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The Spectra Cashmere breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra Cashmere breast pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

The Spectra Cashmere is a powered breast pump intended to express and collect milk from the breasts of lactating women. Two models are available:

• Model MM010035 is the retail model, which includes the breast pump Part # IMP-0034, double collection kit, ac adapter, and 2 collection bottles.
• MM010035-H is multi-user hospital grade model, which includes the breast pump . Part # IMP-0034 and ac adapter only.
  The Spectra Cashmere component(s) consist of:
• Spectra Cashmere pump with ABS housing, .
• Breast shield set, includes polypropylene flange (size 20, 24, 28 and 32 mm), . backflow protector, valve, tubing,
• 12V AC power adapter, ●
• Bottle set (bottle, nipple, cap, disk, cover). .
  Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to select one or both sides for pumping, to switch from massage mode to expression mode and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 5 cycling speed options, while expression mode has 15 suction levels and 5 cycle speed levels.
  The Spectra Cashmere includes a diaphragm pump using two motors, one for each breast, to generate vacuum for breastmilk expression. Backflow protection is provided by the breast pump set's backflow protector. The silicone membrane backflow protector serves as a barrier between the breast shield and collection bottle (user side) and the tubing connected to the pump (pump side) to prevent the introduction of any fluids into the tubing or the pump's housing, thus preventing cross-contamination between users.
  The Spectra Cashmere breast pump is capable of providing vacuum levels from 50-270 mmHg with cycling rates up from 38 to 76 cycles per minute. The Spectra Cashmere breast pump is powered by a 12V DC adaptor.
  The Spectra Cashmere breast pump is a non-sterile device intended for repeated use by multiple users in a hospital setting. It is also intended for repeated use in the home use by a single user.
  Kits used with the Spectra Cashmere are intended for a single user in either the home or hospital environment. The polypropylene breast shields used with the Spectra Cashmere breast pump have direct contact with the user's intact skin. Contact duration is prolonged considering cumulative use of the device.
  The Spectra Cashmere breast pump includes software.

It appears there's a misunderstanding regarding the provided document. The submitted text is a 510(k) premarket notification for a breast pump, the Spectra Cashmere. It is not a document describing a study on an AI/ML-driven medical device, nor does it contain acceptance criteria or performance data related to AI/ML algorithms, expert ground truth, or MRMC studies.

Therefore, I cannot provide the detailed information requested in your prompt based on the given text. The document focuses on demonstrating substantial equivalence of the Spectra Cashmere breast pump to a predicate breast pump (Spectra S3 Plus) in terms of its mechanical and electrical function, rather than an AI's diagnostic or predictive performance.

However, I can still extract information related to the device itself and its non-clinical testing for completeness.

Here's what I can tell you about the Spectra Cashmere breast pump based on the provided document:

Device Description:

• Device Name: Spectra Cashmere
• Common/Usual Name: Breast Pump
• Regulation Number: 21 C.F.R. § 884.5160
• Regulatory Class: Class II
• Product Code: HGX
• Indications for Use: To be used by lactating women to express and collect milk from their breast. Intended for multiple users in a hospital setting and for home use by a single user.
• Key Features:
  • Powered breast pump with a diaphragm pump using two motors (one for each breast) for independent control of vacuum.
  • Backflow protection provided by a silicone membrane backflow protector.
  • Massage mode (5 suction levels, 5 cycling speed options) and Expression mode (15 suction levels, 5 cycle speed levels).
  • Vacuum levels: 50-270 mmHg.
  • Cycling rates: 38-76 cycles per minute.
  • Software included (though no details on its function beyond controlling the pump settings).

Non-Clinical Performance Testing (not AI/ML related):

1. Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria in a quantitative table format related to AI performance. Instead, it states that the device "complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and usability" and that "The Spectra Cashmere breast pump performed equivalently to predicate Spectra S3 Plus breast pump in all test cases."

2. Sample Size and Data Provenance: Not applicable for an AI/ML study. The testing described is for the mechanical and electrical performance of the breast pump. The document mentions "Tests were conducted for 20 minutes to simulate a typical pumping session." No 'data provenance' in the sense of patient data is relevant here.

3. Number of Experts and Qualifications: Not applicable. This is not an AI/ML diagnostic or predictive device.

4. Adjudication Method: Not applicable.

5. MRMC Comparative Effectiveness Study: Not applicable. This is not an AI/ML device that assists human readers.

6. Standalone Performance: The non-clinical performance testing described seems to be a standalone evaluation of the pump's physical and electrical characteristics (vacuum, cycles, safety, EMC).

7. Type of Ground Truth: Not applicable in the context of an AI/ML device. For a breast pump, "ground truth" would be its physical specifications and operation according to engineering and safety standards.

8. Sample Size for Training Set: Not applicable. This refers to software verification and validation, not training an AI model.

9. How Ground Truth for Training Set was Established: Not applicable for an AI/ML model. For the breast pump's software, it states: "Software verification and validation testing verified each output generated by the software and validated that the software performs in a manner that meets the user needs and intended use."

In summary, the provided text describes the regulatory clearance of a standard medical device (a breast pump) and its non-clinical performance testing against safety and engineering standards, not the performance evaluation of an AI/ML medical device.

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