(71 days)
The Stryker System 4000 Battery Powered Heavy Duty System is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
The Stryker System 4000 is comprised of drills, a reamer, a rotary driver, saws, rechargeable batteries, battery chargers, a battery protector kit, sterilization cases and racks, and cutting accessories. The system is designed to meet the IEC 601.1 safety standards.
The provided document is a 510(k) premarket notification for the Stryker System 4000. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance data from a specific study with acceptance criteria.
Therefore, many of the requested fields cannot be directly populated from the given text. The document primarily makes claims of equivalency in intended use, safety, and effectiveness.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria or detailed performance metrics. Instead, it asserts substantial equivalence to existing devices. The key "acceptance criteria" for a 510(k) submission is typically that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: No new intended uses compared to predicate devices. | The Stryker System 4000 is intended for cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue, as well as placing/cutting screws, wires, pins, and other fixation devices, and cutting metal. This is stated to be equivalent to existing powered instrument systems. |
| Safety Equivalence: No new safety concerns compared to predicate devices. | The system is designed to meet IEC 601.1 safety standards. The document states it "does not raise any new safety... concerns when compared to similar devices already legally marketed." |
| Effectiveness Equivalence: No new effectiveness concerns compared to predicate devices. | The document states it "does not raise any new... effectiveness concerns when compared to similar devices already legally marketed." |
| Design Equivalency: Composition and design features are comparable. | The system comprises drills, reamer, rotary driver, saws, rechargeable batteries, chargers, battery protector kit, sterilization cases/racks, and cutting accessories, which are claimed to be equivalent to predicate devices from 3M, Zimmer, Sodem, and Stryker's pre-1976 products. |
Study Information (Based on 510(k) Nature)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided. This document is a 510(k) premarket notification. It does not describe a clinical study with a test set of data in the manner of an AI/ML device. The claim is based on substantial equivalence to predicate devices, potentially through design comparison, bench testing, and compliance with standards rather than clinical performance data from a "test set."
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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. No "ground truth" for a test set is described or established in this document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. No test set requiring adjudication is described.
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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. This is a mechanical surgical instrument, not an AI/ML diagnostic device. An MRMC study is not relevant to this type of device and was not performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided. This is a physical surgical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided. The concept of "ground truth" as typically used for AI/ML or diagnostic studies does not apply here. The "truth" for this submission revolves around demonstrating that the device's design, materials, and intended use are comparable to legally marketed devices already established as safe and effective.
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The sample size for the training set:
- Not Applicable / Not Provided. This is not an AI/ML device; therefore, there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable / Not Provided. As there is no training set, this question is not relevant.
In summary: The provided text is a regulatory submission focused on establishing substantial equivalence for a physical surgical device. It explicitly states that the device does not raise new safety or effectiveness concerns compared to existing, legally marketed predicate devices (Stryker's own pre-1976 products, and products from 3M, Zimmer, and Sodem). The "study" here is essentially the comparison and justification provided within the 510(k) submission itself, supported by design specifications and compliance with standards like IEC 601.1. It does not involve a clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device would.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.