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Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator, 510(k) Number 935674. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator.

The provided documents are a 510(k) clearance letter from the FDA for a replacement battery (LP9) and its "Indications for Use" statement. This type of document does not contain the detailed information necessary to describe acceptance criteria and a study that proves a device meets those criteria, especially for AI/ML devices.

The 510(k) clearance process for this device (a replacement battery) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves:

• Performance testing: Ensuring the battery meets the electrical and safety specifications equivalent to the original battery and the predicate.
• Material compatibility: Ensuring materials are appropriate for the intended use.
• Labeling review: Verifying that the labeling accurately reflects the device's intended use and contraindications.

Here's why the requested information cannot be fully provided from these documents:

• No AI/ML Component: The device is a replacement battery, which does not involve AI or machine learning. Therefore, concepts like "training set," "test set," "ground truth," "MRMC study," "human readers with/without AI assistance" are not applicable.
• Focus on Substantial Equivalence: The letter explicitly states that the device is "substantially equivalent" to predicate devices. This means its performance is compared to an existing device, rather than establishing novel acceptance criteria based on a new technology's performance.
• Lack of Detailed Study Report: The 510(k) clearance letter is an outcome document, not the detailed study report itself. It confirms the clearance but does not provide the specifics of the testing performed, sample sizes, or expert qualifications that would be found in the actual submission.

However, based on the general principles of medical device regulation and what can be inferred for a replacement battery, here's a conceptual outline of what one might expect for such a device, and why it's not present here:

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

Due to the nature of the provided documents (a 510(k) clearance letter), specific numerical acceptance criteria and reported performance values are not detailed. These would be found in the detailed test reports submitted to the FDA.

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

• Test Set Sample Size: Not specified in the provided document. For a battery, this would likely involve a statistically significant number of units (e.g., dozens to hundreds) to demonstrate consistent performance and safety.
• Data Provenance: Not specified. Typically, testing would be conducted in a controlled laboratory environment by the manufacturer or a certified testing house.

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

• Not Applicable: For a battery, "ground truth" isn't established by experts in the same way it is for diagnostic AI/ML. The "ground truth" is typically defined by objective electrical and safety standards (e.g., IEC, UL standards) and the specifications of the original device. Engineers and technicians perform the tests and verify adherence to these objective criteria.

4. Adjudication method for the test set

• Not Applicable: Adjudication is relevant for situations involving subjective interpretation (e.g., image reading). For objective performance tests of a battery, results are directly measured and compared against predefined specifications.

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 type of study is specifically for AI/ML diagnostic tools that impact human interpretation. A replacement battery has no such AI component.

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

• Not Applicable: The device is a physical battery, not an algorithm.

7. The type of ground truth used

• Objective Standards and Electrical Specifications: For a battery, the "ground truth" would be the documented electrical specifications (voltage, capacity, impedance, etc.) of the original battery and the Life-Pak 9 device, as well as adherence to relevant national and international safety standards (e.g., for lithium-ion batteries if applicable, even though specific chemistry isn't mentioned here).

8. The sample size for the training set

• Not Applicable: There is no "training set" as the device is not an AI/ML algorithm.

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

• Not Applicable: There is no "training set."

In summary, the provided FDA clearance letter for a replacement battery is not the type of document that would contain the detailed technical evaluation information asked for, particularly for AI/ML-related questions. The clearance is based on the battery's substantial equivalence in performance and safety to existing predicate devices, verified through standard engineering and safety testing.

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Replacement battery for Sabretek 6060 Homerun Volumetric Infusion Pump (K941984) (and other non-rechargeable 8.4 volt (9-volt) applications).

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

MC146X is a 8.4 volt/800 mAh battery pack which replaces Sabretek 6060 Homerun Volumetric Infustion Pump (K941984) and other 8.4 volt (9-volt) (K941984). applications battery

This document pertains to a 510(k) premarket notification for a battery, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, MRMC studies, standalone performance, training set, and ground truth establishment is not applicable to this submission.

