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510(k) Data Aggregation
(127 days)
X-STEN CORP.
The Vertos Medical mild® Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.
The Vertos Medical mild® Device Kit is a set of specialized arthroscopic surgical instruments. They are supplied sterile, for single use only.
The provided text does not describe an AI medical device or a study proving that it meets acceptance criteria. The document is a 510(k) premarket notification for a traditional medical device, the "Vertos Medical mild® Device Kit," which is a set of specialized arthroscopic surgical instruments.
Therefore, I cannot extract the information required in the requested format as it pertains to AI medical devices and their performance studies. The document only mentions "Biocompatibility evaluation," "Bench testing," and "Cadaveric testing" to demonstrate compliance and substantial equivalence to predicate devices, not AI performance criteria or studies.
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(153 days)
X-STEN CORP.
The X-Sten MILD Tool Kit is a set of specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
The X-Sten MILD Tool Kit is a set of specialized surgical tools for retracting, grasping and excising tissue in the lumbar spine. The kit consists of the following components:
- MILD Tissue Retractor Cobra Device 8.5 Gauge, 8.5" working length .
- MILD Trocars and Handles- 7 Gauge, 6.5" working length ●
- MILD Portals 6 Gauge, 6.5" working length ●
- Surgical Clamp 14" length .
The Trocars, Portals (cannula) and Retractor devices contain stainless steel shafts and plastic handle components. The radiopaque tip and pistol-grip handle aid the user in the Minimally Invasive Lumbar Decompression (MILD) Retractor device positioning and Under fluoroscopic imaging guidance, the MILD Retractor device is advancement. inserted through the Portal into the posterior lumbar spine to retract and grasp tissue. An accessory Clamp can be used to position the Portal and allow handling outside of the fluoroscopic imaging field. A cutting mechanism on the MILD Retractor is advanced by depressing a handle trigger. Excised tissue is removed using an integrated member.
Acceptance Criteria and Device Performance for X-Sten MILD Tool Kit
This document outlines the acceptance criteria and the study that proves the X-Sten MILD Tool Kit meets these criteria, based on the provided 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the X-Sten MILD Tool Kit primarily focuses on demonstrating substantial equivalence to predicate devices. As such, the "acceptance criteria" are implicitly tied to the performance characteristics of these predicate devices and the general safety and effectiveness requirements for similar surgical instruments. Direct quantitative acceptance criteria are not explicitly stated in the provided text. Instead, the performance is reported qualitatively through successful testing.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength and Integrity: The device must possess adequate strength and integrity to safely and effectively perform its stated intended use (retracting, grasping, and excising tissue in the lumbar spine). | The X-Sten MILD Tool Kit Retractor and Access instruments passed the designated mechanical test criteria established for the product assemblies, verifying they have adequate strength and integrity to safely and effectively perform the stated intended use. |
| Functional Performance (Retraction, Grasping, Excising Tissue): The device must be able to successfully retract, grasp, and excise tissue from the posterior lumbar spine using image-guided techniques. | Cadaver evaluations demonstrate that tissue can be simultaneously retracted, grasped and excised from the posterior lumbar spine using image guided techniques. |
| Biocompatibility: Patient-contacting materials must meet established biocompatibility standards. | The patient contacting stainless steel materials were tested for "Externally Communicating Devices, Tissue/Dentin/Bone, Limited Contact", less than 24 hours, as described in ISO 10993 and the FDA Blue Book Memorandum #G95-1. The biocompatibility is substantially equivalent to the predicate devices, and the results fulfill the acceptance criteria for biocompatibility. No new types of safety or effectiveness questions were raised. |
| Sterility: The device must be sterile and maintain sterility for single-use. | The MILD Tool Kit is labeled sterile, for single-use only. The packaging and contents will be sterilized with gamma irradiation by a validated process to a Sterility Assurance Level (SAL) of 10^-6 per AAMI / ISO 11137 and AAMI TIR 27. (This is the acceptance criterion and the method to achieve it, implying successful validation). |
| Substantial Equivalence (Overall Safety and Effectiveness): The device must demonstrate substantial equivalence to legally marketed predicate devices in function, technology, and intended use, raising no new questions of safety or effectiveness. | The X-Sten MILD Tool Kit was tested in accordance with 21 CFR 807.87(d-g) to verify substantial equivalence to the predicate devices. The technological comparisons to the predicates support the substantial equivalence. Combined with product performance test results and substantial equivalence discussions, the X-Sten MILD Tool Kit is demonstrated to be substantially equivalent to the predicates. Any differences do not raise new types of safety or effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for the mechanical tests or the cadaver evaluations. The text only states "The X-Sten Mild Tool Kit Retractor and Access instruments passed the designated mechanical test criteria" and "Cadaver evaluations demonstrate that tissue can be simultaneously retracted, grasped and excised."
- Data Provenance:
- Mechanical Tests: Likely performed in a controlled laboratory setting (in-house or by a testing service). The country of origin and whether it was retrospective or prospective is not specified, but device testing is typically prospective.
- Cadaver Evaluations: Performed using human cadavers. The country of origin and whether it was retrospective or prospective is not specified, but cadaver studies are inherently prospective for the device evaluation.
- Biocompatibility: Performed according to ISO 10993 and FDA Blue Book Memorandum #G95-1, which are international and US standards, respectively. These tests are prospective.
3. Number of Experts and Qualifications for Ground Truth
- Mechanical Tests: No experts are typically used to establish ground truth for mechanical tests; the ground truth is defined by the predetermined engineering specifications and criteria.
- Cadaver Evaluations: The text implies observation and assessment by medical professionals involved in the cadaver evaluation for usability and functional performance. However, the number of experts and their specific qualifications are not specified.
- Biocompatibility: The ground truth is established by the results of the standardized biological tests per ISO 10993 and G95-1, not by expert consensus on individual cases.
4. Adjudication Method for the Test Set
- Adjudication methods (e.g., 2+1, 3+1) are typically used for studies evaluating subjective medical interpretations or diagnoses (e.g., imaging studies). The types of studies described here (mechanical, cadaver, biocompatibility) do not involve such subjective interpretations and therefore do not indicate an adjudication method. The "ground truth" for these tests is objective measurement against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The submission focuses on substantial equivalence based on technological characteristics, intended use, and objective performance tests (mechanical, cadaver, biocompatibility) as opposed to a clinical outcome study or reader performance study. The device is a surgical tool, not an interpretive diagnostic aid. Therefore, there is no mention of human readers or AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The X-Sten MILD Tool Kit is a set of physical surgical instruments, not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study was not conducted. The device inherently requires human operation.
7. Type of Ground Truth Used
- Mechanical Tests: Engineering specifications and objective measurements (e.g., strength, integrity defined by design parameters).
- Cadaver Evaluations: Observational assessment of functional performance (ability to retract, grasp, excise tissue) in a simulated surgical environment. This is a form of empirical functional validation.
- Biocompatibility Tests: Laboratory test results against established scientific standards.
- Substantial Equivalence: Comparison of technological characteristics, intended use, and performance data to legally marketed predicate devices, with FDA's determination serving as the ultimate ground truth for market approval.
8. Sample Size for the Training Set
- Not applicable. The X-Sten MILD Tool Kit is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI or algorithm development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
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