Search Results

Replacement battery pack for MARQUETTE MAC 8, MAC PERSONAL & MAC STRESS This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Replacement battery for Marquette Mac8, and Mac Stress

The provided text is an FDA 510(k) clearance letter for a replacement battery pack. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. Therefore, I cannot generate the requested table and study details.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the clearance is based on substantial equivalence to existing devices, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria for a novel device or AI algorithm.

Ask a specific question about this device

Replacement battery pack for MARQUETTE EAGLE MONITOR MODEL 4000 This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Replacement battery pack for MARQUETTE EAGLE MONITOR MODEL 4000

This document is an FDA 510(k) clearance letter for a replacement battery pack for a Marquette Eagle Monitor. It does not contain any information about acceptance criteria, device performance, study details, or ground truth related to an AI/ML powered device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval for a replacement part, not the performance of an AI system.

Ask a specific question about this device

Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Replacement battery pack for SHERWOOD 224, 324 FEEDING PUMP & SHERWOOD K524 INTRI-FLUSH

This document is a 510(k) premarket notification approval letter for a replacement battery pack. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot generate the requested information based on the provided text.

Ask a specific question about this device

Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Medfusion 2001 & 2010 replacement battery pack:

Based on the provided FDA 510(k) letter (K012259), the primary "study" performed is a demonstration of substantial equivalence to a legally marketed predicate device. This is a regulatory pathway for low-to-moderate risk medical devices and does not typically involve the detailed performance studies common for novel devices or AI/ML-driven software.

Therefore, many of the requested categories (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training sets) are not applicable in the context of this 510(k) submission for a replacement battery pack, as it is a component demonstrating substantial equivalence rather than a novel diagnostic or therapeutic device.

The "acceptance criteria" here are largely implicit in the FDA's decision about substantial equivalence, meaning the new device performs as safely and effectively as a predicate device without raising new questions of safety or effectiveness. For a battery pack, this mainly revolves around physical specifications, electrical compatibility, and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The letter explicitly states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the core "acceptance criteria" and "performance" in this context. The detailed technical specifications that support this substantial equivalence are not contained within this letter.

2. Sample size used for the test set and the data provenance

• Not Applicable. The provided document is an FDA clearance letter for a 510(k) submission based on substantial equivalence for a replacement battery pack. This pathway typically does not involve clinical "test sets" in the way a diagnostic AI/ML device would. The "tests" performed would be engineering bench tests for compatibility, electrical performance, and safety, comparing the new battery to the original or predicate battery. The details of these tests (sample sizes, specific data provenance) are not included in this summary letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. As above, the concept of "ground truth" and expert adjudication for a battery pack's performance is not relevant in the way it is for diagnostic algorithms. Engineering and safety testing typically relies on validated measurement instruments and standards.

4. Adjudication method for the test set

• Not Applicable. See points 2 and 3.

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 is a replacement battery pack, not an AI-driven device.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used

• Not Applicable. For a battery pack, "ground truth" would be established by objective physical and electrical measurements against predefined specifications and existing predicate device performance, not expert consensus or pathology.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" as it is not an AI/ML device.

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

• Not Applicable. See point 8.

Ask a specific question about this device

Replacement battery pack for BAXTER AS40A & AS41 SYRINGE PUMP This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above

Replacement battery pack for BAXTER AS40A & AS41 SYRINGE PUMP

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a replacement battery pack, and it does not contain the details required to answer your request.

Ask a specific question about this device

Replacement battery pack for SCALE-TRONIX MODEL 48, 2001, 2009, 2700, 3003, 4004, 4800, 5005, 5700, 6006, 6500, 6700, 6006C & 20009 SCALES

Replacement battery pack

Unfortunately, this document is a 510(k) premarket notification letter from the FDA regarding a replacement battery pack for medical scales.

It does not contain any information about acceptance criteria, device performance during a study, or the details of any clinical or performance studies. The letter primarily focuses on the FDA's "substantial equivalence" determination to a legally marketed predicate device, allowing the manufacturer to market the product.

Therefore, I cannot provide the requested information from this document. I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification, to answer your questions thoroughly.

Ask a specific question about this device