(20 days)
Shoulder - rotator cuff repair
Made from surgical grade PLL (homopolymer poly (L(-)-lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.
The provided text describes a 510(k) summary for the Li Medical RotorBlade™ suture anchor and the FDA's clearance letter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance through extensive clinical trials with specific acceptance criteria in the way a pharmaceutical or novel medical device might.
Therefore, the information requested for a detailed study description and acceptance criteria is not fully available or applicable in the context of this 510(k) submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal acceptance criteria in a quantitative table. The primary "criterion" for this 510(k) was to demonstrate substantial equivalence to the predicate device (Li Medical RotorBlade™ K983435 & K992938).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Identical to predicate device. | The LM Anchor is identical to the predicate device in its intended use, and similar in safety and effectiveness. Intended use: Shoulder - rotator cuff repair. |
| Safety and Effectiveness: Similar to predicate device. | The LM Anchor is identical to the predicate device in its intended use, and similar in safety and effectiveness. |
| Pullout Strength: Substantially equivalent to predicate device. | Pre-clinical testing showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the predicate device. (No specific numerical values or acceptance ranges are provided for either the new or predicate device's pullout strength.) |
| Material: Same as predicate device. | Made from surgical grade PLL (homopolymer poly (L(-)-lactide). (Implied to be the same as the predicate, as the only described difference is sterilization method). |
| Design: Same as predicate device. | Designed as a propeller blade type anchor device. (Implied to be the same as the predicate, as the only described difference is sterilization method). |
| Sterilization: Acceptable method. | The only difference between the new anchor and the predicate device is that the gamma radiation has been added as a potential sterilization method. (This change was deemed acceptable by the FDA). |
2. Sample Size Used for the Test Set and Data Provenance:
- The text mentions "Pre-clinical testing showed that the mean pullout strength of the LM Anchor was substantially equivalent..."
- Sample Size: Not specified.
- Data Provenance: Not specified, but "pre-clinical testing" typically refers to in vitro or ex vivo studies, not human clinical data. Given the device type, it's highly likely this was mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This type of information (experts establishing ground truth) is not applicable to the pre-clinical mechanical testing described for this device. Ground truth for pullout strength would be objective measurements from testing equipment, not expert consensus.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers or experts, which is not relevant to mechanical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is designed to assess the diagnostic performance of a device with human readers, often for image interpretation. This device is a surgical implant, and the testing described is mechanical, not diagnostic.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical anchor, not an algorithm or AI system. Therefore, "standalone performance" in the context of AI is not relevant.
7. The Type of Ground Truth Used:
- For the "pre-clinical testing" mentioned (specifically pullout strength), the ground truth would be objective engineering measurements (e.g., force in Newtons or pounds-force) obtained directly from a testing machine (e.g., a universal testing machine).
8. The Sample Size for the Training Set:
- Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This device underwent pre-clinical mechanical testing, not algorithm development.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, no training set for an algorithm was used.
In summary: This 510(k) submission relies on demonstrating substantial equivalence primarily through pre-clinical mechanical testing (specifically pullout strength) and by showing identical design, material, and intended use as a previously cleared predicate device, with only the sterilization method changing. The regulatory pathway of 510(k) premarket notification does not typically require the extensive clinical trials or expert consensus-based studies associated with establishing acceptance criteria and ground truth in the way described in your template.
§ 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.