(55 days)
Provide a self-locking device to hold the edges of a wound open for neurosurgical procedures.
Series of dilators, tubular retractors of various lengths and guide wire for use in providing access to the spine for minimally invasive discectomy procedures.
The provided text describes a medical device, the Bright Medical Dilation Retractor System, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving device performance using a test set, ground truth, expert involvement, or specific performance metrics.
Here's what can be extracted and what is missing:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided K992898 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, the Sofamor Danek MicroEndoscopic Discectomy Retractor System, rather than presenting a performance study with specific acceptance criteria and a test set like those typically seen for AI/software devices.
The underlying "acceptance criterion" for this submission appears to be that the device functions in a manner that is "as safe and effective" as its predicate. This is a qualitative assessment based on material equivalence, similar dimensions, and achieving the same surgical objectives.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness: Functions in as safe and effective a manner as the predicate device. | "When used as designed, the Dilation Retractor System functions in as safe and effective a manner as the predicate device." |
| Technological Characteristics: Equivalent materials, similar dimensions, same surgical objectives as the predicate. | "The Bright Medical Dilation Retractor System is manufactured from equivalent materials, with similar dimensions, to achieve the same surgical objectives as the predicate MED MicroEndoscopic Discectomy System." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document does not describe a performance study involving a test set, rather it asserts substantial equivalence based on design and material characteristics compared to a predicate device.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No "ground truth" establishment using experts for a test set is described.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set or related adjudication is described.
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
- MRMC Study: No. This is a mechanical surgical device, not an AI/software device. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This is a mechanical surgical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable. No specific "ground truth" as typically understood for performance studies (e.g., pathology, outcomes) is mentioned. The "truth" in this submission relies on the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
Summary of Missing Information:
The provided document is a 510(k) summary for a surgical retractor system. It focuses on demonstrating "substantial equivalence" to a predicate device rather than detailing a performance study with quantitative acceptance criteria, test sets, ground truth establishment, or expert reviews as would be relevant for devices that require such validation (e.g., diagnostic software, AI/ML devices). Therefore, many of the requested details about performance studies, sample sizes, and expert involvement are not present in this document.
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).