(85 days)
The proposed RC Tack is intended for soft tissue reattachment to host bone for the following indications: SHOULDER Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair KNEE Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair
The RC Tack is a polymmer implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three components: a tip, sleeve, and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The RC Tack is a sterile single use device offered in one size, 4.5mm.
The provided document is a 510(k) Summary for a medical device (RC Tack Bone Anchor). It describes the device, its intended use, and comparison to predicate devices, and reports performance data in support of substantial equivalence. However, this document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets that criteria with the requested level of detail (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance details).
This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, as opposed to providing a detailed performance study with explicit acceptance criteria from an AI/algorithm perspective. There is no mention of an algorithm or AI in this document.
Despite this, I will extract and infer information where possible based on the provided text, and clearly state where information is not available.
Here's an analysis based on the provided text:
Device: RC Tack Bone Anchor
Intended Use: Soft tissue reattachment to host bone in the shoulder, knee, and ankle for specific indications (listed in the document).
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document describes a "Bone Model Testing" study that compares the RC Tack's ultimate holding strength. The acceptance criteria are implicitly tied to demonstrating performance "substantially equivalent" to or better than the predicate devices.
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Ultimate holding strength should be at least equivalent to the predicate device (ROC EZ Suture Bone Fastener) and another comparison device (ConTack Fastener). | "The proposed RC Tack holding strength was greater than that of the predicate device and the ConTack Fastener, demonstrating substantially equivalent performance between the devices." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "Bone Model Testing" was performed.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. It is likely laboratory-based biomechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a mechanical implant, and the assessment of "holding strength" in a bone model test does not typically involve expert clinical review to establish ground truth in the way an AI diagnostic algorithm might. The ground truth (holding strength) would be measured directly using biomechanical testing equipment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically relevant for clinical studies or evaluations where subjective assessments (e.g., image interpretation) are made by multiple observers. For a biomechanical test of holding strength, the result is an objective measurement, not subject to adjudication in this manner.
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 document pre-dates and does not involve AI. The device is a mechanical bone anchor, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This document does not describe an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for the performance test ("ultimate holding strength") was based on direct biomechanical measurement in a bone model.
8. The sample size for the training set
- Not Applicable. This document does not describe an AI/algorithm, so there is no training set in that context. The "training set" concept is not relevant for this type of mechanical device submission.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set in the context of AI/algorithms, this question is 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.