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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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The DVT60 Compression Sleeve is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.

The DVT60 Compression Sleeves are single chamber inflatable cuffs, designed to fit around a patient's calf. They are used with the Huntleigh Flowtron Excel and Universal Pumps. When inflated, they compress the veins in the calf and expel blood out of the leg, promoting circulation and overcoming stasis.

Here's an analysis of the provided text regarding the DVT60 Limb Compression Sleeves, focusing on acceptance criteria and the supporting study:

The provided text does not contain a traditional set of acceptance criteria with quantitative metrics or a detailed study report comparing the DVT60 against specific, pre-defined performance thresholds. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Huntleigh Healthcare DVT10) through functional equivalence in inflation performance.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) submission, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device. The "reported device performance" is a comparative statement.

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

• Sample Size: The text states, "The sleeves are tested by fitting to a subject's calf..." This implies at least one subject, but a specific number is not provided. This is common for this type of equivalence testing which might involve a small number of healthy volunteers for physiological measurements.
• Data Provenance: Not explicitly stated in terms of country of origin. The testing is described as "non-clinical outcome, inflation performance testing," which strongly suggests a prospective study (i.e., conducted specifically for this submission).

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable/not mentioned. Ground truth in this context isn't established by expert consensus on clinical images or diagnoses. Instead, the "ground truth" (or performance measure) is the physiological measurement of blood flow velocity.
• Qualifications of Experts: Not applicable/not mentioned. The testing involves measuring a physiological parameter rather than expert interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not mentioned. Since the performance metric is a direct physiological measurement (blood flow velocity), expert adjudication of results, in the sense of resolving discrepancies between multiple expert opinions, is not relevant. The measurements would be taken by trained personnel using appropriate equipment.

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

• No, an MRMC comparative effectiveness study was not done.
• The device is a limb compression sleeve, not an imaging or diagnostic AI device that would typically involve human reader performance. The evaluation focuses on the physiological effect of the device on blood flow.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This is a physical medical device (compression sleeve), not a software algorithm. Its "performance" is its mechanical action and physiological effect on the human body.

7. Type of Ground Truth Used

• Physiological Measurement Data: The "ground truth" for the test set is established by direct physiological measurement of "the increase in velocity of the blood flow in the veins during compression" on "a subject's calf."

8. Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

• Not applicable. As there is no training set for this device, this question is not relevant.

In summary: The K022786 submission for the DVT60 Limb Compression Sleeves relies on demonstrating substantial equivalence to a predicate device (DVT10) through non-clinical functional performance testing. The "study" involves measuring physiological blood flow velocity increase in subjects wearing the sleeves and confirming its similarity to the predicate device. This is a common approach for Class II devices where a direct comparison to a previously cleared device's functionality is sufficient to establish safety and effectiveness.

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The STS system is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.

The STS range of sleeves, are three chamber graduated, sequential compression sleeves, to be used in conjunction with the Huntleigh AC600 Flowtron Universal pump (K010744). The STS range of compression sleeves consist of two sheets of PVC laminate materials welded together to form three chambers. The size and shape of these chambers are similar to the predicate device, as is the method of fitting to the patient's limb. On the proposed device, a single tube into the lower chamber inflates the complete sleeve. proposed devices and gradient inflation of the middle and upper chambers is achieved by a series of bleed channels between chambers and bleed orifices to atmosphere. On the predicate device, the material in contact with the patient's skin is non-woven fibre. The STS has a layer of polyester foam against the patient's skin, identical in composition to other approved Huntleigh sleeves. The systems have similar fault alarms, i.e. low pressure, blocked/kinked tubes, and system faults.

The provided text describes a 510(k) premarket notification for STS Compression Sleeves, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as would be found for an AI/ML-based device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets is not applicable in this context. The document describes a non-clinical equivalence testing rather than a clinical study or a study validating an AI/ML algorithm.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly defined with quantitative acceptance criteria and performance statistics as would be for an AI/ML device.

The determination of substantial equivalence for this device is based on non-clinical, inflation performance testing. The acceptance criterion implicitly is that the Huntleigh STS compression sleeves demonstrate similar inflation performance (pressure/time cycle) to the predicate device.

