(74 days)
The Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures.
The Multitak 6.0 mm Absorbable Anchor System is indicated for use in securing soft tissue to bone in such applications as the following:
Shoulder:
Bankart lesion repairs
Acromio-clavicular repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
SLAP lesion repairs
Elbow, Wrist, & Hand:
Scapholunate ligament reconstruction
Ulnar collateral ligament reconstruction
Radial collateral ligament reconstruction
Biceps tendon reattachment
Knee:
Extra-capsular repairs
Medial collateral ligament repair
Lateral collateral ligament repair
Posterior oblique ligament repair
Illiotibial band tenodesis
Patellar tendon repair
VMO advancement
Joint capsule closure
Foot & Ankle:
Medial instability repair/reconstruction
Lateral instability repair/reconstruction
Achilles instability repair/reconstruction
Midfoot reconstruction
Hallux valgus reconstruction
Pelvis
Bladder neck suspension procedures
The Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable suture anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures. The 6.0 mm absorbable suture anchor implant is provided sterile and once passed with suture is inserted into a predrilled bone soft tissue repair site (i.e., rotator cuff repairs) with the use of disposable and reusable introduction devices. The threaded design of the suture anchor implant allows it to be screwed into the bone tissue repair site engaging cancellous bone and acts as an anchor in securing soft tissue to bone.
I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding acceptance criteria and a study proving device performance. The document is a 510(k) summary for the Bonutti Research Multitak 6.0 mm Absorbable Anchor System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance metrics.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Metric) | Acceptance Threshold | Reported Device Performance |
|---|---|---|
| Mechanical strengths and failure modes comparison to predicate device | Statistically equivalent | "demonstrated that the anchors are statistically equivalent" |
Missing Information: Specific numerical acceptance thresholds (e.g., minimum tensile strength, push-out strength, failure load) are not provided. The "statistically equivalent" statement is a qualitative summary of the performance rather than a detailed quantitative metric.
2. Sample size used for the test set and the data provenance
Missing Information: The document does not specify the sample size for the test set used in the performance testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: This information is not relevant to the type of performance testing described (mechanical testing of a medical device) and is therefore not present in the document. Ground truth for mechanical device performance is typically established through direct physical measurement, not expert consensus.
4. Adjudication method for the test set
Missing Information: Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation (e.g., medical imaging reviews). For mechanical performance testing of a device, formal adjudication by experts is not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Missing Information: This is not applicable. The device is a physical absorbable anchor system, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance would not have been conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Missing Information: This is not applicable given the nature of the device as a physical surgical implant.
7. The type of ground truth used
- Type of Ground Truth: Direct mechanical measurements of the Multitak 6.0 mm Absorbable Anchor System and the predicate devices. This involves testing parameters such as mechanical strengths and failure modes.
8. The sample size for the training set
Missing Information: This device is a physical implant, not a machine learning algorithm. Therefore, there is no "training set" in the context of an AI model.
9. How the ground truth for the training set was established
Missing Information: As above, this concept does not apply to the testing of this physical medical device.
Summary of available information:
The 510(k) summary states that "Performance testing comparing the mechanical strengths and failure modes of the Multitak 6.0 mm Absorbable Anchor System suture anchor implants to predicate devices demonstrated that the anchors are statistically equivalent." This is the core claim regarding device performance meeting acceptance criteria (i.e., equivalence to a legally marketed predicate device). However, it lacks the specific quantitative details of the tests, sample sizes, and detailed performance figures that would typically be found in a full study report.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.