(43 days)
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.
§ 886.4750 Ophthalmic eye shield.
(a)
Identification. An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.(b)
Classification. Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.