• Pressures in each chamber are similar.
• Compresses a similar area of the patient's limb.
• Made from similar materials. |

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

• Sample Size: Not specified quantitatively. The text states "The sleeves are tested by fitting to a subject's limbs," implying at least one subject, but no specific number is given.
• Data Provenance: The testing appears to be internal to Huntleigh Healthcare, Inc. The country of origin of the data is not specified, but the company is based in the USA (New Jersey). The testing is prospective for the purpose of this 510(k) submission, as it was performed to support the new device.

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

Not applicable. There is no "ground truth" in the sense of expert medical diagnosis or labeling for this type of device. The assessment is based on physical performance comparisons to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described for this non-clinical performance test. The comparison is objective (inflation metrics) against a predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/ML device, nor a diagnostic device that would typically involve human readers. Therefore, an MRMC study is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device (compression sleeves), not an algorithm or AI/ML product.

7. The Type of Ground Truth Used

Predicate Device Performance Data. The "ground truth" (or more accurately, the comparator) for determining equivalence is the established performance characteristics (inflation pressure/time cycles) of the legally marketed predicate device, the Kendall SCD Therapeutic System (K890938).

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not applicable. There is no training set for this device.

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The Baby Dopplex® 4000 is a fetal monitor, which produces CTG's and gives indication of uterine activity by processing received ultrasound/electrical signals.

In basic format, the device performs antepartum fetal monitoring and uterine activity functions.

Connecting separate modules to the Baby Dopplex® 4000 main unit allows it to perform Intrapartum monitoring operations.

In instances of twin presentations, two basic Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

The BD4000 is a fetal monitor, which produces cardiotocographs (CTG) and gives indication of uterine activity by processing received ultrasound/electrical signals. In basic format, the device performs antepartum fetal monitoring and uterine activity functions. Connecting separate modules to the BD4000 main unit allows it to perform Intrapartum monitoring operations.

In instances of twin presentations, two Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

The complete BD4000 system has been tested to ensure compliance with internationally recognised medical electrical equipment standards. Tests have been performed in accordance with the requirements of IEC601-1. BS EN60601-1. UL2601-1. BS EN 60601-1-2. BS EN55011 & DIN VDE 0750-1. A checklist of Essential Requirements tests has been compiled in accordance with the direction of the Medical Devices Directive 93/42/EEC. Biocompatability has been assessed in line with the principles contained within BS EN30993-1 & ISO10993-1.

The provided document (510(k) summary for the Baby Dopplex® 4000) focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use and compliance with general medical device standards. It does not contain information about specific clinical studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies that are typically associated with performance evaluation of new medical devices.

Therefore, most of the requested information cannot be extracted from this document.

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

1. A table of acceptance criteria and the reported device performance

• Not Available: The document does not specify quantitative acceptance criteria or detailed performance metrics from a study demonstrating the device meets those criteria. It focuses on functional equivalence to predicate devices and compliance with safety standards (IEC601-1, BS EN60601-1, UL2601-1, etc.).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available: No clinical or performance study details are provided, so no information on sample size or data provenance is available.

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)

• Not Available: Since no specific test set or clinical study is described, there's no mention of experts establishing ground truth.

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

• Not Available: No test set or related adjudication method is mentioned.

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

• Not Applicable/Not Available: The Baby Dopplex® 4000 is a fetal monitor that processes ultrasound/electrical signals for cardiotocographs (CTG) and uterine activity. It is not an AI-assisted diagnostic tool that involves human readers interpreting images, so an MRMC comparative effectiveness study in the context of "human readers improve with AI" is not relevant to this device. No such study is mentioned.

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

• Not Available: The document describes the device's functionality and its equivalence to predicate devices but does not detail any standalone algorithm performance studies. The device itself is a standalone monitor, but the request refers to performance studies of an algorithm.

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

• Not Available: No specific ground truth methodology for performance evaluation is described.

8. The sample size for the training set

• Not Applicable/Not Available: This device is not described as an AI/ML device that requires a training set in the conventional sense. The "training set" concept is typically associated with AI model development, which is not discussed for this fetal monitor.

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

• Not Applicable/Not Available: As with point 8, this is not relevant to the described device.

