(211 days)
Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Stimulan™ is manufactured from medical grade calcium sulfate that resorbs and is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it may be used at an infected site.
Stimulan™ Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 pans when used in accordance with the device labeling. Stimulan™ is manufactured from 98% medical grade calcium sulfate dihydrate (CaSO4 - 2H2O) and stearic acid.
Here's an analysis of the provided text regarding the Stimulan™ Calcium Sulfate Bone Void Filler, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary and FDA clearance letter. It mainly focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study with strict acceptance criteria in the way a novel AI/software medical device might. Therefore, many of the requested fields will be marked as "Not Applicable" or explained in the context of a substantial equivalence submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Specific Metric/Benchmark) | Reported Device Performance |
|---|---|---|
| Chemical Composition | Equivalent to predicate device. | Stimulan™ is manufactured from 98% medical grade calcium sulfate dihydrate (CaSO4 - 2H2O) and stearic acid. This was deemed equivalent to the predicate device (Wright Medical - Osteoset Pellets, BioGeneration - ProFusion Bone Graft Substitute in terms of chemical composition). |
| Dissolution Rate | Equivalent to predicate device. | "Testing demonstrated that Stimulan™ has equivalent dissolution...characteristics to the predicate device." Resorbed in approximately 30-60 days. |
| Mechanical Characteristics | Equivalent to predicate device. | "Testing demonstrated that Stimulan™ has equivalent...mechanical...characteristics to the predicate device." |
| Mass to Volume Ratio | Equivalent to predicate device. | "Testing demonstrated that Stimulan™ has equivalent...mass to volume ratio characteristics to the predicate device." |
| Pyrogenicity | Non-pyrogenic. | "Testing indicated that the product is non-pyrogenic." |
| Indication for Use | Equivalent to predicate device. | Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable... Also, as the implant is biodegradable and biocompatible, it may be used at an infected site. Deemed equivalent to predicate devices. |
| Biocompatibility | Biocompatible. | Stated as a characteristic; implicit equivalence to predicate devices and established materials. |
| Biodegradability | Biodegradable. | Stated as a characteristic; implicit equivalence to predicate devices and established materials. |
Study Details (Based on available 510(k) Summary)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided summary. The summary mentions "Testing demonstrated..." implying in-vitro or bench testing rather than clinical human trials with a "test set" in the context of an algorithm.
- Data Provenance: Not specified, but likely in-house lab testing, not clinical data from a specific country or setting.
- Retrospective or Prospective: Not applicable in the context of this type of testing.
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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):
- Number of Experts: Not applicable. For a device like a bone void filler seeking substantial equivalence, "ground truth" is typically established via analytical chemistry, material science, and mechanical engineering testing results, rather than expert clinical consensus on a "test set."
- Qualifications of Experts: Not applicable.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This concept is relevant for clinical studies involving human interpretation or subjective endpoints, which are not described here.
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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 device is a calcium sulfate bone void filler, not an AI or imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This refers to an algorithm's performance, which is not relevant for this device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the "Performance Date" section, the ground truth was established through laboratory testing (material science, chemistry, and mechanical engineering tests) to assess dissolution, mechanical properties, mass to volume ratio, and pyrogenicity. The comparison was against predicate devices.
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The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document describes a medical device, not a machine learning model.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable.
§ 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.