(196 days)
The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.
The enSpire™ Discectomy System is a single-use discectomy device that is designed to cut and grind intervertebral disc material. An auger mechanism retrieves the excised debris and ejects it into a collection chamber. The enSpire™ Discectomy System is supplied as a sterile, single patient use, disposable device.
The provided text describes a traditional 510(k) submission for the enSpire™ Discectomy System. This submission focuses on demonstrating substantial equivalence to a predicate device and does not involve AI/ML technology or studies typically associated with diagnostic algorithms. Therefore, much of the requested information regarding acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's functional performance and non-clinical testing.
Here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative "acceptance criteria" in a table format for specific performance metrics in the way one might expect for a diagnostic AI. Instead, the document states that the "enSpire™ Discectorny System meets the established specifications necessary for consistent performance during its intended use." The "reported device performance" is summarized by the successful completion of the non-clinical tests.
| Performance Characteristic (Acceptance Criteria Implicitly Met) | Reported Device Performance (as stated in the document) |
|---|---|
| Tissue Removal efficacy | Demonstrated successful tissue removal. |
| No Breach of Annulus or Endplates | Successfully maintained integrity of annulus and endplates during operation. |
| Cannula Compatibility | Demonstrated compatibility with cannulas. |
| Enable Switch Durability | Switch showed sufficient durability. |
| Deployment & Retraction | Device demonstrated proper deployment and retraction. |
| Working Shaft Length Functionality | Functioned properly across its specified working lengths. |
| Device Durability | Device demonstrated satisfactory durability. |
| Travel Limiter Attachment Integrity | Travel limiter attachment was secure. |
| Travel Limiter Functionality | Travel limiter functioned as intended. |
| Tensile Strength | Met tensile strength requirements. |
| Articulation Function (if applicable for specific configurations) | Articulation function (for articulating models) performed as designed. |
| Articulation Angle (if applicable) | Achieved specified articulation angles. |
| Visualization capability | Provided adequate visualization. |
| Peak Temperature during Operation | Maintained acceptable peak temperatures during operation. |
| Electromagnetic Compatibility and Electrical Safety | Complied with EMC and electrical safety standards (e.g., IEC60601-1). |
| Packaging Integrity | Packaging maintained sterility and protected the device. |
| Shipping Stability | Device remained stable and functional after shipping. |
| Sterility (maintaining sterility) | Device maintained sterility (Gamma sterilized). |
| Shelf Life (maintaining functionality and sterility over time) | Demonstrated required shelf life. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity) | Demonstrated biocompatibility. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of in-vitro bench studies and non-clinical tests as summarized under "I. Summary of Non-Clinical Data" and detailed in the bulleted list.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size:
- For the non-clinical bench studies, the specific sample sizes for each test (e.g., number of devices tested for tissue removal, durability cycles) are not provided in this 510(k) summary.
- Data Provenance: The studies were in-vitro bench studies, meaning they were conducted in a laboratory setting using simulated conditions or non-human tissue models, not from patient data. Therefore, "country of origin of the data" and "retrospective or prospective" do not apply in the context of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
- This information is not applicable as the studies were non-clinical bench tests evaluating device mechanics and functional performance, not diagnostic interpretations requiring expert ground truth in the medical sense.
4. Adjudication Method for the Test Set
- This information is not applicable for non-clinical bench testing. Performance was assessed against predetermined engineering specifications and functional requirements.
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
- No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (surgical tool), not an AI/ML diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical surgical tool, not an algorithm.
7. The Type of Ground Truth Used
- For the non-clinical studies, the "ground truth" was established by engineering specifications, functional requirements, and established industry standards (e.g., for biocompatibility, sterility, electrical safety). For example, "No Breach of Annulus or Endplates" is a direct performance criterion with no "expert consensus" needed beyond confirming the physical result.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.