(59 days)
These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
These devices are bone paste products made by combining gelatin and demineralized bone matrix.
The provided text is a 510(k) Summary for several bone graft substitute devices. It describes the devices, their indications for use, and a summary of technological characteristics. However, it does not include detailed acceptance criteria or a study proving that the device meets specific performance metrics in the way your request outlines for AI/software devices (e.g., sensitivity, specificity, or reader improvement).
This document pertains to a medical device submitted for FDA clearance under the 510(k) pathway, which establishes substantial equivalence to a predicate device, rather than a novel study with clearly defined acceptance criteria and performance data for a diagnostic algorithm.
Therefore, I cannot populate the requested table or answer most of the specific questions about standalone performance, MRMC studies, sample sizes, or ground truth establishment in the context of an AI-based device, as this information is not present in the provided document.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criterion implicitly for a 510(k) is "substantial equivalence" to a predicate device.
- Reported Device Performance:
- The document states: "Results from studies in animal models indicate that these products can be used as a bone graft substitute with equivalent or better healing results when compared to the predicate device."
- "Healing was evaluated radiographically, histologically, and mechanically."
- "DBM and finished product were screened for osteoinductivity in a rat assay."
- Limitation: No specific quantitative performance values (e.g., percentage of improved healing, specific radiographic scores) are provided.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Pro Osteon™ Implant 500R) in terms of safety and effectiveness as a bone graft substitute. | Animal model studies indicate "equivalent or better healing results" compared to the predicate. Healing evaluated radiographically, histologically, and mechanically. Osteoinductivity screened in a rat assay. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "animal models" and "a rat assay" but does not give the number of animals or cases.
- Data Provenance: Animal models (rats).
- Retrospective or Prospective: Not explicitly stated, but typically animal model studies are conducted prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The evaluation of healing in animal models would likely involve animal pathologists, histologists, and veterinary radiologists, but the number and qualifications are not disclosed. This is not a human expert-based ground truth for a diagnostic AI.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This relates to expert consensus for diagnostic decisions, which is not described here.
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 not an AI/software device. The document describes a bone graft substitute.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/software device.
7. The type of ground truth used:
- Animal Outcomes/Pathology: Based on the "radiographically, histologically, and mechanically" evaluation of healing in animal models, the ground truth would be based on these biological and physical measures in animals.
8. The sample size for the training set:
- Not applicable. This is for a physical medical device, not a machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
§ 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.