The document is primarily focused on demonstrating substantial equivalence of the "Alexander Manufacturing Company battery Part Number MC146X" to a legally marketed predicate device (Sabretek 6060 Homerun Part Number Volumetric Infusion Pump battery K941984, and other 8.4-volt applications batteries).

The key elements discussed are:

• Device Description: MC146X is an 8.4 volt/800 mAh battery pack.
• Intended Use: Replacement battery for the Sabretek 6060 Homerun Volumetric Infusion Pump (K941984) and other non-rechargeable 8.4-volt (9-volt) applications.
• Substantial Equivalence: Claimed equivalence to the Sabretek 6060 Homerun Volumetric Infusion Pump battery (K941984) and other 8.4 volt (9-volt) applications batteries.
• Compliance: Alexander Manufacturing Company operates under 21 CFR Part 820 Good Manufacturing Practice for Medical Devices (GMP) and is ISO 9001 registered.
• Testing: "Testing data is located in Appendix C" (though Appendix C is not provided in the prompt). The document mentions the MC146X meets "all US Government ANSI/NEDA specs."

Without Appendix C, specific performance data or acceptance criteria related to battery function (e.g., voltage, capacity, cycle life, safety standards) cannot be detailed. However, the existing information does not describe an AI/ML-driven device or a study involving human readers or ground truth as typically understood in AI/ML performance evaluation.

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Replacement battery for Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor, 510(K) Number K862462. This battery is shipped only to customers who request a replacement battery for a particular device or to customers who specifically order this battery and therefore knows the intended use is as a replacement battery.

Replacement Battery Part Number H134

This document is an FDA 510(k) clearance letter for a replacement battery, part number H134, for the Nihon Kohden, Inc LifeScope 6 Portable Patient Monitor. It does not contain information related to acceptance criteria, study details, or performance metrics for an AI/device for diagnostic or clinical decision support purposes.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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Replacement battery for IVAC Corp. 124915 Electronic Clinical Thermometer 2000, 510(k) Number K820409.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Rechargeable Battery Part Number MS822

The provided document is a 510(k) clearance letter from the FDA for a replacement battery (Alexander Manufacturing Co. Rechargeable Battery Part Number MS822). This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies that would be relevant for a medical device with an algorithm or AI component.

This letter is a regulatory document confirming that the device is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics but raises no new questions of safety and effectiveness and is as safe and effective as a legally marketed device.

Therefore, I cannot provide the requested information based on the input document. The type of information you're asking for (acceptance criteria, study details, expert involvement, etc.) would typically be found in a detailed submission summary, clinical study report, or a performance testing document, not in the 510(k) clearance letter itself for a simple replacement battery.

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Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor, 510(k) Number K831232.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor, 510(k) Number K831232.

I apologize, but the provided text from the FDA 510(k) clearance letter for the GL825-200 replacement battery does not contain information about acceptance criteria or a study demonstrating device performance as it pertains to AI/ML software.

The document is a standard clearance letter for a medical device (a replacement battery) and focuses on the regulatory determination of substantial equivalence to a predicate device. It addresses:

• Device Name: GL825-200
• Intended Use: Replacement battery for Physio-Control 802565-01 Life Stat 200 Blood Pressure Monitor.
• Regulatory Classification: Class II
• Substantial Equivalence: A determination that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Responsibilities: Information regarding annual registration, good manufacturing practices, labeling, etc.

There is no mention of:

• Performance metrics (sensitivity, specificity, AUC)
• Sample sizes for test or training sets
• Ground truth establishment
• Expert review or adjudication
• Multi-reader multi-case (MRMC) studies
• Standalone performance studies

Therefore, I cannot fulfill your request to describe acceptance criteria and a study given the provided input. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) clearance letter.

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Replacement battery for IVAC Corp. 125053 630 Volumetric Infusion Purnp, Infu-Check #1500, 510(k) Number K790373. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Rechargeable Battery #M12/630

The provided text is a 510(k) premarket notification letter from the FDA regarding a replacement battery (Alexander Manufacturing Company Rechargeable Battery #M12/630). This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or AI assistance.

Therefore, I cannot fulfill your request for the requested information based on the provided text. The document is a regulatory approval letter for a medical device and does not detail the technical performance or validation studies of the battery itself.

