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The indications for the PAR 5 Acetabular component are as follows:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
5. Revision procedures where other treatment or devices have failed

The PAR 5 Acetabular Component is a hemispherical metallic acetabular cup, which can accept a modular hook, ilium flange, and/or a modular ischial blade. The shell accepts a standard Ringloc® liner. The outer surface of the shells has porous coating. The shells are also available with or without hydroxyapatite (HA) coating.

The provided documentation is a 510(k) premarket notification for a medical device, the PAR 5 Acetabular Component, and focuses on demonstrating substantial equivalence to a predicate device. It explicitly states:

"Clinical Testing: None provided as a basis for substantial equivalence."
"Non-Clinical Testing: Substrate testing with an Engineering Justification determined that the modified PAR 5 Acetabular Components presented no new risks and were, therefore, substantially equivalent to the predicated device."

Therefore, the information typically required to describe acceptance criteria and a study proving a device meets those criteria (especially related to AI/software performance) is not present in this document. This submission relies on an engineering justification and comparison to a predicate device rather than extensive clinical or statistical performance studies in humans.

Here's a breakdown of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not applicable. There are no performance metrics or acceptance criteria for a clinical or AI study described. The "performance" being evaluated is substantial equivalence based on material properties and design similarity to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for performance comparison is described.
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. There is no test set requiring ground truth establishment by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set is described.
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 a medical device (hip implant component), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established for device performance in this context. The "ground truth" for this 510(k) is the existing predicate device and its established safety and effectiveness.
8. The sample size for the training set: Not applicable. No machine learning model or training set is involved.
9. How the ground truth for the training set was established: Not applicable. No machine learning model or training set is involved.

In summary, this 510(k) submission for the PAR 5 Acetabular Component does not contain information about clinical performance studies or AI/software validation. The basis for its substantial equivalence is an engineering justification and comparison to a previously approved predicate device.

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The indications for the Par 5 Acetabular Component are as follows:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of nonunion, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
5. Revision of failed total joint construction or treatment

The Par 5 Acetabular Component is a hemispherical metallic acetabular cup with a hook, flange and/or blade extending from the rim. The shell has six holes for placement of 6.5mm cancellous screws similar to a traditional acetabular component. Additionally, the shell has three counterbores for attachment of the hook and blade components and a mounting flange for attachment of the ilium flange. The shell accepts a standard Ring-loc liner.

The forked ilium flange is available in three sizes: small, medium and large and in left, right and in straight configurations. Screw holes and more of the shell are incorporated into the flange. The flange is malleable and can be shaped by the surgeon in the will on the shell of the shell at the mounting anatomy to provide additional support. The ilium flange is attached to the m flange by the component geometry and screw fasteners.

The malleable hook is placed within one of the counterbores of the shell in a position where it will reside beneath the teardrop of the ishium. The hook is formed to the patient's anatomy by the reside benefit is held to the shell by a screw.

The blade component is intended to enter the ishium bone in a manner similar to a sceve. The she curvature of the blade resembles the curvature of the component is held to the shell curvature of the blade roosmbles the out secondarily, by a screw.

The ilium flange and hook are fabricated from commercially pure (CP) titanium. The cup and blade are fabricated from titanium alloy (Ti-6Al-4) conformances blade are labhoutou from the shell with titanium plasma spray.

The provided text describes a medical device, the Par 5 Acetabular Component, and its indications for use, but it does not contain information about acceptance criteria, device performance metrics, or any studies proving the device meets acceptance criteria.

The document is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a 510(k) submission to the FDA. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific performance metrics and acceptance criteria.

Therefore, I cannot provide the requested information based on the given text. The text primarily details:

• Device Description: What the Par 5 Acetabular Component is made of and how it works.
• Indications for Use: The medical conditions for which the device is intended.
• Potential Risks: General risks associated with total joint replacement.
• FDA Clearance Letter: Confirmation that the FDA has found the device substantially equivalent to a predicate device.

To fulfill your request, I would need a document that describes the design verification and validation testing for this device, which would typically include performance criteria, test methods, results, and acceptance criteria.

Ask a specific question about this device