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510(k) Data Aggregation
(26 days)
The SaberScope5 Laparoscope is intended to be used in diagnostic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs.
The Articulating Xenoscope™ System is being renamed the SaberScope5 Laparoscope. The subject device contains two separate functioning components. First is the single-use, sterile SaberScope5 Laparoscope Device, which includes a 0° camera on 5 mm rigid shaft with a ± 90° articulating tip, 10 - 36 cm long shaft, and high-definition video image. For certain procedures the shorter 10 cm laparoscope is preferred. Likewise, for other procedures, the longer 36 cm laparoscope is preferred. Except for the length difference, the scientific principles, materials of construction and design are otherwise identical. The second is the XenoBox™, which converts the digital signal from the camera to HDMI signal for display onto the HD video screen for the surgeon to view.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Xenocor® SaberScope5 Laparoscope, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table (Table 2) between the predicate device (Articulating Xenoscope™ Laparoscope, K193315) and the subject device (SaberScope5 Laparoscope). The acceptance criteria implicitly are that the subject device's performance attributes are "Same" as the predicate device or demonstrate equivalent performance, with some notable differences.
| Attribute | Predicate Device Performance (K193315) | SaberScope5 Laparoscope Performance | Acceptance Criteria Met? | Notes |
|---|---|---|---|---|
| Indications for Use | Diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. | Same | Yes | Maintained same Indications for Use. |
| Classification Info. | GCJ, GCQ, HET; Class II | Same | Yes | Maintained same classification. |
| Single Use | Yes | Same | Yes | |
| Sterile | Provided Sterile (EO gas) | Same | Yes | |
| Prescription | Yes | Same | Yes | |
| Anatomical Access | Thoracic and abdominal body cavities, hollow organs, and canals, including female reproductive organs. | Same | Yes | |
| Fundamental Scientific Technology | Imaging sensor that sends digital video, converted to HDMI by Xenobox. | Same as predicate with the additional manual focus capability | Yes (with enhancement) | The addition of manual focus is highlighted as an improvement, not a deviation from acceptance. |
| Part No. | XSA-0-0510, XSA-0-0536 | Same | Yes | These are the model numbers for existing lengths. |
| Design | 0° camera angle, 5 mm rigid shaft, articulating tip with fixed focus. | Same, but with manual focus buttons on handle | Yes (with enhancement) | The addition of manual focus buttons is an enhancement. |
| Shaft Diameter (OD) | 5 mm | Same | Yes | |
| Shaft Tip | Articulating Tip (± 90°) | Same | Yes | |
| Shaft Lengths | 10 cm, 36 cm | Same | Yes | |
| Shaft Material | Carbon Fiber, covered with heat shrink sheathing | Same | Yes | |
| Field of View | 65°-75° (Nominal 69º) | Same | Yes | |
| HD Resolution | 1080p | Same | Yes | |
| Camera Focus | Fixed Focus | 3-10cm | Yes (improved) | This is a key difference. The SaberScope5 moves from "Fixed Focus" to a "3-10cm" focus range, which implies user-adjustable focus. The associated design change is the addition of focus control buttons. This is presented as an improvement that meets acceptance. |
| Focus Control Buttons | N/A | 3 buttons: forward (manual mode), backward (manual mode), manual/auto toggle | N/A | This is a new feature introduced in the SaberScope5. It's not a "met" or "not met" criteria against the predicate, but a feature leading to the "3-10cm" focus range. |
| Frame Rate | 30 fps | Same | Yes | |
| Exposure/Gain Control | Automatic (no user adjustments) | Same | Yes | |
| Latency (<100ms) | No buffering more than 3 frames | Same | Yes | |
| Light Source | 6 LED (ring) | Same | Yes | |
| White Balance | Fixed | Same | Yes | |
| LED Color Brightness Range | 2500k to 7000k | Same | Yes | |
| Handle | Handle with articulation mechanism | Handle with articulation mechanism and focus buttons | Yes (with enhancement) | The addition of focus buttons is an enhancement. |
| Packaging | Double Pouched Tyvek/ Mylar Pouch, and backer card | Same | Yes | Confirmed explicitly in the "Functional/Safety Testing" section that changes did not affect packaging. |
| Sterilization | EO Sterile (SAL 10-6) | Same | Yes | |
| Shelf Life | 1 years | Same | Yes | |
| Biocompatibility | Patient contacting components meet ISO 10993 standard | Same | Yes | Confirmed explicitly in "Functional/Safety Testing" that no new materials were introduced. |
| Applied Part Class | Type CF | Same | Yes |
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 mentions "Design Verification – Performance bench testing was conducted".
- Sample Size: Not specified. The document only mentions "performance bench testing" was conducted, implied to be on the SaberScope5 Laparoscope.
- Data Provenance: Not specified, but generally, bench testing results for FDA submissions are generated by the manufacturer or a contracted lab. There's no indication of country of origin of data or whether it was retrospective or prospective in the clinical sense, as it was bench testing.
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 type of information is not applicable to this submission. The submission pertains to a medical device (laparoscope) that aids human physicians, not an AI or diagnostic software that requires expert-established ground truth for its own performance evaluation in a clinical context. The performance verification here relates to engineering and functional parameters rather than diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is a hardware device undergoing performance bench testing, not an AI or diagnostic algorithm requiring clinical adjudication of results.
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 MRMC study was done. This is not an AI-assisted diagnostic or imaging interpretation device. It is a surgical viewing device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm, but a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implicitly uses engineering specifications and performance standards as "ground truth" derived from the predicate device and relevant industry standards. For example, the "Field of View" (65°-75°) or "HD Resolution" (1080p) are objective, measurable performance characteristics. The term "ground truth" in the context of diagnostic accuracy is not directly applicable here.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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