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510(k) Data Aggregation
(176 days)
UNITY ALPHA SYSTEM
The Unity Alpha PLLA System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.
The Unity Alpha PLLA System is designed for the fixation of tissue, ligament, tendon. and bone. Absorbable poly-1.-lactic acid (PLLA) implant materials are ultrasonically welded to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon. and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management.
The provided text describes the Unity Alpha PLLA System (medical device) and its 510(k) submission. It does not include detailed information regarding acceptance criteria, specific performance metrics, sample sizes for testing/training sets, expert qualifications, or adjudication methods for a study. The document primarily focuses on establishing substantial equivalence to a predicate device.
However, based on the text, here's what can be extracted and what cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The general acceptance criterion implied is "substantial equivalence" to predicate devices. | "Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Alpha PLLA System to predicate devices." No specific quantitative performance metrics are provided. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be internal design verification.
3. 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)
- Not applicable/Not specified. The "ground truth" for this device appears to be comparison against predicate devices' mechanical properties, not expert-adjudicated clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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
- No. This is a medical device for fixation of tissue, ligament, tendon, and bone, not an AI or imaging diagnostic device requiring an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is not an algorithm. Performance is likely assessed through mechanical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference standard for comparison was the mechanical strengths and failure modes of predicate devices. This suggests a comparative engineering/mechanical testing approach.
8. The sample size for the training set
- Not applicable/Not specified. There is no mention of a "training set" in the context of this device's approval process, as it is not an AI or machine learning product.
9. How the ground truth for the training set was established
- Not applicable/Not specified.
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