.
The second part of the provided text, discussing "Automator 2000" and "CF Automator," describes a different device in terms of its mechanical, housing, circuitry, and software design improvements over a predicate. This section also does not discuss acceptance criteria or study results for performance metrics. It focuses on design changes for a device that appears to be related to an external fixator/telescoping rod system, which is different from the "STAT Profile Ultra F, G, H, I, J, K and L Analyzers" mentioned in the FDA letter.
Therefore, I cannot fulfill the request as the necessary information for acceptance criteria and study details is not contained within the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 2 1998
Paul W. MacDonald . Director of Quality Assurance/Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham, Massachusetts 02254-9141
K981426 Re : STAT Profile Ultra F, G, H, I, J, K and L Analyzers Requlatory Class: I & II GKF, GKR, CHL, CGZ, CDS, JIX, CEM, JFP, Product Code: CGA, JGS, KHP, JJS April 16, 1998 Dated: Received: April 16, 1998
Dear Mr. MacDonald:
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 vour 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with ---the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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) 594-4588. 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,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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The motor chosen for Automator 2000 provides higher torque, is a preferable size for the Automator 2000 housing design, and requires less power.
Housing & Enclosure: The CF Automator (predicate device) has separately enclosed components that mount to the external fixator frame: drive units, controller, and battery pack. The components are connected by cables. By comparison, Automator 2000 has the control circuitry, drive components, and battery contained in a single housing. The compact and entirely self contained design of Automator 2000 simplifies the installation of the product. Furthermore, external cables are no longer vulnerable to damage or being inadvertently unplugged in the design of Automator 2000.
Automator 2000's machined aluminum housing is a robust design that comfortably accommodates the axial force and impact load requirements of the device. Additionally, the conductive aluminum housing has been designed to preclude radio frequency interference. By comparison, the CF Automator components are housed in delrin (a plastic composite), which is shaped by plastic injection molding.
Circuitry and Software/ Safety Features: Automator 2000's design has retained the CF Automator's redundant self diagnostic and circuitry controls to assure that the telescoping rod may move only the amount it is intended to move, and only when it is intended to move. Since each Automator 2000 device has its own control circuitry, the complexity built into the CF Automator circuitry for controlling multiple drive units has been removed. Since Automator 2000 is programmed using switches on the control board rather than through an IR communication link to a doctor's master computer, further communication circuitry has also been rendered unnecessary. Consequently, Automator 2000 has a more simplified circuit board and software package.
Programming the device has been simplified as well. The predicated device (CF Automator) allowed the physician to choose from 14 rate settings and 7 rhythm settings for the number of adjustment increments made by the device each day. Automator 2000 has 7 rate setting to chose from and the movement amount per increment is held constant at 1/360th mm.
Regarding motor control, Automator 2000 and the CF Automator very similar software and circuitry safety features. Certain conditions that applied to the CF Model do not apply to Automator 2000 - for example, an unplugged drive unit or unplugged battery. Similarities between the two operating systems include the following: Both systems have been designed to use the final drive gear as an encoder to verify the position of the telescoping rod. Each system will error if the encoder does not verify that distraction is progressing within tolerable accuracy. Both systems check current on the motor circuit to verify the motor runs only when it is supposed to, and furthermore, check current during motor pulses to verify that current is not higher than expected, Both motor circuits have switches that remain open between motor pulses to prevent the motor from receiving current. Both systems use a watch-dog circuit to confirm software operation nearly continuously. Both systems have redundant audio and visual alarms. Furthermore, both units use the same design telescoping rod, which may be used to make manual lengthening adjustments at any time.
§ 864.5600 Automated hematocrit instrument.
(a)
Identification. An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).(b)
Classification. Class II (performance standards).