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The Stryker Zyphr ™ Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick.

The Stryker Zyphr ™ Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.

The Zyphr TM Disposable Cranial Perforator is a mechanically powered tool specifically designed to rapidly create an access hole through the skull in a safe and reliable manner.

The provided text is a 510(k) summary for the Stryker Zyphr™ Disposable Cranial Perforator. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request for providing a table of acceptance criteria and reported device performance based on the input text, nor can I answer the specific questions about the study design. The document focuses on regulatory submission for substantial equivalence rather than detailing performance validation studies.

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The ESSx Microdebrider System is intended for the cutting and removal of soft and osseous tissue in general ENT encompassing the areas of Sinus, Nasopharyngeal /Laryngeal and Head and Neck procedures, such as the following:

Sinus:

• ethmoidectory/sphenoethmoidectomy
• polypectomy
• septoplasty
• antrostomy
• endoscopic DCR
• frontal sinus drill-out
• frontal sinus trephination
• septal spurs removal
• trans-sphenoidal procedures

Nasopharyngeal/laryngeal:

• adenoidectomy
• laryngeal lesion debulking
• laryngeal polypectomy
• tracheal procedures
• tonsillectomy

Head & Neck:

• soft tissue shaving
• rhinoplasty
• removal of fatty tissue in the maxillary and mandibular regions of the face

The Stryker ESSx Microdebrider System is a powered instrument system consisting of a console, footswitch, handpiece, irrigation cassette, and a variety of disposable shaver accessories.

The provided text describes a 510(k) premarket notification for the Stryker ESSx Microdebrider System. This type of document is for a medical device that claims substantial equivalence to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials for efficacy. Therefore, the study described is focused on demonstrating substantial equivalence to existing devices, not on proving new efficacy or meeting specific performance acceptance criteria in the way a novel AI algorithm might.

Here's an analysis of the provided information, addressing your questions where applicable, and highlighting what is not present (which is typical for a 510(k) for this type of device):

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not provided in a 510(k) for a microdebrider. The submission aims to demonstrate that the new device has "the same technological characteristics, the same operating principles, use the same patient contacting materials and have similar performance characteristics" as predicate devices. Specific quantitative "acceptance criteria" and "reported device performance" in terms of clinical outcomes or diagnostic metrics are not typically required or presented for such a device in this type of submission.

The "performance" demonstration is primarily through comparison to predicate devices, ensuring that its design, materials, and intended uses are similar.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable and therefore not provided. This device is a surgical tool, not a diagnostic AI algorithm that uses test sets of data. Device performance is assessed through engineering tests and comparison to predicate devices, not through analysis of a "test set" of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and therefore not provided. "Ground truth" established by experts is relevant for diagnostic algorithms or imaging analyses. For a surgical microdebrider, performance is assessed through its mechanical and functional characteristics, and its safety through its design and materials, not by expert interpretation of data to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods are used to establish a consensus ground truth, which is not relevant for this type of device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specific to evaluating the impact of an AI diagnostic tool on human readers' performance, which is not relevant for a surgical microdebrider.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance evaluation (in the context of an algorithm) was not done. This device is a manual surgical tool; there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

This information is not applicable and therefore not provided. "Ground truth" is a concept primarily used in the evaluation of diagnostic or image analysis algorithms. For a surgical instrument like the Stryker ESSx Microdebrider, "ground truth" in the AI sense does not apply. The "truth" for this device lies in its mechanical functionality, biocompatibility of materials, and safety profile in line with predicate devices.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Stryker ESSx Microdebrider is a physical medical device, not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided. As there is no training set for this device, there is no ground truth to establish for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for a 510(k) of a surgical instrument):

• Acceptance Criteria (Implied for 510(k)): The fundamental "acceptance criteria" for a 510(k) submission is that the new device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, operating principles, patient-contacting materials, and performance characteristics.
• The "Study" (Demonstration of Substantial Equivalence): The provided document itself serves as the "study" or justification for substantial equivalence. It states:
  • "The Stryker ESSx Microdebrider System has the same intended use as the Medtronic XPS 3000 and Gyrus Diego Powered Dissector and Drill."
  • "This device and the predicate devices have the same technological characteristics, the same operating principles, use the same patient contacting materials and have similar performance characteristics."
  • The document lists the specific indications for use, which align with those of the predicate devices.
• Device Performance (as reported): The document affirms that "Based upon the comparison to the predicate devices, the Stryker ESSx Microdebrider System is substantially equivalent to legally marketed devices." This statement is the reported "performance" in the context of a 510(k) for this type of device, meaning it performs similarly enough to established devices to be deemed safe and effective for its indicated uses.

In essence, for this 510(k) for a surgical microdebrider, the "study" is a comparison and justification of equivalence to predicate devices, rather than a clinical trial or a performance evaluation against quantitative acceptance criteria for a novel diagnostic or AI-driven technology.

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