(80 days)
Harpoon® and Mini-Harpoon® Suture Anchors are indicated for use in soft tissue reattachment procedures. Specific Indications are:
Shoulder - Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair, and anterior shoulder instability repair
Wrist - Scapholunate ligament reconstruction
Elbow - Biceps tendon reattachment, Ulnar or radial collateral ligament reconstruction, and lateral epicondylitis repair
Knee - Extracapsular Repair (Medial collateral ligament repair, lateral ligament repair, and posterior oblique ligament repair), joint capsule closure, iliotibial band tenodesis reconstruction, patellar realignment and tendon repair, and vastus medialis obliquus (VMO) muscle advancement
Foot and Ankle - Hallux valgus repairs, medial or lateral instability repair/reconstruction, Achilles tendon repair/reconstruction, midfoot reconstruction, and metatarsal ligament/tendon repair/reconstruction
Hip - Capsular Repair (acetabular labral repair)
The Harpoon® Suture Anchor is comprised of either stainless steel or titanium material designed with a collar that provides resistance to pullout of the device. It is preloaded with a polyethylene suture and available in two sizes.
The provided text is a 510(k) Summary for the Harpoon® Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way typically seen for diagnostic or AI-driven medical devices.
Therefore, most of the requested information cannot be extracted from this document.
Here's an assessment based on the available text:
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria or a reported device performance table as would be expected for a diagnostic or AI device. Instead, it states:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| General statement of functionality. No specific metrics or thresholds provided. | "The results indicated that the device was functional within its intended use." |
2. Sample size used for the test set and the data provenance
A test set was not used in the context of performance evaluation against acceptance criteria, as no clinical testing or specific non-clinical performance evaluation against predefined criteria is detailed.
- Sample Size (Test Set): Not applicable, as no dedicated "test set" for performance evaluation is described.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no ground truth was established from expert review for a test set in this 510(k) submission.
4. Adjudication method for the test set
Not applicable, as no test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not relevant to the Harpoon® Suture Anchor, which is a physical medical device (suture anchor), not an algorithm or a software device.
7. The type of ground truth used
Not applicable. The "ground truth" concept (e.g., pathology, expert consensus) is typically associated with the evaluation of diagnostic or prognostic devices/algorithms. For a physical device like a suture anchor, "ground truth" would refer to its physical properties and mechanical performance, which were assessed via non-clinical testing. However, the details of how this was established are not provided other than: "Non-clinical laboratory testing was performed to determine substantial equivalence."
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set.
Summary of what the document does provide regarding "proof" of meeting criteria:
The document leverages the concept of substantial equivalence to predicate devices. The "study" that proves the device meets (implicitly, rather than explicitly stated) acceptance criteria is the non-clinical laboratory testing that compared the Harpoon® Suture Anchor to its predicates.
"Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
This implies that the non-clinical tests (e.g., mechanical strength, pull-out force, material biocompatibility, etc. – although not detailed in this summary) demonstrated performance comparable to the predicate devices, thereby supporting the claim that it is "functional within its intended use" and "substantially equivalent." No specific quantitative acceptance criteria or detailed results from these non-clinical tests are included in this 510(k) Summary.
§ 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.