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When wed as a non cervical hook and sarel services in indicated for we in prisents with degenerative discover (discosenic back pain with deserentian of the discomplies to racked studies), spondegical sociosis, spinel starts spinel starts with winnely falled back suppens, and frances. Villem wed as credicte screens (a) lawing sever sports (a) lawing sever sport 4) at the L.S.S) joint, , who are receiving fusion using anto cone watt only, (c) who are having the device for attacked to the lumber and (d) who are lasing the clerine "tenoved after development of a stid fision mess The simple, is intended for ossein five levels 17 through S. The Searl Pares are interned for posterior sacral fixation at S1 and S2. Levels of pedicle screw fivation are posterior from levels L3 to through S1 only.

The J.S.Spine System @ inplans are station of the stablic the hunter and torners were to promote insion. The System is to be removed aller fision occurs. The JBS. Spine Systems, sazal plates, pedicle screws, reds, pedicle and laminer hooks and linking plates. J.B.S. has both firm rod systems. The inqlant are composed of surgical implant timinon, T.6ALAVELL, accoming to ASTM-136-92. Instruments to implat the IB.S. Spine System are made of ZOC'l stainless steel source to ATM grace 400 staries see) with a polyna handle, ar surgical implant titanium, Ti 6Al 4V EI I .

I am sorry, but the provided text is a 510(k) summary for a medical device (J.B.S. SPINE SYSTEM® WITH PEDICLE SCREWS) and does not contain any information regarding acceptance criteria, study design, or performance data.

The document primarily focuses on:

• Regulatory information: Company, contact, trade names, classification.
• Device description: Components, materials.
• Indications for Use: What the device is intended for.
• Contraindications: When the device should not be used.
• Warnings, Precautions, and Potential Adverse Effects: Risks associated with the device.
• Substantially Equivalent Devices: Other similar devices on the market.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them based on this document.

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Fixation of C1-C2 in case of fracture or multi-operated back.

The J.B.S. Posterior C1-C2 Clamp System is a single-use. temporary device used for fixation of the C1-C2 vertebrae. The System is to be removed after fusion occurs. It consists of a cervical hook, a superior hook, a linking screw and a locking screw. All these components are made of surgical implant titanium with the composition Ti-6AL-4V ELI according to ASTM-136-92 or ISO 5832-3-90.

The provided text describes a medical device called the "J.B.S. POSTERIOR C1-C2 CLAMP SYSTEM®", which is a spinal fixation device. However, the text is a 510(K) summary for a medical device and does not contain any information about acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/algorithm-driven device.

The request asks for information relevant to the testing and evaluation of an AI-driven medical device, including aspects like sample size for test and training sets, ground truth establishment, expert qualifications, and multi-reader multi-case studies. These concepts are not applicable to the non-AI, mechanical spinal clamp system described in the input.

Therefore, I cannot fulfill the request using the provided input. The input describes a physical medical implant, not an AI/algorithm device.

Ask a specific question about this device

Ask a specific question about this device