(61 days)
The UroTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The UroTac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility.
Consisting of: UroTac Bone Anchor Device for soft tissue to bone attachment. UroTac Bone Anchor Inserter Instrument used to insert bone anchor in desired situs.
This looks like a 510(k) submission for a medical device called the UroTac Bone Anchor System. While it describes the device's function, materials, intended use, and comparison to predicate devices, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, or ground truth establishment.
The document states: "The mean failure load of the UroTac Bone Anchor, when pulled from pubic bone, has been tested in a manner consistent with the Guidance Document for Testing Bone Anchor Devices (Draft November 1, 1993). The mean fixation strength of the device was demonstrated to be substantially equivalent to that of the Mitek predicate device."
This indicates that a non-clinical test was performed to assess fixation strength and compare it to a predicate device, but no specific numerical acceptance criteria or detailed study results are provided in this excerpt.
Therefore, I cannot fill in the requested table or answer most of the questions based on the provided text.
Here's an attempt to address what can be inferred:
Acceptance Criteria and Device Performance (Based on Inferred Information):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in mean fixation strength to Mitek GII Bone Anchor. | Mean fixation strength was demonstrated to be substantially equivalent to that of the Mitek predicate device. |
Detailed Study Information:
- Sample size used for the test set and the data provenance: Not specified in the provided text. The testing was "non-clinical," implying laboratory or bench testing rather than human clinical trials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. "Ground truth" for a non-clinical, mechanical strength test would typically be objective physical measurements, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not specified. This is relevant for clinical studies with subjective interpretations, not mechanical testing.
- 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 bone anchor, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Objective, measured mechanical force (failure load/fixation strength).
- The sample size for the training set: Not applicable. This is a physical device, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of what is known from the text regarding the study:
- Study Type: Non-clinical (bench/laboratory) testing.
- Purpose: To demonstrate the mean fixation strength of the UroTac Bone Anchor when pulled from pubic bone.
- Methodology: Conducted "in a manner consistent with the Guidance Document for Testing Bone Anchor Devices (Draft November 1, 1993)."
- Comparison: Compared to the Mitek GII Bone Anchor (predicate device).
- Conclusion: The device's mean fixation strength was "substantially equivalent" to that of the Mitek predicate device, and the tests "did not yield any data suggesting safety or effectiveness issues which are other than those presented by the Mitek predicate device."
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(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 § 888.9.