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The DIOP8 surgical Doppler is indicated for use by qualified healthcare practitioners in a sterile condition in the operating theatre for the assessment of vascular blood flow by direct application to the vessel wall.

The DIOP8 is a sterile, single use, high sensitivity probe that assists in the performance of safe surgery. It is a lightweight, 8MHz ultrasound, handheld pencil probe' that has a small diameter tip that enables the detection of blood flow in vessels. The DIOP8 ultrasound probe operates in pulsed-wave mode. It has one circular piezo-electric crystal that is mounted behind the front faceplate and the crystal is used for both transmit and receive functions. The DIOP8 is manufactured at a frequency of 8MHz. The output ultrasonic parameters are fixed during the manufacturing process and cannot be adjusted by the user. A connector system at the end of the cable allows the DIOP8 to be removed from the hand held Doppler. An interconnection adapter houses the bi-directional electronics, which are specific for the device application, and is required as an interface between the main unit and DIOP8. The connector is similar to a conventional connector, but has no external conductive contacts, and is totally sealed, thus preventing the ingress of fluid and contaminants. Within the connector is a small coil that transfers electrical energy to and from a similar, but larger coil in the corresponding socket at the end of the PA8/PA8XS adapter. Transmitted and received electrical signals are passed through this connector, but there is no direct electrical connection between the probe and the PA8/PA8XS adapter. The connector provides electrical isolation between the probe and the PA8/PA8XS adapter, which optimises system electrical safety by limiting patient leakage currents to very low levels. During use, the adapter is securely held in the probe holder that is an integral part of the Doppler main unit. When connected this way, the hand held Doppler unit operates as if a normal VP8 probe is connected.

The requested information is not available in the provided text. The document is a 510(k) summary for a medical device (Disposable Intraoperative Probe - DIOP8) and details the device's characteristics, comparison to a predicate device, and various performance tests conducted. However, it does not include specific acceptance criteria with reported device performance values in a table, nor does it describe a study proving the device meets those criteria with a breakdown of sample sizes, ground truth establishment, expert involvement, or MRMC study results.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general performance testing (biocompatibility, mechanical, functional, electrical safety, EMC, environmental, and software).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, sample size details for test and training sets, data provenance, number of experts, adjudication methods, MRMC study results, or standalone performance results based on the provided text.

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The 10P8 is a passive, self contained, sterilizable, reusable, Pulsed Doppler pencil probe. It enables easy detection of blood flow in vessels of varying diameters, providing evidence of success in vascular reconstructive procedures, including skin grafting.

The IOP will be located on the surface of vessels to assist in the assessment of blood flow. The probe will not be inserted into vessels and does not contact circulating blood.

The IOP8 consists of a small diameter stainless steel tube and an interconnection cable. The tube houses a PZT crystal that is protected by a faceplate. A cable links the IOP8 probe tube to an interconnection adapter (designated PA8) that houses the bi-directional electronics. This adapter in turn connects to a main Doppler unit, which is required to drive the IOP8 / PA8 system.

A connector system at the end of the cable allows the IOP8 to be removed and externally sterilized before use. The interconnection adapter and main Doppler unit(s) are not sterilizable, and remain outside the sterile field.

The provided text is a 510(k) summary for the Huntleigh Healthcare Intra Operative Probe (IOP8). This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study against specific acceptance criteria for a new AI/diagnostic algorithm.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/diagnostic algorithm cannot be extracted from this document.

The document discusses the following:

1. Acceptance Criteria and Device Performance:

• This document does not specify quantitative acceptance criteria or detailed performance metrics in the way a clinical study for a diagnostic device often would.
• The primary "performance" discussed relates to the device's functional equivalence to a predicate device. The IOP8 is described as a "passive, self-contained, sterilizable, PW Doppler pencil probe" that "enables easy detection of blood flow in vessels of varying diameters."
• It states that the IOP8 and its associated PA8 Adapter are "only for use with Dopplex devices manufactured by Huntleigh Healthcare Ltd." and lists compatible control units (MD200, SD2, RD2, D900, MD2).
• The document implies that the device performs its intended function of detecting blood flow, similar to its predicate device, the Dopplex Surgical Probes (DSP) (specifically the IOP10A model).

2. Study Details (for demonstrating substantial equivalence, not a new performance study):

• Sample size for test set and data provenance: Not applicable. The document describes a comparison to a predicate device, not a new clinical study with a test set of patient data.
• Number of experts and qualifications for ground truth: Not applicable. Ground truth for a clinical study is not established here.
• Adjudication method for test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This document is not a report of an MRMC study.
• Standalone performance: The device itself is a probe, so standalone performance is inherent in its function when connected to the listed Doppler units. No separate "algorithm-only" performance is discussed as it is a hardware device.
• Type of ground truth used: Not applicable in the context of typical diagnostic algorithm studies. The "truth" being established here is substantial equivalence to a legally marketed predicate device.
• Sample size for training set: Not applicable. There is no mention of a training set as this is a hardware device submission, not an AI/software algorithm.
• How ground truth for training set was established: Not applicable.

