(75 days)
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Meropenem in the dilution range of 0.004 – 8 ug/ml to the Sensititre 18 – 24 hour MIC panel for testing gram negative isolates.
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The provided text is a 510(k) clearance letter from the FDA for a susceptibility testing device. It does not contain the detailed information necessary to answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. This document primarily confirms that the device, a Sensititre 18-24 Hour Susceptibility Plate with Meropenem, has been found substantially equivalent to a legally marketed predicate device.
Therefore, many of your questions cannot be answered from the provided text.
Here's what can be inferred or stated based on the text:
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A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The 510(k) clearance letter states that the device is "substantially equivalent" to predicate devices, but it does not detail the specific performance metrics or acceptance criteria used to make that determination.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided document.
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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): This information is not present in the provided document. For susceptibility testing, the "ground truth" would typically be established by a reference method (e.g., agar dilution or broth microdilution performed according to CLSI guidelines), not necessarily by human experts in the same way as imaging analysis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided document.
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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 present in the provided document. MRMC studies are typically associated with diagnostic imaging AI, not susceptibility testing.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "Susceptibility Test Panel" (in vitro diagnostic product) which determines the susceptibility of organisms to an antibiotic. It is inherently a standalone analytical test, not an AI algorithm requiring human-in-the-loop performance. Its performance would be evaluated on its ability to accurately determine susceptibility based on growth patterns in the presence of various antibiotic concentrations.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): While not explicitly stated, for an in vitro diagnostic susceptibility test, the ground truth would almost certainly be established by a reference method (e.g., standard broth microdilution or agar dilution) performed by a qualified laboratory, following recognized standards (like those from CLSI - Clinical and Laboratory Standards Institute). It would not be expert consensus, pathology, or outcomes data.
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The sample size for the training set: This information is not present in the provided document. For an in vitro diagnostic device like this, there wouldn't typically be a "training set" in the machine learning sense. Instead, performance is evaluated against known bacterial isolates with established susceptibility profiles.
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How the ground truth for the training set was established: As mentioned in point 8, a "training set" in the AI sense is not applicable here. The ground truth for the performance evaluation of such a device would be established using a gold standard reference method (e.g., CLSI-defined methods like broth microdilution) to determine the true Minimum Inhibitory Concentration (MIC) for tested organisms against the antibiotic Meropenem.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 30 1998
Cynthia C. Knapp Director Lab Services AccuMed International, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145
Re: K983244
Trade Name: Sensititre 18-24 Hour Susceptibility Plates with addition Meropenem Regulatory Class: II Product Code: JTW Dated: September 2, 1998 Received: September 16, 1998
Dear Ms. Knapp:
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 legally marketed predicate 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 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 (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 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 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 regulations.
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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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
Steven Autman
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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510(k) Number (if known):
Device Name: Susceptibility Test Panel
Indications For Use:
The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.
This 510(k) is for the addition of Meropenem in the dilution range of 0.004 – 8 ug/ml to the Sensititre 18 – 24 hour MIC panel for testing gram negative isolates.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Wordy Dubois
510(k) Number
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.