(257 days)
The asap multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, discectomy, and foraminotomy.
The asap multiscope is a rigid or semiflex-type multi-channel endoscope provided with a rod lens system to transmit light and images, a working channel and one or two irrigation channel(s) and stopcocks. The body consists of an outer and an inner tube of surgical steel. The light-carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod lens system, the working channel and the irrigation/suction channel(s). The eyepiece and light post are adaptable to standard endoscopic cameras and light systems. The endoscope is intended for use with standard working sheaths (cannulas) for minimally invasive access. Accessories include working sheaths, spinal needles, guide wire, dilators, trephine, hammers, trocars, forceps, and rongeurs, as well as cleaning brushes, a rubber sealing cap, spare O-rings, and a protection sheath.
Here's an analysis of the provided text regarding the acceptance criteria and study for the asap multiscope device:
This 510(k) summary for the asap multiscope is a Substantial Equivalence (SE) premarket notification. This means the manufacturer is asserting their device is as safe and effective as existing legally marketed predicate devices, rather than demonstrating novel performance against pre-defined criteria. Therefore, the information you're requesting regarding acceptance criteria, specific performance metrics, and detailed study parameters (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, and human reader studies) is typically not provided in this type of submission, as it's not required for a SE determination.
The core of the submission revolves around demonstrating that the asap multiscope is substantially equivalent to its predicate devices (Joimax Tessys Multiscope, Arthro Kinetics Endoscopic Spine System, and maxMorespine Endoscope).
Here's an attempt to address your points based on the provided text, highlighting where information is absent or inferred due to the nature of a 510(k) SE submission:
Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Claim)
Since this is a Substantial Equivalence submission, the "acceptance criteria" are generally that the device performs at least as well as and has no significant differences in safety or effectiveness compared to the predicate devices. The "reported device performance" is essentially that it meets this standard.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance specifications and intended use are the same as predicate devices. | "Specifications and intended use of the asap multiscope are the same as those of the predicate devices." |
| No significant differences in design or usage conditions compared to predicate devices. | "There are no significant differences between the asap multiscope and the predicates in design or usage conditions." |
| Materials are identical to those of the predicate devices, ensuring high performance and biocompatibility. | "Materials are identical to those of the predicate devices, ensuring high performance and biocompatibility." |
| Recommended cleaning and sterilization processes are validated. | "The recommended cleaning and sterilization processes have been validated." |
| Meets applicable safety standards for endoscopic equipment. | "Performance testing was conducted according to the applicable sections of standard IEC 60601-2-18. Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment." |
| Overall, safe and effective, and substantially equivalent to predicate devices. | "The information provided in this 510(k) submission provides reasonable assurance that the asap multiscope is safe and effective and that it is substantially equivalent to the predicate devices with respect to intended use and technological characteristics." |
Here's a breakdown of the specific points you requested, with indications of what is and isn't available in this 510(k) summary:
-
A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" for a 510(k) SE typically revolve around demonstrating equivalency to known safe and effective predicate devices, rather than meeting specific quantifiable performance thresholds for clinical accuracy or efficacy.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. This type of detail is not required or typically included in a 510(k) SE submission for a device like an endoscope, where the primary demonstration is mechanical and material equivalence and adherence to recognized safety standards. The "performance data" mentioned refers to testing against safety standards and validation of sterilization, not clinical performance with a specific patient dataset.
-
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):
- Not applicable/Not provided. Since there's no clinical "test set" in the sense of patient data being evaluated for diagnostic or therapeutic accuracy, there's no ground truth established by experts in this context. The "truth" being established is that the device meets engineering specifications and safety standards and is comparable to predicates.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As with point 3, there's no clinical test set requiring adjudication.
-
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, not done. This device is an endoscope, a visualization and access tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI improvement effect size are irrelevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, not applicable. This device is a manual, physical tool; it does not involve any algorithms.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is its adherence to engineering specifications, material biocompatibility, and validated sterilization processes, and its equivalence to legally marketed predicate devices. This is established through bench testing and documentation of material properties and manufacturing processes, not clinical outcomes or expert consensus on patient data.
-
The sample size for the training set:
- Not applicable/Not provided. There is no "training set" as this is not an AI/ML device.
-
How the ground truth for the training set was established:
- Not applicable/Not provided. There is no "training set."
In summary:
This 510(k) notification for the asap multiscope is a prime example of a Substantial Equivalence (SE) submission for a traditional medical device (an endoscope). The "study" mentioned primarily refers to:
- Engineering and material testing to ensure the device meets its own specifications (which are asserted to be similar to predicates).
- Biocompatibility testing of materials (by stating they are "identical to those of the predicate devices").
- Validation of cleaning and sterilization processes.
- Compliance with recognized industry safety standards (IEC 60601-2-18).
The crucial point is that for a 510(k) of this nature, the manufacturer does not perform independent clinical studies to demonstrate new safety or effectiveness. Instead, they demonstrate that their device is substantially equivalent to existing devices that have already been deemed safe and effective by the FDA. Therefore, detailed clinical performance metrics, sample sizes for patient data, expert reviews, or AI-related study details are not part of this type of submission.
§ 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.