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NanOss™ BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

NanOss BVF-E is a resorbable bone void filler consisting of calcium phosphate in a porcine gelatin carrier provided in granular form. This submission introduces a packaging modification intended to facilitate reconstitution of the device by mixing with saline or blood at the time of implantation.

NanOss BVF-E is radiopaque, provided sterile and is intended for single use only.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a packaging modification of the NanOss BVF-E bone void filler. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing performance studies for the modified device.

The document discusses:

• Administrative information for the 510(k) submission.
• Device Name and Classification.
• Intended Use of the NanOss BVF-E.
• Device Description, highlighting a packaging modification.
• Equivalence to Marketed Product, emphasizing similarities to the unmodified NanOss BVF-E to claim substantial equivalence.
• An FDA letter confirming the 510(k) clearance based on substantial equivalence.
• The official Indications for Use statement.

There are no details presented regarding:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance studies.
7. Type of ground truth used (pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory submission for a device modification, focusing on substantial equivalence, not a clinical study report or performance evaluation against specific criteria for a novel device.

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NanOss Bone Void Filler is intended only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., 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 void filler that resorbs and is replaced by the growth of new bone during the healing process.

NanOss Bone Void Filler is an osteoconductive, resorbable, calcium phosphate implant for use as a bone graft substitute or bone void filler. The device consists of prefabricated cylindrical calcium phosphate pellets. The device is radiopaque and is presterilized for single use. The nanocrystalline processing of the material results in sintered hydroxyapatite pellets that are translucent and uniform in density and strength.

This 510(k) premarket notification for the Angstrom Medica NanOss™ Bone Void Filler does not contain the detailed study information typically required to describe acceptance criteria and device performance in the context of AI/ML or diagnostic devices. Instead, it is a submission for a bone void filler product, which is a medical device, but not one that involves software algorithms, AI, or diagnostic performance metrics like sensitivity, specificity, or accuracy.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission as they pertain to performance evaluation of diagnostic or AI-driven systems.

However, based on the provided document, I can extract information relevant to the device's equivalence to marketed products, which serves as the "proof" for this type of device, rather than a performance study against acceptance criteria in the AI/ML sense.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

For this type of device, "acceptance criteria" are not reported as specific performance metrics and thresholds (like sensitivity > X%). Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially that it is chemically, functionally, and indication-wise similar to already cleared devices.

2. Sample sized used for the test set and the data provenance

• Not Applicable. This submission relies on demonstrating equivalence to predicate devices, not on a "test set" in the context of AI/ML performance evaluation studies. Chemical and physical properties of the NanOss pellets would have been tested, but these are not clinical "test sets" of data as understood in AI/ML.
• Data Provenance: The document doesn't specify an external "data provenance" for performance testing, as the "proof" is largely based on internal material characterization and comparison to established predicate properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No ground truth in the AI/ML sense (e.g., expert consensus on images or pathology results) was established for a "test set." The basis for clearance is material science and clinical equivalence to existing products.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No adjudication method for a "test set" was used as described for AI/ML performance studies.

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

• Not Applicable. This is not a diagnostic device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical bone void filler, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For material properties and claims of equivalence: The "ground truth" is established based on standard material characterization techniques (e.g., chemical analysis, density measurements, dissolution studies) and comparison to the known properties and regulatory clearances of the predicate devices.
• For clinical benefit: The "ground truth" is that similar calcium phosphate/sulfate bone void fillers are already cleared and used safely and effectively in clinical practice, and this new device functions equivalently.

8. The sample size for the training set

• Not Applicable. No training set for an AI/ML algorithm was used.

9. How the ground truth for the training set was established

• Not Applicable. No training set for an AI/ML algorithm was used.

Summary of the "Study" that Proves Acceptance Criteria are Met:

The "study" in this context is the demonstration of substantial equivalence to legally marketed predicate devices. The manufacturer, Angstrom Medica, Inc., submitted evidence to the FDA showing that their NanOss™ Bone Void Filler shares the same intended use, design principles, and functional characteristics as several already cleared bone void fillers.

Key elements of this "study" (as implied by the document):

• Comparison to Predicate Devices: NanOss was compared to:
  • Biomet Calcium Phosphate Granular Bone Void Filler (K011531)
  • NovaBone Resorbable Bone Graft Substitute (K021336)
  • Wright Medical Technology Osteoset Resorbable Mini Bead Kit (K010532)
  • Orthovita Vitoss Scaffold (K994337)
  • Interpore Pro Osteon 500R (K990131)
• Material Characterization: Evidence was presented that NanOss pellets are:
  • Chemically similar to calcium phosphate predicates.
  • Exhibit expected phase purity and calcium/phosphorus stoichiometry.
  • Have trace element levels below ASTM F1185 limits.
  • Possess a density approaching theoretical density for ceramic hydroxyapatite.
  • Have a bulk density in the expected range for small cylindrical pellets.
  • Demonstrate dissolution behavior within the range of predicate devices.

The FDA's letter (K050025) confirms that, based on this submission, the device was determined to be "substantially equivalent" to the predicate devices for the stated indications for use, thereby meeting the regulatory acceptance criteria for market clearance.

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