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Nature's Bond breast pump is a single user device intended for lactating women to express and collect milk from their breasts to complement breast feeding.

The Nature's Bond series of breast pumps are electriconically powered suction devices used to express and collect breast milk from lactating mothers. The Nature's Bond series is comprised of two pumps, the model 600 and the model 603. The Nature's Bond breast pump system consists the pump, breast shields, tubing, power cord, bottle and cap, valve, and carrying bag exclusively for the model 603.

All available accessories are included in the Nature's Bond 600/603 package. Customers may purchase additional accessories if needed. Below is a list of all accessories included in the package:

• . 2*80mm Breast Shield
• 2*76mm Breast Shield ●
• 2*74mm Breast Shield .
• 2*Bottle .
• 2*Valve .
• . 1*Tubing

Both models of the Natuer's Bond breast pump is a software driven pump made from plastic. The details of the materials can be found in the bill of material. The pump can provide a pressure range from 0 mmHg to 206 mmHg. The model 603 has battery power (6 AA batteries) while the model 600 is only AC powered. While in using, the breast shields are in contact with human body. The device is design to be used by a single patient through one lactating period.

The device is designed for home use and is non-sterile.

Both pumps are the same in operation, use and design with the exception that the model 603 has the option to be battery powered. The pump provides intermittent suction in 6 different vacuum pressure settings to the breast to stimulate milk expression. The breast shields provide a seal around the breast to facilitate the suction. The bottles and caps are used to collect and store the milk. The tubing is used to connect the pump to the shields. The carrying bag is used to store all components when not in use.

The provided text is a 510(k) summary for a breast pump, "Nature's Bond 600" and "Nature's Bond 603". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria based on clinical outcomes or a novel performance metric.

Therefore, the requested information, specifically acceptance criteria and a study proving the device meets those criteria, is not present in the document in the context of advanced AI/CAD system evaluation. The document describes performance testing performed to show comparability with the predicate device, which is a different type of evaluation.

However, I can extract information related to the device's technical specifications and how its performance was compared to a predicate device, which are analogous to certain aspects of acceptance criteria and performance reporting.

Here's what can be extracted and how it relates to your request:

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

The document doesn't define explicit "acceptance criteria" in the sense of a clinical diagnostic study with sensitivity, specificity, etc. Instead, it relies on demonstrating substantial equivalence to a predicate device through technological characteristic comparison and bench testing.

The "study that proves the device meets the acceptance criteria" in this context is the Performance Testing described, which aimed to show the Nature's Bond 600/603 is substantially equivalent to the predicate device.

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

• The document describes bench and laboratory testing. This type of testing typically does not involve human subjects or patient data.
• No sample size for a test set is mentioned because no clinical or human-subject study using a "test set" in the context of AI evaluation was performed. The "tests" refer to engineering and regulatory compliance assessments.
• Data provenance is not applicable, as it's not a data-driven AI study.

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 applicable. No ground truth in the sense of expert consensus for diagnostic accuracy was established as this is a mechanical breast pump, not an AI diagnostic device. The "ground truth" for compliance would be the technical specifications and regulatory standards.

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

• Not applicable. No clinical test set or adjudication was performed.

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. This device is a breast pump, not an AI/CAD system, therefore, no MRMC study was conducted.

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

• The device is a breast pump. While it has software, it is a physical product directly performing a function (milk expression). There is no "standalone algorithm" in the typical AI sense. The performance testing (e.g., pressure test, battery depreciation test) can be considered "standalone" in that they evaluate the device's technical functioning independent of a user, but this is a different context than AI performance.

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

• The "ground truth" for this submission are the technical specifications of the device itself, relevant engineering standards (e.g., IEC, ISO), and FDA regulations (e.g., 21 CFR). The performance tests verify that the device operates according to its design specifications and complies with these standards and regulations.

8. The sample size for the training set

• Not applicable. This document is for a physical medical device (breast pump), not an AI algorithm requiring a training set.

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

• Not applicable. See point 8.

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The extriCARE 2400 Negative Pressure Wound Therapy Pump System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.

The system consists of a vacuum pump, canister, and tubing. In operation, the device is attached via the tubing to a Negative Pressure Wound bandage. Maximum pressure and mode selection are digitally programmable. The extriCARE pump can be sold alone or as a part of the extriCARE 2400 system with extriCARE bandages. The extriCARE bandages are an all-in-one wound dressing, with no wound packing required.

The provided text describes the extriCARE 2400 Negative Pressure Wound Therapy System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria related to AI or a diagnostic performance claim.

Instead, the document focuses on:

• Device Description and Intended Use: Explaining what the extriCARE 2400 system is and what it's designed to do (generate negative pressure to remove wound exudates, infectious material, and tissue debris).
• Substantial Equivalence: Arguing that the device is technologically similar to existing predicate devices (NPD 1000, MobIVAC W.C., Renasys Gauze Dressing Kit).
• Performance Testing: Listing functional and mechanical tests (e.g., vacuum pressure calibration, flow rate, alarm verification, battery verification, exudate removal, bandage tests like peel strength, shear adhesion, leakage), and compliance with EMC and electrical safety standards (IEC 60601-1-2, UL 60601-1). These are engineering performance tests, not diagnostic accuracy studies.
• Biocompatibility Testing: Reporting results for tests on the bandage (Guinea Pig Maximization Sensitization, Cytotoxicity, Intracutaneous Irritation) to ensure it's safe for body contact.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study proving a device meets them, especially regarding diagnostic accuracy, AI performance, or MRMC studies, as this information is not present in the provided text.

Specifically, the following points from your request cannot be answered from the provided document:

1. A table of acceptance criteria and the reported device performance: While performance tests are listed, the acceptance criteria for these tests (e.g., "vacuum pressure must be within X% of target") are not explicitly stated, nor are the detailed quantitative results ("reported device performance") beyond "successfully passed" or "did not elicit sensitization/non-cytotoxic/non-irritant" for biocompatibility tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
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 applicable as this is not a diagnostic device or AI study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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