Search Results
Found 1 results
510(k) Data Aggregation
(22 days)
The SonoScape S8 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (breast, testes, thyroid), Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, Cephalic, OB/Gyn and Urology. This is the same intended use as previously cleared for the SonoScape S8 Diagnostic Ultrasound System, K092922.
The SonoScape S8 Ultrasound System, previously cleared under K092922, is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The only modifications that were made are: The original S8 Diagnostic Ultrasound System, was previously cleared in K092922 dated March 12, 2009, uses an internal SMPS as its power supply system. And the proposed device was redesigned, changing from AC to battery power, i.e. the internal Li-ion Battery Pack (with an external AC adapter). Such a change is accompanied by labeling changes, but not including new indication for use.
The SonoScape S8 Diagnostic Ultrasound System (K112451) is a re-submission of a previously cleared device (K092922) with modifications. The primary modification is the change in the power supply system from an internal SMPS to an internal Li-ion Battery Pack with an external AC adapter. This submission does not introduce new indications for use.
Based on the provided information, the acceptance criteria and study details are primarily focused on safety and substantial equivalence to the predicate device, rather than a clinical performance study with specific diagnostic accuracy metrics.
Here's an analysis of the provided document points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) for a given clinical task. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards.
The "reported device performance" referenced here relates to its conformity with safety standards and its functionality as a diagnostic ultrasound system, rather than clinical efficacy metrics.
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Safety | - IEC 60601-1: Medical Electrical Equipment - General Requirements for Safety (1988; Amdt 1, 1991-11; Amdt 2, 1995) | Device found to conform to applicable medical device safety standards in regards to thermal, mechanical, and electrical safety. |
| - IEC 60601-1-2: Electromagnetic Compatibility - Requirements and Tests (2001) | Device found to conform to applicable medical device safety standards. | |
| - IEC 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (2004, Amdt 2, 2005) | Device found to conform to applicable medical device safety standards. | |
| Acoustic Output | - NEMA UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment (2004) | Acoustic output measured and calculated according to NEMA UD 2: 2004 and NEMA UD3: 2004 (for real-time display of thermal and mechanical acoustic output indices). The device was tested as a Track 3 Device per FDA Guidance. |
| Biocompatibility | - ISO 10993-5: Biological evaluation of medical devices - Tests for In Vitro cytotoxicity (1999) | Device found to conform to applicable medical device safety standards, including biocompatibility. |
| - ISO 10993-10: Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity (2002) | Device found to conform to applicable medical device safety standards, including biocompatibility. | |
| Functional Equivalence | Functionality of the power supply system (comparison to predicate device's SMPS) | The redesigned power supply system (Li-ion Battery Pack and AC Adapter) performs the same function of converting mains voltage/charging battery and supplying required DC voltages to the system's electronic parts. It also controls LED indicators. (This demonstrates functional equivalence in power delivery). |
| Intended Use | Same as predicate device (K092922) | The intended use for evaluating Abdomen, Cardiac, Small Organ, Peripheral Vascular, Musculo-skeletal, Pediatric, Fetal, Cephalic, OB/Gyn and Urology is the same as the previously cleared S8 Diagnostic Ultrasound System, K092922. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission describes "Laboratory testing was conducted to verify that the S8 Diagnostic Ultrasound System met all design specification and was substantially equivalent to the currently marketed Predicate Device." This implies engineering and performance verification testing against technical specifications and safety standards, rather than a clinical study with a "test set" of patient data.
- Sample Size for Test Set: Not applicable in the context of clinical data for diagnostic performance. The "test set" here refers to the device and its components undergoing engineering and safety tests.
- Data Provenance: The testing was laboratory-based. No patient or clinical data provenance is mentioned as this is not a clinical performance study. The manufacturer is SonoScape Company Limited, located in Shenzhen, P.R. China.
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 applicable. The submission is for a modified diagnostic ultrasound system, with the focus on safety and functional equivalence to a predicate device, rather than a new AI/CAD device requiring expert-established ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no clinical test set requiring adjudication in this 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
No MRMC study was done. This device is a diagnostic ultrasound system itself, not an AI/CAD system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a diagnostic ultrasound system and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable in the context of clinical ground truth. For the engineering and safety testing, the "ground truth" would be the specified parameters and limits in the referenced standards (e.g., maximum acoustic output levels, electrical safety thresholds, biocompatibility criteria).
8. The sample size for the training set
This is not applicable. The device is a hardware ultrasound system, not an AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI algorithm.
Ask a specific question about this device
Page 1 of 1