(193 days)
Synthes chronOS Composite is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Synthes chronOS Composite is indicated for use in the treatment of bony defects created surgically or through traumatic injury. Synthes chronOS Composite, combined with autogenous blood and/or bone marrow or autograft, is intended to be used in spine for posterolateral fusion. Following placement into the bony void, chronOS Composite resorbs and is replaced with bone during the healing process.
Synthes chronOS Composite is a synthetic, porous, osteoconductive, resorbable bone void filler made from chronOS ß-TCP granules imbedded in a matrix of poly (lactide-co-ε-caprolactone). The composite is flexible and may be molded by the surgeon or used directly as supplied. The flexible chronOS Composite provides contourability and malleability of the device to the bony implant site.
The provided text is a 510(k) summary for the Synthes chronOS Composite device, which is a resorbable calcium salt bone void filler. This document primarily focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC) or standalone studies cannot be found in the provided text.
Based on the information given, here's what can be extracted and what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not available | Not available |
Explanation: The document does not specify quantitative acceptance criteria (e.g., minimum tensile strength, degradation rate, osteoconductive properties, clinical success rates). The general "acceptance" in this context is the FDA's determination of "substantial equivalence" to predicate devices, meaning it is considered safe and effective for its intended use based on comparison rather than new performance data against specific, pre-defined metrics.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This document is a 510(k) summary for substantial equivalence, not a report of a new clinical or performance study with a distinct "test set" in the context of AI/device performance.
- Data Provenance: Not applicable. No specific test data from a study is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No test set requiring ground truth established by experts is mentioned.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set requiring adjudication is mentioned.
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
- MRMC Study: No. This is a medical device (bone void filler), not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is a medical device (bone void filler), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable. There is no specific "ground truth" mentioned in the context of a performance study for this device. The basis for approval is substantial equivalence to legally marketed predicate devices, meaning the already accepted performance and safety profile of the predicate devices serves as the benchmark.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. This is not an AI/machine learning device.
Summary of Study (as per the 510(k) in the provided text):
The document states: "Documentation is provided which demonstrates that Synthes chronOS Composite is substantially equivalent to other legally marketed Synthes devices."
This indicates that the "study" conducted for K071046 was a substantial equivalence comparison study. This type of study does not involve new clinical trials or performance tests to establish novel performance metrics against predefined acceptance criteria. Instead, it involves comparing the new device (Synthes chronOS Composite) to predicate devices (Synthes (USA) chronOS™ (K043045) and chronOS TCP (K013072)) based on:
- Intended Use: Identical or very similar.
- Technological Characteristics: Similar materials, design, mechanism of action. The chronOS Composite differs by adding poly (lactide-co-ε-caprolactone) to chronOS ß-TCP granules, making it flexible and moldable.
- Performance Data: Often includes bench testing (e.g., mechanical properties, degradation), biocompatibility testing, and potentially some in-vivo animal data for safety, all demonstrating that the new device performs as safely and effectively as the predicate devices. The document does not detail these tests or their results, only that they were provided to demonstrate substantial equivalence.
The FDA's review concluded that the device is substantially equivalent to the predicate devices for the stated indications for use. This means the device met the regulatory acceptance criterion for market access under the 510(k) pathway by demonstrating it is as safe and effective as existing legally marketed devices.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.