(161 days)
The Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the nasal sinuses within the first 14 days following surgery. The Sinus Spacer also helps to prevent obstructions.
The Sinus Spacer is a device that maintains an opening at the intended sinus not to exceed 14 days postoperatively. The subject device can be manually removed during an office follow-up visit at any time.
The provided document is a 510(k) Summary for a medical device called "Sinus Spacer". It is a regulatory submission to the FDA, and as such, it does not contain the detailed study information typically associated with establishing acceptance criteria and proving device performance in a clinical or scientific study. The document states in a general manner that "The Sinus Spacer met all performance acceptance criteria" and "The Sinus Spacer is substantially equivalent to the predicate devices as confirmed through relevant performance tests."
However, it does not provide the specific acceptance criteria, the detailed results from a study, or the methodology to fulfill the request. The 510(k) summary focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed independent clinical study with specific performance metrics.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: Not explicitly stated with quantifiable metrics. The document only states: "The Sinus Spacer met all performance acceptance criteria."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not mentioned.
3. 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 as no such test set or ground truth establishment is described for a clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no such test set or adjudication is described.
5. 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
- Not applicable. This device is a physical "Sinus Spacer" and not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical "Sinus Spacer" and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no ground truth is described for a clinical study on this device. Performance tests mentioned are likely engineering/bench tests related to material properties, retention mechanism, etc., rather than clinical outcomes with a ground truth.
8. The sample size for the training set
- Not applicable as this is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable as this is a physical medical device, not a machine learning model requiring a training set.
Summary Table (based on available information):
| Criterion/Information | Description |
|---|---|
| Acceptance Criteria | Not explicitly stated in the document. The document only indicates: "The Sinus Spacer met all performance acceptance criteria." These likely refer to engineering or bench testing criteria for material properties, mechanical integrity, and retention, rather than clinical performance metrics. |
| Reported Device Performance | The document states: "The Sinus Spacer met all performance acceptance criteria." No specific performance metrics or results (e.g., retention force, biocompatibility test results, etc.) are provided in this summary. It's also mentioned that it "is substantially equivalent to the predicate devices as confirmed through relevant performance tests." |
| Sample size used for the test set and data provenance | Not specified. The "performance tests" mentioned are likely bench tests or in vitro studies, not human clinical trials with a test set in the conventional sense. |
| Number of experts used to establish ground truth & qualifications | Not applicable. No clinical ground truth establishment described. |
| Adjudication method for the test set | Not applicable. |
| MRMC comparative effectiveness study for human readers with/without AI assistance | Not applicable. The device is a physical spacer, not an AI or imaging-based diagnostic tool. |
| Standalone (algorithm only) performance study | Not applicable. The device is a physical spacer, not an algorithm. |
| Type of ground truth used | Not applicable. The "performance tests" likely used engineering measurements or material standards as their "ground truth" rather than clinical outcomes or pathology, which are typically associated with diagnostic or therapeutic efficacy studies. |
| Sample size for the training set | Not applicable. This is a physical medical device, not an AI/machine learning model. |
| How the ground truth for the training set was established | Not applicable. This is a physical medical device, not an AI/machine learning model. |
Study Context:
The document is a 510(k) premarket notification for regulatory clearance. For devices classified as Class I exempt that are substantially equivalent to existing predicates, the FDA often relies on bench testing, material characterization, and comparison to predicate devices, rather than extensive clinical efficacy studies with human subjects that establish "ground truth" in the way an AI diagnostic device would. The "performance data" mentioned would typically refer to non-clinical tests (e.g., biocompatibility, sterilization validation, mechanical strength, retention capability in an in vitro model).
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 the limitations in § 878.9.