(46 days)
The Illuminated Retractor is a manual surgical instrument with an integrated light source that will be sold separately as a single use only device. This can be used with the Knifelight to facilitate ligament or tissue division, or it can be used by itself to retract soft tissue.
The Stryker Illuminated Retractor is a manual surgical instrument with an integrated light source that will be sold separately as a single use only device. This can be used with the Knifelight to facilitate ligament or tissue division, or it can be used by itself to retract soft tissue.
The provided document, K981717, is a Premarket Notification 510(k) Summary for the Stryker Illuminated Retractor. This document primarily focuses on establishing substantial equivalence to previously marketed devices and does not contain detailed information about acceptance criteria, specific device performance studies, or quantitative results from such studies. Therefore, it is not possible to complete the requested table or answer most of the questions based solely on the provided text.
Here's an explanation of why and what information is missing:
Explanation Regarding Missing Information:
The document explicitly states: "The Stryker Illuminated Retractor is equivalent to existing marketed products by companies such as Ruggles and Stryker. Intended use, function, and safety risks are all substantially equivalent." and "The Stryker Illuminated Retractor does not raise any new safety and efficacy concerns when compared to similar legally marketed devices. Therefore, the Stryker Illuminated Retractor is substantially equivalent to these existing devices."
This type of 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical or performance studies with specific outcome metrics and acceptance criteria. The FDA's letter confirms substantial equivalence but doesn't detail performance metrics.
What We Can Infer (and what we cannot):
- Acceptance Criteria & Device Performance: The document does not define specific acceptance criteria (e.g., minimum brightness, durability cycles, precise surgical outcomes) or report quantitative performance data. The "performance" assessment is based on a qualitative claim of equivalence.
- Study Details: There's no mention of a formal study with a defined test set, training set, ground truth, expert involvement, or statistical analysis.
- Sample Size: No sample sizes are provided for any testing, as no specific performance testing is described beyond the general equivalence claim.
- Data Provenance: Not applicable as no specific data or studies are mentioned.
- Experts: No experts are mentioned as being involved in establishing ground truth or evaluating the device's performance in a study context.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not mentioned, and highly unlikely for a device of this nature in a 510(k) submission focused on substantial equivalence.
- Standalone Performance: Not mentioned.
- Ground Truth Type: Not applicable, as performance studies establishing ground truth are not described.
- Training Set Sample Size & Ground Truth: Not applicable, as no machine learning or AI component is mentioned, and therefore no training set.
Summary of Information from the Provided Text:
- Device Name: Stryker Illuminated Retractor
- Classification Name: Surgical Instrument Illuminated Retractor, Surgical Instrument Light
- Common/Usual Name: Illuminated Retractor
- Proprietary Name: Stryker Illuminated Retractor
- Intended Use: A manual surgical instrument with an integrated light source, sold separately as a single-use-only device. Can be used with the Knifelight to facilitate ligament or tissue division, or by itself to retract soft tissue.
- Regulatory Class: Class II
- Basis for Marketing: Substantial Equivalence to existing marketed products (Ruggles and Stryker).
- Safety and Effectiveness Claim: "Does not raise any new safety and efficacy concerns when compared to similar legally marketed devices."
Conclusion:
Based strictly on the provided text, it's impossible to fill out the table or answer the specific questions about acceptance criteria and detailed study information, as the document is a 510(k) summary focused on establishing substantial equivalence for a medical instrument, not a report on a detailed performance study with quantitative results.
§ 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.