(302 days)
The Tiger Discectomy Device is indicated for use in endoscopic and non-endoscopic spinal procedures to assist in the removal of fibrous disc material between the T12 to S1 spinal segments.
The Tiger Discectomy Device is a single-use manual instrument. The components of the device include a "T" handle, a shaft, two cutting blades and blade holder, retaining pins and a blunt tip. Cutting blades are available in 8mm, 10mm and 12mm widths. A cannula is provided for endoscopic applications. The device is provided sterile.
Here's an analysis of the provided text regarding the "Tiger Discectomy ® Device" and its acceptance criteria, focusing on the requested information.
It's important to note that the provided text is a 510(k) summary for a medical device. This type of filing primarily aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through rigorous clinical studies as might be expected for novel or high-risk devices. Therefore, much of the requested information about clinical study details (like sample size for test sets, expert involvement, MRMC studies, ground truth for training data) is not typically found in a 510(k) summary for this type of device.
The provided document focuses on the design and intended use of the device, rather than detailed performance metrics that would necessitate such studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: | The device performs the intended function of assisting in the removal of fibrous disc material. |
| - Ability to remove fibrous disc material | (Not explicitly quantified, but implied by substantial equivalence to predicate devices) |
| - Operability in endoscopic and non-endoscopic spinal procedures | (No specific performance data provided beyond statement of indication) |
| - Operability within T12 to S1 segments | (No specific performance data provided beyond statement of indication) |
| Mechanical Integrity/Safety: | (Addressed by device description and substantial equivalence, but no specific performance data cited) |
| - Sterile provision | Device is provided sterile. |
| - Single-use nature | Device is a single-use manual instrument. |
| - Material compatibility, biocompatibility, etc. | (Implied by substantial equivalence and assumed to meet general device requirements, but not explicitly stated or quantified in this summary) |
| Substantial Equivalence to Predicate Devices: | Claimed substantially equivalent to: |
- Disk Whisk Cutting Device (K971342)
- Trans1 Trans-sacral Spinal Access and Preparation Device (K032891) |
Explanation: In a 510(k), acceptance criteria are often implied by demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This means it performs similarly and has similar technological characteristics to previously approved devices. Specific, quantitative performance acceptance criteria (e.g., "removes X grams of tissue with Y% efficiency") are typically not detailed in this type of submission unless a new performance claim is being made or a significant difference from the predicate exists. The "reported device performance" is essentially the description of the device and its intended function, aligning with the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The 510(k) summary does not describe a clinical study with a "test set" for performance evaluation in the way a diagnostic algorithm or a novel therapeutic device might. Substantial equivalence is often demonstrated through comparisons of design, materials, and intended use, and sometimes non-clinical (e.g., bench) testing, rather than human clinical trials for devices like this.
- Data Provenance: Not applicable, as no dedicated clinical test set is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No clinical test set requiring expert-established ground truth is described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. This device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve an MRMC study.
- Effect Size of AI Improvement: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done? No. This is a manual surgical instrument, not an algorithm, so a "standalone" or "algorithm-only" performance study is not relevant.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No clinical study with ground truth establishment is described in this 510(k) summary. For a surgical instrument like this, the "ground truth" of its function would likely be demonstrated through mechanical testing (e.g., cutting efficacy on cadaveric tissue) and comparison to the predicate device's design and performance claims, rather than a clinical outcome measure requiring expert-adjudicated ground truth.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no training set for an algorithm.
Summary of Study Type:
The document describes a 510(k) Premarket Notification whose primary purpose is to demonstrate substantial equivalence to existing predicate devices (Disk Whisk Cutting Device K971342 and Trans1 Trans-sacral Spinal Access and Preparation Device K032891). This is not a clinical performance study with defined acceptance criteria in the sense of an efficacy trial. Instead, the "study" is a comparison of the new device's design, materials, indications for use, and technological characteristics to those of the predicate devices. The approval indicates that the FDA found the device to be as safe and effective as the predicate devices, based on this comparison and presumably non-clinical testing data (which is not detailed in this summary).
§ 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.