The accuDEXA is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. accuDEXA BMD estimates can be used as an aid to the physician in determining fracture risk.

Device Description

The accuDEXA device is a Dual Energy X-Ray Absorptiometer (DEXA) device. The device is intended to estimate bone mineral density in the middle finger of the non-dominant hand. By changing the high voltage on the X-ray tube, two energies are produced. Each of the two settings produces an image of the finger and each image is analyzed using various algorithms to produce a value of bone mineral density (BMD) and bone mineral content (BMC). These values are compared with a normative database, yielding a t-score and a z-score. The t-score is the number of standard deviations that the patient is above or below the mean of a reference sample of young healthy individuals. The z-score is the number of standard deviations that the patient is above or below the mean of a reference sample of individuals of the same age as the patient.

AI/ML Overview

The provided 510(k) summary for the Schick accuDEXA Bone Densitometer does not contain the detailed clinical study information requested to fill out the table and answer all the questions. The submission focuses on demonstrating substantial equivalence to a predicate device (Norland pDEXA and Model 178) based on technological characteristics and indications for use, rather than presenting a new clinical study with acceptance criteria and performance data.

Specifically, the document states:

"The accuDEXA Bone Densitometer is substantially equivalent to the Norland pDEXA and Model 178 bone densitometer devices with respect to the fracture risk claim."
"The addition to the indications statement for the accuDEXA and the indications statement cleared by FDA for the predicate device are the same. The accuDEXA Bone Densitometer has the same technological characteristics as the predicate devices."
"Schick Technologies has demonstrated through its comparison of characteristics with the predicate devices that the accuDEXA Bone Densitomctor is substantially equivalent to the predicate devices."

This means that Schick Technologies did not conduct a new clinical study to prove the device meets specific acceptance criteria for fracture risk determination. Instead, they leveraged the existing clearance of predicate devices that had already established their utility for fracture risk assessment. There is no new performance data or acceptance criteria reported for the accuDEXA itself in this document.

Therefore, most of the requested information cannot be extracted from this specific 510(k) submission.

However, I can populate the table and answer questions based on the information provided about the premise of substantial equivalence, which is that the device should perform "the same" as the predicate.

Device: Schick accuDEXA Bone Densitometer

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Implicit Acceptance Criteria (based on substantial equivalence to predicate devices for fracture risk claim):The device's ability to estimate bone mineral density (BMD) in the middle finger and use this BMD value as a relative indicator of bone density elsewhere in the body should be comparable to the predicate devices (Norland pDEXA and Model 178) to aid physicians in determining fracture risk. This implies that the device's measurements (BMD, t-score, z-score) should be consistent with the established scientific principles and clinical utility demonstrated by the predicate devices for this indication. The specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy against a gold standard for fracture prediction) for this specific device's performance were not provided, as the submission relies on the predicate's established performance.	Reported Device Performance (based on substantial equivalence claim):The accuDEXA Bone Densitometer has "the same technological characteristics as the predicate devices" (Norland pDEXA and Model 178) and its indications for use are "the same." Therefore, its performance in estimating BMD and aiding in fracture risk determination is implicitly claimed to be equivalent to these legally marketed predicate devices. The document does not provide specific numerical performance metrics (e.g., sensitivity, specificity, or correlation coefficients) for the accuDEXA itself in relation to fracture risk. It relies on the understanding that the predicate devices are already accepted for this purpose. The device produces a value of bone mineral density (BMD) and bone mineral content (BMC) by analyzing two images using various algorithms. These values are compared with a normative database, yielding a t-score and a z-score, which are the standard outputs for bone densitometers used in fracture risk assessment. The recommendations of the World Health Organization and the National Osteoporosis Foundation were used in developing the patient report printout, User Manual, and Patient Information Brochure, suggesting alignment with clinical best practices for interpreting results for fracture risk.

Acceptance Criteria

Reported Device Performance

Implicit Acceptance Criteria (based on substantial equivalence to predicate devices for fracture risk claim):The device's ability to estimate bone mineral density (BMD) in the middle finger and use this BMD value as a relative indicator of bone density elsewhere in the body should be comparable to the predicate devices (Norland pDEXA and Model 178) to aid physicians in determining fracture risk. This implies that the device's measurements (BMD, t-score, z-score) should be consistent with the established scientific principles and clinical utility demonstrated by the predicate devices for this indication. The specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy against a gold standard for fracture prediction) for this specific device's performance were not provided, as the submission relies on the predicate's established performance.

Reported Device Performance (based on substantial equivalence claim):The accuDEXA Bone Densitometer has "the same technological characteristics as the predicate devices" (Norland pDEXA and Model 178) and its indications for use are "the same." Therefore, its performance in estimating BMD and aiding in fracture risk determination is implicitly claimed to be equivalent to these legally marketed predicate devices. The document does not provide specific numerical performance metrics (e.g., sensitivity, specificity, or correlation coefficients) for the accuDEXA itself in relation to fracture risk. It relies on the understanding that the predicate devices are already accepted for this purpose. The device produces a value of bone mineral density (BMD) and bone mineral content (BMC) by analyzing two images using various algorithms. These values are compared with a normative database, yielding a t-score and a z-score, which are the standard outputs for bone densitometers used in fracture risk assessment. The recommendations of the World Health Organization and the National Osteoporosis Foundation were used in developing the patient report printout, User Manual, and Patient Information Brochure, suggesting alignment with clinical best practices for interpreting results for fracture risk.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable / Not provided. The submission relies on substantial equivalence to predicate devices, not on a new clinical study with a test set.
Data Provenance: Not applicable / Not provided for the accuDEXA itself. The predicate devices (Norland pDEXA and Model 178) were already on the market, originating from earlier clearances (K973104, K931996 for pDEXA, and pre-1976 for Model 178).

