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510(k) Data Aggregation
(154 days)
COMPRESSYN BAND
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.
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(308 days)
COMPRESSYN BAND
The Compressyn™ Band is intended for use in stabilization and fixation 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 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.
The acceptance criteria and study proving the device meets them are summarized below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Sternal compression | Not explicitly stated; device found substantially equivalent to predicates. |
| Static performance to a 5mm gap | Not explicitly stated; device found substantially equivalent to predicates. |
| Static performance to point of failure | Not explicitly stated; device found substantially equivalent to predicates. |
| Cyclic performance to a 5mm gap | Not explicitly stated; device found substantially equivalent to predicates. |
| Cyclic performance to point of failure | Not explicitly stated; device found substantially equivalent to predicates. |
| Cyclic performance to 2000 cycles | Not explicitly stated; device found substantially equivalent to predicates. |
Note: The document states, "The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate devices." Specific numerical acceptance criteria and the Compressyn™ Band's performance against them are not provided, only that the outcome met the substantial equivalence criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set (number of devices tested) or the data provenance (country of origin, retrospective/prospective). It only mentions that "All necessary verification and validation testing has been performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a medical device (cerclage bone fixation) testing, not an AI or diagnostic imaging study that would require expert-established ground truth. The testing involves mechanical and performance characteristics.
4. Adjudication Method for the Test Set
N/A. The testing described is performance-based (mechanical tests) typically without human adjudication in the context of diagnostic agreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A. This is a medical device (cerclage bone fixation) testing, not an AI or diagnostic imaging study that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" or reference for comparison appears to be the performance characteristics of the predicate devices. The study aimed to demonstrate "substantial equivalence" of the Compressyn™ Band's mechanical and physical performance to these predicate devices. The specific physical properties or failure points of the predicate devices would form the benchmark for comparison.
8. The Sample Size for the Training Set
N/A. This is not an AI/machine learning study, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
N/A. As there is no training set for an AI model, this question is not applicable.
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