(154 days)
The Compressyn™ Band is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
The Compressyn™ Band System consists of a stainless steel coupler preloaded with a polymer coated polyester fiber band. It is a cerclage fixation device that is placed around or through the sternum and locked in place to provide stabilized fixation.
This Dallen Medical, Inc. 510(k) submission (K130431) describes the Compressyn™ Band, a cerclage bone fixation device. The submission focuses on demonstrating substantial equivalence to a predicate device (Compressyn™ Band, K101484) rather than establishing new performance criteria.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Outcome) |
|---|---|
| Sternal Compression (Implied function of the device) | "The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate device." |
| Static Performance (Implied mechanical strength) | "The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate device." |
| Cyclic Performance to 2000 cycles (Implied durability) | "The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate device." |
Note: The document explicitly states that the device has "similar physical and technical characteristics to the predicate device" and that "all necessary verification and validation testing has been performed... to assure substantial equivalence to the predicate device." The acceptance criteria were not quantitative, but rather qualitative: demonstrating substantial equivalence to the previously cleared predicate device for the specified performance tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the sternal compression, static, or cyclic performance tests. It simply states "Comparative testing."
- Data Provenance: Not specified, but implied to be laboratory testing conducted by or for Dallen Medical, Inc. (retrospective in relation to the submission date). No human patient data is mentioned; the "performance data" refers to mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device's performance was evaluated through mechanical, engineering-based tests, not through expert-reviewed clinical or imaging data. The "ground truth" was established by the physical and mechanical properties of the predicate device, against which the new device was compared.
4. Adjudication Method for the Test Set
Not applicable, as this was a mechanical engineering study, not a clinical study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device (cerclage band) and the performance data described is mechanical testing. MRMC studies are typically used for diagnostic devices (e.g., AI algorithms for image interpretation).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation was the established mechanical performance and characteristics of the predicate device (Compressyn™ Band, K101484). The goal of the study was to demonstrate that the new device performed equivalently to the predicate.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is a mechanical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.