(74 days)
The SPOTLIGHTTM Access System is intended to provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement/positioning of the port, down to the posterior and posterolateral bony spinal elements. These ports provide access to the spinal site which can be visualized using a microscope or loupes, and through which surgical instruments can be manipulated.
The SPOTLIGHT™ Access System consists of a series of dilators and tubular retractors with and without integrated light source of various lengths and diameters designed to provide minimally invasive surgical access to the spine. The SPOTLIGHT™ Access System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SPOTLIGHT™ Access System:
This document describes a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy trials. Therefore, the "study" described here is primarily a series of engineering and biocompatibility tests designed to show the new device performs similarly to or better than the predicate.
1. Acceptance Criteria and Reported Device Performance
| Test System | Acceptance Criteria (Implied by "Pass" or "Conforms") | Reported Device Performance |
|---|---|---|
| Compressive Force Testing | Met the same specification as the predicate device | Met the same specification as the predicate device |
| Static Torque Testing on Fixed Handle Connection | All samples met the acceptance criteria | All samples met the acceptance criteria |
| Validation of Reprocessing Instructions | Equivalency to previously validated devices for cleaning and sterilization | An evaluation of the devices for equivalency to previously validated devices for reprocessing cleaning and sterilization was performed and documented according to DePuy Spine, Inc. internal procedures. |
| USP Physiochemical Test for Plastics | Non-volatile Residue - Conforms | |
| Residue on Ignition - Conforms | ||
| Heavy Metals - Conforms | ||
| Buffering Capacity - Conforms | Non-volatile Residue - Conforms | |
| Residue on Ignition - Conforms | ||
| Heavy Metals - Conforms | ||
| Buffering Capacity - Conforms | ||
| In vitro Cytotoxicity Agar Diffusion | Non-cytotoxic | Cell culture treated with test sample exhibited Slight (Grade I) Reactivity |
| In vitro Cytotoxicity MEM Elution Test | Non-cytotoxic | Cell culture treated with sample extract exhibited no cells lysis (Grade 0 Reactivity) |
| Sensitization Test - Guinea Pig Maximization | Non-sensitizing (No significant difference in biological response between test article and negative control) | No significant difference in biological response between test article and negative control. |
| Irritation/Intracutaneous Reactivity USP Intracutaneous Test | Non-irritating (Difference between mean scores for sample extracts and corresponding blanks 0.5 or less) | The difference between the mean scores for the sample extracts and corresponding blanks was 0.5 or less. |
| Acute Systemic Toxicity USP Systemic Injection Test | Non-toxic (No signs of toxicity, all gained weight) | None of the animals treated with the sample extracts showed any signs of toxicity and all gained weight. |
| In vitro Genotoxicity - Ames Bacterial Mutagenicity Assay | Non-mutagenic (None of the five tester strains produced two-fold increases in the number of revertants; no zone of increased reversion or inhibition) | None of the five tester strains produced two-fold increases in the number of revertants. The spot tests showed no zone of increased reversion or of inhibition. |
| Implantation USP Implantation Test | Met the requirements of the USP Implantation Test when implanted for seven days (No encapsulation observed grossly, no irritation microscopically) | No encapsulation was observed grossly in any of the test or control sites, and no irritation was observed microscopically at the test sites compared to the control sites. |
| In vitro Hemolysis Extraction Method | Non-hemolytic (Less than 5% hemolysis) | Less than 5% hemolysis- A test sample with 5% or less hemolysis is considered non-hemolytic. |
| In vitro Hemolysis Direct Contact | Non-hemolytic (Less than 5% hemolysis) | Less than 5% hemolysis- A test sample with 5% or less hemolysis is considered non-hemolytic. |
| Material-Mediated Pyrogenicity USP Rabbit Pyrogen Test | Non-pyrogenic (No rabbit showed an individual rise in temperature of 0.5°C or more) | No rabbit showed an individual rise in temperature of 0.5°C or more. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state sample sizes for each test in numerical terms (e.g., "n=X units"). However, for tests like "Static Torque Testing on Fixed Handle Connection," it states "All samples met the acceptance criteria," implying a sample was tested. For animal studies (e.g., Guinea Pig Maximization, USP Systemic Injection Test, USP Rabbit Pyrogen Test), it refers to "animals" but does not give a specific number.
- Sample Size: Not explicitly quantified in numerical terms for most tests. General phrasing "All samples" or "None of the animals" is used.
- Data Provenance: The document does not specify the country of origin of the data. Given it's a submission to the U.S. Food and Drug Administration, it's likely conducted in compliance with US or internationally recognized standards (e.g., ASTM, USP). The studies appear to be retrospective in the sense that they are conducted on manufactured devices or materials to demonstrate compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This type of submission (510(k) for a surgical access system) relies on engineering and biocompatibility testing against established standards, not expert clinical interpretation of results. Therefore, no "medical experts" were used to establish ground truth in the way one would for diagnostic imaging. The "ground truth" is defined by the technical specifications and biological standards (e.g., USP standards) themselves.
4. Adjudication Method for the Test Set
N/A. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving human interpretation or subjective assessments. The tests presented here are objective, quantitative, or qualitative assessments against predefined scientific/engineering criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No. A MRMC comparative effectiveness study is designed to assess the performance of diagnostic devices often with human interpretation. This document pertains to a surgical access system where efficacy is demonstrated through mechanical and biological safety testing, not diagnostic accuracy.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
N/A. The "SPOTLIGHT™ Access System" is a physical surgical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply. The tests described are for the physical device itself.
7. The Type of Ground Truth Used
The ground truth for these tests is based on established scientific and engineering standards and specifications.
- Engineering Specifications: For tests like Compressive Force and Static Torque, the "ground truth" is the predefined mechanical performance requirement, often derived from predicate device performance.
- Biological Standards: For biocompatibility tests (e.g., Cytotoxicity, Pyrogenicity, Implantation), the "ground truth" is defined by widely accepted standards, particularly those published by the United States Pharmacopeia (USP) and relevant ISO standards (though not explicitly listed, USP often aligns with ISO for biological evaluations). These standards define what constitutes "non-toxic," "non-irritating," etc.
8. The Sample Size for the Training Set
N/A. This device is not an AI/ML algorithm, so there is no concept of a "training set" in the context of model development. The manufacturing processes and material selection might be informed by historical data, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set was Established
N/A. As there is no AI/ML training set, this question is not applicable.
§ 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).