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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria Category	Description of how criteria are met (Reported Device Performance)
Intended Use Equivalence	NanOss Bone Void Filler is intended for bony voids or gaps not intrinsic to bony structure stability, for filling defects in the skeletal system (extremities, spine, pelvis), and to resorb and be replaced by new bone. This is substantially the same as the intended use of the predicate devices.
Design Principles Equivalence	NanOss Bone Void Filler is an osteoconductive, resorbable, calcium phosphate implant for use as a bone graft substitute or bone void filler, consisting of prefabricated cylindrical calcium phosphate pellets, radiopaque, and presterilized. These design principles are substantially the same as the predicate devices.
Functional Characteristics Equivalence	NanOss Bone Void Filler pellets are chemically similar to calcium phosphate predicates, exhibiting expected phase purity, calcium/phosphorus stoichiometry, and trace element levels below ASTM F1185 limits. Density is essentially theoretical for ceramic hydroxyapatite, and bulk density is in the expected range for small cylindrical pellets. Dissolution behavior is within the range of predicate devices.
Material Composition Equivalence	Chemically similar to calcium phosphate predicates (hydroxyapatite), meeting phase purity and stoichiometry expectations, and trace element levels below ASTM F1185.
Regulatory Classification Equivalence	Classified as Class II, Special Controls, under 21 CFR 888.3045 (Resorbable calcium salt bone void filler device), which aligns with predicates. Calcium phosphate devices have been cleared as substantially equivalent to calcium sulfate 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.

Summary

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FEB - 3 7005

0 50025

510(k) Summary

Angstrom Medica NanOss™ Bone Void Filler

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ADMINISTRATIVE INFORMATION

Manufacturer Name:	Angstrom Medica, Inc.150-A New Boston Street,Woburn, MA 01801
Official Contact:	Paul J. Mraz, CEOTelephone: (781) 933-6121FAX: (781) 933-5981
Representative/Consultant:	Floyd G. LarsonPaxMed International4329 Graydon RoadSan Diego, CA 92130Telephone: (858) 792-1235FAX: (858) 792-1236e-mail: flarson@paxmed.com

DEVICE NAME

Classification Name: Trade/Proprietary Name: Common Name: Product Code:

Filler, calcium sulfate preformed pellets NanOss™ Bone Void Filler bone void filler MQV

DEVICE CLASSIFICATION

Calcium sulfate preformed pellets have been classified by FDA as Class II, Special Controls, in a Final Rule effective July 2, 2003 (68 FR 32635) (21 CFR 888.3045). Calcium phosphate devices have been cleared as substantially equivalent to calcium sulfate devices.

CONFORMANCE WITH PERFORMANCE STANDARDS

No performance standards have been established under Section 514.

INTENDED USE

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DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

NanOss Bone Void Filler is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices. The intended use, design and functional characteristics of NanOss Bone Void Filler and the predicate devices are substantially the same. These devices include 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) and Interpore Pro Osteon 500R (K990131). These devices all are intended to fill voids or gaps in osseous defects, are not intended to be load-bearing and consist of a variety of calcium compounds.

NanOss Bone Void Filler pellets are chemically similar to the calcium phosphate predicates, with the expected phase purity and calcium/phosphorus stoichiometry, and with trace element levels below the limit set by ASTM F1185. Density is essentially the theoretical density for ceramic hydroxyapatite and bulk density is in the expected range for small cylindrical pellets. Dissolution behavior is within the range of that of the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

FEB - 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Floyd G. Larson Angstrom Medica, Inc. C/o Paxmed International 4329 Graydon Road San Diego, California 92130

Re: K050025

Trade/Device Name: NanOss™Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: January 04, 2005 Received: January 07, 2005

Dear Mr. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a showe and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abo stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, arons provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I ederal battler and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Floyd G. Larson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours of substantial equivalence of your device to a legally prematics notification. The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at not any at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoranding by reference to presence to presessorsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: NanOss™ Bone Void Filler

Indications for Use:

NanOss Bone Void Filler is intended only for bony voids or gaps that are not intrinsic to the NahObs Done Vota Finer ire. The product is indicated to be gently packed into bony voids or buoney 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.

Mark N. Millenn

Division Sign Division of General, Restorative, and Neurological Devices

510(k) Number K050025

Prescription Use __X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 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.