(80 days)
The XTool™ Device is indicated for spinal discectomy procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.
The XTool™ is an orthopedic manual hand held surgical instrument for use in performing discectomy in open and minimally invasive spine procedures. It is composed of an angled cutting head with serrated cutting edges and a distal guard, and a hollow shaft that connects the cutting head to the handle proximal. The handle has a port for connecting to standard hospital wall or pump suction. Two different diameter devices are specified to accommodate the range of disc heights for which a discectomy can be performed, with the smaller diameter for lower height discs, and the larger diameter for larger height disc. Two different tip angles are also specified to facilitate ipsilateral and contralateral disc removal. The finished assembly working length is 22 cm, Tip Angle is 15° or 40° and the cutter head diameter is either 5.2 mm or 6.3 mm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the XTool™ MIS DISCECTOMY Device:
Based on the provided 510(k) summary (K122861), the device is a manual handheld surgical instrument for discectomy, not an AI/ML-driven device. Therefore, many of the requested elements (like AI-specific performance metrics, reader studies, training/test sets, ground truth establishment methods typical for AI/ML, etc.) are not applicable or not explicitly detailed in the way they would be for an AI/ML device submission.
The acceptance criteria and supporting studies described are typical for traditional medical devices, focusing on safety, performance, and substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standards (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | In compliance with ISO 10993 | Device is in compliance with ISO 10993 for biocompatibility. |
| Sterilization Validation | In compliance with ISO 11137 standards | Device is in compliance with ISO 11137 standards for product sterility assurance. |
| Packaging Validation | In compliance with ISO 11607-1 | Device is in compliance with ISO 11607-1. |
| Bench Testing | Compliance with pertinent standards; meets expectations of the medical community and product labeling | Device is in compliance with pertinent standards, expectations of the medical community, and product labeling. |
| Simulated Use (Cadaver) | Demonstrated ability to be used as intended in humans | Demonstrated that the device can be used as intended in humans. |
| Substantial Equivalence | Equivalence in intended use and technology to predicate devices (HydroCision Arthrojet/SpineJet, Blackstone Medical Inc. Laparoscopic Disc Removal System) | Achieved substantial equivalence determination by FDA. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for specific tests.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
- For biocompatibility, sterilization, and packaging, these are typically laboratory tests performed on device samples.
- Bench testing would also be laboratory-based.
- Simulated use testing was conducted using cadavers, implying a controlled laboratory environment rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable in the traditional AI/ML sense. The device is a surgical instrument. The "ground truth" for its performance relates to its physical properties, material safety, and functional capability as assessed through engineering testing and cadaver studies. This doesn't involve expert consensus on medical images or diagnoses for a "test set" in the context of an AI/ML algorithm. Instead, it would involve qualified engineers and possibly surgeons (for the cadaver study) assessing the physical performance and safety.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers generating ground truth for AI/ML model evaluation. This device is not an AI/ML diagnostic tool, and its evaluation methods (biocompatibility, sterilization, bench, cadaver studies) don't involve such adjudication processes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is typically performed to evaluate the diagnostic performance of a new system (often AI-assisted) compared to human readers, with or without AI assistance. The XTool™ is a surgical instrument; therefore, an MRMC study is not relevant to its stated evaluation.
6. If a Standalone Study (Algorithm-Only Performance) was Done
- No. This question is specific to AI/ML algorithms. The XTool™ is a physical surgical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is primarily established through:
- Scientific Standards: Compliance with ISO standards (10993, 11137, 11607-1) for material safety, sterility, and packaging.
- Engineering Specifications: Performance metrics derived from bench testing, comparing against established engineering and functional requirements.
- Functional Demonstration: Successful demonstration of the device's intended use and performance in a simulated environment (cadaver testing).
- Predicate Device Comparison: Establishing substantial equivalence based on comparison of intended use and technological characteristics to previously cleared devices.
8. The Sample Size for the Training Set
- Not Applicable. This device is a manual surgical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for one.
§ 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.