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Use of the Model 5700 and 2264 Series Non-Invasive Watertight Transducers are indicated as accessories to Corometrics Fetal and Fetal/Maternal Monitors. The Model 5700 Watertight Transducer provides for the detection of fetal heart rate and the Model 2264 Watertight Transducer provides for the detection of uterine activity. Both transducers are intended to be used in either water or non-water environments. When used in water environment applications both transducers are intended to be directly connected to telemetry and not directly connected to a Fetal or Fetal Maternal monitor or any AC powered monitoring devices. Labeling and labels, on the transducers themselves, instruct the care provider to directly connect the transducers to a telemetry system when the devices are exposed to a water environment.

The Model 5700 and 2264 Series Non-Invasive Watertight Transducers are intended as accessories to Corometrics' Fetal and Fetal/Maternal Monitors. The Model 5700 Series Transducer provides for the detection of fetal heart rate and the Model 2264 Series Transducer provides for the detection of uterine activity.

This 510(k) summary for the Corometrics Model 5700 and 2264 Watertight Transducer does not contain the detailed information typically found in a study report, as it focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal scientific study as would be described in a clinical trial or performance evaluation.

Therefore, providing a table of acceptance criteria and reported device performance, sample sizes, expert details, adjudication methods, MRMC study results, or training set information is not possible based on the provided text.

Here's an explanation of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Missing. The 510(k) summary explicitly states: "To date, the Food and Drug Administration have promulgated no performance standards relating to accessories of this type." This means there were no pre-defined formal acceptance criteria for device performance (like sensitivity, specificity, accuracy metrics) established by the FDA for this type of accessory at the time of submission.
• The document implies that "extensive testing" was performed to meet requirements and design, but it does not specify what those requirements were or present the results of such testing in a quantitative format against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Missing. The document mentions "extensive testing" but does not provide any details about the sample size (number of patients, number of tests), the type of data used (e.g., retrospective recordings, prospective collection), or the origin of the data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Missing. There is no mention of ground truth establishment by experts, as the document doesn't describe a study involving human interpretation or performance evaluation that would necessitate this.

4. Adjudication Method for the Test Set:

• Missing. Without a described test set or expert involvement, there is no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document does not describe a MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a transducer accessory, not an AI diagnostic algorithm.

6. Standalone (Algorithm Only) Performance:

• No. This device is a physical transducer, not a standalone algorithm. Its function is to detect fetal heart rate and uterine activity, which are then processed by a separate Fetal and Fetal/Maternal Monitor.

7. Type of Ground Truth Used:

• Missing. Since no formal performance study against a "ground truth" (such as pathology, outcomes, or expert consensus) is described, this information is not available. The primary "ground truth" or reference for this type of device would likely be its ability to accurately detect and transmit the physiological signals (FHR and UA) compared to established methods, but specific data is not provided.

8. Sample Size for the Training Set:

• Not applicable. As this device is a physical transducer and not an AI/ML algorithm, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

Summary of Device Acceptance (as described in the 510(k) Summary):

The acceptance of these devices (Corometrics Model 5700 and 2264 Watertight Transducers) was based on demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific performance criteria from a formal study.

The comparison focused on technological characteristics and intended use:

• Model 5700 Watertight US Transducer:
  • Intended Use: Fetal Heart Rate (FHR)
  • Key Differentiators/Improvements over predicate (Model 5700 US Transducer): Watertight (Yes vs. No), Water Environment Application Use (Yes vs. No).
  • Similarity to predicate (HP M1356A Watertight US Transducer): Both are watertight, perform FHR detection, and use pulsed Doppler. The Corometrics device uses 9 crystals compared to HP's 7.
• Model 2264 Watertight Toco Transducer:
  • Intended Use: Uterine Activity (UA)
  • Key Differentiators/Improvements over predicate (Model 2260 Toco Transducer): Watertight (Yes vs. No), Water Environment Application Use (Yes vs. No).
  • Similarity to predicate (HP M1355A Watertight Toco Transducer): Both are watertight, and perform UA detection.

The manufacturer states that "The Corometrics Model 5700 and 2264 Series Watertight Transducers have been extensively tested to meet their requirements and design." This implies internal validation and verification activities, but the 510(k) summary does not provide specific data from these tests or define the "acceptance criteria" met by these tests in a quantifiable manner typical of clinical studies for AI or diagnostic devices.

The FDA's letter (K982651) affirms that the device is "substantially equivalent" for the stated indications for use to legally marketed predicate devices, thereby permitting its market entry. The "acceptance criteria" from a regulatory perspective for this submission was successful demonstration of substantial equivalence.

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Replaces R&D Batteries part Number 5164 (K933687 and K951403) which are used in Sonicaid fetal heart monitors D100RE, D102R PN 1000-0006 K#873673.

MOOlo Replacement Battery

The provided text is a 510(k) premarket notification letter from the FDA to Alexander Manufacturing Company for a replacement battery, and an "Indications For Use" statement.

Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter is an FDA determination of substantial equivalence for a replacement battery (Part no. M006) to a predicate device, as required for marketing in the United States. It references previous 510(k) numbers for the devices the battery replaces.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is a regulatory approval letter, not a study report or technical specifications document.

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