(163 days)
HM-LAMP II is a device intended to be used to provide visible illumination of the surgical/field or the patient. They are designed for minor surgical procedures.
The HM-LAMP II Series are operating lamps with high performance. Flexible movement arm and mobile stand. Designed for minor surgical procedures as well as additional operating room needs.
This document, K100234, is a 510(k) summary for a surgical lamp (HM-LAMP II Series). It demonstrates substantial equivalence to a predicate device, rather than providing a study with acceptance criteria for device performance. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of submission.
Here's an breakdown of the information that can be extracted and a clear indication of what is not applicable or not provided in this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria for device performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (ST. FRANCIS OPERATING THEATRE LAMPS, K003423). The comparison is primarily qualitative, stating that the devices are used in "exactly same manner" and both provide "excellent visible illumination." The only specific differences mentioned are "Weight and Dimension only."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study data is provided. This type of 510(k) submission generally relies on comparisons to the predicate device's established safety and effectiveness, conformity to recognized standards, and design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no test set requiring ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable, as no test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC study was conducted or reported in this 510(k) summary.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable, as this is a medical device (surgical lamp), not an AI algorithm.
7. The Type of Ground Truth Used
Not applicable, as no specific clinical or performance study requiring ground truth is detailed. The "ground truth" for this submission is based on the predicate device's established safety and effectiveness, and the device's adherence to relevant standards.
8. The Sample Size for the Training Set
Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is a physical medical device.
Summary of available relevant information from the document:
- Device Name: HM-LAMP II Serie (Hill-Med)
- Classification Name: Lamp, Surgical (Class II, Regulation # 878.4580, Product Code: FTD)
- Predicate Device: ST. FRANCIS OPERATING THEATRE LAMPS, K003423
- Intended Use: To provide visible illumination of the surgical field or the patient, designed for minor surgical procedures.
- Performance Standards: The device complies with ISO 9001-2000, CE, and ISO 13485. (These are quality management system and safety standards, not performance criteria for a specific clinical outcome).
- Comparison to Predicate: Used in the exact same manner, provides excellent visible illumination. Main differences are Weight and Dimension.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.