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The Spectra Q is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Q is intended for home use by a single user.

The Spectra Q breast pump is comprised of a Spectra Q pump, breast shield (20, 24, 28, 32 mm), backflow protector, silicone valve, tubing, bottles (including the nipple, cap, cover, and disk), 2-wav connector (for double pumping), and power adapters. The breast pump is provided with one 24 mm and one 28 mm breast shield. Optional components include a small cap converter, assembled with the feeding bottle, the 20 and 32 mm breast shields, and a wide bottle stand. The Spectra Q breast pump is used by lactating women to express and collect milk from their breasts. The pump is intended for home use by a single user. Pumping with the Spectra Q breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). The Spectra O breast pump allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -50 to -270 mmHq with cycle rates up to 110 cycles per minute. The device is powered by a 6 V AC/DC power adapter or a 5 V USB C type power adapter. The device is provided non-sterile.

The provided text is related to the K191109 510(k) clearance for the Spectra Q breast pump. It describes the device, its intended use, and its substantial equivalence to a predicate device (Spectra 9Plus).

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML or diagnostic performance. The non-clinical tests mentioned are primarily related to:

• Electrical Safety/Electromagnetic Compatibility: Compliance with standards like AAMI / ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-1-11.
• Software Validation: In accordance with FDA Guidance for software in medical devices (May 11, 2005).
• Biocompatibility: Evaluation based on ISO-10993 and compliance of milk-contacting components with 21 CFR 177.1520, leveraging information from the predicate device.
• Bench Performance Testing: Confirming minimum/maximum vacuum levels and cycle rates, and demonstrating sustained specifications over its use life.

These tests are standard for a breast pump and focus on physical and electrical safety and performance parameters, not on the diagnostic accuracy or classification capabilities that would typically require the kind of "acceptance criteria" table and study details (sample size, ground truth, expert consensus, MRMC studies) you've requested.

Therefore, I cannot fulfill your request for the specific information regarding AI/ML device acceptance criteria and studies from this document. The document does not describe such a device or study.

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MIM software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical images. The medical image modalities include, but are not limited to, CT. MRI. CR. DX. MG. US. SPECT. PET and XA as supported by ACRNEMA DICOM 3.0. MIM assists in the following indications:

• · Receive, transmit, store, retrieve, display, print, and process medical images and DICOM objects.
• · Create, display and print reports from medical images.
• · Registration, fusion display, and review of medical images for diagnosis, treatment planning,
  · Evaluation of cardiac left ventricular function, including left ventricular end-diastolic volume, end-systolic volume, and ejection fraction.
  · Localization and definition of objects such as tumors and normal tissues in medical images.
  · Creation, transformation, and modification of contours for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transfering contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
  · Quantitative and statistical analysis of PET/SPECT brain scans by comparing to other registered PET/SPECT brain scans.
  · Planning and evaluation of permanent implant brachytherapy procedures (not including radioactive microspheres).
• · Post-treatment dose calculation of permanent Yttrium-90 (Y90) microsphere implants.
  Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Images that are printed to film must be printed using a FDA-approved printer for the diagnosis of digital mammography images. Mammographic images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images.

The software is not to be used for mammography CAD.

MIM - SPECTRA Quant is a feature of MIM. It is designed for use in medical imaging and operates on both Windows and Mac computer systems. MIM - SPECTRA Quant extends the functionality MIM - Y90 Dosimetry (K172218) software. The following functions have been added to allow quantitative reconstructions of Single Photon Emission Computed Tomography (SPECT) scans:

• Allows for decay correction of activity back to time of injection ●
• Allows for correction of photon attenuation ●
• . Allows for correction of photon scatter
• Allows for correction of collimator detector resolution effects ●
• Allows for camera sensitivity calibration providing output in Becquerels per ml (Bq/ml) .

Here's a breakdown of the acceptance criteria and study details for MIM - SPECTRA Quant based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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