(112 days)
The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectorny procedures in the cervical, thoracic and lumbar spine.
The modified 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 modified enSpire™ Discectorny System is supplied as a sterile, single patient use, disposable device.
The provided text describes a 510(k) submission for the enSpire™ Discectomy System, a medical device for discectomy procedures. It focuses on demonstrating substantial equivalence to a predicate device and outlines non-clinical testing performed.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of non-clinical (bench) tests performed and makes a general statement about their success.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional/Mechanical Performance: | |
| Cannula Compatibility | "Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the modified enSpire™ Discectomy System meet the established specifications necessary for consistent performance during its intended use." Additionally, "non-clinical testing was conducted to validate the performance of the device and ensure the modified enSpire™ Discectomy System performs as intended and meets the design specifications." |
| Enable Switch Durability | Same as above. |
| Deployment & Retraction | Same as above. |
| Working Shaft Length | Same as above. |
| Device Durability | Same as above. |
| Travel Limiter Attachment | Same as above. |
| Travel Limiter | Same as above. |
| Tensile Strength | Same as above. |
| Articulation Function | Same as above. |
| Articulation Angle | Same as above. |
| Tissue Volume/Material Removal | "No Breach of Annulus or Endplates" (specifically for this test), and generally, "meet the established specifications necessary for consistent performance during its intended use." |
| No Breach of Annulus or Endplates (during material removal) | "No Breach of Annulus or Endplates" |
| Safety/Biocompatibility/Sterilization: | |
| Visualization | Same as functional/mechanical performance. |
| Peak Temperature during Operation | Same as functional/mechanical performance. |
| Electromagnetic Compatibility and Electrical Safety | Same as functional/mechanical performance. |
| Packaging Testing | Same as functional/mechanical performance. |
| Shipping Testing | Same as functional/mechanical performance. |
| Sterility Testing | Same as functional/mechanical performance. |
| Shelf Life Testing | Same as functional/mechanical performance. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity) | "Biocompatible for Intended Use: Yes" (in comparison table to predicate) and generally, "meet the established specifications necessary for consistent performance during its intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any of the non-clinical tests conducted. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective, as these are in-vitro bench studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The testing described is non-clinical (bench testing) and does not involve human subjects or expert assessment for ground truth determination in the typical sense of a clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided, as the studies are non-clinical bench tests, not clinical studies requiring adjudication of outcomes or diagnoses.
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 such study was performed or mentioned. The device is a surgical discectomy system, not an AI-assisted diagnostic tool requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a mechanical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench studies, the "ground truth" would be established by the design specifications and engineering requirements of the device. For example, for "Tensile Strength," the ground truth would be a defined tensile strength threshold. For "No Breach of Annulus or Endplates," the ground truth is the absence of such breaches, directly observed during the in-vitro tissue volume removal testing.
8. The sample size for the training set
This information is not applicable and not provided. The device described is a mechanical surgical tool, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no training set for this device.
§ 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.