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The Forma Medical Optimal Plating System is intended for fixation of fractures, osteotomies, arthrodeses, and bone reconstructions in adult patients with normal or osteopenic bone. Indications include flat (scapula), long (clavicle, upper and lower extremities including metacarpals, and phalanges), irregular (pelvis, hand, foot) bones and joints (wrist, ankle). The Forma Medical Optimal Plating System is not indicated for ribs, sternum, spine, or the skull.

The Forma Medical Optimal Plating System is designed to hold bones in relative stability for fracture fixation and arthrodesis. The plates and screws are available in multiple sizes based on patient anatomy and clinical application. The screws are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1537, and F138. The plates are manufactured from titanium, titanium alloy, or stainless steel, as specified in ASTM F67, F136, and F138. The system includes plates, screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials.

The provided text describes mechanical testing performed to demonstrate substantial equivalence for the Forma Medical Optimal Plating System. It does not contain information about an AI/ML-enabled device or a study involving human readers. Therefore, many of the requested fields are not applicable.

Here's the relevant information:

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

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

The document does not explicitly state the sample size (number of screws or plates) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable for mechanical testing of a physical device.

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)

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement, not expert consensus.

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

Not applicable. Adjudication methods are relevant for subjective assessments, not for objective mechanical testing.

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 device is a physical bone fixation system, not an AI-enabled diagnostic tool.

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

Not applicable. This device is a physical bone fixation system, not an AI-enabled diagnostic tool.

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

The ground truth for the mechanical testing is based on established engineering standards (ASTM F543-23, ASTM F382-17) and an analytical formula (Chapman analytical formula for pullout strength).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

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The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

The subject devices are metallic bone staples to be marketed under the name 'Staple All-in-One'' as part of the APTUS® Foot System. The subject device staples are provided in designs to address clinical needs depending on the size and surface of the bone to be fused, and include two sizes and two angulations (or offsets). Each subject device is provided as a set, comprising the staple and a set of attached instruments. The instruments consist of two drill guide, and a positioning instrument. The drills and drill guide are snapped off of the set prior to use of the staple. The positioning instrument is snapped off of the staple after implantation. The subject device staples and instruments are made of stainless steel conforming to ISO 5832-1 and ASTM F139.

The provided text is a 510(k) summary for the Medartis AG APTUS® Foot System, which is a medical device for bone fixation. It describes the device, its intended use, and how it was deemed substantially equivalent to a predicate device.

It does NOT contain information about any AI/ML-driven device or study results proving acceptance criteria for such a device. The document explicitly states:

"Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1, and ISO 11137-3; bacterial endotoxin testing according to ANSI AAMI ST72; sterile barrier shelf life testing according to ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M; biocompatibility testing according to ISO 10993-12, ISO 10993-15, and ISO 10993-18: and comparative mechanical testing according to ASTM F564. Clinical data were not provided in this submission."

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided text is for a traditional medical device (a bone fixation staple) and does not involve AI or clinical performance studies for its clearance.

To answer your question accurately, I would need a document that describes the clinical performance evaluation of an AI/ML-driven medical device.

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