(26 days)
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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.
§ 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).