Information provided in the document related to "acceptance criteria" and "study":

The document primarily focuses on compliance with international safety and electrical standards as its "acceptance criteria" for market clearance:

• Acceptance Criteria (as implied by compliance testing):

  • Compliance with IEC601-1 (medical electrical equipment general requirements)
  • Compliance with BS EN60601-1
  • Compliance with UL2601-1
  • Compliance with BS EN 60601-1-2 (electromagnetic compatibility)
  • Compliance with BS EN55011 (industrial, scientific and medical (ISM) radio-frequency equipment)
  • Compliance with DIN VDE 0750-1
  • Compliance with Medical Devices Directive 93/42/EEC (Essential Requirements checklist)
  • Biocompatibility assessed in line with BS EN30993-1 & ISO10993-1.

• "Study" (as implied by the document): The document states:

  • "The complete BD4000 system has been tested to ensure compliance with internationally recognised medical electrical equipment standards."
  • "Tests have been performed in accordance with the requirements of IEC601-1. BS EN60601-1. UL2601-1. BS EN 60601-1-2. BS EN55011 & DIN VDE 0750-1."
  • "A checklist of Essential Requirements tests has been compiled in accordance with the direction of the Medical Devices Directive 93/42/EEC."
  • "Biocompatability has been assessed in line with the principles contained within BS EN30993-1 & ISO10993-1."

In summary, the provided 510(k) document is a regulatory submission for substantial equivalence based on technical specifications and compliance with general safety standards, not a detailed clinical performance study with specific acceptance criteria as you've outlined for AI/diagnostic devices.

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Venous photoplethysmography and bi-directional Doppler for venous and arterial vonous protoproxity and for screening for the absence of deep venous thrombosis (DVT) in the lower limb.

Not Found

This 510(k) submission describes the expansion of indications for use for the Rheo Dopplex® II device to include "screening for the absence of deep venous thrombosis (DVT) in the lower limb." The provided documents contain a summary of the clinical study conducted to support this new indication.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific acceptance criteria for sensitivity, specificity, and predictive values. However, it reports the device performance in these metrics. Without explicitly stated acceptance criteria, it's impossible to determine if the reported device performance met predefined targets. The reported values are presented as descriptive statistics from the study.

Note: The low specificity and positive predictive value (PPV) might be a concern in some contexts, but without explicit acceptance criteria, it's difficult to comment on whether these values were considered acceptable by the regulatory body for the intended use of screening for the absence of DVT. High sensitivity and NPV are often prioritized for screening devices where missing a condition could have severe consequences.

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

The provided text does not specify the sample size used for the test set in the clinical studies.

The data provenance is also not explicitly stated (e.g., country of origin). The studies are described as "Clinical data to support this expanded Indications for Use," implying they were conducted to gather evidence for this specific submission. It is not mentioned whether the studies were retrospective or prospective.

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

The document states that the clinical data included "studies comparing the Rheo Dopplex® II with duplex imaging and venography for the confirmation of the absence of a DVT in the lower limb."

• Ground Truth Modalities: Duplex imaging and venography are mentioned as the reference standards for DVT confirmation.
• Number of Experts: The number of experts involved in interpreting the duplex imaging and venography results, or in establishing the ground truth, is not specified.
• Qualifications of Experts: The qualifications of any experts involved are not specified.

4. Adjudication Method for the Test Set

The adjudication method for establishing the ground truth from duplex imaging and venography is not described in the provided text.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The Rheo Dopplex® II is a device for physiological measurement (venous photoplethysmography and bi-directional Doppler), not an AI-powered diagnostic imaging system that aids human readers in image interpretation. Therefore, this type of study would not be applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The performance metrics (Sensitivity, Specificity, NPV, PPV) described are for the standalone performance of the Rheo Dopplex® II device. The clinical data directly compares the device's output to established reference standards (duplex imaging and venography) for DVT confirmation. There is no indication of a human-in-the-loop component in how these performance metrics were derived.

7. Type of Ground Truth Used

The ground truth used was established by referencing duplex imaging and venography. These are established clinical diagnostic methods used for confirming the presence or absence of deep venous thrombosis.

8. Sample Size for the Training Set

The document does not mention a "training set". Given that the Rheo Dopplex® II is a physiological measurement device and not described as an AI/ML-based system, the concept of a separate "training set" and "test set" in the context of machine learning model development is likely not applicable here. The "clinical data" described would typically refer to data used for validation/testing of the device's performance against a reference standard.

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

As stated above, a "training set" is not referenced for this device. The ground truth for the clinical studies (validation/testing) was established using duplex imaging and venography.

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