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K Number
K014289
Device Name
ORTHOSS RESORBABLE BONE VOID FILLER
Manufacturer
GEISTLICH-PHARMA
Date Cleared
2002-03-28

(90 days)

Product Code
LYC,MQV
Regulation Number
872.3930
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ORTHOSS is indicated for bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). ORTHOSS is indicated only for use in bone voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Device Description

ORTHOSS™ Resorbable Bone Void Filler

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called ORTHOSS™ Resorbable Bone Void Filler. This type of letter indicates that the device has been found substantially equivalent to a legally marketed predicate device, and it does not contain the detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way a clinical study report would.

Therefore, for the acceptance criteria and study details you requested, the document states:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter. The letter confirms substantial equivalence, which means the device is as safe and effective as a predicate device, but it doesn't detail specific performance metrics against pre-defined acceptance criteria from a study.
  2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not provided in the 510(k) clearance letter.
  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): This information is not provided in the 510(k) clearance letter.
  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided in the 510(k) clearance letter.
  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: This device is a bone void filler, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this product.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As this is a bone void filler and not a diagnostic algorithm, this concept is not applicable.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided in the 510(k) clearance letter.
  8. The sample size for the training set: This information is not provided in the 510(k) clearance letter.
  9. How the ground truth for the training set was established: This information is not provided in the 510(k) clearance letter.

In summary: The provided document is a regulatory clearance letter focused on substantial equivalence to a predicate device. It does not contain the detailed study design, acceptance criteria, or performance data that would be found in a clinical study report or a pre-market approval (PMA) application for a novel, high-risk device. The assessment for a 510(k) clearance primarily involves demonstrating that the new device is as safe and effective as devices already on the market, often through comparison of technological characteristics, materials, and intended use, rather than a full-scale clinical trial with pre-defined acceptance criteria and reported device performance.

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.