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510(k) Data Aggregation
(88 days)
NATIONAL HEALTHCARE MFG. CORP.
This kits are a convenience assemblage of sterile, disposable medical devices intended for use by trained physicians for various gynocological and obstetrical procedures. See the attached list of "Obstetrical and Gynecological Devices". NHMC does not cause or promote new intended uses for the devices within these kits.
The NHMC custom Ob/Gyn procedure trays or kits are sterile , disposable , medical device convenience kits. NHMC currently markets these kit in Canada as Vaginal Delivery Pack, C Section Pack, and others. These kits are custom to the customer, whose specifies the type and quantity of the materials to be included in the kit.
The provided text is a 510(k) summary for a medical device (National Healthcare Manufacturing Corp. Ob/Gyn Kit or Tray). It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the requested table or answer the specific questions about studies proving the device meets acceptance criteria.
The document focuses on establishing substantial equivalence based on material, packaging, sterilization, and intended use, rather than presenting performance data from studies against specific acceptance criteria.
Based on the provided text, the device is a medical convenience kit, and its approval process relies on demonstrating that its components are already legally marketed and that the assembly itself does not introduce new intended uses or technological characteristics that differ from predicate devices.
This type of device approval (via 510(k) for custom convenience kits) often doesn't involve the rigorous performance studies with acceptance criteria, sample sizes, and expert ground truth establishment that would be seen for a novel diagnostic or therapeutic device. The "proof" is demonstrating that the components are safe and effective, and the assembly maintains those characteristics.
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(43 days)
NATIONAL HEALTHCARE MFG. CORP.
These kits are a convenience assemblage of sterile, disposable, legally marketed medical devices intended for use by trained physicians for Healthcare Manufacturing ophthalmic surgical procedures. National Corporation does not cause or promote new intended uses for the devices within these kits.
The National Healthcare Manufacturing custom ophthalmic procedure trays or kits are sterile, disposable, medical device convenience kits. These kits are custom to the customer, whose specifications determine the devices included in the kit.
The provided document is a 510(k) summary for the National Healthcare Manufacturing Corp. Ophthalmic Kit or Tray, submitted to the FDA in 1997. This document details the device's classification, intended use, technological characteristics, and a list of components, primarily for the purpose of demonstrating substantial equivalence to a predicate device.
Crucially, this document is a regulatory submission for a medical device kit, not an AI/ML device. Therefore, the standard acceptance criteria and study descriptions typically associated with AI/ML device performance (like accuracy, F1-score, sample sizes for training/test sets, ground truth establishment by experts, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The "acceptance criteria" for a 510(k) submission for a non-AI medical device like this kit revolve around demonstrating substantial equivalence to a legally marketed predicate device, ensuring the device is safe and effective for its stated intended use. This is achieved through comparisons of materials, packaging, sterilization, and intended use, rather than performance metrics.
Based on the provided text, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device because the document describes a sterile, disposable ophthalmic procedure kit, not an AI/ML medical device.
However, I can extract information relevant to the device as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance (as applicable to a non-AI kit):
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device "Performance" / Characteristics |
|---|---|
| Substantial Equivalence to Predicate Device | The NHMC Custom Ophthalmic packs are "substantially identical in materials" to "The Nithous Custom Ophulanas Fpackaging, Trays legally marketed under K880961." The document states: "There are no differences in the characteristics of the subject device and the predicate." This is the primary "performance" metric for a 510(k) non-AI device. |
| Intended Use | "These kits are a convenience assemblage of sterile, disposable, legally marketed medical devices intended for use by trained physicians for Healthcare Manufacturing ophthalmic surgical procedures. National Corporation does not cause or promote new intended uses for the devices within these kits." The FDA's concurrence on this intended use is implicit in their approval letter. |
| Sterility | "The National Healthcare Manufacturing custom ophthalmic procedure trays or kits... are sterile, disposable..." This is a stated characteristic of the device. |
| Disposable Nature | "...disposable..." This is a stated characteristic of the device. |
| Device Components | The document provides a detailed list of components (e.g., cannula, towel cap, eye pad, various needles, gauze, syringes, drapes, etc.) indicating what is included in the kit. The "performance" here is that the kit contains the listed items suitable for ophthalmic procedures, matching or being equivalent to the predicate device in content. |
| Regulatory Classification | The devices within the kit are Class I and Class II. The FDA confirms the regulatory class for the submitted device (II) and the product codes (78 KKX, 86 HMX, 86 HOY, 86 HNM, 86 HQR). This is an "acceptance" criterion in the sense that the FDA confirms the appropriate regulatory pathway has been followed. |
| Compliance with General Controls | The FDA's letter states that marketing is "subject to the general controls provisions of the Act," including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. This is an ongoing "acceptance" requirement, verified through GMP inspections. |
The following numbered points cannot be answered from the provided text as they relate to AI/ML device studies, which are not described in this document.
- Sample sizes for the test set and data provenance: Not applicable.
- Number of experts and their qualifications for ground truth: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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(29 days)
NATIONAL HEALTHCARE MFG. CORP.
Not Found
Orthopedic Kit or Tray
I am sorry, but the provided text from the 510(k) summary (Attachment 1) does not contain information about acceptance criteria, device performance, clinical studies, sample sizes, ground truth, or expert involvement.
The document primarily focuses on:
- Submitter Information: Name and address of National Healthcare Manufacturing Corp. and their general manager.
- 510(k) Summary Preparer: Information about the consultant preparing the summary.
- Date Prepared: April 1, 1997.
- Device Name/Classification: Identifying the device as an "Orthopedic Pack, Tray, or Kit" and noting the absence of a specific classification name.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text.
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(36 days)
NATIONAL HEALTHCARE MFG. CORP.
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(47 days)
NATIONAL HEALTHCARE MFG. CORP.
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(58 days)
NATIONAL HEALTHCARE MFG. CORP.
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(20 days)
NATIONAL HEALTHCARE MFG. CORP.
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