3. 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 / Not provided. No new ground truth establishment process for a test set is described. The basis for fracture risk determination for the predicate devices would have been established through a combination of clinical research and expert consensus over time, but these details are not provided here for the accuDEXA.

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

Adjudication Method: Not applicable / Not provided. No new test set or adjudication process is described in this 510(k) submission.

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 submission describes a bone densitometer, which measures bone mineral density, not an AI-assisted diagnostic imaging interpretation device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not conducted.

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

Standalone Performance Study: Not applicable in the context of fracture risk determination as a standalone claim. The device itself (accuDEXA) calculates BMD, t-score, and z-score autonomously. However, these estimates are explicitly stated to be "an aid to the physician in determining fracture risk," indicating a human-in-the-loop model where the physician interprets the device's output within the broader clinical context. The 510(k) does not present a study directly linking the algorithm's output alone to fracture outcomes without physician interpretation.

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

Ground Truth Type: Not explicitly stated for the accuDEXA. For the general understanding of bone densitometry and fracture risk, the "ground truth" for the predicate devices and the underlying science of BMD would be based on:
- Clinical Outcomes Data: Longitudinal studies correlating low BMD with increased fracture incidence.
- Expert Consensus: Guidelines from organizations like the World Health Organization (WHO) and National Osteoporosis Foundation (NOF) which define osteopenia and osteoporosis based on T-scores and relate these to fracture risk. The submission explicitly mentions using these recommendations.

8. The sample size for the training set

Training Set Sample Size: Not applicable / Not provided. The submission focuses on substantial equivalence based on technological characteristics, not on a machine learning model that requires a discrete training set. The device compares patient values to a "normative database," which serves as a reference, but its size is not specified here.

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

Ground Truth Establishment for Training Set: Not applicable / Not provided. As above, this is not a machine learning submission. The "normative database" would have been established through large-scale epidemiological studies to define age- and gender-specific bone density distributions, which then form the basis for t-scores and z-scores, but the specifics are not in this document.

Summary

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981124

510(k) Summary

Schick accuDEXA Bone Densitometer Fracture Risk Claim

Common/Classification Name. Bone Densitometer 21 CFR 892.1170

Schick Technologies, Inc. 31-00 47th Avenue Long Island City, NY 11101 718-937-5765. 718-937-5962 (FAX) Contact: Enrico Renzi, Prepared: March 6, 1998

LEGALLY MARKETED PREDICATE DEVICES A.

The accuDEXA Bone Densitometer is substantially equivalent to the Norland pDEXA and Model 178 bone densitometer devices with respect to the fracture risk claim. The Norland pDEXA device was found to be substantially equivalent (K973104) with regard to claims of fracture risk to the Norland Model 178, which has been determined by CDRH to have been in commercial distribution prior to May 28, 1976 for use as an aid to the physician in determining fracture risk. The Norland pDEXA device was originally cleared under K931996

DEVICE DESCRIPTION B.

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C. INDICATIONS FOR USE

SUBSTANTIAL EQUIVALENCE SUMMARY D.

The addition to the indications statement for the accuDEXA and the indications statement cleared by FDA for the predicate device are the same. The accuDEXA Bone Densitometer has the same technological characteristics as the predicate devices. The descriptive characteristics with respect to the fracture risk claim are precise enough to assure substantial equivalence. Therefore, the accuDEXA Bone Densitometer is substantially equivalent to the predicate devices with respect to the fracture claim.

TECHNOLOGICAL CHARACTERISTICS E.

See Device Description, above.

F. FRACTURE RISK DETERIMINATION

The recommendations of the World Health Organization and the National Osteoporosis Foundation were used in developing a modification to the patient report printout, an addition to the User Manual, and a Patient Information Brochure.

G. CONCLUSIONS

Schick Technologies has demonstrated through its comparison of characteristics with the predicate devices that the accuDEXA Bone Densitomctor is substantially equivalent to the predicate devices.

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Public Health Service

21 CFR 892.1170/Procode: 90 KGI

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K981124 Re: accuDEXA Bone Densitometer Dated: March 25, 1998 Received: March 27, 1998 Regulatory class: II

Dear Mr. Athey:

IUN

Whit Athey

1 1998

c/o C.L. Mcintosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625

Schick Technologies, Inc.

Rockville, MD 20852

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to 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 Festeral Food, Drug, and Commenc Act (Act.). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Feleral Regulations, Title 21, Parts 800 to 895. A substantially oquivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 and additionally 809.10 for in vitro diagnostic devices). please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

William Hio, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Far, Nose and Thros and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): _

Device Name: _Schick accuDEXA Bone Densitometer

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Bergman
Division Sign Off

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Ramrological Devices
510(k) Number K981124

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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Regulation Number and Section

§ 892.1170 Bone densitometer.

(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.