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This product will be used to detect fetal heartbeats to help determine fetal viability.

OB1 Obstetrical Doppler is a handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats. There are only four user controls; Up and Down audio volume, Freeze Display, and Power On/Off. A three inch loudspeaker provides good Doppler audio. A digital LCD readout shows the fetal heart rate when it is stable for three or four seconds.

The provided text is a 510(k) summary for the OB1 Obstetrical Doppler, a handheld fetal Doppler. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting their device is as safe and effective as devices already on the market, rather than conducting a de novo study to establish new performance metrics against specific acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the document. A 510(k) submission for this type of device typically relies on demonstrating that the new device performs similarly to predicate devices, rather than setting and meeting specific, quantifiable acceptance criteria in a dedicated performance study. The "Technology Summary" states, "Recursive filter techniques are used to detect the fetal heart rate displayed on the digital readout. This achieves similar results as the techniques (not published) in the predicate devices." This implies performance is judged by its similarity to existing, cleared devices.

2. 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 document. Since a specific performance study with a test set is not described, these details are not provided.

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):

This information is not present in the document. As no specific test set or ground truth establishment process is described, this data is unavailable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not present in the document.

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:

This information is not present in the document. An MRMC study is not mentioned. Also, this device is a handheld fetal Doppler, not an AI-assisted diagnostic tool for "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply directly to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not present in the document. The OB1 Obstetrical Doppler is described as a "handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats." It's a direct-use device, and the concept of an "algorithm only" performance study in the context of AI is not relevant here. Its performance would be assessed through its ability to detect fetal heartbeats and display the rate, likely compared to known standards or predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not present in the document. For a device like this, the "ground truth" for basic function would typically involve physical measurements (e.g., accuracy of heart rate detection against a known signal generator or a highly accurate reference method) rather than a clinical ground truth like pathology.

8. The sample size for the training set:

This information is not present in the document. This type of device relies on established Doppler ultrasound technology and recursive filter techniques, not machine learning or AI models that require a training set in the conventional sense.

9. How the ground truth for the training set was established:

This information is not present in the document for the reasons explained in point 8.

Summary regarding the provided text:

The 510(k) summary for the OB1 Obstetrical Doppler demonstrates substantial equivalence to predicate devices (Huntleigh Dopplex II, Medasonics Cadance, Summit LifeDop). The "technology summary" highlights that its Doppler ultrasound technology and recursive filter techniques achieve "similar results" to these predicate devices. The review process involved assessing device features, materials, intended use, and performance characteristics in comparison to these already-cleared devices, as is standard for 510(k) submissions.

The clearance letter also mandates a post-clearance special report containing "complete information, including acoustic output measurements based on production line devices." This indicates that quantifiable performance data (specifically acoustic output) was required, but this is a post-market requirement to ensure the manufactured devices conform to the design, not a pre-market study establishing acceptance criteria in the manner you've described for a diagnostic AI device.

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The Babycom™ is meant to be applied to a woman's abdomen during pregnancy in order to measure the fetal heart rate (FHR) as a general indicator of fetal well-being.

The Babycom™ is a fetal ultrasonic heart rate monitor that is designed to transmit and receive ultrasonic energy into and from a pregnant woman by means of continuous wave doppler echoscopy. The Babycom™ is used to represent the fetal heart rate in an immediately perceptible form, i.e., a digital display of the rate in beats per minute (bpm) and by an audible beating signal of the same rate. The Babycom™ includes a transducer module for transmitting and receiving ultrasound signals and a signal analysis, control and display module, that we refer to as the base, that carries out all the other Babycom™ functions. The Babycom™ measures the fetal heart rate by determining the doppler shift between the transmitted and received signals.

The provided text describes the K013547 submission for the Babycom™ fetal ultrasonic heart rate monitor. However, it does not contain specific information regarding a detailed study with acceptance criteria or performance metrics for the device.

The document states: "The differences between the Babycom™ and the predicate device [Fetal Dopplex II] raise no new issues of safety or effectiveness." This implies that the device's safety and effectiveness were primarily established by demonstrating substantial equivalence to a legally marketed predicate device, rather than through a new, comprehensive clinical performance study with defined acceptance criteria.

Therefore, I cannot provide the detailed information requested in your prompt based on the provided text alone. The text focuses on the regulatory submission process and the determination of substantial equivalence.

If this information were available in the text, it would typically be found in sections describing performance testing, clinical data, or preclinical studies.

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