(229 days)
Stryker's Precision Thin Reciprocating Blade, 0.010 inch (REF 5100-437-010) is a sterile, single use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure.
Stryker's Precision Thin Reciprocating Blade, 0.010in is a sterile, single use cutting accessory which is operated by a surgical drill (handpiece). This handpiece moves the Precision Thin Reciprocating Blade, 0.010in. in a reciprocating manner so that the blade removes bone material on the back stroke of its cut. The Precision Thin Reciprocating Blade, 0.010in. has a thickness of 0.010 inches and therefore can be used in surgical procedures where a narrow kerf width is required when cutting bone.
The document describes a 510(k) premarket notification for a medical device called "Precision Thin Reciprocating Blade, 0.010in." This device is a sterile, single-use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure. The submission argues for its substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the typical sense (e.g., a specific numerical threshold for performance metrics). Instead, it describes performance tests designed to demonstrate functionality, integrity, safety, and effectiveness. The "acceptance criteria" are implied to be satisfactory performance in these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Kerf Width Requirements | Met via "Kerf Width Testing" |
| Durability and Longevity (Simulated Use) | Met via "Life, Simulated Use Testing" |
| Thermal Performance (Safety during operation) | Met via "Temperature Testing" |
| Functionality, Integrity, Safety, and Effectiveness for Indication | Demonstrated via simulated use in cadaveric human temporal bone and PHACON Temporal Bone Model with ENT surgeons. |
| Biocompatibility (Non-toxic, non-sensitizing, non-irritating) | Met via biocompatibility testing in accordance with ISO 10993-1. |
2. Sample size used for the test set and the data provenance
- Simulated Use (Cadaveric): 3 ENT surgeons used the device in fresh cadaveric Human temporal bone. The provenance is not explicitly stated (e.g., country of origin for the cadaveric specimens), but it is prospective (a new study conducted for this submission).
- Simulated Use (Model): 8 ENT surgeons used the device with PHACON's Temporal Bone Model. This is also prospective.
- Kerf Width Testing, Life Testing, Temperature Testing: The sample sizes for these specific engineering tests are not provided. The data provenance is implied to be from the manufacturer's internal testing as part of the design validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For the simulated use studies (both cadaveric and model), 3 ENT surgeons and 8 ENT surgeons, respectively, were involved. Their qualifications are stated as "ENT surgeons," indicating medical specialists in the Ear, Nose, and Throat field. The level of experience is not specified (e.g., "10 years of experience"). For these performance tests, the "ground truth" is not a diagnostic label but rather their expert assessment of the device's functionality and performance during the simulated surgical procedures.
4. Adjudication method for the test set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the simulated use studies. The role of the surgeons was to perform the simulated procedures and contribute to the validation, not necessarily to adjudicate findings. Their collective feedback and successful completion of the tasks would be considered the "acceptance."
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
There is no MRMC comparative effectiveness study mentioned in the document. This is a medical device, not an AI software. The study involves surgeons using the device, not interpreting images with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a surgical instrument (a blade), not an algorithm or AI software. Its performance is always in a "human-in-the-loop" context as it is operated by a surgeon.
7. The type of ground truth used
For the performance section ("Section 5.8 Performance Data"):
- Functional/Performance Ground Truth: The "ground truth" for the Kerf Width, Life, and Temperature testing is based on engineering specifications and acceptable limits for those parameters.
- Clinical Performance Ground Truth: For the simulated use studies, the "ground truth" is the expert assessment and successful completion of the intended surgical task by qualified ENT surgeons in relevant models (cadaveric human temporal bone and PHACON model). This is a form of expert consensus/opinion on functionality and safety in a simulated environment, rather than pathology or outcomes data in a live patient, as no clinical studies were performed.
8. The sample size for the training set
This question is not applicable. The device is a physical surgical instrument, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as above.
§ 874.4140 Ear, nose, and throat bur.
(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(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 § 874.9.