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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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