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Replacement battery for Sonicaid 1000-0007 Fetal Monitoring System D205, 510(k) Number K780487. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Rechargeable Battery Part Number M007

This document is a 510(k) Premarket Notification from the FDA regarding a Rechargeable Battery Part Number M007 for a Fetal Monitoring System. It does not contain any information about acceptance criteria or a study proving device performance in relation to an AI/medical device.

The letter is a notification of substantial equivalence for a replacement battery, indicating that the FDA has determined the battery is substantially equivalent to devices marketed before May 28, 1976. This process is for device classification and market entry, not for performance evaluation against specific clinical acceptance criteria or a study with human subjects or AI algorithms.

Therefore, I cannot provide the requested information. The document pertains to regulatory approval of a hardware component (a battery) and not a software-based medical device with performance metrics related to diagnostic accuracy or human-AI interaction.

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Replacement battery for Physio-Control 800285-01 Life Pak 6 & 7 Monitor, 510(k) Number K810154. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Replacement battery for Physio-Control 800285-01 Life Pak 6 & 7 Monitor

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a replacement battery (LP6/100) for medical devices.

This document does not contain any information about acceptance criteria or a study proving the device meets those criteria for the battery. It is a regulatory approval letter stating that the device is substantially equivalent to a predicate device.

Therefore, I cannot provide the requested information based on the input text.

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Replacement battery for Ross Laboratories, Div. of Abbott Labs Flexiflo II Infusion Pump, 510(k) Number K821661. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.

Rechargeable Battery Part Number GL625

This document is solely a 510(k) clearance letter for a replacement battery, indicating its substantial equivalence to a previously marketed device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details that would allow for a discussion of AI performance or comparative effectiveness.

Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving device performance based on the provided text.

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Replacement battery for Corpak 415A R200, VTR300D Enteral Pump, 510(k) Number K832167. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore the intended use is as a replacement battery.

Rechargeable Battery Part Number MS3030P

This is a 510(k) clearance letter for a replacement battery, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable. The document confirms that the Alexander Manufacturing Company's Rechargeable Battery Part Number MS3030P is substantially equivalent to legally marketed predicate devices.

Here's how the provided information relates to the request, and why it doesn't fit the AI/ML device study format:

1. A table of acceptance criteria and the reported device performance: Not applicable. For a replacement battery, "performance" would relate to electrical characteristics and compatibility, which are demonstrated through testing to ensure the device meets specified standards and functions equivalently to the original or predicate battery. This document doesn't detail those specific tests or acceptance criteria as it's a clearance letter, not a test report.

2. Sample size used for the test set and the data provenance: Not applicable. For a battery, testing involves physical and electrical measurements, not data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of AI/ML refers to accurately labeled data. For a battery, validation relies on engineering specifications and laboratory testing by qualified technicians/engineers.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This method is used to reconcile differing expert opinions in AI/ML performance evaluation.

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. MRMC studies are specific to evaluating diagnostic systems used by human readers, often involving radiological or pathological images.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This concept applies to AI/ML algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a battery.

8. The sample size for the training set: Not applicable. Batteries are tested, not trained like an AI model.

9. How the ground truth for the training set was established: Not applicable.

Summary from the provided document:

• Device Name: Alexander Manufacturing Company Rechargeable Battery Part Number MS3030P
• Regulatory Class: II
• Product Code: MRZ
• Indications for Use: Replacement battery for Corpak 415A R200, VTR300D Enteral Pump, 510(k) Number K832167. Intended for customers requesting a replacement for a particular device or to replace a competitor's replacement battery.
• Substantial Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. This implies that the battery's design, materials, and performance characteristics are comparable to a predicate device, ensuring it functions safely and effectively for its intended use as a replacement.

The document is a clearance letter indicating that the battery has met the regulatory requirements for market entry based on substantial equivalence, which primarily involves demonstrating that it performs equivalently to a legally marketed predicate device. The detailed testing and acceptance criteria would have been part of the 510(k) submission, but are not explicitly detailed in this clearance letter.

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