(49 days)
The Ti-Screw Anchor SP is indicated for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder Indications - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand Indications - Ulnar/radial collateral ligament reconstruction.
Ankle/Foot Indications - Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow Indications - Ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee Indications - Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, and patellar ligament/tendon repair.
The Ti-Screw Anchor SP consists of a screw tip, a screw body, and an internal cross pin to attach the suture. The screw tip engages the bone while the screw body provides the means to drive the anchor in, and the pin is used to attach the suture to the anchor.
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the Ti-Screw Anchor SP, which focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical mechanical testing.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The submission relies on substantial equivalence to predicate devices, implying that performance comparable to those devices is the "acceptance criterion" for marketing.
- Reported Device Performance: Mechanical testing found the Ti - Screw Anchor SP to be substantially equivalent to the predicate Harpoon Suture Anchor and Metal Screw Anchor in terms of mechanical properties. Specific numerical performance metrics or thresholds are not provided in this summary.
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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)
- Sample Size: Not specified for the mechanical testing.
- Data Provenance: Not specified. It's non-clinical testing, likely conducted in a lab environment.
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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)
- This is not applicable as there was no clinical testing performed as a basis for substantial equivalence. The "ground truth" for non-clinical mechanical testing would be based on engineering specifications and direct measurements against those specifications.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as there was no clinical testing requiring human adjudication.
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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
- Not applicable. This device is a surgical implant, not an AI software or diagnostic tool that would involve human readers or AI assistance. No clinical testing, let alone an MRMC study, was conducted.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a surgical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical mechanical testing, the ground truth would be the established engineering specifications and physical properties of the materials and design, measured directly. There's no clinical "ground truth" like pathology or outcomes data presented here because no clinical testing was performed.
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The sample size for the training set
- Not applicable. No training set is mentioned as this is not a learning algorithm or AI device.
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How the ground truth for the training set was established
- Not applicable.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.